ENDV Endonovo Therapeutics Inc (PK)

 

As filed with the Securities and Exchange Commission on August 25, 2023

 

PART II – INFORMATION REQUIRED IN OFFERING CIRCULAR

 

An Offering Statement pursuant to Regulation A relating to these securities has been filed with the Securities and Exchange Commission (the “SEC”). Information contained in this Preliminary Offering Circular is subject to completion or amendment. These securities may not be sold nor may offers to buy be accepted before the Offering Statement filed with the SEC is qualified. This Preliminary Offering Circular shall not constitute an offer to sell or the solicitation of an offer to buy nor may there be any sales of these securities in any state in which such offer, solicitation or sale would be unlawful before registration or qualification under the laws of any such state. We may elect to satisfy our obligation to deliver a Final Offering Circular by sending you a notice within two business days after the completion of our sale to you that contains the URL where the Final Offering Circular or the Offering Statement in which such Final Offering Circular was filed may be obtained.

 

PRELIMINARY OFFERING CIRCULAR SUBJECT TO COMPLETION

 

Dated August XX, 2023

 

 

ENONOVO THERAPEUTICS, INC.

 

6320 Canoga Avenue - 15th Floor

Woodland Hills, CA 91367

(800) 489-4774

220,000,000 Shares of Common Stock

 

Endonovo Therapeutics Inc., a Delaware corporation (the “Company”, “ENDV”, “we”, or “our”), is offering up to a maximum of 220,000,000 shares (the “Maximum Amount”) of our Common Stock, par value $0.0001 per share (the “Shares”) to be sold in this offering (the “Offering”). The Shares are tentatively being offered at a purchase price of $0.01 per Share, for gross proceeds of up to $5,000,000 (the “Maximum Amount”), pursuant to this Offering Circular (this “Offering Circular”). Before this Offering is qualified, the Company will pick a final price for the shares (the “Offering Price”) which we anticipate will be between $0.01 and $0.05 per share.

 

We are selling the Public Shares on a “best efforts” basis through a Tier 2 offering pursuant to Regulation A (Regulation A+) under the Securities Act of 1933, as amended (the “Securities Act”), and we intend to sell the Shares either directly to investors or through registered broker-dealers who are paid commissions. This Offering will terminate on the earlier of (i) ____, 2023, (ii) the date on which the Maximum Amount is sold, or (iii) when the Board of Directors of the Company elects to terminate the Offering (in each such case, the “Termination Date”). The minimum investment amount from an investor is $2,500; however, we expressly reserve the right to waive this minimum in the sole discretion of our management. See “Securities Being Offered” beginning on page XX for a discussion of certain items required by Item 14 of Part II of Form 1-A. We will hold closings upon the receipt of investors’ subscriptions and acceptance of such subscriptions by the Company. If, on the initial closing date, we have sold less than the Maximum Amount, then we may hold one or more additional closings for additional sales of Shares, until the earlier of (i) the sale of the Maximum Amount or (ii) the Termination Date. There is no aggregate minimum requirement for the Offering to become effective; therefore, we reserve the right, subject to applicable securities laws, to begin applying the proceeds from the Offering towards our business strategy, including, without limitation, research and development expenses, offering expenses, working capital and general corporate purposes and other uses, as more specifically set forth in the “Use of Proceeds” section of this Offering Circular.

 

Subscriptions for Shares are irrevocable and the purchase price is non-refundable, unless the Company rejects a subscription, as expressly stated in this Offering Circular. All proceeds received by us from subscribers in this Offering will be available for use by us upon our acceptance of subscriptions for the Shares. We expect to commence the sale of Shares of our Common Stock on approximately ________ , 2023.

 

Our Common Stock is presently quoted on the OTCQB, one of the OTC Markets Group over-the-counter markets, under the trading symbol “ENDV.” On August __, 2023, the closing sale price for our Common Stock was $0.0XX.

 

Investing in the Shares involves a high degree of risk. These are speculative securities. You should purchase these securities only if you can afford a complete loss of your investment. See “Risk Factors” starting on page 3 for a discussion of certain risks that you should consider in connection with an investment in the Shares.

 

THE SEC DOES NOT PASS UPON THE MERITS OF OR GIVE ITS APPROVAL TO ANY SECURITIES OFFERED OR THE TERMS OF THE OFFERING, NOR DOES IT PASS UPON THE ACCURACY OR COMPLETENESS OF ANY OFFERING CIRCULAR OR OTHER SOLICITATION MATERIALS. THESE SECURITIES ARE OFFERED PURSUANT TO AN EXEMPTION FROM REGISTRATION WITH THE SEC; HOWEVER, THE SEC HAS NOT MADE AN INDEPENDENT DETERMINATION THAT THE SECURITIES OFFERED ARE EXEMPT FROM REGISTRATION.

 

		Price to Public				Broker-Dealer Discount and Commissions (1)				Proceeds to Company (2)				Proceeds to Other Persons
Per Share		$	0.01			$	0.0005			$	0.0095			$	0
Total Offering		$	5,000,000			$	250,000			$	4,750,000			$	0

 

(1)	The company has engaged Dalmore Group, LLC, a member FINRA/SIPC (“Dalmore”), to perform administrative and compliance related functions in connection with this offering, but not for underwriting or placement agent services. Dalmore will receive a cash fee of 2% of the gross proceeds we receive with respect to the sale of our shares of common stock in this Offering in addition to a consulting fee of $20,000 payable by the Company to Dalmore. See “Plan of Distribution” for details of the compensation payable to Dalmore Group. Dalmore Group will act as our broker/dealer of record for this Offering. The Company has also entered into a Finder’s Fee Agreement with J.H. Darbie & Co., a member of FINRA/SIPC (“Darbie”) which provides that to the extent persons introduced by Darbie invest in this offering Darbie will receive a 3% fee. The above table is presented as though all investors were introduced to the offering by Darbie.
(2)	The amounts shown are before deducting estimated Offering costs to us of approximately $4,500, which include legal, accounting, printing, due diligence, marketing, consulting, selling and other costs incurred in the Offering. (See “Use of Proceeds” and “Plan of Distribution.”)
(3)	The Shares are being offered pursuant to Regulation A of Section 3(b) of the Securities Act for Tier 2 offerings. The Shares are only issued to purchasers who satisfy the requirements set forth in Regulation A. We have the option in our sole discretion to waive the minimum investment.

 

GENERALLY, NO SALE MAY BE MADE TO YOU IN THIS OFFERING IF THE AGGREGATE PURCHASE PRICE YOU PAY IS MORE THAN TEN PERCENT (10%) OF THE GREATER OF YOUR ANNUAL INCOME OR YOUR NET WORTH. DIFFERENT RULES APPLY TO ACCREDITED INVESTORS AND NON-NATURAL PERSONS. BEFORE MAKING ANY REPRESENTATION THAT YOUR INVESTMENT DOES NOT EXCEED APPLICABLE THRESHOLDS, WE ENCOURAGE YOU TO REVIEW RULE 251(D)(2)(I)(C) OF REGULATION A+. FOR GENERAL INFORMATION ON INVESTING, WE ENCOURAGE YOU TO REFER TO WWW.INVESTOR.GOV.

 

This Offering Circular contains all of the representations by us concerning this Offering, and no person shall make different or broader statements than those contained herein. Investors are cautioned not to rely upon any information not expressly set forth in this Offering Circular.

 

The securities underlying this Offering Circular may not be sold until qualified by the Securities and Exchange Commission. This Offering Circular is not an offer to sell, nor soliciting an offer to buy, any Shares in any state or other jurisdiction in which such sale is prohibited.

 

The Company is following the “Offering Circular” format of disclosure under Regulation A+.

 

The date of this Preliminary Offering Circular is August __, 2023.

 

IMPORTANT INFORMATION ABOUT THIS OFFERING CIRCULAR

 

We are offering to sell, and seeking offers to buy, our securities only in jurisdictions where such offers and sales are permitted. Please carefully read the information in this Offering Circular and any accompanying offering circular supplements, which we refer to collectively as the Offering Circular. You should rely only on the information contained in this Offering Circular. We have not authorized anyone to provide you with any information other than the information contained in this Offering Circular. The information contained in this Offering Circular is accurate only as of its date or as of the respective dates of any documents or other information incorporated herein by reference, regardless of the time of its delivery or of any sale or delivery of our securities. Neither the delivery of this Offering Circular nor any sale or delivery of our securities shall, under any circumstances, imply that there has been no change in our affairs since the date of this Offering Circular. This Offering Circular will be updated and made available for delivery to the extent required by the federal securities laws.

 

This Offering Circular is part of an Offering Statement that we filed with the SEC using a continuous offering process pursuant to Rule 251(d)(3)(i)(F) under the Securities Act. Periodically, we may provide an offering circular supplement that would add, update or change information contained in this Offering Circular. Any statement that we make in this Offering Circular will be modified or superseded by any inconsistent statement made by us in a subsequent offering circular supplement. The Offering Statement we filed with the SEC includes exhibits that provide more detailed descriptions of the matters discussed in this Offering Circular. You should read this Offering Circular and the related exhibits filed with the SEC and any offering circular supplement, together with additional information contained in our annual reports, semi-annual reports and other reports that we will file periodically with the SEC. The offering statement and all supplements and reports that we have filed or will file in the future can be read at the SEC website, www.sec.gov.

 

Unless otherwise indicated, data contained in this Offering Circular concerning the business of the Company are based on information from various public sources. Although we believe that these data are generally reliable, such information is inherently imprecise, and our estimates and expectations based on these data involve a number of assumptions and limitations. As a result, you are cautioned not to give undue weight to such data, estimates or expectations.

 

In this Offering Circular, unless the context indicates otherwise, references to the “Company,” “ENDV,” “we,” “our,” and “us” refer to the activities of and the assets and liabilities of the business and operations of Endonovo Therapeutics, Inc.

 

 

NASAA UNIFORM LEGEND

 

FOR RESIDENTS OF ALL STATES: THE PRESENCE OF A LEGEND FOR ANY GIVEN STATE REFLECTS ONLY THAT A LEGEND MAY BE REQUIRED BY THAT STATE AND SHOULD NOT BE CONSTRUED TO MEAN AN OFFER OR SALE MAY BE MADE IN A PARTICULAR STATE. IF YOU ARE UNCERTAIN AS TO WHETHER OR NOT OFFERS OR SALES MAY BE LAWFULLY MADE IN ANY GIVEN STATE, YOU ARE HEREBY ADVISED TO CONTACT THE COMPANY. THE SECURITIES DESCRIBED IN THIS OFFERING CIRCULAR HAVE NOT BEEN REGISTERED UNDER ANY STATE SECURITIES LAWS (COMMONLY CALLED ‘BLUE SKY’ LAWS).

 

IN MAKING AN INVESTMENT DECISION INVESTORS MUST RELY ON THEIR OWN EXAMINATION OF THE PERSON OR ENTITY CREATING THE SECURITIES AND THE TERMS OF THE OFFERING, INCLUDING THE MERITS AND RISKS INVOLVED. THESE SECURITIES HAVE NOT BEEN RECOMMENDED BY ANY FEDERAL OR STATE SECURITIES COMMISSION OR REGULATORY AUTHORITY. FURTHERMORE, THE FOREGOING AUTHORITIES HAVE NOT CONFIRMED THE ACCURACY OR DETERMINED THE ADEQUACY OF THIS DOCUMENT. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.

 

THESE SECURITIES ARE SUBJECT TO RESTRICTIONS ON TRANSFERABILITY AND RESALE AND MAY NOT BE TRANSFERRED OR RESOLD EXCEPT AS PERMITTED UNDER THE SECURITIES ACT, AS AMENDED, AND THE APPLICABLE STATE SECURITIES LAWS, PURSUANT TO REGISTRATION OR EXEMPTION THEREFROM. INVESTORS SHOULD BE AWARE THAT THEY MAY BE REQUIRED TO BEAR THE FINANCIAL RISKS OF THIS INVESTMENT FOR AN INDEFINITE PERIOD OF TIME.

 

PATRIOT ACT RIDER

 

The Investor hereby represents and warrants that Investor is not, nor is it acting as an agent, representative, intermediary or nominee for, a person identified on the list of blocked persons maintained by the Office of Foreign Assets Control, U.S. Department of Treasury. In addition, the Investor has complied with all applicable U.S. laws, regulations, directives, and executive orders relating to anti-money laundering , including but not limited to the following laws: (1) the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001, Public Law 107-56, and (2) Executive Order 13224 (Blocking Property and Prohibiting Transactions with Persons Who Commit, Threaten to Commit, or Support Terrorism) of September 23, 2001.

 

NO DISQUALIFICATION EVENT (“BAD BOY” DECLARATION)

 

NONE OF THE COMPANY, ANY OF ITS PREDECESSORS, ANY AFFILIATED ISSUER, ANY DIRECTOR, EXECUTIVE OFFICER, OTHER OFFICER OF THE COMPANY PARTICIPATING IN THE OFFERING CONTEMPLATED HEREBY, ANY BENEFICIAL OWNER OF 20% OR MORE OF THE COMPANY’S OUTSTANDING VOTING EQUITY SECURITIES, CALCULATED ON THE BASIS OF VOTING POWER, NOR ANY PROMOTER (AS THAT TERM IS DEFINED IN RULE 405 UNDER THE SECURITIES ACT OF 1933) CONNECTED WITH THE COMPANY IN ANY CAPACITY AT THE TIME OF SALE (EACH, AN “ISSUER COVERED PERSON”) IS SUBJECT TO ANY OF THE “BAD ACTOR” DISQUALIFICATIONS DESCRIBED IN RULE 506(D)(1)(I) TO (VIII) UNDER THE SECURITIES ACT OF 1933 (A “DISQUALIFICATION EVENT”), EXCEPT FOR A DISQUALIFICATION EVENT COVERED BY RULE 506(D)(2) OR (D)(3) UNDER THE SECURITIES ACT. THE COMPANY HAS EXERCISED REASONABLE CARE TO DETERMINE WHETHER ANY ISSUER COVERED PERSON IS SUBJECT TO A DISQUALIFICATION EVENT.

 

 

ABOUT THIS OFFERING CIRCULAR

 

This offering circular is part of Form A-1 that we filed with the SEC under the Securities Act. This offering circular does not contain all of the information included in the registration statement. For further information, we refer you to the Form 1-A, including its exhibits, filed with the SEC. Statements contained in this offering circular about the contents of any document are not necessarily complete. If SEC rules require that a document be filed as an exhibit to the Form 1-A, please see such document for a complete description of these matters. You should carefully read this offering circular, together with the additional information described under the headings “Where You Can Find More Information.”

 

Neither we nor the placement agent have authorized anyone to provide you with any information or to make any representations other than that contained in this offering circular or in any free writing offering circular we may authorize to be delivered or made available to you. We take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. Neither we nor the placement agent are making an offer to sell securities in any jurisdiction in which the offer or sale is not permitted. The information in this offering circular is accurate only as of the date on the front cover of this offering circular, regardless of the time of delivery of this offering circular or of any sale of our shares of common stock and the information in any free writing offering circular that we may provide to you in connection with this offering is accurate only as of the date of that free writing offering circular. Our business, financial condition, results of operations and prospects may have changed since those dates.

 

For investors outside the United States: We have not and the placement agent has not, done anything that would permit this offering, or possession or distribution of this offering circular, in any jurisdiction where action for that purpose is required, other than in the United States. Persons who come into possession of this offering circular in jurisdictions outside the United States are required to inform themselves about and to observe any restrictions as to this offering and the distribution of this offering circular applicable to those jurisdictions.

 

Unless otherwise indicated, information contained in this offering circular concerning our industry and the markets in which we operate, including our general expectations and market position, market opportunity and market share, is based on information from our own management estimates and research, as well as from industry and general publications and research, surveys and studies conducted by third parties. Management estimates are derived from publicly available information, our knowledge of our industry and assumptions based on such information and knowledge, which we believe to be reasonable. In addition, assumptions and estimates of our and our industry’s future performance are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in “Risk Factors.” These and other factors could cause our future performance to differ materially from our assumptions and estimates. See “Cautionary Notice Regarding Forward-Looking Statements.”

 

This offering circular contains summaries of certain provisions contained in some of the documents described herein, but reference is made to the actual documents for complete information. All of the summaries are qualified in their entirety by the actual documents. Copies of some of the documents referred to herein have been, or will be, filed or incorporated by reference as exhibits to the Form 1-A of which this offering circular is a part, and you may obtain copies of those documents as described below under the heading “Where You Can Find More Information.”

 

All product and company names are trademarks of their respective owners. Solely for convenience, trademarks and trade names referred to in this offering circular, including logos, artwork and other visual displays, may appear without the ® or TM symbols, but such references are not intended to indicate, in any way, that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. We do not intend our use or display of other companies’ trade names or trademarks to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

 

Throughout this offering circular, the terms “we,” “us,” “our,” and “our Company” and “the Company” refer to Endonovo Therapeutics, Inc., a Delaware corporation, and/or its related subsidiaries, as the context may require.

 

Corporate Information  

 

Our principal executive offices are located at 6320 Canoga Avenue, 15th Floor, Woodland Hills, CA 91367, and our telephone number is (800) 489-4774. We maintain a website at www.endonovo.com. Information contained on or accessible through our website is not, and should not be considered, part of, or incorporated by reference into, this offering circular.

 

 

The Offering

 

Shares offered by us	Up to 220,000,000 shares at $0.XX per share on a best efforts basis.
Total shares of common stock outstanding immediately after this offering	shares of common stock, assuming that all of the Shares offered by this offering circular is sold in this offering.
Use of Proceeds	We intend to use the net proceeds of this offering for general corporate purposes, which includes, among other purposes development and redesign of the Company’s SofPulse® medical device, the settlement and repayment of debt, funding of clinical trials, consulting fees to obtain medical insurance reimbursement sales and marketing and expansion into additional lines of business including telemedicine platform development, non-medical device development and further expansion of mergers and acquisitions division to include acquisitions in biotechnology companies and specialty construction companies. See “Use of Proceeds.”
Existing Trading Market	Our common stock is currently quoted on the OTCQB, one of the OTC Markets Group over-the-counter markets, under the trading symbol “ENDV”.
Risk Factors	Investing in our securities involves a high degree of risk. You should carefully review and consider “Risk Factors” beginning on page 3 of this offering circular.
Dividend Policy	We have never declared or paid any cash dividends on our common stock. We do not anticipate paying any cash dividends in the foreseeable future.

 

 

DETERMINATION OF OFFERING PRICE

 

This Offering is a self-underwritten offering, which means that it does not involve the participation of an underwriter to market. Our Offering Price is arbitrary with no relation to value of the Company.

 

RISK FACTORS

 

An investment our common stock is highly speculative and involves a high degree of risk. The risk factors described below summarize some of the material risks inherent in an investment in us. These risk factors are not presented in any particular order of significance. Each prospective investor should carefully consider the following risk factors inherent in and affecting our business and the Offering before making an investment decision. You should also refer to the other information set forth in this Offering Circular and to the risk factors in our SEC filings.

 

Risks Relating to our Financial Condition

 

We are a company with a limited operating history and have not generated significant revenues to date. We may never generate significant revenues. Our predecessor company, Hanover Asset Management, Inc. was incorporated in November 2008 in California. For the purpose of reincorporating in Delaware, we merged with a newly incorporated successor company, now called Endonovo Therapeutics, Inc., in July 2011. We have incurred losses since our inception. As of December 31, 2022, we had a total accumulated deficit of $(XX,XXX,XXX) and we continue to incur deficits. While we have begun to realize revenues from the sale of SofPulse® devices, these revenues have fluctuated and been adversely affected by the COVID Pandemic. Accordingly, it is impossible for us meaningfully project the revenue levels that might be achieved or whether and when we might become profitable. In order to increase the market of our devices and to capitalize on the potential of our intellectual property, we must conduct clinical trials, obtain FDA approvals and seek recognition of our therapies within the healthcare industry including third party payors. We must also attract, retain, and motivate qualified personnel. There can be no assurance that we will be successful in addressing such risks, and the failure to do so could lead to an inability to meet our financial obligations and therefore result in bankruptcy and the loss of your entire investment in our common shares.

 

Our internal controls are not effective, which could cause our financial reporting to be unreliable and lead to misinformation being disseminated to the public.

 

Our management is responsible for establishing and maintaining adequate internal control over financial reporting. As defined in Exchange Act Rule 13a-15(f), internal control over financial reporting is a process designed by, or under the supervision of, the principal executive and principal financial officer and effected by the board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that: (i) pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the Company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the Company are being made only in accordance with authorizations of management and directors of the Company, and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s assets that could have a material effect on the financial statements.

 

 

We currently have a limited executive management group managing the financial controls of the Company.

 

We have a Chief Executive Officer, Alan Collier, who is responsible for monitoring and ensuring compliance with our internal control procedures. As a result, our internal controls may be inadequate or ineffective, which could cause our financial reporting to be unreliable and lead to misinformation being disseminated to the public. Investors relying upon the reporting may make an uninformed investment decision.

 

Risks Relating to our Present Business and our Present Industry

 

We may encounter numerous difficulties frequently encountered by companies in the early stage of operations.

 

We have a limited operating history upon which an investor can evaluate our current business and future prospects. Any potential investor must consider the risks and difficulties frequently encountered by early-stage companies. Historically, there has been a high failure rate among early-stage companies. Our future performance will depend upon a number of factors, including our ability to:

 

	●	generate revenues and implement our business plan and growth strategy;
	●	attract and retain marketing and commercial sponsors;
	●	aggressively counter and respond to actions by our competitors;
	●	maintain adequate control of our expenses;
	●	attract, retain and motivate qualified personnel;
	●	react to member preferences and demands;
	●	maintain regulatory compliance; and
	●	generate sufficient working capital through our operations or through issuance of additional debt or equity financing, and to continue as a going concern.

 

We cannot assure investors that we will successfully address any of these factors, and our failure to do so could have a material adverse effect on our business, financial condition, results of operations and future prospects.

 

The loss of the services of our key management and personnel or the failure to attract additional key personnel could adversely affect our ability to operate our business.

 

A loss of one or more of our current officers or key employees or consultants could severely and negatively impact our operations. We have no present intention of obtaining key-man life insurance on any of our executive officers or management. Additionally, competition for highly skilled technical, managerial and other personnel is intense. As our business develops, we might not be able to attract, hire, train, retain and motivate the highly skilled managers and employees we need to be successful. If we fail to attract and retain the necessary technical and managerial personnel, our business will suffer and might fail.

 

Our limited operating history could delay our growth and result in the loss of your investment.

 

We were incorporated in 2011. However, our prospects must be considered in light of the risks, expenses and difficulties frequently encountered by companies in their growth stage of development. Such risks include, but are not limited to, dependence on the growth of use of technology and services, complete product development, clinical trials and obtain industry acceptance while responding to competitive developments and attracting, retaining, and motivating qualified personnel. There can be no assurance that we will be successful in addressing such risks, and the failure to do so could lead to an inability to meet our financial obligations and therefore result in bankruptcy and the loss of your entire investment in our common shares. In November 2017 we acquired substantial intellectual property related to our Electroceutical® business from Rio Grande Neurosciences, Inc. However, we will be required to allocate our limited resources effectively to complete required clinical trials and obtain market acceptance for our products.

 

 

Our ability to implement and manage growth strategy is uncertain.

 

We plan on expanding the market segments in which we acquire approval of medical indications. Implementation of our growth strategy may impose significant strain on our management, operating systems and financial resources. Failure by the Company to manage its growth, or unexpected difficulties encountered during expansion into different markets, could have a materially adverse impact on our results of operations or financial condition. Our ability to continue to operate our business depends upon a number of factors, including (i) generating sufficient funds for operations, (ii) our executive management team and our financial and accounting controls, and (iii) staffing, training and retaining skilled on-site management personnel. Certain of these factors are beyond our control and may be affected by the economy or actions taken by competing companies. Further, there can be no assurance that our market analysis and proprietary business data will continue to support our current marketing plans.

 

We may not be able to retain our key personnel or attract additional personnel, which could affect our ability to complete necessary clinical trials and obtain approvals so that we can generate revenue sufficient to continue as a going concern diminishing your return on investment.

 

Our performance is substantially dependent on the services and on the performance of our Management. Endonovo Therapeutics is, and will be, heavily dependent on the skill, acumen and services of our key executives. Our performance also depends on our ability to attract, hire, retain and motivate our officers and key employees. The loss of the services of our executives could result in lost revenue depending on the length of time and effort required to find qualified replacements. We have not entered into long-term employment agreements with all of our key personnel and currently have no “Key Employee” life insurance policies.

 

Our future success may also depend on our ability to identify, attract, hire, train, retain and motivate other highly skilled technical, managerial, marketing, sales and customer service personnel.

 

Competition for such personnel is intense, and there can be no assurance that we will be able to successfully attract, assimilate or retain sufficiently qualified personnel. If we are unable to attract, retain, and train the necessary technical, managerial, marketing and customer service personnel, our expectations of increasing our clientele could be hindered, and the profitability of Endonovo Therapeutics reduced.

 

As the Company intends to be conducting international business transactions, it will be exposed to local business risks in different countries, which could have a material adverse effect on its financial condition or results of operations.

 

The Company intends to promote and sell its products internationally by virtue of the global access to its products line and it expects to have customers located in several countries. The Company’s international operations will be subject to risks inherent in doing business in foreign countries, including, but not necessarily limited to:

 

	●	New and different legal and regulatory requirements in local jurisdictions;
	●	Potentially adverse tax consequences, including imposition or increase of taxes on transactions or withholding and other taxes on remittances and other payments by subsidiaries;
	●	Risk of nationalization of private enterprises by foreign governments;
	●	Legal restrictions on doing business in or with certain nations, certain parties and/or certain products; and,
	●	Local economic, political and social conditions, including the possibility of hyperinflationary conditions and political instability.

 

The Company may not be successful in developing and implementing policies and strategies to address the foregoing factors in a timely and effective manner in the locations where it will do business. Consequently, the occurrence of one or more of the foregoing factors could have a material adverse effect on its base operations and upon its financial condition and results of operations.

 

 

Since our products may be available over the Internet in foreign countries and the Company may have customers residing in foreign countries, foreign jurisdictions may require it to qualify to do business in their country. It will be required to comply with certain laws and regulations of each country in which it conducts business, including laws and regulations currently in place or which may be enacted related to Internet services available to the residents of each country from online sites located elsewhere.

 

The Company’s operations in developing markets could expose it to political, economic and regulatory risks that are greater than those it may face in established markets. Further, its international operations may require it to comply with additional United States and international regulations.

 

For example, it may be required to comply with the Foreign Corrupt Practices Act, or “FCPA,” which prohibits companies or their agents and employees from providing anything of value to a foreign official or agent thereof for the purposes of influencing any act or decision of these individuals in their official capacity to help obtain or retain business, direct business to any person or corporate entity or obtain any unfair advantage. The Company may operate in some nations that have experienced significant levels of governmental corruption. Its employees, agents and contractors, including companies to which it outsources business operations, may take actions in violation of its policies and legal requirements. Such violations, even if prohibited by its policies and procedures, could have an adverse effect on its business and reputation. Any failure by the Company to ensure that its employees and agents comply with the FCPA and applicable laws and regulations in foreign jurisdictions could result in substantial civil and criminal penalties or restrictions on its ability to conduct business in certain foreign jurisdictions, and its results of operations and financial condition could be materially and adversely affected.

 

We may be subject to litigation that will be costly to defend or pursue and uncertain in its outcome.

 

Our business relies in large part on granted patents which we own. However, the grant of a patent does not ensure that litigation will not arise where the validity of the patent is challenged or that the patent will not be found by a court to infringe upon patents held by others. Furthermore, any litigation relating to our patent rights is likely to be expensive and may require a significant amount of management’s time and attention, at the expense of other aspects of our business. The outcome of litigation is always uncertain, and in some cases could include judgments against us that require us to pay damages, enjoin us from certain activities, or otherwise affect our legal or contractual rights, which could have a significant adverse effect on our business and financial condition.

 

We may not be able to obtain third-party reimbursement or favorable product pricing, which would reduce our ability to operate profitably.

 

Our ability to successfully commercialize certain of our proposed products may depend to a significant degree on reimbursement of the costs of such products and related services at acceptable levels from government authorities and other organizations. We cannot assure you that reimbursement in the United States or foreign countries will be available for any products we may develop or, if available, will not be decreased in the future, or that reimbursement amounts will not reduce the demand for, or the price of, our products with a consequent harm to our business. We cannot predict what additional regulation or legislation may be enacted in the future or what effect such regulation or legislation may have on our business. If additional regulations are overly onerous or expensive, makes our business more expensive or burdensome than originally anticipated, we may be forced to significantly downsize our business plans or completely abandon our business model.

 

We have not adopted various corporate governance measures, and as a result, stockholders may have limited protections against interested director transactions, conflicts of interest and similar matters.

 

Federal legislation, including the Sarbanes-Oxley Act of 2002, has resulted in the adoption of various corporate governance measures designed to promote the integrity of corporate management and the securities markets. Because our securities are not yet listed on a national securities exchange, we are not required to adopt these corporate governance measures and have not done so voluntarily in order to avoid incurring the additional costs associated with such measures. Furthermore, the absence of the governance measures referred to above with respect to our Company may leave our stockholders with more limited protection in connection with interested director transactions, conflicts of interest and similar matters.

 

Certain provisions of Delaware law applicable to Endonovo could also delay a merger, tender offer, or proxy contest or make one more difficult.

 

As a Delaware corporation, we are subject to Delaware law, including Section 203 of the Delaware General Corporation Law. In general, Section 203 prohibits a Delaware corporation from engaging in any business combination with any interested stockholder for a period of three years following the date that the stockholder became an interested stockholder unless certain specific requirements are met as set forth in Section 203. These provisions, alone or together, could have the effect of deterring or delaying changes in incumbent management, proxy contests or changes in control.

 

 

Risks Relating to Our Reliance on Third Parties

 

Because our Business Involves Medical Technology, Our Business Tends to be Capital Intensive.

 

We are likely to require additional capital to maintain operations or expand our business. We have not made any arrangements to obtain any additional financing. Any additional financing may only be available on terms unfavorable to us and disadvantageous to our shareholders.

 

The Protection from our Future Patents is Uncertain.

 

We will rely on patents and trade secrets for the protection of our intellectual property. The issuance of a patent by the Patent Office does not ensure that the patent will be upheld if it is challenged in litigation or that the patent will not be found to infringe upon patents validly issued to others. We could be exposed to substantial litigation expense defending their intellectual property as well as liability to others.

 

Our Products may Become Technologically Obsolete.

 

The medical products market is characterized by extensive research and development activities. New developments are expected to continue at a rapid pace and there can be no assurance that new discoveries will not render our products, processes and devices uneconomical or obsolete. The likelihood of success for our products must be considered in light of the problems, expenses, difficulties, complications and delays frequently encountered in connection with the development of new medical processes, devices and products and their level of acceptance by the medical community.

 

We may Encounter Liabilities Involving Customers and Third Parties.

 

The sale of medical devices can result in claims for injury if a product causes harm or fails to perform as promised. Although we have not been subject to any such claim, no assurance can be given that such claims will not be made in the future or that we can obtain any insurance coverage. If we were subject to an uncovered claim, our assets could be greatly reduced.

 

Government Regulations May Result in Costs and Delays.

 

The development, testing, production and marketing of our future products are subject to regulation by the FDA as devices under 1976 Medical Device Amendments to the Federal Food, Drug and Cosmetic Act. Additionally, our products may be subject to regulation by similar agencies in other states and foreign countries. While we believe that we have complied with all applicable laws and regulations, continued compliance with such laws or regulations, including any new laws or regulations, might impose additional costs on us which could adversely affect its financial performance and results of operations.

 

We depend on our collaborators to help us develop and test our devices, and our ability to develop and commercialize our devices may be impaired or delayed if collaborations are unsuccessful.

 

Our strategy for the development, testing and commercialization of our devices may require that we enter into collaborations with consultants, corporate partners, licensors, licensees and others. We are dependent upon the subsequent success of these other parties in performing their respective responsibilities and the continued cooperation of our partners. Our collaborators may not cooperate with us or perform their obligations under our agreements with them. We cannot control the amount and timing of our collaborators’ resources that will be devoted to our research and development activities related to our collaborative agreements with them. Our collaborators may choose to pursue existing or alternative technologies in preference to those being developed in collaboration with us.

 

Under agreements with collaborators, we may rely significantly on such collaborators to, among other things, design prototypes for and value our intellectual property, and market for us any commercial products that result from our collaborations.

 

  

With respect to any additional clinical studies for our products which are required by the FDA or with respect to Clinical Trials relating to the development of our core technology for other applications, we rely on clinical investigators and clinical sites, some of which are private practices, and some of which are research university- or government-affiliated, to enroll patients in our Clinical Trials. We may rely on: pathologists and pathology laboratories; a contract research organization to assist in monitoring, collection of data, and ensuring FDA Good Clinical Practices (“GCP”) are observed at our sites; a consultant biostatistician; and other third parties to manage the trial and to perform related data collection and analysis.

 

However, we may not be able to control the amount and timing of resources that clinical sites and other third parties may devote to our Clinical Trials. If these clinical investigators and clinical sites fail to enroll a sufficient number of patients in our Clinical Trials, or if the clinical sites fail to comply adequately with the clinical protocols, we will be unable to complete these trials, which could prevent us from obtaining regulatory approvals for our products or other products developed from our core technology. Our agreements with clinical investigators and clinical sites for clinical testing place substantial responsibilities on these parties and, if these parties fail to perform as expected, our trials could be delayed or terminated.

 

If these clinical investigators, clinical sites or other third parties do not carry out their contractual duties or obligations or fail to meet expected deadlines, or if the quality or accuracy of the clinical data they obtain are compromised due to their failure to adhere to our clinical protocols or for other reasons, our Clinical Trials may be extended, delayed or terminated, and we may be unable to obtain regulatory approval for, or successfully commercialize, our products or other products developed from our core technology.

 

In addition to the foregoing, any initial or additional clinical studies for any of our products which are required by the FDA and any Clinical Trials relating to the development of our core technology for other applications may be delayed or halted for numerous other reasons, including, but not limited to, the following:

 

	●	the FDA, an Institutional Review Board (“IRB”) or other regulatory authorities place our clinical trial on hold;
	●	patients do not enroll in Clinical Trials at the rate we expect;
	●	patient follow-up is not at the rate we expect;
	●	IRBs and third-party clinical investigators delay or reject our trial protocol;
	●	third-party organizations do not perform data collection and analysis in a timely or accurate manner;
	●	regulatory inspections of our Clinical Trials or manufacturing facilities, among other things, require us to undertake corrective action or suspend or terminate our Clinical Trials, or invalidate our Clinical Trials;
	●	changes in governmental regulations or administrative actions; and
	●	the interim or final results of the clinical trial are inconclusive or unfavorable as to safety or effectiveness.

 

If our products are approved for reimbursement, we anticipate experiencing significant pressures on pricing.

 

 

We may not develop a substantial number of commercialized products.

 

We are a development stage company and currently have one commercialized product, the SofPulse®. We believe that the patents that we have acquired will allow us to develop additional devices and prove usefulness for other applications. However, while we believe we will achieve the desired clinical results, commercialization of each of our products remains subject to certain significant risks. Our efforts may not lead to commercially successful products for a number of reasons, including:

 

	●	we may not be able to obtain regulatory approvals for our devices, or the approved indication may be narrower than we seek;
	●	any of our devices may not prove to be safe and effective in Clinical Trials to the FDA’s satisfaction;
	●	physicians may not receive any reimbursement from third-party payers, or the level of reimbursement may be insufficient to support widespread adoption of our devices;
	●	we may experience delays in our continuing development program;
	●	any products that are approved by regulators may not be accepted in the marketplace by physicians or patients;
	●	we may not have adequate financial or other resources to complete the continued development or to commence the commercialization of our devices and we will not have adequate financial or other resources to achieve significant commercialization of our devices;
	●	we may not be able to manufacture our products in commercial quantities or at an acceptable cost; and
	●	rapid technological change may make our technology and products obsolete.

 

If we are unable to obtain regulatory approval for or successfully commercialize our products, we will be unable to generate revenue outside of our present approved device, the SofPulse®.

 

Non-FDA Government Regulation May Affect our Results.

 

The advertising of our devices will be subject to both FDA and Federal Trade Commission regulations. In addition, the sale and marketing of our devices will be subject to a complex system of federal and state laws and regulations intended to deter, detect, and respond to fraud and abuse in the healthcare system. These laws and regulations restrict and may prohibit pricing, discounting, commissions and other commercial practices that may be typical outside of the healthcare business. In particular, anti-kickback and self-referral laws and regulations will limit our flexibility in crafting promotional programs and other financial arrangements in connection with the sale of our products and related services, especially with respect to physicians seeking reimbursement through Medicare or Medicaid. These federal laws include, by way of example, the following:

 

	●	the anti-kickback statute prohibits certain business practices and relationships that might affect the provision and cost of healthcare services reimbursable under Medicare, Medicaid and other federal healthcare programs, including the payment or receipt of remuneration for the referral of patients whose care will be paid by Medicare or other federal healthcare programs;
	●	the physician self-referral prohibition, commonly referred to as the Stark Law, which prohibits referrals by physicians of Medicare or Medicaid patients to providers of a broad range of designated healthcare services in which the physicians or their immediate family members have ownership interests or with which they have certain other financial arrangements;
	●	the anti-inducement law, which prohibits providers from offering anything to a Medicare or Medicaid beneficiary to induce that beneficiary to use items or services covered by either program;
	●	the Civil False Claims Act, which prohibits any person from knowingly presenting or causing to be presented false or fraudulent claims for payment by the federal government, including the Medicare and Medicaid programs; and
	●	the Civil Monetary Penalties Law, which authorizes the US Department of Health and Human Services (“HHS”) to impose civil penalties administratively for fraudulent or abusive acts.

 

Sanctions for violating these federal laws include criminal and civil penalties that range from punitive sanctions, damage assessments, money penalties, imprisonment, denial of Medicare and Medicaid payments, or exclusion from the Medicare and Medicaid programs, or both. These laws also impose an affirmative duty on those receiving Medicare or Medicaid funding to ensure that they do not employ or contract with persons excluded from the Medicare and other government programs.

 

Many states have adopted or are considering legislative proposals similar to the federal fraud and abuse laws, some of which extend beyond the Medicare and Medicaid programs to prohibit the payment or receipt of remuneration for the referral of patients and physician self-referrals regardless of whether the service was reimbursed by Medicare or Medicaid. Many states have also adopted or are considering legislative proposals to increase patient protections, such as limiting the use and disclosure of patient-specific health information. These state laws typically impose criminal and civil penalties similar to the federal laws.

 

 

In the ordinary course of their business, medical device manufacturers and suppliers have been and are subject regularly to inquiries, investigations and audits by federal and state agencies that oversee these laws and regulations. Recent federal and state legislation has greatly increased funding for investigations and enforcement actions, which have increased dramatically over the past several years. This trend is expected to continue. Private enforcement of healthcare fraud also has increased, due in large part to amendments to the Civil False Claims Act in 1986 that were designed to encourage private persons to sue on behalf of the government. These whistleblower suits by private persons, known as qui tam relaters, may be filed by almost anyone, including physicians and their employees and patients, our employees, and even competitors. The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), in addition to its privacy provisions, created a series of new healthcare-related crimes.

 

Proposed Spin-off of SofPulse Inc. from Endonovo Therapeutics could be delayed , cancelled, or postponed indefinitely which may have a material adverse effect on our business by factors we have little control.

 

The proposed spin-off of SofPulse Inc. from Endonovo could be delayed by a number of factors that may include, but are not limited to, SEC OTC market regulations, required registrations and prospectus delays to complete sale of proposed spin-out, shareholder approval, regulatory approval delays, unforeseen legal challenges, delays to complete required paperwork, availability of funds to complete transaction, difficulty raising funds by each company to complete the proposed sale. As a result, the proposed spin-off of SofPulse Inc. from Endonovo Therapeutics could be delayed, cancelled, or postponed indefinitely which may have a material adverse effect on our business.

 

Our Clinical Trials could be delayed by factors over which we have little control.

 

The start or conduct of a clinical trial can be delayed by a number of factors that may include, but are not limited to, government sequestration that could limit the availability of federal grants or delay in the approval and compliance process of where our clinical trial will be conducted. As a result, the purchase of equipment necessary to prepare and optimize the prototype for the clinical trial could be delayed.

 

The FDA may require additional Clinical Trials and any adverse results in such Clinical Trials, or difficulties in conducting such Clinical Trials, could have a material adverse effect on our business.

 

While we are undertaking the Clinical Trials we believe to be compliant with FDA regulations, for new devices. The occurrence of unexpected findings in connection with any initial or subsequent clinical trial required by the FDA may prevent or delay obtaining approval. In addition, subsequent clinical studies would require the expenditure of additional company resources and could be a long and expensive process subject to unexpected delays. Any adverse results in such Clinical Trials, or difficulties in conducting such Clinical Trials, could have a material adverse effect on our business.

 

If any additional products are approved by the FDA, they may be approved only for narrow indications.

 

Even if approved, our devices may not be approved for the indications that are necessary or desirable for successful commercialization.

 

If we wish to modify any of our devices after receiving FDA approval, including changes in indications or other modifications that could affect safety and effectiveness, additional approvals could be required from the FDA, we may be required to submit extensive pre-clinical and clinical data, depending on the nature of the changes. Any request by the FDA for additional data, or any requirement by the FDA that we conduct additional clinical studies, could delay the commercialization of our devices and require us to make substantial additional research, development and other expenditures. We may not obtain the necessary regulatory approvals to market our devices in the U.S. or anywhere else. Any delay in, or failure to receive or maintain, approval for our proprietary square wave form device and/or cell-free therapies could prevent us from generating revenue or achieving profitability, and our business, financial condition, and results of operations would be materially adversely affected.

 

Management of our Company is within the control of our sole director who is also our CEO.

 

All decisions with respect to the management of the Company will be made by our board of directors and our officers, who will beneficially own X % of our common stock and 25,000 shares super voting of Preferred AA, as calculated in accordance with Rule 13d-3 promulgated under the Securities Exchange Act of 1934. Holders of the common stock who purchase in this offering will not obtain majority control of the Company. Therefore, management will retain the power to elect all of the board of directors who shall, in turn, have the power to appoint the officers of the Company and to determine, in accordance with their fiduciary duties and the business judgment rule, the direction, objectives and policies of the Company including, without limitation, the purchase of businesses or assets; the sale of all or a substantial portion of the assets of the Company; the merger or consolidation of the Company with another corporation; raising additional capital through financing and/or equity sources; the retention of cash reserves for future product development, expansion of our business and/or acquisitions; the filing of Form 1-As with the Securities and Exchange Commission for offerings of our capital stock; and transactions which may cause or prevent a change in control of the Company or its winding up and dissolution. Accordingly, no investor should purchase the common stock we are offering unless such investor is willing to entrust all aspects of the management of the Company to one individual.

 

 

Our reliance on the activities of our non-employee consultants whose activities are not wholly within our control may lead to delays in development of proposed products or in the development of our business.

 

We rely extensively upon and have relationships with consultants. These consultants are not our employees and may have commitments to, or consulting or advisory contracts with, other entities that may limit their availability to us. We have limited control over the activities of these consultants and, except as otherwise required by our collaboration and consulting agreements to the extent they exist, can expect only limited amounts of their time to be dedicated to our activities.

 

The outbreak of Corona Virus has negatively impacted our business.

 

In December 2019, a novel strain of coronavirus was reported to have surfaced in Wuhan, China, which has and is continuing to spread throughout China and other parts of the world, including the United States. On January 30, 2020, the World Health Organization declared the outbreak of the coronavirus disease (COVID-19) a “Public Health Emergency of International Concern.” On January 31, 2020, U.S. Health and Human Services Secretary Alex M. Azar II declared a public health emergency for the United States to aid the U.S. healthcare community in responding to COVID-19, and on March 11, 2020 the World Health Organization characterized the outbreak as a “pandemic”. The significant outbreak of COVID-19 has resulted in a widespread health crisis that has adversely affected the economies and financial markets worldwide, and has adversely affected our business, results of operations and financial condition. While we are unable to quantify the impact, we are aware that our sales representatives’ activities have been substantially curtailed by their being unable to access hospital staff and administration in the customary manner. Management hopes that the pandemic abates and that we are able to reestablish an active sales representative network.

 

Our Proposed Additional Operations, should they be realized, also involve significant risks.

 

The Company has been investigating several acquisitions in the construction industry. All of the proposed targets are profitable and generate cash flow. The Company has entered into a non-binding letter of intent with one acquisition target, but has not entered into any definitive binding agreements to acquire any target. Even if we are successful in acquiring a target, no assurance can be given that we would be able to operate such company profitably. Present management has no experience in operating a construction company and the construction industry has its own set of risks.

 

Risks Related to Common Stock

 

The large number of shares eligible for immediate and future sales may depress the price of our stock.

 

As of the date of this offering circular we have shares of common stock outstanding. shares are “free trading” and may serve to overhang the market and depress the price of our common stock.

 

“Penny Stock” rules may make buying or selling our common stock difficult. Limitations upon Broker-Dealers Effecting Transactions in “Penny Stocks”

 

Trading in our common stock is subject to material limitations as a consequence of regulations which limit the activities of broker-dealers effecting transactions in “penny stocks.” Pursuant to Rule 3a51-1 under the Exchange Act, our common stock is a “penny stock” because it (i) is not listed on any national securities exchange or The NASDAQ Stock Market™, (ii) has a market price of less than $5.00 per share, and (iii) its issuer (the Company) has net tangible assets less than $2,000,000 (if the issuer has been in business for at least three (3) years) or $5,000,000 (if the issuer has been in business for less than three (3) years).

 

Rule 15g-9 promulgated under the Exchange Act imposes limitations upon trading activities on “penny stocks”, which makes selling our common stock more difficult compared to selling securities which are not “penny stocks.” Rule 15a-9 restricts the solicitation of sales of “penny stocks” by broker-dealers unless the broker first (i) obtains from the purchaser information concerning his financial situation, investment experience and investment objectives, (ii) reasonably determines that the purchaser has sufficient knowledge and experience in financial matters that the person is capable of evaluating the risks of investing in “penny stocks”, and (iii) delivers and receives back from the purchaser a manually signed written statement acknowledging the purchaser’s investment experience and financial sophistication.

 

Rules 15g-2 through 15g-6 promulgated under the Exchange Act require broker-dealers who engage in transactions in “penny stocks” first to provide their customers with a series of disclosures and documents, including (i) a standardized risk disclosure document identifying the risks inherent in investing in “penny stocks”, (ii) all compensation received by the broker-dealer in connection with the transaction, (iii) current quotation prices and other relevant market data, and (iv) monthly account statements reflecting the fair market value of the securities.

 

 

There can be no assurance that any broker-dealer which initiates quotations for the Common Stock will continue to do so, and the loss of any such broker-dealer likely would have a material adverse effect on the market price of our common stock.

 

FINRA sales practice requirements may also limit a stockholder’s ability to buy and sell our stock.

 

In addition to the “penny stock” rules described below, FINRA has adopted rules that require that in recommending an investment to a customer, a broker-dealer must have reasonable grounds for believing that the investment is suitable for that customer. Prior to recommending speculative low priced securities to their non-institutional customers, broker-dealers must make reasonable efforts to obtain information about the customer’s financial status, tax status, investment objectives and other information. Under interpretations of these rules, FINRA believes that there is a high probability that speculative low priced securities will not be suitable for at least some customers. The FINRA requirements make it more difficult for broker-dealers to recommend that their customers buy our common stock, which may limit your ability to buy and sell our stock and have an adverse effect on the market for our shares.

 

Because our common stock is deemed a low-priced “penny stock,” it will be cumbersome for brokers and dealers to trade in our common stock, making the market for our common stock less liquid and negatively affect the price of our stock.

 

We will be subject to certain provisions of the Securities Exchange Act of 1934 (the “Exchange Act”), commonly referred to as the “penny stock” rules as defined in Rule 3a51-1. A penny stock is generally defined to be any equity security that has a market price less than $5.00 per share, subject to certain exceptions. Since our stock is deemed to be a penny stock, trading is subject to additional sales practice requirements of broker-dealers. These require a broker-dealer to:

 

	●	Deliver to the customer, and obtain a written receipts for, a disclosure document;
	●	Disclose certain price information about the stock;
	●	Disclose the amount of compensation received by the broker-dealer or any associated person of the broker-dealer;
	●	Send monthly statements to customers with market and price information about the penny stock; and
	●	In some circumstances, approve the purchaser’s account under certain standards and deliver written statements to the customer with information specified in the rules.

 

Consequently, penny stock rules and FINRA rules may restrict the ability or willingness of broker-dealers to trade and/or maintain a market in our common stock. Also, prospective investors may not want to get involved with the additional administrative requirements, which may have a material adverse effect on the trading of our shares.

 

We Have Paid No Dividends

 

We have never paid any dividends on our common stock and we do not intend to pay any dividends in the foreseeable future.

 

 

We have the right to issue shares of preferred stock. If we were to issue preferred stock, it is likely to have rights, preferences and privileges that may adversely affect the common stock. Our CEO has, by virtue of his preferred stock ownership, voting control over all matters.

 

We are authorized to issue 5,000,000 shares of “blank check” preferred stock, with such rights, preferences and privileges as may be determined from time-to-time by our board of directors. We currently have 25,000 shares of Series AA Super Voting Preferred Stock outstanding which will have majority voting power for the foreseeable future, all of which is held by our CEO and sole director. Our board of directors is empowered, without shareholder approval, to issue preferred stock in one or more series, and to fix for any series the dividend rights, dissolution or liquidation preferences, redemption prices, conversion rights, voting rights, and other rights, preferences and privileges for the preferred stock. The issuance of shares of preferred stock, depending on the rights, preferences and privileges attributable to the preferred stock, could adversely reduce the voting rights and powers of the common stock and the portion of the Company’s assets allocated for distribution to common stock holders in a liquidation event, and could also result in dilution in the book value per share of the common stock we are offering. The preferred stock could also be utilized, under certain circumstances, as a method for raising additional capital or discouraging, delaying or preventing a change in control of the Company, to the detriment of the investors in the common stock offered hereby. We cannot assure you that the Company will not, under certain circumstances, issue shares of its preferred stock.

 

We may allocate the net proceeds from this offering in ways which differ from our estimates based on our current plans and assumptions discussed in the section titled “Use of Proceeds” and with which you may not agree.

 

The allocation of net proceeds of the offering set forth in the “Use of Proceeds” section below represents our estimates based upon our current plans and assumptions regarding industry and general economic conditions, our future revenues and expenditures. The amounts and timing of our actual expenditures will depend on numerous factors, including market conditions, cash generated by our operations, business developments and related rate of growth. We may find it necessary or advisable to use portions of the proceeds from this offering for other purposes. Circumstances that may give rise to a change in the use of proceeds and the alternate purposes for which the proceeds may be used are discussed in the section entitled “Use of Proceeds” below. You may not have an opportunity to evaluate the economic, financial or other information on which we base our decisions on how to use our proceeds. As a result, you and other shareholders may not agree with our decisions. See “Use of Proceeds” for additional information.

 

Management will have substantial discretion over the use of the proceeds of this Offering and may not choose to use it effectively.

 

We plan to use the proceeds from this Offering as set forth in the section entitled “Use of Proceeds.” Our management will have significant flexibility in applying the net proceeds of this Offering and may apply the proceeds in ways with which you do not agree. The failure of our management to apply these funds effectively could materially harm our business.

 

Limitations on director and officer liability and indemnification of our officers and directors by us may discourage stockholders from bringing suit against a director.

 

Endonovo Therapeutics’ Articles of Incorporation and Bylaws provide, with certain exceptions as permitted by governing state law, that a director or officer shall not be personally liable to us or our stockholders for breach of fiduciary duty as a director, except for acts or omissions

 

 

USE OF PROCEEDS

 

We estimate that our net proceeds from this offering, net of expenses, will be approximately $4,745,500 in the event all of the Shares are sold.

 

We intend to use approximately $1,500,000 of the net proceeds of this offering to repay our secured lender pursuant to the orally agreed terms of settlement negotiations and any additional amounts for general corporate purposes, which includes, among other purposes, the expansion of its traditional biotechnology medical device development, marketing efforts for our products, manufacturing, pre-clinical and clinical trials, consulting fees to obtain medical insurance reimbursement and expansion into additional lines of business including development of additional lines of business, such as telemedicine platform, non-medical device development, while continuing its expansion through mergers and acquisitions, targeting both biotechnology companies and specialty construction companies. A portion of the proceeds may be applied to further these efforts.

 

Our expected use of net proceeds from the offering represents our current intentions based upon our present plans and business condition. Investors are cautioned, however, that expenditures may vary substantially from these uses. Investors will be relying on the judgment of our management, who will have broad discretion regarding the application of the proceeds of this offering. The amounts and timing of our actual expenditures will depend upon numerous factors, including the amount of cash generated by our operations, the amount of competition and other operational factors. We may find it necessary or advisable to use portions of the proceeds from this offering for other purposes.

 

PLAN OF DISTRIBUTION

 

Currently, we plan to have our sole director and executive officer sell the shares in this Offering. He will receive no discounts or commissions. Our executive officer will deliver this Offering Circular to those persons who he believes might have interest in purchasing all or a part of this Offering. We may generally solicit investors, including, but not limited to, the use of social media, newscasts, advertisements, roadshows and the like.

 

Our sole director and officer will not register as a broker-dealer under Section 15 of the Securities Exchange Act of 1934 in reliance upon Rule 3a4-1. Rule 3a4-1 sets forth those conditions under which a person associated with an issuer may participate in the Offering of the issuer’s securities and not be deemed to be a broker-dealer. The conditions are that: the person meets the conditions of paragraph (a)(4)(ii) of Rule 3a4-1 of the Exchange Act, in that he (i) primarily performs, or is intended primarily to perform at the end of the offering, substantial duties for or on behalf of the issuer otherwise than in connection with transactions in securities; and (ii) is not a broker or dealer, or an associated person of a broker or dealer, within the preceding 12 months; and (iii) does not participate in selling and Offering of securities for any issuer more than once every 12 months other than in reliance on paragraphs (a)(4)(i) or (a)(4)(iii) of Rule 3a4-1 of the Exchange Act.

 

 

Our sole officer and director is not statutorily disqualified, is not being compensated, and is not associated with a broker-dealer. He is and will continue to hold his positions as officer and director following the completion of the Offering and have not been during the past 12 months and is currently not a broker or a dealer or associated with brokers or dealers. He has not nor will he participate in the sale of securities of any issuer more than once every 12 months.

 

Our Common Stock is not listed on any national securities exchange or the NASDAQ stock market. However, our stock is quoted on the OTC:QB under the symbol “ENDV.” Recently there has been limited trading volume. There is no guarantee that an active trading market will develop in our securities. Accordingly, our shares should be considered highly illiquid, which inhibits investors’ ability to resell their shares.

 

Upon this Offering Circular being qualified by the SEC, the Company may offer and sell shares from time to time until all of the shares registered are sold; however, this Offering will terminate one year from the qualification date of this amended Offering Circular, unless extended or terminated by the Company. The Company may terminate this Offering at any time and may also extend the Offering term by 90 days.

 

There can be no assurances that we will sell any or all of the securities. All shares will be offered on a “best efforts” basis.

 

All of the foregoing and following may affect the marketability of our securities. Should any fundamental change occur regarding the status or other matters concerning the selling shareholders or us, we will file an amendment to this Offering Circular disclosing such matters.

 

Generally, no sale may be made to you in this Offering if the aggregate purchase price you pay is more than 10% of the greater of your annual income or net worth. Different rules apply to accredited investors and non-natural persons. Before making any representation that your investment does not exceed applicable thresholds, we encourage you to review Rule 251(d)(2)(i)(C) of Regulation A. For general information on investing, we encourage you to refer to www.investor.gov.

 

We are offering up to 220,000,000 shares of our Common Stock for a tentative price of $0.01 to $0.05 per share, for a total of up to $5,000,000 in gross offering proceeds, assuming all securities are sold. There is no minimum investment established for investors and no minimum Offering amount. We may sell significantly fewer shares of common stock than those offered hereby. All accepted subscription funds will be immediately available for our use. We may, in our sole discretion, choose to accept the cancelation of debt owed by us as consideration for shares of common stock offered hereby. Any shares of Common Stock sold for debt cancellation shall be subject to the same terms and conditions as other shares sold hereunder, including the purchase price for such shares.

 

All subscription agreements and checks are irrevocable until accepted or rejected by the Company and should be delivered to us at the address provided in the subscription agreement. A subscription agreement executed by a subscriber is not binding on us until it is accepted on our behalf by our CEO or by specific resolution of our Board of Directors. We may accept or reject any subscription, in whole or in part, in its sole discretion.

 

We will deliver stock certificates to the purchasers within five days from request by a shareholder; otherwise shareholders’ shares may be noted and held in our corporate shareholder register.

 

Effective February, 2022, Dalmore Group has agreed to act as our broker of record in connection with the sale of our Common Stock, subject to the terms and conditions of a Broker-Dealer Agreement dated February, 2022. Pursuant to the agreement, Dalmore Group’s role in the offering is limited to serving as the broker of record, including providing investor qualification recommendations (e.g., “Know Your Customer” and anti-money-laundering checks) and coordinating with third-party providers to ensure adequate review and compliance. Dalmore Group will have access to the subscription information provided by investors and will serve as broker of record for the Offering. Dalmore Group will not solicit any investors on our behalf, act as underwriter or provide investment advice or investment recommendations to any investor.

 

 

Dalmore Group is a broker-dealer registered with the Commission and a member of FINRA and SIPC and is registered in each state where we sell shares of our Common Stock. Dalmore Group will receive a brokerage fee but will not purchase any interests and, therefore, will not be eligible to receive any discounts, commissions or any underwriting or finder’s fees in connection with this Offering.

 

We paid Dalmore Group a consulting fee of $20,000 as well as an advance of $5,000 for expenses and $1,250 for the FINRA corporate filing fee. In addition, we agreed to indemnify Dalmore Group and each of its affiliates and their respective representatives and agents for any loss, liability, judgment, arbitration award, settlement, damage or cost (which we refer to as losses) incurred in any third-party suit, action, claim or demand (which we refer to, collectively, as a proceeding) to the extent they are based upon our breach of any provision of Broker-Dealer Agreement, our wrongful acts or omissions or this Offering. Dalmore Group agreed to indemnify us and each of our affiliates and their and our representatives and agents from any losses arising out of any proceeding to the extent they are based upon Dalmore Group’s breach of the agreement or the wrongful acts or omissions of Dalmore Group or Dalmore Group’s failure to comply with any applicable federal, state or local laws, regulators or codes in the performance of its obligations under the agreement.

 

The Broker-Dealer Agreement has a 12-month term beginning February 2022 and will renew automatically for successive 2-months terms unless either party provides notice of non-renewal at least 30 days prior to the expiration of the then-current term. Additionally, the agreement may be terminated by either party for breach, misrepresentation, failure to comply with legal requirements or insolvency.

 

On March 15, 2022 we entered into a Finder’s Fee Agreement with J. H. Darbie & Co. (“Darbie”) pursuant to which we will compensate Darbie in the amount of 3% of investments by parties introduced to us by Darbie who invest in this offering. The Finder’s Fee Agreement provides for certain indemnifications of Darbie and has a 120 day term. The agreement was amended on June 13, 2023 to provide for a new 120 day term

 

OTC Markets Considerations

 

The OTC Markets is separate and distinct from the New York Stock Exchange and Nasdaq stock market or other national exchange. Neither the New York Stock Exchange nor Nasdaq has a business relationship with issuers of securities quoted on the OTC Markets. The SEC’s order handling rules, which apply to New York Stock Exchange and Nasdaq-listed securities, do not apply to securities quoted on the OTC Markets.

 

Although other national stock markets have rigorous listing standards to ensure the high quality of their issuers and can delist issuers for not meeting those standards; the OTC Markets has no listing standards. Rather, it is the market maker who chooses to quote a security on the system, files the application, and is obligated to comply with keeping information about the issuer in its files.

 

Investors may have greater difficulty in getting orders filled than if we were on Nasdaq or other exchanges. Trading activity in general is not conducted as efficiently and effectively on OTC Markets as with exchange-listed securities. Also, because OTC Markets stocks are usually not followed by analysts, there may be lower trading volume than New York Stock Exchange and Nasdaq-listed securities.

 

 

MARKET INFORMATION

 

MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS

 

The Company’s Common Stock is currently trading on the OTCQB market under the symbol “ENDV”. The following sets forth the high and low closing prices of the Company’s Common Stock in the US for the most recent quarter and each quarter during the preceding two fiscal years.

 

The prices for the Company’s common stock quoted by brokers are not necessarily a reliable indication of the value of the Company’s common stock.

 

Holders of Common Equity:

 

On August 24, 2023 there were approximately 427 shareholders of record of the Company’s common stock. The number of record holders was determined from the records of our transfer agent and does not include beneficial owner’s common stock whose shares are held in the names of various securities brokers, dealers and registered clearing agencies. The transfer agent of our common stock is Equity Stock Transfer, 237 W 37th Street - Suite 601, New York, NY 10018. The phone number of the transfer agent is (212) 575-5757.

 

Dividends:

 

Cash dividend: The Company has not declared or paid a cash dividend to common stock shareholders since the Company’s inception. The Board of Directors presently intends to retain any earnings to finance company operations and does not expect to authorize cash dividends to common shareholders in the foreseeable future. Any payment of cash dividends in the future will depend upon Company’s earnings, capital requirements and other factors.

 

DILUTION

 

If you invest in our common stock and warrants, your interest will be diluted immediately to the extent of the difference between the public offering price per unit and the as-adjusted net tangible book value per share after this offering.

 

The net tangible book value (deficit) of our common stock as of December 31, 2022 was approximately $[●], or approximately $[●] per share. Net tangible book value per share represents the amount of our total tangible assets less total liabilities divided by the total number of our shares of common stock outstanding as of September 30, 2022.

 

After giving effect to the sale of 220,000,000 Shares in this offering at the offering price of $0.XX per Share, our as adjusted net tangible book value as of December 31, 2022 would have been approximately $      , or approximately $                per share. This represents an immediate increase in net tangible book value of approximately $        per share to our existing security holders and an immediate dilution in as-adjusted net tangible book value of approximately $       per share to purchasers of units in this offering, as illustrated by the following table:

 

Public offering price per Share
Consolidated net tangible book value per Common Share
Increase in consolidated net tangible book value per Common Share
As adjusted consolidated net tangible book value per Common Share
Dilution per Common Share to new investors participating in this offering

 

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations.

 

The following discussion and analysis of financial condition and results of operations should be read in conjunction with our consolidated financial statements and related notes included elsewhere in this report. The information and financial data discussed below is only a summary and should be read in conjunction with the historical financial statements and related notes contained elsewhere in this 10-K. The financial statements contained elsewhere in this 10-K fully represent the Company’s financial condition and operations; however, they are not indicative of the Company’s future performance. Although management believes that the assumptions made and expectations reflected in the forward-looking statements are reasonable, there is no assurance that the underlying assumptions will, in fact, prove to be correct or that actual results will not be different from expectations expressed in this 10-K.

 

Cautionary Notice Regarding Forward Looking Statements

 

The information contained in Item 2 contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Actual results may materially differ from those projected in the forward-looking statements as a result of certain risks and uncertainties set forth in this report. Although management believes that the assumptions made and expectations reflected in the forward-looking statements are reasonable, there is no assurance that the underlying assumptions will, in fact, prove to be correct or that actual results will not be different from expectations expressed in this report.

 

This filing contains a number of forward-looking statements which reflect management’s current views and expectations with respect to our business, strategies, products, future results and events, and financial performance. All statements made in this filing other than statements of historical fact, including statements addressing operating performance, events, or developments which management expects or anticipates will or may occur in the future, including statements related to distributor channels, volume growth, revenues, profitability, new products, adequacy of funds from operations, statements expressing general optimism about future operating results, and non-historical information, are forward looking statements. In particular, the words “believe,” “expect,” “intend,” “anticipate,” “estimate,” “may,” variations of such words, and similar expressions identify forward-looking statements, but are not the exclusive means of identifying such statements, and their absence does not mean that the statement is not forward-looking. These forward-looking statements are subject to certain risks and uncertainties, including those discussed below. Our actual results, performance or achievements could differ materially from historical results as well as those expressed in, anticipated, or implied by these forward-looking statements. We do not undertake any obligation to revise these forward-looking statements to reflect any future events or circumstances.

 

Readers should not place undue reliance on these forward-looking statements, which are based on management’s current expectations and projections about future events, are not guarantees of future performance, are subject to risks, uncertainties and assumptions (including those described below), and apply only as of the date of this filing. Our actual results, performance or achievements could differ materially from the results expressed in, or implied by, these forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in prior filings, in press releases and in other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

 

 

Critical Accounting Policies and Estimates

 

We prepare our consolidated financial statements in accordance with accounting principles generally accepted in the U.S. (U.S. GAAP). In doing so, we have to make estimates and assumptions that affect our reported amounts of assets, liabilities, revenues, and expenses, as well as related disclosure of contingent assets and liabilities. In some cases, we could reasonably have used different accounting policies and estimates. In some cases, changes in the accounting estimates are reasonably likely to occur from period to period. Accordingly, actual results could differ materially from our estimates. To the extent that there are material differences between these estimates and actual results, our financial condition or results of operations will be affected. We base our estimates on past experience and other assumptions that we believe are reasonable under the circumstances, and we evaluate these estimates on an ongoing basis. We refer to accounting estimates of this type as critical accounting policies and estimates, which we discuss further below.

 

Impairment of Other Intangible and Long-Lived Assets

 

The Company accounts for its intangible assets under the provisions of ASC 350, “Intangibles - Goodwill and Other”. In accordance with ASC 350, intangible assets with a definite life are analyzed for impairment under ASC 360-10-05 “Property, Plant and Equipment” and intangible assets with an indefinite life are analyzed for impairment under ASC 360 annually, or more often if circumstances dictate. The Company performs its annual simplified impairment test in the fourth quarter of each year. The Company reviews its long-lived assets for impairment whenever events or changes in business circumstances indicate that the carrying amount of assets may not be fully recoverable or that the useful lives of these assets are no longer appropriate. If impairment is indicated, the asset is written down to its estimated fair value.

 

Use of estimates

 

Preparing financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, and expenses. The significant estimates were made for the fair value of common stock issued for services, with notes payable arrangements, in connection with note extension agreements, and as repayment for outstanding debt, in estimating the useful life used for depreciation and amortization of our long-lived assets, in the valuation of the derivative liability, and the valuation of deferred income tax assets. Actual results and outcomes may differ from management’s estimates and assumptions.

 

Recently Issued Accounting Pronouncements

 

The Company has evaluated all the recent accounting pronouncements and determined that there are no accounting pronouncements that will have a material effect on the Company’s financial statements.

 

 

Results of Operations Year Ended December 31, 2022, vs. Year Ended December 31, 2021

 

		Year Ended December 31,								Favorable
		2022				2021				(Unfavorable)				%
Revenue		$	135,355			$	73,105				62,250				85.2
Cost of revenue			9,990				14,985				4,995				33.3
Gross profit			125,365				58,120				67,245				115.7
Operating expenses			3,389,705				2,284,667				(1,105,038	)			(48.4	)
Loss from operations			(3,264,340	)			(2,226,547	)			(1,037,793	)			(46.6	)
Other expense			(15,210,495	)			(878,347	)			(14,332,148	)			(1,631.8	)
Net loss		$	(18,474,835	)		$	(3,104,894	)		$	(15,369,941	)			(495.0	)

 

Revenue

 

Revenue of the Company’s SofPulse® product during the current year increased by $62,250 or 85.2% compared to the previous year.

 

Revenues for sales of our SofPulse® product is typically recognized at the time the product is shipped, at which time the title passes to the customer, and there are no further performance obligations. During the year ended December 31, 2022, the Company also recognized $113,620 in royalty/licensing revenue from a former related party.

 

We anticipate that revenue will increase in future periods as the roll out of the SofPulse® product continues. The Company is looking to partner with global participants in the medical device market to spur its expansion. The Company expects such investment alternatives to include partnerships, joint ventures, distribution, and licensing agreements for the PEMF medical technology. The Company also look to expand on current initiatives with the Department of Defense, the Department of Veterans Affairs, and other surgical and pain management markets.

 

 

Cost of Revenue

 

Cost of revenue decreased by $4,995 or 33.3% from the previous year to $9,990 during the current year compared to $14,985 during the previous year. Cost of revenue is recognized on those sales recorded as gross for which we are the principal in the transaction as opposed to net sales which reflect no cost of revenue.

 

It is anticipated that cost of revenue will increase in future periods as the roll out of the SofPulse® product continues.

 

Operating Expenses

 

Our operating expenses increased by $1,105,038 or 48.4% to $3,389,705 in 2022 compared to $2,284,667 in 2021. The operating expenses were comprised primarily of consulting fees, professional fees, and stock-based compensation. This change was due primarily to an increase in stock-based compensation of approximately $1.2 million.

 

Depreciation and Amortization

 

We incur depreciation and amortization expenses for costs related to our patents. Our depreciation and amortization expense was $646,912 in 2022 compared to $648,492 in 2021. The Company has not impaired its finite-lived intangible as of December 31, 2022 and 2021.

 

Other Expense

 

Other expense was $15,210,495 in 2022 compared to $878,347 in 2021. Other Expense includes interest expense, change in fair value of derivative liability, amortization of debt issuance cost, gain on extinguishment of debt and make-good expense.

 

The increase in other expense during our fiscal year 2022 was primarily the result of re-valuation of the derivative liability embedded in the convertible notes issued with variable conversion rates. The Change in fair value of the Company’s derivative liability resulted in an expense of $14 million in 2022 compared to a gain of approximately $41,000 in 2021, resulting from changes to the inputs to the fair value option pricing model. The Company also incurred an increase in interest expense of approximately $380,000 and approximately $225,000 of additional expenses attributed to the make good provision embedded in the fixed rate convertible notes, offset by an increase of approximately $340,700 of gain from debt extinguishment in 2022.

 

Liquidity and Capital Resources

 

		As of December 31,								Increase
		2022				2021				(Decrease)
Working Capital
Current assets		$	15,822			$	94,855			$	(79,033	)
Current liabilities			33,381,760				17,701,710				15,680,050
Working capital deficit		$	(33,365,938	)		$	(17,606,855	)		$	15,759,083
Long-term debt		$	79,825			$	79,825			$	-
Stockholders’ deficit		$	(32,180,319	)		$	(15,774,324	)		$	16,405,995

 

		For Years Ended December 31,								Increase
		2022				2021				(Decrease)
Statements of Cash Flows Select Information
Net cash provided (used) by:
Operating activities		$	(678,838	)		$	(986,584	)		$	(307,746	)
Financing activities		$	593,000			$	1,059,100			$	(466,100	)

 

 

		As of December 31,								Increase
		2022				2021				(Decrease)
Balance Sheet Select Information
Cash		$	98			$	85,936			$	(85,838	)
Accounts payable and accrued liabilities		$	8,869,451			$	7,078,283			$	1,791,168

 

Securities Authorized for Issuance under Equity Compensation Plans

 

We do not have in effect any compensation plans under which our equity securities are authorized for issuance.

 

Unregistered Sales of Equity Securities

 

During the year ended December 31, 2022, we issued the following unregistered equity securities:

 

Number of
Common Shares				Source of
Issued				Payment		Amount
	25,850,000			Conversion of notes and accrued interest		$	517,000
	2,428,777			Settlement of debt		$	46,147
	66,500,000			Services		$	1,316,900
	3,450,000			Commitment shares		$	46,793
	15,000,000			Issuance for cash		$	142,000
	25,500,000			Conversion of preferred stock		$	-

 

The above issuances were exempt from registration pursuant to Section 4(2), and/or Regulation D promulgated under the Securities Act. These securities qualified for exemption under Section 4(2) of the Securities Act since the issuance of securities by us did not involve a public offering. The offering was not a “public offering” as defined in Section 4(2) due to the insubstantial number of persons involved in the deal, size of the offering, manner of the offering and number of securities offered. We did not undertake an offering in which we sold a high number of securities to a high number of investors. In addition, these stockholders had the necessary investment intent as required by Section 4(2) since they agreed to and received share certificates bearing a legend stating that such securities are restricted pursuant to Rule 144 of the Securities Act. This restriction ensures that these securities would not be immediately redistributed into the market and therefore not be part of a “public offering.” Based on an analysis of the above factors, we have met the requirements to qualify for exemption under Section 4(2) of the Securities Act for this transaction.

 

Item 7A. Quantitative and Qualitative Disclosures About Market Risk.

 

We are a Smaller Reporting Company (“SRC”) and are not required to provide the information under this item.

 

 

Going Concern

 

Our independent registered auditors included an explanatory paragraph in their opinion on our consolidated financial statements as of and for the fiscal year ended December 31, 2022 that states that our ongoing losses and lack of resources causes doubt about our ability to continue as a going concern.

 

The World Health Organization declared the Coronavirus outbreak a pandemic on March 11, 2020 and in the United States various emergency actions have been taken on the National, State and Local levels. The effects of this pandemic on our business have been substantial and have been negative.

 

Since inception and through December 31, 2022, the Company has raised approximately $19 million in equity and debt transactions. These funds have been used to commence the operations of the Company to acquire and begin the development of its intellectual property portfolio. These activities include attending trade shows and corporate development. Our accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business for the twelve-month period following the date of these consolidated financial statements. The Company has incurred substantial losses since inception. Its current liabilities exceed its current assets and available cash is not sufficient to fund expected future operations. The Company is raising additional capital through debt and equity securities in order to continue the funding of its operations. However, there is no assurance that the Company can raise enough funds or generate sufficient revenues to pay its obligations as they become due, which raises substantial doubt about our ability to continue as a going concern. To reduce the risk of not being able to continue as a going concern, management has implemented its business plan to materialize revenues from potential future license and distribution agreements, has raised capital through the issuance of promissory notes, has engaged a broker/dealer to raise additional capital and is seeking out profitable companies. Our cash on hand at December 31, 2022 was less than $1,000. This will not be sufficient to fund operations if additional capital is not raised. The Company raised an aggregate of $0.275 million through the sale of equity and debt securities since January 1, 2023

 

Controls and Procedures.

 

Disclosure of controls and procedures.

 

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports, filed under the Securities Exchange Act of 1934, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our chief executive officer and chief financial officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable and not absolute assurance of achieving the desired control objectives. In reaching a reasonable level of assurance, management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. In addition, the design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, a control may become inadequate because of changes in conditions or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

 

As required by the SEC Rule 13a-15(b), we carried out an evaluation under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of December 31, 2022. Based on the foregoing, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were not effective as of December 31, 2022, at the reasonable assurance level due to the material weaknesses described below.

 

 

A material weakness is a control deficiency (within the meaning of the Public Company Accounting Oversight Board (PCAOB) Auditing Standard No. 2) or combination of control deficiencies that result in more than a remote likelihood that a material misstatement of the annual or interim financial statements will not be prevented or detected. Management has identified the following two material weaknesses which have caused management to conclude that as of December 31, 2022, our disclosure controls and procedures were not effective at the reasonable assurance level:

 

1. We do not have written documentation of our internal control policies and procedures. Written documentation of key internal controls over financial reporting is a requirement of Section 404 of the Sarbanes-Oxley Act which is applicable to us for the year ended December 31, 2022. Management evaluated the impact of our failure to have written documentation of our internal controls and procedures on our assessment of our disclosure controls and procedures and has concluded that the control deficiency that resulted represented a material weakness.

 

2. We do not have sufficient segregation of duties within accounting functions, which is a basic internal control. Due to our size and nature, segregation of all conflicting duties may not always be possible and may not be economically feasible. However, to the extent possible, the authorization of transactions, the custody of assets and the recording of transactions should be performed by separate individuals. The recording of transactions function is maintained by a third-party consultant whereas authorization and custody remains under the Company’s Chief Executive Officer’s responsibility. Management evaluated the impact of our failure to have segregation of duties on our assessment of our disclosure controls and procedures and has concluded that the control deficiency that resulted represented a material weakness.

 

To address these material weaknesses, management performed additional analyses and other procedures to ensure that the financial statements included herein fairly present, in all material respects, our financial position, results of operations and cash flows for the periods presented.

 

Changes in internal controls over financial reporting.

 

There has been no change in our internal control over financial reporting that occurred during the fiscal that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

 

Certain Expenses and Liabilities

 

On an ongoing basis, management evaluates its estimates related to certain expenses and accrued liabilities. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of liabilities that are not readily apparent from other sources. Actual results may differ materially from these estimates under different assumptions or conditions.

 

Inflation

 

We believe that inflation has not had a material adverse impact on our business or operating results during the periods presented.

 

Off-balance Sheet Arrangements

 

We have no off-balance sheet arrangements as of May , 2023.

 

PRINCIPAL ACCOUNTANT FEES AND SERVICES

 

For the Company’s fiscal years ended December 31, 2022 and 2021, we were billed approximately $101,915 and $98,250, respectively, for professional services rendered for the audit and review of our financial statements.

 

Audit Related Fees

 

There were no fees for audit related services for the years ended December 31, 2022 and 2021.

 

Tax Fees

 

For the Company’s fiscal years ended December 31, 2022 and 2021, we were billed approximately $7,195 and $8,400 for professional services rendered for tax compliance, tax advice, and tax planning.

 

All Other Fees

 

For the Company’s fiscal years ended December 31, 2022, and 2021, we were billed approximately $500 and $0, respectively.

 

The Company did not incur any other fees related to services rendered by our principal accountant for the fiscal years ended December 31, 2022 and 2021.

 

Effective May 6, 2003, the Securities and Exchange Commission adopted rules that require that before our auditor is engaged by us to render any auditing or permitted non-audit related service, the engagement be:

 

●	approved by our audit committee; or
●	entered into pursuant to pre-approval policies and procedures established by the audit committee, provided the policies and procedures are detailed as to the particular service, the audit committee is informed of each service, and such policies and procedures do not include delegation of the audit committee’s responsibilities to management.

 

We do not have an audit committee. Our board of directors pre-approves all services provided by our independent auditors. The pre-approval process has just been implemented in response to the new rules. Therefore, our board of directors does not have records of what percentage of the above fees was pre-approved. However, all of the above services and fees were reviewed and approved by the board of directors either before or after the respective services were rendered.

 

 

CHANGES AND DISAGREEMENTS WITH ACCOUNTANTS

 

None.

 

OUR BUSINESS

 

Overview

 

Endonovo Therapeutics, Inc. (Endonovo or the “Company”) is an innovative biotechnology company that has developed a bio-electronic non-invasive and drug-free approach to regenerative medicine.

 

The Company develops, manufactures and distributes revolutionary medical devices that utilize Pulsed Electro Magnetic Field (PEMF) therapy that are focused on the rapid recovery of wounds and reduction of pain, edema and inflammation on and in the human body. The company has already received FDA clearance for SofPulse® for the reduction of pain and edema postoperatively. Additionally, the Company’s non-invasive bioelectric medical devices are designed to target inflammation, cardiovascular diseases, chronic kidney disease, central nervous system disorders (“CNS” disorders) including Multiple Sclerosis (MS), Traumatic Brain Injury (TBI), Dementia, Alzheimer’s, and Ischemic stroke among others.

 

Endonovo’s core mission is to transform the field of medicine by developing safe, wearable, non-invasive bioelectric medical devices that deliver the Company’s Electroceutical® Therapy. Endonovo’s bioelectric Electroceutical® devices harnesses bioelectricity to restore key electrochemical processes that initiate anti-inflammatory processes and growth factors in the body necessary for healing to rapidly occur.

 

Recently management has entered into a program to expand our operations through a program of acquisition of specialty construction and facilities maintenance companies. The company expanded the program to include biotechnology firms that would help to diversify its offerings and better position the company to serve a broader range of customers and markets. We have had contact with several potential acquisition targets and entered into a letter of intent with one such company. However, no definitive agreements have been signed and no assurance can be given that we will be able to make any such acquisition or that it will prove profitable.

 

In December 2022 the Company brought in new management in order to re-initiate the domestic sales of SofPulse® and further develop its international global market as well. As part of the reorganization of company management, the company is in the process of expanding their distribution and sales networks to include the development of a robust telemedicine (telehealth) platform expansion efforts for their medical devices.

 

Corporate History

 

Our predecessor company, Hanover Asset Management, Inc. was incorporated in November 2008 in California. For the purpose of reincorporating in Delaware, we merged with a newly incorporated successor company, Hanover Portfolio Acquisitions, Inc., in July 2011 under which we continue to operate.

 

IP Resources International, Inc. began operations on September 1, 2011 and was formally incorporated on October 17, 2011.

 

Reverse Acquisition

 

On March 14, 2012, we entered into a Share Exchange Agreement (“Agreement”) with IPR and certain of its shareholders. Under the Agreement, each participating IPR shareholder exchanged all of their issued and outstanding IPR common shares totaling 33,234,294, free and clear of all liens, and $155,000 for Company common shares equal to 1.2342 times the number of IPR shares being transferred to the Company for a total of 410 of our shares (410,177 pre-reverse split). The $155,000 was not paid at closing. The Company recorded the $155,000 as acquisition payable. IPR agreed to make payments of up to 25% of the proceeds from any private placement or gross profits earned by IPR until the obligation is satisfied. The percentage of the proceeds to be paid is at the sole discretion of IPR’s Chief Executive Officer and the ex-Chief Executive Officer of the Company based on the liquidity of the Company.

 

As a result of the Agreement, the former shareholders of IPR, immediately post acquisition, owned approximately 89% of the Company and its officers and directors constituted the majority of the officers and directors of the Company. Since the shareholders, officers and directors of IPR have control of the Company, the acquisitions constitutes a reverse acquisition, so IPR was the accounting acquirer and we were the accounting acquiree. For legal purposes, we are the legal parent and IPR is the legal subsidiary.

 

Acquisition of Aviva Companies Corporation

 

On April 2, 2013, the Company entered into an Acquisition Agreement (the “Acquisition Agreement”) with (i) The Aviva Companies Corporation (“Aviva”) and (ii) all of the shareholders of Aviva (the “Shareholders”) pursuant to which the Company acquired all of the outstanding shares of Aviva in exchange for the issuance of 60 shares of our common stock (60,000 pre-reverse split), par value $0.0001 per share to the Shareholders (the “Share Exchange”). As a result of the Share Exchange, Aviva became a wholly-owned subsidiary of the Company.

 

 

Other than in respect to the transaction, there is no material relationship among Aviva’s stockholders and any of the Company’s affiliates, directors or officers. We are not currently actively pursuing the development of the Aviva Companies Corporation.

 

Acquisition of WeHealAnimals, Inc.

 

On November 16, 2013, the Company entered into an Acquisition Agreement (the “Acquisition Agreement”) with (i) WeHealAnimals, Inc. (“WHA”) and (ii) the sole shareholder of WHA (the “Shareholder”) pursuant to which the Company acquired all of the outstanding shares of WHA in exchange for the issuance of 3 shares of our common stock (3,000 shares pre- reverse split), par value $0.0001 per share and $96,000 to the Shareholder (the “Share Exchange”). As a result of the Share Exchange, WHA became a wholly-owned subsidiary of the Company and all of the equity of WHA including its and its sole shareholder’s intellectual property became the property of the Company. This obligation was fully paid on December 15, 2015 through the issuance of 350 shares of stock (350,000 pre-reverse split) to Shareholder. WHA is a Nevada corporation with intellectual property in the fields of bio-technology including its biologics and time-varying electromagnetic frequencies with potential applications on people and animals that management believes can be developed to the benefit of the Company and its shareholders. WHA’s sole shareholder was formerly Chairman and Chief Scientist of Regenetech, Inc. Regenetech was acquired by a company that wanted its technology, biomolecules grown in microgravity, for use in cosmetics. WHA’s sole shareholder left Regenetech with exclusive rights to this proprietary square wave form technology and stem cell technologies, including the patents and patent applications relating thereto.

 

Other than in respect to the transaction, there is no material relationship between WHA’s sole stockholder and any of the Company’s affiliates, directors or officers.

 

Acquisition of Rio Grande Assets

 

On December 22, 2017, we acquired intellectual property and other assets (the “RGN Assets”) from Rio Grande Neurosciences, Inc. (RGN). The price was $4,500,000 of which we paid $3,000,000 in cash and delivered a $1,500,000 secured promissory note due November 30, 2018 and security agreement. Before such note was due, the note was assigned to Eagle Equities, LLC (“Eagle”) its due date was extended to November 30, 2019, and it was made convertible into our common stock at a price related to our common stock’s market price at the time of conversion. The maturity date was then extended to December 31, 2021. The RGN Assets relate to RGN’s PEMF portfolio of intellectual property, including 27 issued patents with foreign patent protection covering the therapeutic use of PEMF as well as the treatment of various central nervous system disorders. We intend to initiate and fund future clinical trials to evaluate the further use of PEMF in the treatment of central nervous system disorders, including traumatic brain injury, post-concussion syndrome, stroke and multiple sclerosis. However, no assurance can be given that we will be successful in these endeavors or that the results of any tests will indicate further development of the RGN Assets.

 

The PEMF assets acquired include SofPulse®, a portable, disposable PEMF device having an FDA 510(k) clearance for the treatment of post-surgical pain and edema, in addition to working to obtain medical reimbursement, the company has been CE Marked for the promotion of wound healing, reduction of pain and post operative edema. Endonovo Therapeutics is selling SofPulse^® in the United States through various sales channels and distribution agreements and expects to initiate sales in Taiwan in Q4, 2023.

 

Business Restructuring

 

In March 2023, the Company announced that a binding Letter of Intent (LOI) to spin off its current medical device division to an entity controlled by Ira Weisberg, who will be the future President and CEO of a newly formed publicly traded Delaware company, tentatively named SofPulse, Inc. The consummation of the proposed spin off is subject to various contingencies and no assurance can be given that it will be consummated, including, but not limited to the spun off company being listed on NASDAQ or a similar exchange and paying cash and securities to the Company (and its shareholders) equal to between $50 and $100 million.

 

SofPulse, Inc. is set to expand the sales and marketing programs to promote the SofPulse^® portfolio of commercial and clinical-stage therapeutic devices and IP. The acquisition of the SofPulse^® assets and IP aligns with SofPulse, Inc.’s growth plans to provide targeted non-invasive pain and edema reduction while mitigating the risks of addiction and dependence on opioids while accelerating recovery in surgical patients.

 

SofPulse, Inc. plans to continue its focus on bringing PEMF technology to the global pain management market. It will also expand on current initiatives with the Department of Defense, the VA and other surgical and pain management markets. In addition to the United States, Endonovo is also expanding the availability of SofPulse® in Europe and Asia. The company has already secured distribution partners in these regions, and it is working to build a network of sales representatives. The company believes that the expansion of SofPulse® will be a major driver of growth for the company. The company expects to generate significant revenue from the sale of SofPulse® in the coming years.

 

As a condition of the executed LOI and to establish fair market value for the completion of the acquisition, SofPulse^® assets and Intellectual Property (IP) are currently being evaluated by Ocean Tomo, a part of JS Held. This acquisition is subject to financing or Sofpulse, Inc. becoming a listed company on a major exchange, the successful completion of due diligence, negotiation and execution of a definitive purchase agreement as well as receipt of all necessary regulatory approvals.

 

The Ocean Tomo fairness opinion report will be used in SEC filings and will include opinions on the current Fair Market Value (FMV) and purchase price of the assets. Endonovo will retain its non-medical PEMF assets and the future telehealth division. Non-medical PEMF assets include the right to make over the counter (non-prescription) sales of PEMF products. We note that other marketers of PEMF devices have entered the over the counter market.

 

The last valuation report issued for SofPulse^® IP and assets, completed in 2018, stated that these assets were worth $75 million. Upon completion of the current Ocean Tomo valuation, the company believes that SofPulse, Inc. could have a pre-money valuation similar in value to previous valuations. We note that this amount is substantially above the market capitalization of the Company, however, management believes that the market has not reflected the true value of the Company due to the presence of toxic (variable rate) convertible notes on our balance sheet and the effects of the pandemic on our business operations.

 

Until the completion of the Spin-Off, which will require, among other things, the entry into a formal detailed agreement containing full sets of representations and warranties typical of agreements of this type and the filing with the Securities and Exchange Commission and effectiveness of a Registration Statement on Form S-1, Alan Collier, our CEO will own super voting preferred stock in SofPulse, Inc. which will give him voting control of the company and Collier will release these shares upon completion of the purchase. We anticipate that the completion of the Spin-Off will take approximately six months, although no assurance can be given as to any particular time frame.

 

 

Present Development Plans

 

We now are a biotechnology company developing bioelectronic devices and cell therapies for regenerative medicine and a commercial-stage developer of non-invasive wearable Electroceuticals™ therapeutic devices.

 

The Company’s current portfolio of commercial and clinical-stage wearable Electroceuticals™ therapeutic devices addresses wound healing, pain, post-surgical pain and edema, cardiovascular disease, chronic kidney disease, and Central Nervous System (CNS) Disorders, including traumatic brain injury (TBI), acute concussions, post- concussion syndrome and multiple sclerosis. The Company’s non-invasive Electroceutical™ therapeutic device, SofPulse®, using pulsed short-wave radiofrequency at 27.12 MHz has been FDA-Cleared for the palliative treatment of soft tissue injuries and post-operative pain and edema, has been CE Marked for the promotion of wound healing, reduction of pain and post operative edema, and has CMS National Coverage for the treatment of chronic wounds. The Company’s current portfolio of pre-clinical stage Electroceuticals™ therapeutic devices address chronic kidney disease, liver disease non-alcoholic steatohepatitis (NASH), cardiovascular and peripheral artery disease (PAD), and ischemic stroke. The Company’s non-invasive, wearable Electroceuticals™ therapeutic devices work by restoring key electrochemical processes that initiate anti-inflammatory and growth factor cascades necessary for healing to occur.

 

These bioelectronics devices are also commonly referred to as “electroceuticals.” These products are part of an emerging field termed “Bioelectronic Medicine,” that seeks to harness electrical signals in nerves and cells to alter the course of diseases and conditions. Whereas our competitors are primarily using implantable electrical nerve stimulators, we are developing devices that are not implantable and use electromagnetic pulses to deliver electrical stimulation to cells and tissues. We are developing these bioelectronic devices for the treatment of inflammatory conditions in tissues and vital organs with a broad range of therapeutic uses, potentially including some chronic pain conditions, through future research and development studies.

 

Telemedicine Platform Development

 

Endonovo is developing a telemedicine platform that will allow patients to connect with a doctor from the comfort of their own home for a variety of medical needs. This includes follow-up appointments, consultations, and prescriptions. The telemedicine platform will be powered by Endonovo’s proprietary technology, which will allow for real-time video and audio communication between patients and doctors. The platform will also include a secure messaging system and a medical record repository. Endonovo believes that the telemedicine platform will be a valuable tool for patients and doctors. The platform will make it easier for patients to access care, and it will help to improve the quality of care that patients receive. The telemedicine platform is still in development, but Endonovo expects to launch it in the coming months. The company believes that the platform will be a major driver of growth for the company.

 

Direct to Consumer PEMF Products

 

Endonovo is in the process of developing direct to consumer PEMF products that will allow patients to purchase SofPulse® and other PEMF devices without the need for a prescription. This will make it easier for patients to access the benefits of PEMF therapy, and it will help to expand the reach of Endonovo’s products. The companies direct to consumer PEMF products will be available through the company’s websites which are being updated to support sales and patient and through select retailers. The company believes that the direct-to-consumer market is a large and growing market, and it expects to generate significant revenue from the sale of its direct to consumer PEMF products.

 

Development of Holding Company for Biotechnology and Specialty Construction Companies

 

Endonovo has established a mergers and acquisition (M&A) division that will allow Endonovo to act as a holding company for acquisitions of profitable biotechnology and specialty construction companies. The acquisitions of profitable companies in the biotechnology and specialty construction sectors can provide Endonovo with the resources it needs to grow its businesses and to achieve its long-term goals while allowing management to more effectively manage its operations and focus on its core competencies, and to grow its Endonovo business after the proposed spin-off of SofPulse®.

 

 

Intellectual Property:

 

SofPulse^®: We have 29 issued patents with foreign patent protection covering the therapeutic use of tPEMF as well as the treatment of various central nervous system disorders. Additionally to date, we have filed seven patent applications in the U.S. through the U.S. Patent and Trademark Office (USPTO) and four international patent applications in the E.U., China, South Korea and Japan covering our Time-Varying Electromagnetic Field (TVEMF) technology, the production of biomolecules, the creation of an allogeneic mesenchymal stem cell product a treatment for chemical and radiation injuries, production of stem cell secretome and a method of treating tissues and organs using our TVEMF technology. To date, we have been granted one U.S. Patent (U.S. Patent No. 9,410,143) issued on August 9, 2017 covering the production of human biomolecules using our TVEMF technology. We will continue to seek to strengthen our portfolio of intellectual property by filing additional patents around uses of our core technologies.

 

Our business strategy is aimed at building value by positioning each of our technologies and therapies to treat specific diseases that lack effective treatment, post-operative pain and edema, or whose current standard of treatment involves invasive procedures and/or potentially harmful side effects. We anticipate updating and refining the business strategy as new medical and/or clinical advancements are made as a result of extensive research and development. In general, the component functions of the business model are to:

 

● Commercialize SofPulse^®, our FDA cleared technology, through direct sales to consumers, community-based and ambulatory surgical centers, integrated delivery networks (IDNs) such as Veterans Administration and Department of Defense hospitals, medical centers, community hospitals among others;

 

● Opportunistically license our technologies for off-strategy uses;

 

● Develop additional medical indications for our medical devices;

 

● Develop additional non-invasive, medical technologies;

 

● Conduct pre-clinical and clinical human studies for FDA Approval of our medical devices and cell therapies;

 

● Acquire subsidiaries under the parent company, Endonovo Therapeutics, to assist in the development and distribution of medical technologies;

 

● Incrementally invest, market, and refine acquired and developed medical technologies and therapies.

 

Industry Overview

 

Bioelectrical Medicine (“PEMF”) within the Healthcare Industry

 

The healthcare industry is one of the world’s largest and fastest-growing industries. Consuming over 10 percent of Gross Domestic Product (GDP) of most developed nations, health care can form an enormous part of a country’s economy.

 

	●	The number of people with health insurance in the US was over 300 million in 2021, about 92% of the population. The health system in the US is a mix of both public and private insurers, but private is the main form of health insurance coverage among the U.S. population. During 2021, healthcare costs reached $4.3 trillion, or approximately $12,900 per person. The share of U.S. GDP devoted to healthcare was 18.3% of U.S. Gross Domestic Product (GDP), the largest of any country in the world. According to the US Center for Medicare and Medicaid Services (CMS), on average over 2021-2030, National Health Expenditures (NHE) and Gross Domestic Product (GDP) are both projected to grow 5.1% per year
	●	Globally, by 2040, Healthcare spending is expected to exceed $18 Trillion annually.

 

 

Bio-Electrical Medicine is a $17.2 Billion sector of the Healthcare Industry growing at more than a 11% CAGR estimated to exceed $35.5 Billion by 2025, according to Grand View Research.

 

Bioelectric medicine is premised on a 21^st century treatment modality using electrical pulses, instead of drugs, to trigger the body’s recovery capabilities. Bioelectric medicine develops nerve stimulating and sensors activation technologies to regulate biological functions and treat diseases by combining bioengineering, neuroscience, molecular medicines and electronics. These technologies may change the future of therapies for wide range of diseases.

 

On the basis of type of device, the global Electroceuticals®/Bioelectrical Medicine Market is classified into two major classes:

 

● Implantable Electroceuticals® Devices, and,

 

● Non-Invasive Electroceuticals® Devices.

 

BioElectric Medicine vs. Drug Therapies

 

Over the past 15 years, long-acting and extended-release opioids have been used to treat open wounds, post-operative wounds and chronic pain. These opioids are normally administered at high doses and over long treatment durations particularly in the United States, resulting in a drastic increase in the number opioid-tolerant individuals and a prescription opioid abuse epidemic. Endonovo offers an alternative, non-opioid treatment through its Electroceuticals® systems: The Company’s SofPulse® system is a medical device and is FDA-Cleared for the palliative treatment of soft tissue injuries and post-operative pain and edema. In a recently concluded clinical trial comparing the use of SofPulse^® versus a traditional narcotic analgesic to manage post-mastectomy pain, SofPulse^® was demonstrated to be equally effective with no adverse events being reported.

 

Additionally, through medical studies, SofPulse® has shown to reduce pain and accelerate the recovery of chronic wounds using PEMF. Chronic pain therapy via PEMF works by relieving the underlying cause of pain – inflammation.

 

Management believes that bioelectronic medicine has developed as a viable, 21^st century alternative for the treatment of many inflammatory disorders.

 

Telehealth Business Development

 

Management believes that Telehealth, also known as telemedicine, provides Endonovo with a lucrative business opportunity for financial sales for Telehealth developers and sales professionals. The hardware segment is expected to grow at a revised CAGR of 27.3% for the next 8-year period, indicating a huge demand for telehealth equipment. Financial sales professionals can capitalize on this demand by providing financing options for telehealth equipment. This trend is expected to continue as telehealth becomes more commonplace in healthcare. Endonovo’s development of a robust telehealth platform for SofPulse Health offers significant opportunities for increased growth and revenue of the company.

 

Telehealth Global Healthcare Market

 

Telehealth is a rapidly growing field within the healthcare industry. It uses technology to provide remote medical care and consultation to patients, reducing the need for in-person visits. The telehealth market has experienced an unprecedented surge in growth as a result of the COVID-19 pandemic. According to a recent report by Reportlinker.com titled: “Global Telehealth Industry”, the global market for telehealth is projected to reach $723.3 billion by 2030, with a CAGR of 23% from 2022 to 2030. The software and services segment is expected to record a CAGR of 21.1%, reaching $462.8 billion by the end of the analysis period. The pandemic has served as a catalyst for this growth, as patients seek alternative ways to access healthcare services amid restrictions on in-person visits.

 

 

Telehealth Direct to Consumer Distribution Model for SofPulse® PEMF

 

The rise of telehealth and digital health technologies has opened new opportunities for healthcare providers to improve patient healthcare access and reduce costs and expand distribution significantly through direct-to-consumer sales. The SofPulse® telehealth system being developed by Endonovo, is a patient-friendly treatment system that can be used at home and offers providers a cost-effective, non-invasive, and patient-friendly treatment option for pain and inflammation. With the increasing availability of smartphones and other mobile devices, telehealth can provide access to medical care to people who might otherwise not have access. Patients will have the opportunity to call into the telehealth system and speak to a MD regarding a health condition that could be treated or have benefits in utilizing SofPulse® PEMF system. Telehealth provides an opportunity to provide access to the best doctors, remote consultations, educational services, new and innovative products and best treatment options available regardless of location.

 

Telehealth Improved Outcomes and Cost Savings

 

Incorporating SofPulse® PEMF into telehealth services, can easily help to improve patient outcomes and reduce patient visit costs. Telehealth appointments can help reduce healthcare costs by eliminating the need for expensive time consuming in-person visits. Medical providers can expand access to care and improve patient outcomes, making specialty care faster and more efficient. Telehealth allows patients to participate in their own care and providers can remotely monitor the effectiveness of the treatment. The development of video tools, patient education and remote patient monitoring for ongoing conditions and can improve efficiency by allowing providers to see more patients in less time. Telehealth helps patients save time and money and make it easier for patients using SofPulse® to receive care from specialists who might not be available locally.

 

Veterans Health Administration (VHA) and US Dept of Defense Expansion

 

The recently announced partnership between Endonovo Therapeutics and Academy Medical offers a significant expansion opportunity for the SofPulse® medical device market, benefiting veterans and military personnel. Academy Medical, a Service-Disabled Veteran-Owned Small Business (SDVOSB), is one of the largest procurement and supply groups within the federal government. The company holds several Indefinite Delivery, Indefinite Quantity contracts and Blanket Purchase Agreements and offers over 45,000 products from over 30 supplier partners to the Department of Defense and other federal agencies, with the VHA as its largest customer.

 

Partnership with Academy Medical Improves Procurement Process

 

Through the partnership with Academy Medical, Endonovo expects to enhance the distribution of SofPulse®, reaching a larger patient population. With SofPulse® included in the VHA and DoD procurement system, military personnel and veterans will have access to top-notch medical and surgical supplies. The inclusion of SofPulse® will ensure that this innovative medical device is available to those who need it most, bringing enhanced benefits to veterans, including reduced opioid use postoperatively and improved recovery times, allowing military personnel and veterans to get back to their lives faster. With its FDA-clearance and clinical efficacy, SofPulse® has the potential to make a significant impact on military personnel and veteran patient outcomes and quality of life.

 

Partnership with Academy Medical

 

Academy Medical’s mission is to improve the health, well-being, and quality of life of veterans and service members by making the complex procurement process easier for its federal agency customers and supplier partners. As a Service-Disabled Veteran-Owned Small Business, the company is led by combat veterans and patriotic employees who understand the unique needs of the military community. The company’s focus on service-driven business and commitment to meeting the needs of its customers and supplier partners makes it a valuable partner in the federal procurement space.

 

 

International Market Expansion

 

Endonovo is pursuing an aggressive initiative as part of its global go to market strategy, with the aim of introducing and developing sales of SofPulse® medical devices into multiple international markets. Efforts to expand SofPulse® international distribution and sales distribution are expected to involve targeting physicians, hospitals, and patients as key customers. The company is engaged in negotiations and discussions for licensing and distribution agreements with recognized distribution partners in South and Central America, Australia, Europe, and various Southeast Asian markets.

 

Global Expansion Initiative

 

Endonovo plans to expand its sales and marketing of SofPulse® in the domestic and international surgical and pain markets and expects to generate revenues of$100 million in sales by 2024. Endonovo’s international expansion initiative is to introduce the benefits of SofPulse® to each targeted surgical market to provide a viable alternative to opioid pain management for surgical patients. To expedite international expansion and increase awareness and sales of SofPulse®, President, and Chief Commercial Officer of the Medical Division of Endonovo, Ira Weisberg, is utilizing prior professional relationships with well-established international sales organizations, distributors, hospitals, outpatient ASCs, and rehabilitation centers, as well as online pharmacies. Weisberg’s previous work with medical devices through international partners increased sales for his previous companies netting millions in sales revenues. The company expects SofPulse® to gain rapid acceptance through our aggressive marketing efforts targeting physicians and patients in the breast cancer, breast reconstruction and plastic surgery markets. The goal is to provide these groups with information about the benefits of PEMF (Pulsed Electro Magnetic Frequency) therapy and how it can be used as a safe and effective alternative to opioids for managing pain and reducing edema following surgery.

 

Global Plastic Surgery Market Expected to Drive Growth for SofPulse®

 

Breast cancer is the most common cancer among women and impacts nearly 2.1 million women annually, making it the most frequently diagnosed form of cancer among women, according to the World Health Organization (WHO). The global breast reconstruction market will witness a robust CAGR of 7.11%, valued at $2.68 billion in 2021, expected to appreciate and reach $4.98 billion by 2030, confirms Strategic Market Research. Alliedmarketresearch.com reports, “The global cosmetic surgery market is valued at $67.3 billion in 2021, and is projected to reach 201 billion by 2031, growing at a CAGR of 11.6% from 2022 to 2031.”

 

Breast cancer is the most prevalent diagnosis in South and Central America, Taiwan, Australia, and Europe. In South America, the estimated breast cancer incidence rate is approximately 50 cases per 100,000 with over 2.5 million plastic surgery procedures performed in the region in 2019. According to data from the European Society of Plastic, Reconstructive and Aesthetic Surgeons (ESPRAS), breast reconstruction was the most common plastic surgery procedure performed in Europe in 2017, with a total of over 188,000 procedures performed.

 

Expansion into Mexico and Costa Rica

 

In January 2023, Endonovo announced a non-exclusive stocking distributor agreement with Pulse Therapeutics Technology to distribute its SofPulse® medical devices in Mexico and Costa Rica. International distribution into these markets is expected to increase and grow quarterly over the term of the agreement. Endonovo’s Medical division SofPulse will work with international distributors to ensure successful implementation of the product in the region and establish a dedicated customer service team to support its continued international expansion. With the international distribution of SofPulse®, the company expects a significant increase in quarterly revenues.

 

Taiwan FDA Expansion

 

Endonovo’s SofPulse® division is poised to make a significant impact for postoperative pain management for Taiwanese surgical patients with the upcoming TFDA approval expected in the third quarter of 2023. With an average breast cancer incident rate of 40 cases per 100,000 and over 300,000 plastic surgery procedures performed in Taiwan in 2019, SofPulse®’s potential impact on the market can be significant. Endonovo’s distribution partner, Evermed, will lead the charge in bringing SofPulse® to Taiwanese surgical markets, which see over 1,000,000 in-hospital surgeries and over 900,000 outpatient surgeries annually. The successful sales and marketing launch, including coverage under Taiwan’s National Insurance program, is being developed in partnership with the Evermed management team. This development holds significant potential for Endonovo’s shareholders as the company continues to expand its presence in the global surgical and pain management markets.

 

 

Current Product Being Sold – SofPulse^®

 

SofPulse^® is an FDA cleared. medical device intended for the palliative treatment of soft tissue injuries and post-operative pain and edema. In clinical trials, SofPulse® was proven to reduce mean pain scores by nearly 300% and inflammation by 275% thereby improving and reducing recovery time. Additionally, active patients have experienced a 2.2-fold reduction in narcotic use. The SofPulse® delivers tPEMF to enhance post-surgical recovery, naturally. With more than 20,000 patient-weeks of use, there have been no reported averse events reported for SofPulse^® along with no potential for overdose or dependency.

 

How SofPulse^® Works

 

SofPulse^® delivers low intensity microcurrents of energy directly to the site of the injury. Its proprietary technology delivers targeted Pulsed Electromagnetic Field Therapy (tPEMF) to injured tissues, activating the body’s innate healing mechanism and promoting postoperative recovery on a cellular level. Clinical studies have shown that SofPulse® reduces Interleukin 1-β by 275%, speeding up and enhancing the recovery process. The natural healing process allows patients to get back to life faster without adverse events.

 

SofPulse^® is easily placed over the surgical or wounded site. It can be placed over the surgical dressing, cast or clothing and can easily be applied and/or removed in many cases by the patient themselves.

 

Further to this point, SofPulse^® has also been demonstrated to be effective in enhancing the healing of chronic wounds. The electromagnetic field developed and delivered by SofPulse^® stimulates cell surfaces to increase the production of cytokines to accelerate recovery and remodeling as well as the production of new blood vessels. The Company has data confirming improved healing times for chronic wounds.

 

SofPulse^® allows patients to get back to an active life faster with no adverse events

 

● Immediately Usable and Effective - Single use patient device applied immediately after surgery.

 

● Easy to Use - SofPulse^® can easily be applied and or removed, including in many cases by the patient themselves.

 

● Automated Dosing - Device is activated automatically or can be used as needed.

 

● Versatile - The product comes as a single device or dual device to accommodate different surgical procedures.

 

Manufacturing and Quality

 

SofPulse^® is manufactured for us by ADM Tronics, Inc. in an FDA approved facility in Northvale, New Jersey.

 

Quality and performance of SofPulse^® is assured by ADM through a 100% inspection and testing program of each SofPulse^® unit manufactured and shipped.

 

In addition, ADM provides regulatory affairs support, warehousing, shipping and logistical support for all SofPulse^® operations.

 

 

Sales and Marketing

 

Our prime objective is to position Endonovo as a market leader in pain management, and other aligned markets achieving estimated annualized revenues of $100 million by the end of 2024. In so doing, we intend to make SofPulse^® the standard of care for the management of acute and chronic pain.

 

In order to achieve this objective, we developed a compelling and disruptive marketing strategy to include:

 

	●	Direct to consumer sales
	●	Sales to community-based outpatient surgical offices and facilities
	●	Veterans Administration, Department of Defense and other healthcare facilities within the federal supply system
	●	Medical centers and other hospitals

 

Endonovo has established an effective marketing plan to communicate directly to consumers to both make them aware of SofPulse^® as well as its benefits. Brand recognition is certainly a challenge. However, the SofPulse^®brand promise is unique to the market. SofPulse^® will be presented to and seen as aby consumers as a life changing and life affirming brand. We will continually emphasize the ability of SofPulse^® to get a patient back to their lives faster, to improve the quality of their lives and to allow patients to re-take control of the inevitability of pain. This is our Brand Promise.

 

The Brand Promise of SofPulse^® is premised on both its established safety and efficacy and will be enhanced and maintained by the trust we gain through its usage. Our messaging and communication plans will continue to reinforce the benefits of SofPulse^®. Our websites will become trusted sources for information about non-pharmacological pain management.

 

Social media is central in our communications with our targeted consumers. We have already established a presence on key social media platforms such as Twitter, Facebook, Instagram and LinkedIn, to name a few.

 

To create a greater awareness within the consumer market, we have established a Brand Ambassador program. To date we have several world class athletes, musicians and artists already promoting the benefits of SofPulse^® and are in discussion with several others. We expect to have the ability to attract more than 100 million followers of these ambassadors to the SofPulse^® websites.

 

Creating awareness is key. In addition to the strategic placement of digital and print advertising, we are also planning on publishing a periodic newsletter promoting both the successes of SofPulse^® along with clinical and scientific advances in the non-pharmacological management of pain and wound healing. The intent would be to distribute the newsletter to key opinion leaders in medicine and media. We also anticipate having a consumer-centric version for physician and hospital waiting rooms.

 

SofPulse^® awareness will be further promoted through:

 

	●	Mailings, Journal advertising and other “traditional” marketing modalities to physicians and other healthcare practitioners
	●	Medical meetings and conferences – SofPulse® will be promoted and exhibited at key surgical and pain management meetings both in the US and global sites. The Company will be sponsoring investigators and key opinion leaders to present their SofPulse® study outcomes at these meetings and conferences
	●	Engage regional speakers – the Company has several clinical investigators who will attend regional pain and surgery meetings to talk with colleagues about their experiences with SofPulse® and the benefits their patients experienced
	●	The Sales and Marketing staff will schedule lunch and learn meetings in Ambulatory Surgical Centers and community-based offices to educate the staffs about SofPulse®
	●	Online advertising to include the use of retargeting and collateral sites
	●	Print advertising in targeted publications. For example, cosmetic surgery is an important target. We will be advertising SofPulse® in beauty-oriented magazines
	●	Radio in key regional markets
	●	Cable television in key regional markets

 

 

The SofPulse Health^® platform will also provide our customers with training on the optimal use of SofPulse^® and our aftermarket services. Our aftermarket services would include:

 

	●	Following the purchase of SofPulse® our customer service team will contact the customer by either phone calls/text messaging to answer any questions they may have, to understand their experience with SofPulse® and to make certain that they are using it correctly to get maximum benefit
	●	Provide hotline phone number to answer any customer service questions
	●	Training in how to best apply and use SofPulse®️ through on-line videos and telephone support
	●	Online chat rooms staffed with trained experts
	●	Social media direct interaction with patients
	●	Frequently Asked Questions to provide customer support
	●	The ability to talk with our physician, if necessary

 

The company will be working with a leading telemedicine partner in the US. that have the proven ability to successfully roll out the initiative and promote it to potential users.

 

As SofPulse^® expands into the out-patient ASC market, and successfully demonstrates its patient benefits, we expect SofPulse^® to quickly becoming the go to pain and edema reduction option for many out-patient surgical procedures performed at ASC facilities throughout the US. ASC centers provide patients with cosmetic and reconstructive procedures resulting in a need for postoperative pain management. Many ASC sites have state-of-the-art surgical suites and recovery rooms equipped to hospital standards. We will work with these centers helping them adopt SofPulse as a standard of care.

 

Endonovo has recently partnered with Academy Medical, a Service-Disabled Veteran-Owned Small Business (SDVOSB) Government Reseller. The partnership with Academy Medical provides Endonovo with the preferred procurement benefits accorded Academy Medical as a SDVOSB.

 

The addition of SofPulse® into the Veterans Health Administration (VHA) procurement system offers Endonovo the ability to sell into the largest healthcare Integrated Delivery Network (IDN) in the country. The procurement system is designed to streamline logistics and supply management for medical and surgical items providing veterans and military healthcare facilities with easier access to the products they need. The partnership aims to provide better access to medical and surgical supplies, along with telehealth solutions, with the goal of making a tangible impact on the lives of those who have served their country. The VHA, which serves 9 million enrolled veterans annually through its 1,298 healthcare facilities, including 171 medical centers and 1,113 outpatient sites, will benefit from the inclusion of SofPulse® medical devices in the VHA procurement system.

 

A continued element of the SofPulse^® marketing plan is to continue focus on marketing to medical centers and hospitals; however, with an updated bottom-up approach.

 

By creating the demand for SofPulse^® within the consumer market along with its use in the community-based surgical sites and within the VHA/Federal Supply System, we will drive use in medical centers and other hospitals. Additionally, we will be generating surgeon ambassadors who will be championing the use of SofPulse within their hospitals. We will be generating more real time data that will drive favorable decisions from the Value Analysis Committees (VAC) in the hospitals, the gating organization within hospitals allowing new products onto their formularies.

 

Gaining institutional usage, brand awareness and VAC approvals will also facilitate third party reimbursement.

 

 

We also will be obtaining endorsements from well-known and respected individuals or organizations to increase the credibility of our messaging and value of SofPulse^®. We expect to be able to generate endorsements from leading physicians and key opinion leaders, from athletes and advocacy groups

 

In addition to the above, Endonovo is also either using or will be developing the following marketing programs:

 

	●	Email marketing – we will be acquiring and developing a comprehensive database of surgeons, physicians and other influential decision makers in order to maintain a communication flow about Endonovo, SofPulse and other important information
	●	Mobile marketing/Apps – we will also maintain a communication flow through mobile phone sites and apps
	●	Print marketing materials (brochures, flyers, etc.)
	●	Public relations – the Company will engage a healthcare specific public relations firm to help create and maintain the awareness of SofPulse® throughout its intended ecosystem
	●	Referrals and Word-of-mouth – the positive outcomes experienced by our customers will generate significant goodwill that will permeate throughout the market

 

Third Party Reimbursement

 

The Company is working to achieve reimbursement for SofPulse^® from Medicare and other third-party payers for its in-hospital use. To achieve this, we are developing the materials necessary for presentation to the hospital-based Value Analysis Committees (VACs). VACs are multidisciplinary groups that manage medical and surgical product use within a hospital or IDN. We also plan to engage reimbursement professionals to assist us.

 

Initially, we will use the E1399 or A9999 (Miscellaneous DME) codes for DTC sales to both aid customers to obtain reimbursement for home use from their providers as well as to drive sales volume. On a longer-term basis, we will obtain a unique code for SofPulse^®.

 

Endonovo partnered with Academy Medical, Inc., a Service-Disabled Veteran-Owned Small Business (SDVOSB) Government Reseller. Academy Medical will be reselling SofPulse^® medical devices to the Veterans Health Administration (VHA) healthcare facilities. The partnership is expected to benefit military personnel, veterans and their families who are among the largest user groups of these healthcare delivery systems. The addition of SofPulse® into the VHA procurement system offers Endonovo the ability to sell into the largest healthcare Integrated Delivery Network (IDN) in the country. The procurement system is designed to streamline logistics and supply management for medical and surgical items providing veterans and military healthcare facilities with easier access to the products they need.

 

Furthermore, the reimbursement of SofPulse^® is not a prerequisite for use within the federal supply system hospitals and medical centers.

 

Two current and Company independent clinical trials using SofPulse^® are being conducted at Columbia University and Stanford University. When completed and published these studies will provide additional supportive results supporting our reimbursement efforts for SofPulse^®. The two current clinical trials are as follows and are listed and updated on clinicaltrials.gov

 

The Columbia University study is being conducted by the Chief of the Division of Plastic Surgery at Columbia University Hospital, Christine Hsu Rohde, MD, and is titled “PEMF and PEC Blocks in Mastectomy Reconstruction Patients”, was completed on March 9, 2022 and we are waiting for the published results https://www.clinicaltrials.gov/ct2/show/NCT03360214?term=sofpulse&draw=2&rank=8

 

 

The Stanford University Clinical trial is being conducted by Board certified Orthopedic surgeon Geoffrey Abrams, MD and is titled, “Pulsed Electromagnetic Field (PEMF) Therapy for Post-operative Pain”, is in recruitment stage with scheduled completion date of August 2023. https://www.clinicaltrials.gov/ct2/show/NCT04109638?term=sofpulse&draw=2&rank=6

 

Possible Expansion into Taiwan

 

Endonovo entered into a distribution agreement with Evermed Medical Enterprise Ltd. (“Evermed”) In Taiwan in 2019 in order commercialize SofPulse^®. In July 2021, Evermed through its dedicated team, in unison with Endonovo’s US operations, a has received QSD (Quality System Documentation) approval with the Taiwan FDA which is a major milestone in the commercialization of SofPulse^® in Taiwan.

 

In May 2023, Evermed submitted a final distribution approval application for the completion of the TFDA process and is now in the final stages in securing marketing approval from the Taiwan FDA.

 

Evermed and Endonovo expect to initiate the marketing of SofPulse^® by Q4, 2023 thereby allowing SofPulse^® to provide its benefits to an addressable market of more than 23.5 million Taiwanese. The surgical market in Taiwan is attractive having 1,123,077 in-hospital surgical cases annually along with more than 900,000 outpatient surgeries annually.

 

Competition

 

The pain management market is intensely competitive, highly fragmented and characterized by rapidly changing technology and drugs. We currently compete with other not as effective medical device manufacturers as well as pharmaceutical companies that have developed drugs that are highly invasive injectables and many have shown addiction and limited uses that affect patient outcomes negatively

 

However, SofPulse^® has shown through clinical studies and surgical results to be a highly effective non-pharmacologic pain and edema reduction product that directly addresses the cause of pain and can naturally activate the anti-inflammatory response that helps to speed up recovery time and positively impact quality of life.

 

New Product Development

 

Endonovo has an exhaustive pipeline of new products as well as new indications for the SofPulse^® PEMF technology. These would include:

 

	●	Dual Coil Device to provide a greater surface area for larger incisions or wounds
	●	Wearables – we are developing various head gear, braces and wraps to assist in fixing SofPulse® to various body sites
	●	Battery Replacement or Recharging – we are developing an subscription-based option for consumers to either replace or recharge the in-place batteries
	●	Physical and occupational therapy products

 

Another area of strategic importance is the development of orphan indications. Orphan devices are medical devices intended for the in-vivo diagnosis, prevention or treatment of a very rare life-threatening or chronically debilitating condition. FDA will designate medical devices that intend to benefit patients in treating or diagnosing a disease or condition that affects fewer than 8,000 individuals in the U.S. per year.

 

With orphan designation, the FDA grants a seven-year market exclusivity for that device that applies specifically to that designated orphan use. We intend to pursue this opportunity.

 

 

SofPulse will also be clinically evaluated for use in several other surgical and medical areas. These would include but not necessarily be limited to:

 

	●	Musculoskeletal pain
	●	Post Stroke Pain
	●	Chronic Pain
	●	Osteoarthritic joints
	●	Migraine
	●	Fibromyalgia
	●	Traumatic Brain Injury
	●	Multiple Sclerosis
	●	Post Stroke Pain

 

Employees

 

We do not have any employees but rely on consultants. We have retained approximately 9 individuals as independent contractors that are involved in management, business development and sales, research & development and administrative functions.

 

Properties

 

We have one office location in a serviced office suite in Woodland Hills, California which we rent on a month-to-month basis. We believe such office is adequate for our present needs.

 

Legal Proceedings

 

We were defendants in a case entitled Auctus Fund, LLC v. Endonovo Therapeutics, Inc. et.al 20-cv-11286-PBS filed in the Federal District Court in Massachusetts in July 2020. The complaint sought damages related to a variable rate convertible note dated in August 2019 in the original amount of $275,250 and alleged various counts of State and Federal securities laws violations, breach of contract, fraud, consumer fraud and other claimed theories of damages while claiming damages in excess of $500,000, other unspecified damages and attorney fees. Auctus filed an amended complaint that was responded to by way of a motion to dismiss. On February 28, 2022, the Court granted our motion to dismiss, refused to extend supplemental jurisdiction over the State law claims and held that as a result of the dismissal, the Company’s counterclaims were moot. To date neither party has appealed the ruling. Due to the nature of our business, we may become active in litigation relating to the defense, or assertion of our patent rights or other corporate matters. Refer to Note 9 Commitments and Contingencies for further discussion.

 

MANAGEMENT

 

The following table sets forth the name and age of officers and director. Our Executive officers are elected annually by our Board of Directors. Our executive officers hold their offices until they resign, are removed by the Board, or his successor is elected and qualified.

 

Name		Age		Position
Alan Collier		57		Director, Chief Executive Officer, Interim Chief Financial Officer, and Secretary
Ira Weisberg		74		President and Commercial Officer of Medical Division

 

 

Biographies

 

Alan Collier has been the Chief Executive Officer, Secretary, and a director of the Company Since March 2012. Mr. Collier has more than twenty (20) years of experience in finance, telecommunications, and consumer products. Over the progression of his career, he has specialized in the development and financing of early stage, high growth, and acquisitive companies (public and private). He has structured, participated in, and completed numerous transactions including mergers and acquisitions, equity and debt placements, capital restructuring, joint venture development, and channel partner procurement. Additionally, Mr. Collier was a Senior Managing Director at Mid-Market Securities, a FINRA-registered Broker-Dealer. He is also the co-founder and a Managing Member of C2 Capital, LLC, which provides management consulting services to companies preparing to go public. Prior to joining Mid-Market Securities, Mr. Collier was a Managing Director of Mosaic Capital and co-managed its Capital Markets Group at Mosaic Capital. He was previously a Vice President at Corporate Capital Group and Managing Director and CEO of Greenbridge Capital Group. He has held numerous board and executive positions throughout his career.

 

Ira Weisberg has been the President & Chief Commercial Officer of Company’s Medical Division since December 2022.

 

Mr. Weisberg has more than thirty years of experience in healthcare and pharmaceutical management, business development, corporate finance and marketing with a concentration in pharmaceutical and biotechnology corporate fund-raising strategy over the past five years. His expertise is in developing strategies to guide emerging medical companies to advance revenue and enhance company diversity, developmental pipelines and geographic reach particularly in fast-growing emerging medical device and pharmaceutical markets. Mr. Weisberg has been instrumental in developing licensing and acquisition strategy for an emerging specialty pharmaceutical and medical device biotechnology companies. Prior to his appointment as Endonovo’s President and Chief Commercial Officer of its Medical Division, Mr. Weisberg served as CEO and President of Amherst Pharmaceuticals, CEO of AlphaVax and Senior Vice President of Neurotrope Biosciences where he was responsible for commercial development, corporate funding, strategic planning and overseeing expansion of global operations through acquisition of licensing and partnering agreements for emerging pharmaceuticals, medical devices and other products.

 

Over his career, Mr. Weisberg has extensive executive experience in healthcare and pharmaceutical management, business development, finance, sales and marketing. Mr. Weisberg led negotiations and signed licensing agreements for strategic acquisitions, distribution and development deals for multiple companies in the medical device and pharmaceutical industry. His past medical administrative experience includes executive positions at Alphavax, Inc., Lifecycle Pharma, Chugai Pharma USA, Haemacure Corp and Aventis Behring. As Senior business development director with Aventis Behring, a global leader in recombinant albumin, he negotiated out-licensing, supply, distribution and development agreements with major pharmaceutical companies in excess of $100 million and contributed to revenues for the company’s specialty product valued at $500 million while assisting the company to be valued in excess of $750 million. As Vice President of Operations for Haemacure Corp., the U.S. market leader in plasma-derived surgical hemostats and adhesives, Mr. Weisberg established and positioned the company globally through negotiations and signing of multinational licensing and joint venture agreements. He guided growth and generated revenue more than $30 million in an IPO, providing capital for growth and product development.

 

Over the progression of his career, Mr. Weisberg has been recognized as a leading executive who has specialized in the marketing, operations and product development with established pharmaceutical and early-stage biotechnology companies (both public and private). He has structured, participated in and completed numerous transactions including mergers and acquisitions, equity, and joint ventures.

 

He joins the Endonovo executive team to structure and oversee the global expansion of licensing and distribution for SofPulse^® and Roma^® PEMF medical device technology.

 

Except as set forth in our discussion below in “Certain Relationships and Related Transactions,” none of our directors or executive officers has been involved in any transactions with us or any of our directors, executive officers, affiliates or associates which are required to be disclosed pursuant to the rules and regulations of the Commission.

 

 

Key Staff Member

 

In February 2022, we retained Garry Michael Kann, age 65, as Head of Corporate Development. Mr. Kann’s primary responsibilities will be to oversee the development of Endonovo’s “build up strategy” of acquiring complementary specialty service providers in the construction industry. Key responsibilities will be in identifying, preforming due diligence on, evaluating and otherwise assisting in company mergers and acquisitions, principally in the specialty construction industry. For more than the past five years, Mr. Kann has been the CEO of Firebird Partners a private investment firm and chairs the Capital Markets Group at Mosaic Capital LLC, a financial advisory firm both located in Los Angeles, California. Mr. Kann has been a prominent corporate finance professional in the United States on both the East and West Coasts for over 30 years. Over that time, he has been an innovator in asset backed financial instruments and has worked with clientele around the globe including Europe, Asia, Central and South America. As an investment banker he has completed more than 60 mergers and acquisition transactions exceeding $2 billion in value. Previously, while in senior management positions for a wide variety of financial institutions serving the middle market, he structured and completed more than 200 transactions exceeding several billion dollars in value.

 

Code of Ethics

 

We do not have a code of ethics that applies to our officers, employees and directors.

 

Corporate Governance

 

The business and affairs of the company are managed under the direction of our board. We have a board consisting of one member. In addition to the contact information in this annual report, each stockholder will be given specific information on how he/she can direct communications to the officers and our director of the corporation. All material communications from stockholders are relayed to our board.

 

Role in Risk Oversight

 

Our board is primarily responsible for overseeing our risk management processes. The board receives and reviews periodic reports from management, auditors, legal counsel, and others, as considered appropriate regarding our company’s assessment of risks. The board focuses on the most significant risks facing our company and our company’s general risk management strategy, and also ensures that risks undertaken by our company are consistent with the board’s appetite for risk. While the board oversees our company’s risk management, management is responsible for day-to-day risk management processes. We believe this division of responsibilities is the most effective approach for addressing the risks facing our company and that our board leadership structure supports this approach.

 

Section 16(a) Beneficial Ownership Reporting Compliance

 

We became subject to the reporting requirements of the Securities Exchange Act of 1934, as amended (“34 Act”) on June 15, 2015 when we filed a Form 8-A. Our officers and director have made appropriate filings under Section 16(a) of the Exchange Act, although on two occasions, Mr. Mann filed his Form 4 a few days late. These instances involved reporting of open market purchases and did not involve any short swing profits.

 

Executive Compensation.

 

The following executives of the Company received compensation in the amounts set forth in the chart below for the fiscal years ended December 31, 2022 and 2021. No other item of compensation was paid to any officer or director of the Company other than reimbursement of expenses.

 

Summary Compensation Table From 10-K

 

Name and Principal Position		Fiscal Year		Salary ($)				Bonus ($)				Stock Awards ($)				All Other Compensation ($)				Total ($)
Alan Collier, CEO, Interim		2022		$	300,000			$	-			$	550,000			$	-			$	850,000
CFO, Secretary and Director (*)		2021		$	300,000			$	-			$	-			$	-			$	300,000

 

(*) Salary information as reflected above represents compensation earned but not paid based on the terms of the consulting agreement. The Company’s Chief Executive was paid $170,000 as compensation. The Company’s Chief Executive Officer advanced $28,021 for corporate expenses, of which $25,521 was reimbursed by the Company leaving a balance of $2,625 in accounts payable as of December 31, 2022. For the year ended December 31, 2021, the Company’s Chief Executive was paid $243,650 as compensation and receive $13,405 of expenses reimbursement and $6,529 of accounts payable.

 

On April 12, 2022, a Company controlled by our Chief Executive Officer, received 25,000,000 shares of common stock with an estimated fair value of $550,000.

 

Outstanding Equity Awards at Fiscal Year-End Table

 

Name

Number of Securities Underlying Unexercised Options (#) Exercisable

Number of Securities Underlying Unexercised Options (#) Unexercisable

Option Exercise Price ($)

Option Expiration Date

Alan Collier, CEO, Interim

5,000

-

$

54.00

4/17/2027

CFO, Secretary and Director

 

 

Compensation of Directors

 

The directors receive no compensation for serving as directors. However, the Company may reimburse its directors for any out-of-pocket cost reasonably incurred to attend a Board meeting.

 

Compensation Agreements

 

All of the new officers pursuant to the terms of the Share Exchange Agreement dated March 14, 2012, have agreed to accrue and defer payment of their compensation until the Company has generated sufficient financing proceeds or revenue to pay such compensation. Mr. Collier received compensation of $25,000 per month. No compensation was provided for Michael Mann (former President of the Company) during the year ended December 31, 2022, and 2021. Mr. Mann has been acting as an advisor since he retired on February 28, 2019.

 

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.

 

The following table sets forth certain information regarding our shares of common stock beneficially owned as of April 13, 2023, for (i) each stockholder known to be the beneficial owner of 5% or more of our outstanding shares of common stock, (ii) each named executive officer and director, and (iii) all executive officers and directors as a group. A person is considered to beneficially own any shares: (i) over which such person, directly or indirectly, exercises sole or shared voting or investment power, or (ii) of which such person has the right to acquire beneficial ownership at any time within 60 days through an exercise of stock options or warrants. Unless otherwise indicated, voting and investment power relating to the shares shown in the table for our directors and executive officers is exercised solely by the beneficial owner or shared by the owner and the owner’s spouse or children.

 

For purposes of this table, a person or group of persons is deemed to have “beneficial ownership” of any shares of common stock that such person has the right to acquire within 60 days of April 13, 2023. For purposes of computing the percentage of outstanding shares of our common stock held by each person or group of persons named above, any shares that such person or persons has the right to acquire within 60 days of April 13, 2023, is deemed to be outstanding but is not deemed to be outstanding for the purpose of computing the percentage ownership of any other person. The inclusion herein of any shares listed as beneficially owned does not constitute an admission of beneficial ownership. Unless otherwise specified, the address of each of the persons set forth below is care of the company at the address of 6320 Canoga Avenue, 15th Floor Woodland Hills, CA 91367.

 

Name of Beneficial Owner		Amount of Beneficial Ownership (1)				Percent of Ownership (2)
Alan Collier			45,031,219				16.7	%
James Greenland			20,175,000				7.5	%
Michael Mann			13,525,437				5.0	%
All officers and directors as a group (1 person)			45,031,219				16.7	%

 

	(1)	This includes common shares controlled by Mr. Collier, Chairman, Chief Executive Officer, and Chief Financial Officer.
	(2)	Based on shares of common stock outstanding as of April 14, 2023.

 

Certain Relationships and Related Transactions, and Director Independence.

 

On February 10, 2015, the Company issued a promissory note to Michael Mann (former President) for a principal amount of $50,000. The Note carries an interest rate of 12% per annum and a maturity date of June 4, 2015, with interest due monthly. On September 29, 2019, the maturity date of the promissory note was extended to December 31, 2019. As of December 31, 2022 and 2021, the Company has a remaining principal balance of $12,100 and $26,100, respectively. During the years ended December 31, 2022 and 2021, the Company has repaid 14,000 and $16,900 in cash, respectively.

 

 

On December 21, 2017, the Company issued a promissory note to Michael Mann (former President) for a principal amount of $100,000. The Note carries an interest rate of 10% per annum and a maturity date of March 22, 2018, with interest due monthly. On September 29, 2019, the maturity date of the promissory note was extended to December 31, 2019. As of December 31, 2022 and 2021, the Company has a remaining principal balance of $100,000.

 

The outstanding notes to Mr. Mann equal to $112,100 and $126,100 at December 31, 2022 and December 31, 2021, respectively. In the opinion of management, these notes were on terms no less favorable to the lender than the Company might have obtained from an unaffiliated party.

 

Director Independence

 

We do not have any independent directors. Because our common stock is not currently listed on a national securities exchange, we have used the definition of “independence” of The NASDAQ Stock Market to make this determination. NASDAQ Listing Rule 5605(a)(2) provides that an “independent director” is a person other than an officer or employee of the company or any other individual having a relationship which, in the opinion of the Company’s Board of Directors, would interfere with the exercise of independent judgment in carrying out the responsibilities of a director. The NASDAQ listing rules provide that a director cannot be considered independent if:

 

●	the director is, or at any time during the past three years was, an employee of the company;
●	the director or a family member of the director accepted any compensation from the company in excess of $120,000 during any period of 12 consecutive months within the three years preceding the independence determination (subject to certain exclusions, including, among other things, compensation for board or board committee service);

 

	a family member of the director is, or at any time during the past three years was, an executive officer of the company;
●	the director or a family member of the director is a partner in, controlling stockholder of, or an executive officer of an entity to which the company made, or from which the company received, payments in the current or any of the past three fiscal years that exceed 5% of the recipient’s consolidated gross revenue for that year or $200,000, whichever is greater (subject to certain exclusions);
●	the director or a family member of the director is employed as an executive officer of an entity where, at any time during the past three years, any of the executive officers of the company served on the compensation committee of such other entity; or
●	the director or a family member of the director is a current partner of the Company’s outside auditor, or at any time during the past three years was a partner or employee of the Company’s outside auditor, and who worked on the company’s audit.

 

Mr. Alan Collier is not considered independent because he is the Company’s Chief Executive Officer and acting Chief Financial Officer.

 

We do not currently have a separately designated audit, nominating or compensation committee.

 

 

DESCRIPTION OF CAPITAL STOCK

 

The Company’s Articles of Incorporation, as amended (the “Articles of Incorporation”) authorize us to issue (a) 2,500,000,000 shares of Common Stock, par value $0.0001 per share, of which, 281,635,405 shares are issued and outstanding as of May 19, 2023, and (b) 5,000,000 shares of Preferred Stock, $0.001 par value per share, 26,338 of which were issued and outstanding on May 19, 2023.

 

Common Stock

 

Holders of Common Stock are entitled to one vote for each share on all matters submitted to a vote of shareholders. Holders of Common Stock do not have cumulative voting rights. Holders of Common Stock are entitled to share in all dividends that the Board of Directors, in its discretion, declares from legally available funds. In the event of our liquidation, dissolution or winding up, subject to the preferences of any shares of Preferred Stock which may then be authorized and outstanding, each outstanding share entitles its holder to participate in all assets that remain after payment of liabilities and after providing for each class of stock, if any, having preference over the Common Stock.

 

Holders of Common Stock have no conversion, preemptive or other subscription rights, and there are no redemption provisions for the Common Stock. The rights of the holders of Common Stock are subject to any rights that may be fixed for holders of Preferred Stock, when and if any Preferred Stock is authorized and issued. All outstanding shares of Common Stock are duly authorized, validly issued, fully paid and non-assessable.

 

Preferred Stock

 

Our articles of incorporation authorized the issuance of up to 5,000,000 shares of Preferred Stock in one or more series with such designations, voting powers, if any, preferences and relative, participating, optional or other special rights, and such qualifications, limitations and restrictions, as are determined by resolution of our Board of Directors.

 

Series AA Super Voting Preferred Stock

 

On April 3, 2013, the Company filed a Certificate of Designation that authorized the issuance of up to one million (1,000,000) shares of a new series designated “Series AA Super Voting Preferred Stock,” and established the rights, preferences and limitations thereof.

 

Each holder of outstanding shares of Series AA Super Voting Preferred Stock shall be entitled to one hundred thousand (100,000) votes for each share of Series AA Super Voting Preferred Stock held on the record date for the determination of stockholders entitled to vote at each meeting of stockholders of the Company.

 

There are no rights to dividends, liquidation preferences or conversion rights associated with the Series AA Super Voting Preferred Stock. We presently have 25,000 shares of Series AA Super Voting Preferred Stock outstanding which are held by Alan Collier our CEO. This gives him effective control over all shareholder votes conducted by us.

 

The summary of the rights, privileges and preferences of the Series AA Super Voting Preferred Stock described above is qualified in its entirety by reference to the Certificate of Designation, a copy of which is an exhibit hereto.

 

Series B Convertible Preferred Stock

 

On February 7, 2017, the Company filed a certificate of designation for 50,000 shares of Series B Convertible Preferred Stock designated as Series B (“Series B”) which are authorized and convertible, at the option of the holder, commencing six months from the date of issuance into common shares and warrants. For each share of Series B, the holder, on conversion, shall receive the stated value divided by 75% of the market price on the date of purchase of Series B and a three-year warrant exercisable into up to a like amount of common shares with an exercise price of 150% of the market price as defined in the Certificate of Designation. Dividends shall be paid only if dividends on the Company’s issued and outstanding Common Stock are paid and the amount paid to the Series B holder will be as though the conversion shares had been issued. The Series B holders have no voting rights. Upon liquidation, the holder of Series B, shall be entitled to receive an amount equal to the stated value, $100 per share, plus any accrued and unpaid dividends thereon before any distribution is made to Series C Secured Redeemable Preferred Stock or common stockholders. As of the date of this Prospectus, 600 shares of Series B are outstanding.

 

 

Series C Convertible Redeemable Preferred Stock

 

On December 22, 2017, the Company filed a certificate of designation for 8,000 shares of Series C Secured Redeemable Preferred Stock (“Series C”). Each share of the C Preferred is entitled to receive a $20.00 quarterly dividend commencing March 31, 2018 and each quarter thereafter and is to be redeemed for the stated value, $1,000 per share, plus accrued dividends in cash (i) at the Company’s option, commencing one year from issuance and (ii) mandatorily as of December 31, 2019. On January 29, 2020, the Company filed the amended and restated certificate of designation fort its Series C Secured Redeemable Preferred Stock. The amendment changed the rights of the Series C by (a) removing the requirement to redeem the Series C, (b) removing the obligation to pay dividends on the Series C, (c) Allowing the holders of shares of Series C to convert the stated value of their shares into common stock of the Company at 75% of the last closing price of such common stock on the day prior to conversion. The C Preferred does not have any rights to vote with the common stock.

 

Upon liquidation, the holder of Series C, shall be entitled to receive an amount equal to the stated value, $1,000 per share, plus any accrued and unpaid dividends thereon before any distribution is made to common stockholders but after distributions are made to holders of Series B.

 

Management reviewed the guidance in ASC 470-60 Troubled Debt Restructurings and ASC 470-50 Debt Modifications and Extinguishments and concluded that the changes to the terms of the Series C qualified for debt extinguishment and recorded a loss on debt extinguishment totaling approximately $604,000.

 

During the year ended December 31, 2022, and 2021, the Company converted 25 and 1,051 shares of Series C into 1,111,111 and 2,754,822 shares of common stock, respectively. As of December 31, 2022, and 2021, there were 738 shares of Series C outstanding, respectively

 

Series D Convertible Preferred Stock

 

On November 11, 2019, the Company filed a certificate of designation for 20,000 shares of Series D Convertible Preferred Stock designated as Series D (“Series D”), which are convertible, at the option of the holder, at any time from the date of issuance, into shares of common shares. On or prior to August 1, 2020, for each share of Series D, the holder, on conversion, shall receive a number of common shares equal to 0.01% of the Company’s issued and outstanding shares on conversion date and for conversion on or after August 2, 2020, the holder shall receive conversion shares as though the conversion date was August 1, 2020, with no further adjustments for issuances by the Company of common stock after August 1, 2020, except for stock split or reverse stock splits of the common stock.

 

The Series D holders have no voting rights. Upon liquidation, the holder of Series D, shall be entitled to receive an amount equal to the stated value, $1,000 per share, plus any accrued and unpaid dividends thereon before any distribution is made to common stockholders.

 

In September 2022, the Company offered to each holder of Series D the opportunity to convert each share of Series D into 100,000 shares of the Company’s common stock at an effective conversion price of $0.01. In addition, the Company included a make whole provision, which assures each holder a 15% return on the resale, effectively potentially granting them additional common shares until the holder realizes a 15% return upon resale.

 

During the year ended December 31, 2022, the Company issued 25,500,000 shares of common stock upon conversion of 255 shares of Series D preferred stock, for a total value of $255,000. At December 31, 2022, based on the stock price, the value of these shares was in excess of the 15% guaranteed return.

 

As of December 31, 2022 and 2021, there were 50 and 305 shares of Series D outstanding, respectively.

 

Dividend Policy

 

We have not declared dividends since our inception. Holders of Common Stock are entitled to receive ratably such dividends, if any, as may be declared by the Board of Directors out of funds legally available. We presently anticipate that all earnings, if any, will be retained for development of our business. Any future disposition of dividends will be at the discretion of our Board of Directors and will depend upon, among other things, our future earnings, operating and financial condition, capital requirements, and other factors.

 

 

Transfer Agent

 

The transfer agent for our common stock is Equity Stock Transfer, 237 W 37th Street - Suite 601, New York, NY 10018; phone: (212) 575-5757.

 

LEGAL MATTERS

 

The validity of the common stock offered by this offering circular will be passed upon for us by Frank J. Hariton, Esq. White Plains, New York.

 

DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT LIABILITIES

 

Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers or persons controlling the registrant pursuant to the foregoing provisions, the registrant has been informed that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is therefore unenforceable.

 

EXPERTS

 

The financial statements for the years ended December 31, 2022 and December 31, 2021, included in this prospectus have been audited by Rose, Snyder & Jacobs LLP, Encino, California, to the extent and for the periods indicated in their report thereon. Such financial statements have been included in this prospectus and Registration Statement in reliance upon the report of Rose Snyder & Jacobs LLP and upon the authority of such firm as experts in auditing and accounting.

 

WHERE YOU CAN FIND MORE INFORMATION

 

We have filed a registration statement on Form S-1 with the SEC for the stock offered pursuant to this prospectus. This prospectus does not contain all of the information set forth in the registration statement and the exhibits and schedules thereto. Statements contained in this prospectus as to the contents of any contract or other document referred to are not necessarily complete and in each instance reference is made to the copy of such contract or other document filed as an exhibit to the registration statement, each such statement being qualified in all respects by such reference. For further information with respect to us and the common stock offered hereby, please refer to the registration statement and its exhibits and schedules for further information relating to us and our common stock.

 

We are subject to the information and periodic reporting requirements of the Securities Exchange Act of 1934 and in accordance therewith file reports, proxy statements and other information with the SEC. Such reports, proxy statements, other information and a copy of the registration statement may be inspected by anyone without charge and copies of these materials may be obtained upon the payment of the fees prescribed by the SEC, at the Public Reference Room maintained by the SEC at Room 1580, 100 F Street, N.E., Washington, D.C. 20549. You may obtain information on the operation of this public reference room by calling 1-800-SEC-0330. The Registration Statement, including all exhibits, schedules and amendments, has been filed with the SEC through the Electronic Data Gathering Analysis and Retrieval system and is available to the public from the SEC’s web site at http://www.sec.gov.

 

 

INDEX TO FINANCIAL STATEMENTS

 

Audited Consolidated Financial Statements of Endonovo Therapeutics, Inc.

 

Report of Independent Registered Public Accounting Firm (PCAOB ID No: 468)	F-2
Consolidated Balance Sheets for December 31, 2022 and 2021	F-4
Consolidated Statements of Operations for the Years Ended December 31, 2022 and 2021	F-5
Consolidated Statements of Stockholders’ Deficit for the Years Ended December 31, 2022 and 2021	F-6
Consolidated Statements of Cash Flows for the Years Ended December 31, 2022 and 2021	F-8
Notes to Consolidated Financial Statements for the Years Ended December 31, 2022 and 2021	F-9

 

 

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

To the Board of Directors and Stockholders

Endonovo Therapeutics, Inc. and Subsidiaries

 

Opinion on the Financial Statements

 

We have audited the accompanying consolidated balance sheets of Endonovo Therapeutics, Inc. and Subsidiaries (the Company) as of December 31, 2022 and 2021, and the related statements of operations, shareholders’ deficit, and cash flows for each of the years in the two-year period ended December 31, 2022, and the related notes to the consolidated financial statements (collectively referred to as the consolidated financial statements). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2022 and 2021, and the results of its operations and its cash flows for each of the years in the two-year period ended December 31, 2022, in conformity with accounting principles generally accepted in the United States of America.

 

Explanatory Paragraph – Going Concern

 

The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the consolidated financial statements, the Company has continued to incur significant operating losses and negative cash flows from operations, during the year ended December 31, 2022, and has negative working capital at December 31, 2022. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 1. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

Basis for Opinion

 

These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

 

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

 

Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.

 

Critical Audit Matters

 

The critical audit matters communicated below are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.

 

 

Instruments with Embedded Conversion Features

 

Description of the Matter

 

As discussed in Note 1 to the Consolidated Financial Statements, the Company issues instruments with embedded conversion features. Some of these embedded conversion features result in a derivative liability that is measured at fair value.

 

Auditing derivative liability is complex and highly judgmental due to the variability and uncertainty associated with the Company’s assessment of estimates used in calculating the value of the derivative liability. Changes in these estimates would have a significant effect on the valuation of the derivative liability and the related change in fair value of derivative liability.

 

How We Addressed the Matter in Our Audit

 

To test the derivative liability, our audit procedures included, among others, evaluating the appropriateness of the Company’s accounting policy for instruments with embedded conversion features and the estimates and assumptions used in calculating the fair value of the derivative liability. We evaluated whether the methods used to calculate the fair value of the derivative liability were applied consistently. We also tested the completeness and accuracy of the underlying data used for the fair value measurement.

 

/s/ Rose, Snyder & Jacobs LLP

 

We have served as the Company’s auditor since 2008.

 

Encino, CA

April 17, 2023

 

 

Endonovo Therapeutics, Inc. and Subsidiaries

Consolidated Balance Sheets

As of December 31,

 

		2022				2021
ASSETS
Current Assets:
Cash		$	98			$	85,936
Accounts receivable, net			-				944
Prepaid expenses and other current assets			15,724				7,975
Total current assets			15,822				94,855
Patents, net			1,265,444				1,912,356
Total assets		$	1,281,266			$	2,007,211
LIABILITIES AND SHAREHOLDERS’ DEFICIT
Current Liabilities
Accounts payable and accrued liabilities		$	884,195			$	658,463
Accrued interest			3,542,650				2,528,459
Deferred compensation			4,442,606				3,891,361
Notes payable, net of discounts of $10,587 and $75,800 as of December 31, 2022 and 2021, respectively			7,041,145				7,055,030
Notes payable – former related party			112,100				126,100
Derivative liability			17,359,064				3,442,297
Total current liabilities			33,381,760				17,701,710
Other long term liabilities			79,825				79,825
Total liabilities			33,461,585				17,781,535
COMMITMENTS AND CONTINGENCIES, note 8
Shareholders’ deficit
Super AA super voting preferred stock, $0.001 par value; 1,000,000 authorized and 25,000 issued and outstanding at December 31, 2022 and December 31, 2021			25				25
Series B convertible preferred stock, $0.0001 par value; 50,000 shares authorized and 600 issued and outstanding at December 31, 2022 and December 31, 2021			1				1
Series C convertible preferred stock, $0.0001 par value, 8,000 shares authorized, 738 shares issued and outstanding at December 31, 2022 and December 31, 2021			-				-
Series D convertible preferred stock, $0.0001 par value; 20,000 shares authorized and 50 and 305 issued and outstanding at December 31, 2022 and December 31, 2021, respectively			-				-
Common stock, $0.0001 par value; 2,500,000,000 shares authorized; and 213,227,538 and 74,498,761 shares issued and outstanding as of December 31, 2022 and December 31, 2021, respectively			21,322				7,449
Additional paid-in capital			42,919,086				40,663,187
Stock subscriptions			(1,570	)			(1,570	)
Accumulated deficit			(75,119,183	)			(56,443,416	)
Total shareholders’ deficit			(32,180,319	)			(15,774,324	)
Total liabilities and shareholders’ deficit		$	1,281,266			$	2007,211

 

See accompanying summary of accounting policies and notes to consolidated financial statements.

 

 

Endonovo Therapeutics, Inc. and Subsidiaries

Consolidated Statements of Operations

For the Years Ended December 31,

 

		2022				2021
Revenue		$	135,355			$	73,105
Cost of revenue			9,990				14,985
Gross profit			125,365				58,120
Operating expenses			3,389,705				2,284,667
Loss from operations			(3,264,340	)			(2,226,547	)
Other income (expense)
Change in fair value of derivative liability			(14,026,546	)			41,057
Gain on extinguishment of debt			362,894				22,162
Other expense			(225,268	)			-
Interest expense, net			(1,321,575	)			(941,566	)
Total other expense			(15,210,495	)			(878,347	)
Loss before income taxes			(18,474,835	)			(3,104,894	)
Provision for income taxes			-				-
Net loss		$	(18,474,835	)		$	(3,104,894	)
Basic and diluted loss per share		$	(0.13	)		$	(0.05	)
Weighted average common share outstanding:
Basic and diluted			139,206,511				59,836,620

 

See accompanying summary of accounting policies and notes to consolidated financial statements.

 

 

Endonovo Therapeutics, Inc. and Subsidiaries

Consolidated Statement of Shareholders’ Deficit

For the Years Ended December 31, 2022 and 2021

 

		Series AA								Series B Convertible								Series D Convertible								Series C Convertible																Additional												Total
		Preferred Stock								Preferred Stock								Preferred Stock								Preferred Stock								Common Stock								Paid-in				Subscription				Accumulated				Shareholders’
		Shares				Amount				Shares				Amount				Shares				Amount				Shares				Amount				Shares				Amount				Capital				Receivable				Deficit				Deficit
Balance December 31, 2020			25,000			$	25				600			$	1				305			$	-				763				-				24,536,689			$	2,453			$	38,963,827			$	(1,570	)		$	(53,338,522	)		$	(14,373,786	)
Issuance of commitment shares in connection with promissory notes			-				-				-				-				-				-				-				-				7,868,668				787				221,905				-				-				222,692
Common stock issued for cash			-				-				-				-				-				-				-				-				7,000,000				700				125,300				-				-				126,000
Shares issued for conversion of notes payable and accrued interest			-				-				-				-				-				-				-				-				27,461,307				2,746				1,115,244				-				-				1,117,900
Shares issued for conversion of Preferred Series C to common share			-				-				-				-				-				-				(25	)			-				1,111,111				111				(111	)			-				-				-
Common shares issued for debt settlement			-				-				-				-				-				-				-				-				1,515,152				151				57,576				-				-				57,727
Common shares issued as settlement of debt with former related party			-				-				-				-				-				-				-				-				2,505,834				251				84,446				-				-				84,697
Common shares issued pursuant to consulting agreements			-				-				-				-				-				-				-				-				2,500,000				250				95,000				-				-				95,250
Net loss			-				-				-				-				-				-				-				-				-				-				-				-				(3,104,894	)			(3,104,894	)
Balance December 31, 2021			25,000				25				600				1				305				-				738				-				74,498,761				7,449				40,663,187				(1,570	)			(56,443,416	)			(15,774,324	)

 

 

Endonovo Therapeutics, Inc. and Subsidiaries

Consolidated Statement of Shareholders’ Deficit

For the Years Ended December 31, 2022 and 2021

 

		Series AA								Series B Convertible								Series D Convertible								Series C Convertible																Additional												Total
		Preferred Stock								Preferred Stock								Preferred Stock								Preferred Stock								Common Stock								Paid-in				Subscription				Accumulated				Shareholders’
		Shares				Amount				Shares				Amount				Shares				Amount				Shares				Amount				Shares				Amount				Capital				Receivable				Deficit				Deficit
Balance December 31, 2021			25,000			$	25				600			$	1				305			$	-				738				-				74,498,761			$	7,449			$	40,663,187			$	(1,570	)		$	(56,443,416	)		$	(15,774,324	)
Issuance of Commitment shares in connection with promissory notes			-				-				-				-				-				-				-				-				3,450,000				345				46,448				-				-				46,793
Common Stock issued for cash			-				-				-				-				-				-				-				-				15,000,000				1,500				140,500				-				-				142,000
Shares issued for conversion of notes payable and accrued interest			-				-				-				-				-				-				-				-				25,850,000				2,585				514,415				-				-				517,000
Shares issued for conversion of Preferred Series D to common share			-				-				-				-				(255	)			-				-				-				25,500,000				2,550				(2,550	)			-				-				-
Inducement loss related to conversion of preferred stock			-				-				-				-				-				-				-				-				-				-				200,932								(200,932	)			-
Common Shares issued from debt settlement			-				-				-				-				-				-				-				-				2,428,777				243				45,904				-				-				46,147
Common Shares issued for services			-				-				-				-				-				-				-				-				66,500,000				6,650				1,310,250				-				-				1,316,900
Net loss			-				-				-				-				-				-				-				-				-				-				-				-				(18,474,835	)			(18,474,835	)
Balance December 31, 2022			25,000			$	25				600			$	1				50				-				738				-				213,227,538				21,322				42,919,086				(1,570	)			(75,119,183	)			(32,180,319	)

 

See accompanying summary of accounting policies and notes to consolidated financial statements.

 

 

Endonovo Therapeutics, Inc. and Subsidiaries

Consolidated Statements of Cash Flows

For the Years Ended December 31,

 

		2022				2021
Operating activities:
Net loss		$	(18,474,835	)		$	(3,104,894	)
Adjustments to reconcile net loss to cash used in operating activities:
Depreciation and amortization expense			646,912				648,492
Bad debt expense			944				-
Stock-based compensation			45,000				-
Fair value of commitment shares issued with debt			7,698				70,970
Fair value of equity issued for services			1,311,900				95,250
Amortization of note discount and original issue discount			110,611				144,196
Change in fair value of derivative liability			14,026,546				(41,057	)
Gain on extinguishment of debt			(362,894	)			(22,162	)
Changes in assets and liabilities:
Accounts receivable			-				(2	)
Prepaid expenses and other current assets			(7,750	)			23,850
Accounts payable and accrued liabilities			269,391				(42,470	)
Accrued interest			1,196,394				733,999
Deferred compensation			551,245				507,244
Net cash used in operating activities			(678,838	)			(986,584	)
Financing activities:
Proceeds from the issuance of notes payable			465,000				950,000
Repayments on former related party advances			(14,000	)			(16,900	)
Proceeds from issuance of common stock and units			142,000				126,000
Net cash provided by financing activities			593,000				1,059,100
Net increase (decrease) in cash			(85,838	)			72,516
Cash, beginning of year			85,936				13,420
Cash, end of year		$	98			$	85,936
Supplemental disclosure of cash flow information:
Cash paid for interest		$	-			$	-
Cash paid for income taxes		$	-			$	-
Non-Cash Investing and Financing Activities:
Conversion of notes payable and accrued interest to common stock		$	517,000			$	493,748
Conversion of Preferred stock to common stock		$	255,000			$	33,333
Original debt discount on convertible notes		$	45,398			$	-
Issuance of common stock to settle debt		$	-			$	202,697

 

See accompanying summary of accounting policies and notes to consolidated financial statements.

 

 

Endonovo Therapeutics, Inc. and Subsidiary

Notes to Consolidated Financial Statements

For the Years Ended December 31, 2022 and 2021

 

Note 1 - Nature of Business and Summary of Significant Accounting Policies

 

Endonovo Therapeutics, Inc. (Endonovo or the “Company”) is an innovative biotechnology company that has developed a bio-electronic approach to regenerative medicine. Endonovo is a growth stage company whose stock is publicly traded (OTCQB: ENDV).

 

The Company develops, manufactures, and distributes evolutionary medical devices focused on the rapid healing of wounds and reduction of inflammation on and in the human body. The Company’s non-invasive bioelectric medical devices are designed to target inflammation, cardiovascular diseases, chronic kidney disease, and central nervous system disorders (“CNS” disorders).

 

Endonovo’s core mission is to transform the field of medicine by developing safe, wearable, non-invasive bioelectric medical devices that deliver the Company’s Electroceutical^® Therapy. Endonovo’s bioelectric Electroceutical^® devices harnesses bioelectricity to restore key electrochemical processes that initiate anti-inflammatory processes and growth factors in the body necessary for healing to rapidly occur.

 

On January 22, 2014, Hanover Portfolio Acquisitions, Inc. (the “Company”) received written consents in lieu of a meeting of stockholders from holders of a majority of the shares of Common Stock representing in excess of 50% of the total issued and outstanding voting power of the Company approving an amendment to the Company’s Certificate of Incorporation to change the name of the Company from “Hanover Portfolio Acquisitions, Inc.” to “Endonovo Therapeutics, Inc.” The name change was affected pursuant to a Certificate of Amendment (the “Certificate of Amendment”), filed with the Secretary of State of Delaware on January 24, 2014.

 

Basis of Presentation and Principles of Consolidation

 

The consolidated financial statements of the Company include the accounts of ETI, IP Resources International, Inc., Aviva Companies Corporation, WeHealAnimals, Inc. and SofPulse, Inc. All significant intercompany accounts and transactions are eliminated in consolidation.

 

Going Concern

 

These accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business for a period following the date of these consolidated financial statements. The Company has accumulated losses of $75.1 million, negative cash flows from operations of approximately $0.7 million and $33.4 million of working capital deficit. The Company has raised approximately $0.6 million in debt and equity financing for the year ended December 31, 2022. The Company is raising additional capital through debt and/or equity securities in order to continue the funding of its operations. However, there is no assurance that the Company can raise enough funds or generate sufficient revenues to pay its obligations as they become due, which raises substantial doubt about our ability to continue as a going concern. No adjustments have been made to the carrying value of assets or liabilities as a result of this uncertainty. To reduce the risk of not being able to continue as a going concern, management has implemented its business plan to materialize revenues from potential future license and distribution agreements, has raised capital through the issuance of promissory notes and has engaged a broker/dealer to raise additional capital.

 

Use of Estimates

 

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Critical estimates include the value of shares issued for services and in connection with notes payable agreements, the valuation of the derivative liability, and the valuation of deferred income tax assets. Management uses its historical records and knowledge of its business in making these estimates. Actual results could differ from these estimates.

 

 

Cash and cash equivalents

 

The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents. Financial instruments that potentially subject us to a concentration of credit risk consist of cash and cash equivalents. Cash is deposited with what we believe are highly credited, quality institutions. The deposited cash may exceed Federal Deposit Insurance Corporation (“FDIC”) insured limits. At December 31, 2022 and 2021, the Company does not hold any cash in excess of FDIC limits and does not have any cash equivalents.

 

Accounts Receivable

 

The Company uses the specific identification method for recording the provision for doubtful accounts, which was $0 at December 31, 2022 and 2021. Account receivables are written off when all collection attempts have failed.

 

Impairment of Long-lived Assets

 

The Company reviews its long-lived assets for impairment whenever events or changes in business circumstances indicate that the carrying amount of assets may not be fully recoverable or that the useful lives of these assets are no longer appropriate. If impairment is indicated, the asset is written down to its estimated fair value. The Company did not recognize any impairment loss during the years ended December 31, 2022 and 2021.

 

Equity-Based Compensation

 

The Company measures equity-based compensation cost at the grant date based on the fair value of the award and recognizes it as expense, net of forfeitures which are recognized as they occur, over the vesting or service period, as applicable, of the stock award using the straight-line method.

 

Income Taxes

 

The Company records a tax provision for the anticipated tax consequences of its reported results of operations. The provision for income taxes is computed using the asset and liability method, under which deferred tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the financial reporting and tax bases of assets and liabilities, and for operating losses and income tax credit carry-forward. Deferred tax assets and liabilities are measured using the currently enacted tax rates that apply to taxable income in effect for the years in which those tax assets are expected to be realized or settled. The Company records a valuation allowance to reduce deferred tax assets to the amount that is more likely than not to be realized.

 

The Company has adopted ASC Topic 740, which clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements. ASC Topic 740 prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return, and also provides guidance on derecognition of tax benefits, classification on the balance sheet, interest and penalties, accounting in interim periods, disclosure and transition. The Company has determined that the adoption did not result in the recognition of any liability for unrecognized tax benefits and that there are no unrecognized tax benefits that would, if recognized, affect the Company’s effective tax rate.

 

Net Loss per Share

 

Basic net loss per share is calculated based on the net loss attributable to common shareholders divided by the weighted average number of shares outstanding for the period excluding any dilutive effects of options, warrants, unvested share awards and convertible securities. Diluted net loss per common share assumes the conversion of all dilutive securities using the if-converted method and assumes the exercise or vesting of other dilutive securities, such as options, common shares issuable under convertible debt, warrants and restricted stock using the treasury stock method when dilutive.

 

The Company has 3,012,410 stock options, of which 262,410 are exercisable and 2,000 warrants convertible into an equivalent number of common stock as of December 31, 2022. The Company has 513,730 stock options, of which 513,730 are exercisable and 22,200 warrants convertible into an equivalent number of common stock as of December 31, 2021.

 

As of December 31, 2022 and 2021, the Company has variable rate convertible notes in an aggregate amount of $7,039,832 and $6,442,035, respectively, including principal and accrued interest, which are convertible into 1,355,310,243 and 632,789,106, respectively, shares of common stock. Such shares are not included in the calculation of the diluted net loss per share as they would have an antidilutive effect.

 

 

Fair Value of Financial Instruments

 

Accounting guidance on fair value measurements and disclosures defines fair value, establishes a framework for measuring the fair value of assets and liabilities using a hierarchy system, and defines required disclosures. It clarifies that fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants in the market in which the reporting entity transacts business.

 

The Company’s balance sheet contains derivative liability that is recorded at fair value on a recurring basis. The three-level valuation hierarchy for disclosure of fair value is as follows:

 

Level 1: uses quoted market prices in active markets for identical assets or liabilities.

 

Level 2: uses observable market-based inputs or unobservable inputs that are corroborated by market data.

 

Level 3: uses unobservable inputs that are not corroborated by market data.

 

The fair value of the Company’s recorded derivative liability is determined based on unobservable inputs that are not corroborated by market data, which require a Level 3 classification. A Black-Sholes option valuation model was used to determine the fair value. The Company records derivative liability on the consolidated balance sheets at fair value with changes in fair value recorded in the consolidated statements of operation.

 

The following table presents balances of the liabilities with significant unobservable inputs (Level 3) as of December 31, 2022 and 2021:

 

		Fair Value Measurements at December 31, 2022 Using
		Quoted Prices in Active Markets for				Significant Other				Significant
		Identical Assets				Observable Inputs				Unobservable Inputs
		(Level 1)				(Level 2)				(Level 3)				Total
Derivative liability		$	-			$	-			$	17,359,064			$	17,359,064
Total		$	-			$	-			$	17,359,064			$	17,359,064

 

		Fair Value Measurements at December 31, 2021 Using
		Quoted Prices in Active Markets for				Significant Other				Significant
		Identical Assets				Observable Inputs				Unobservable Inputs
		(Level 1)				(Level 2)				(Level 3)				Total
Derivative liability		$	-			$	-			$	3,442,297			$	3,442,297
Total		$	-			$	-			$	3,442,297			$	3,442,297

 

 

 

The following table presents changes of the liabilities with significant unobservable inputs (Level 3) for the years ended December 31, 2022 and 2021:

 

		Derivative
		Liability
Balance December 31, 2020		$	4,202,597
Settlement by debt extinguishment			(133,386	)
Settlement by debt conversion			(585,857	)
Change in estimated fair value			(41,057	)
Balance December 31, 2021		$	3,442,297
Settlement by debt Extinguishment			(109,779	)
Change in estimated fair value			14,026,546
Balance December 31, 2022		$	17,359,064

 

Derivative Liability

 

As of December 31, 2022 and 2021, the Company has variable rate convertible promissory notes, which contained variable conversion rates based on unknown future prices of the Company’s common stock. This resulted in the recognition of a derivative liability as the conversion feature failed the scope exception for derivative accounting due to the variability of its conversion price. The Company measures the derivative liability using the Black-Scholes option valuation model using the following assumptions:

 

			For Years Ending December 31,
			2022				2021
Expected term			0-1 month				1 -4 months
Exercise price			$0.004-$0.015				$0.01-$0.03
Expected volatility			153%-169%				177%-206%
Expected dividends			None				None
Risk-free interest rate			1.63%-4.73%				0.06%-0.39%
Forfeitures			None				None

 

The assumptions used in determining fair value represent management’s best estimates, but these estimates involve inherent uncertainties and the application of management’s judgment. As a result, if factors change, including changes in the market value of the Company’s common stock, managements’ assessment, or significant fluctuations in the volatility of the trading market for the Company’s common stock, the Company’s fair value estimates could be materially different in the future.

 

The Company computes the fair value of the derivative liability at each reporting period and the change in the fair value is recorded as non-cash expense or non-cash income. The key component in the value of the derivative liability is the Company’s stock price, which is subject to significant fluctuation and is not under its control, and the assessment of volatility. The resulting effect on net loss is therefore subject to significant fluctuation and will continue to be so until the Company’s Variable Debentures, which the convertible feature is associated with, are converted into common stock or paid in full with cash. Assuming all other fair value inputs remain constant, the Company will record non-cash expense when its stock price increases and non-cash income when its stock price decreases.

 

 

Recent Accounting Standard Updates

 

The Company has evaluated all the recent accounting pronouncements and determined that there are no accounting pronouncements that will have a material effect on the Company’s financial statements.

 

Note 2 - Revenue Recognition

 

Contracts with Customers

 

We have adopted ASC 606, Revenue from Contracts with Customers effective January 1, 2018, using the modified retrospective method applied to those contracts which were not substantially completed as of January 1, 2018. These standards provide guidance on recognizing revenue, including a five-step model to determine when revenue recognition is appropriate. The standard requires that an entity recognize revenue to depict the transfer of control of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services.

 

We routinely plan on entering into contracts with customers that include general commercial terms and conditions, notification requirements for price increases, shipping terms and in most cases prices for the products and services that we offer. Our performance obligations are established when a customer submits a purchase order notification (in writing, electronically or verbally) for goods and services, and we accept the order. We identify performance obligations as the delivery of the requested product or service in appropriate quantities and to the location specified in the customer’s contract and/or purchase order. We generally recognize revenue upon the satisfaction of these criteria when control of the product or service has been transferred to the customer at which time, we have an unconditional right to receive payment. Our sales and sale prices are final, and our prices are not affected by contingent events that could impact the transaction price.

 

Revenues for sales of our SofPulse® product is typically recognized at the time the product is shipped, at which time the title passes to the customer, and there are no further performance obligations. Royalty/licensing revenue is also recognized at one point in time, when the units are shipped.

 

In connection with offering products and services provided to the end user by third-party vendors, we review the relationship between us, the vendor, and the end user to assess whether revenue should be reported on a gross or net basis. In asserting whether revenue should be reported on a gross or net basis, we consider whether we act as a principal in the transaction and control the goods and services used to fulfill the performance obligation(s) associated with the transaction.

 

During the years ended December 31, 2022 and 2021, we recognized revenue of $135,355 and $73,105, respectively, from SofPulse® devices.

 

Sources of Revenue

 

We have identified the following revenues disaggregated by revenue source:

 

	1.	Sales to plastic surgeons
	2.	Sales to wound care facilities
	3.	Sales to hospitals
	4.	Sales to other physicians
	5.	Royalty fee from licensing, net

 

 

For the years ended December 31, 2022 and 2021, the sources of revenue were as follows:

 

		Years Ended
		December 31,
		2022				2021
Direct sales- Plastic surgeons, gross			21,732				73,105
Royalty/licensing, net			113,623				-
Total sources of revenue		$	135,355			$	73,105

 

The royalty/licensing revenue recognized in 2022 resulted from specific transactions. No general patent rights were assigned to the distributor. The revenue recognized was based on the number of items included in the transactions.

 

Warranty

 

Our general product warranties do not extend beyond an assurance that the product delivered will be consistent with stated specifications and do not include separate performance obligations.

 

Significant Judgments in the Application of the Guidance in ASC 606

 

There are no significant judgments associated with the satisfaction of our performance obligations. We generally satisfy performance obligations upon delivery of the product to the customer. This is consistent with the time in which the customer obtains control of the products. Performance obligations are also generally settled quickly after the purchase order acceptance, therefore the value of unsatisfied performance obligations at the end of any reporting period is generally immaterial.

 

We consider variable consideration in establishing the transaction price. Forms of variable consideration applicable to our arrangements include sales returns, rebates, volume-based bonuses, and prompt pay discounts. We use historical information along with an analysis of the expected value to properly calculate and to consider the need to constrain estimates of variable consideration. Such amounts are included as a reduction to revenue from the sale of products in the periods in which the related revenue is recognized and adjusted in future periods as necessary.

 

Practical Expedients

 

Our payment terms for sales direct to distributors, end users, hospitals and doctors are substantially less than the one-year collection period that falls within the practical expedient in determination of whether a significant financing component exists.

 

Effective Date and Transition Disclosures

 

Adoption of the new standards related to revenue recognition did not have a material impact on our consolidated financial statements.

 

Note 3 – Patents

 

In December 2017, we acquired from RGN a patent portfolio for $4,500,000. The earliest patent expires in 2024.

 

The following is a summary of patents less accumulated amortization at December 31, 2022 and 2021:

 

		December 31,
		2022				2021
Patents		$	4,500,000			$	4,500,000
Less accumulated amortization			3,234,556				2,587,644
Patents net		$	1,265,444			$	1,912,356

 

Amortization expense for the years ended December 31, 2022 and 2021, was $646,912.

 

 

The estimated future amortization expense related to patents as of December 31, 2022, is as follows:

 

Years Ended December 31,		Amount
2023		$	646,910
2024			618,534
Total		$	1,265,444

 

The Company determined that the patents were not impaired as of December 31, 2022 and 2021.

 

Note 4 - Notes payable

 

As of December 31, 2022 and December 31, 2021, the notes payable activity was as follows:

 

		As of December 31,
		2022				2021
Notes payable at beginning of period		$	7,256,930			$	6,835,196
Notes payable issued			465,000				950,000
Settlements on note payable			(163,826	)			(117,770	)
Repayments of notes payable in cash			(14,000	)			(16,900	)
Less amounts converted to stock			(380,272	)			(393,596	)
Notes payable at end of period			7,163,832				7,256,930
Less debt discount			(10,587	)			(75,800	)
		$	7,153,245			$	7,181,130
Notes payable issued to former related party		$	112,100			$	126,100
Notes payable issued to non-related party		$	7,041,145			$	7,055,030

 

The maturity dates on the notes are as follows:

 

Twelve months ending,		Non-related parties				Former Related party				Total
Past due		$	6,626,145			$	112,100			$	6,738,245
December 31, 2023			415,000				-				415,000
Total		$	7,041,145			$	112,100			$	7,153,245

 

Activity during the year ended December 31, 2022

 

Fixed rates convertible notes

 

During the year ended December 31, 2022, the Company issued seven (7) fixed rate promissory notes totaling $465,000 in principal, for funding of $465,000 with original terms of nine to twelve months and interest rates of 15% and 18%. The holder of the promissory notes can convert the outstanding unpaid principal and accrued interest at a fixed conversion rate, subject to standard anti-dilution features, immediately to six-month after issuance date. These fixed rate promissory notes include a prepayment feature at a premium of 15% and a make good provision, which guarantees the holder additional shares if the holder does not realize a 15% or 18% return on the resale of the common shares.

 

 

As of December 31, 2022, the Company has twenty (20) fixed-rate promissory notes with an outstanding balance of $1,819,728, of which $1,404,728 are past maturity. As of December 31, 2022, the Company has a total of sixteen (16) fixed rate notes for total principal amount of $1,465,000 includes a make good shares provision. Such provision will require the Company to issue additional shares to ensure that the investor can realize a profit of 15% or 18% reselling the conversion shares. The Company accrued approximately $225,000 related to the make-good provision as the amount is probable and can be reasonably estimated pursuant to ASC 450 Contingencies. Such amount was presented as other expense in the consolidated statements of operations and accounts payable and accrued expenses in the consolidated balance sheet as of December 31, 2022.

 

During year ended December 31, 2022, the Company converted $136,728 in accrued interest and $380,272 in principal balance into 25,850,000 shares of common stock.

 

Certain fixed-rate notes include a prepayment provision, which entitles the holder to a 15% or 18% premium upon cash redemption by the Company. The prepayment penalty approximates $62,800 as of December 31, 2022, but the Company determined that such liability was not probable as of December 31, 2022, pursuant to ASC 450 Contingencies.

 

Variable-rate notes

 

The gross amount of all convertible notes with variable conversion rates outstanding as of December 31, 2022, is $4,607,100, which are all past maturity. There was no conversion of notes into the Company’s common stock during the year ended December 31, 2022.

 

During the year ended December 31, 2022, the Company settled one variable note with a principal of $163,826 and $45,475 in accrued interest for no consideration.

 

Activity during the year ended December 31, 2021

 

During the year ended December 31, 2021, the Company issued eight (8) fixed rate promissory notes totaling $950,000 for funding of $950,000 with original terms of twelve months and interest rates of 15%. The holders of the promissory notes can convert the outstanding unpaid principal and accrued interest at a fixed conversion rate, subject to standard anti-dilution features. As of December 31, 2021, the fixed-rate notes had an outstanding balance of $1,735,000, of which $785,000 are past maturity. As of December 31, 2021, the Company has 13 fixed rate promissory notes with unrelated parties for total amount of $1,735,000. Nine of these fixed rates promissory notes for total balance of $1,000,000 carry a make whole provision requiring the Company to issue additional shares of its common stock if the underlying investor is not able to realize a profit of 15% against the conversion price of such shares after customary and reasonable expenses.

 

During the year ended December 31, 2021, the Company amended the terms of two of its promissory notes to accelerate the conversion feature and amend the conversion price of the instruments. The Company recorded the modification in accordance with ASC 470-50 Debt-Modifications and Extinguishments and recorded $58,407 as loss from debt extinguishment in the consolidated statements of operations.

 

During the year ended December 31, 2021, the Company settled one of its promissory notes by issuing 1,515,152 restricted shares of the Company’s common stock with a fifteen percent (15%) make-whole provision. The Company recorded a gain on debt extinguishment of approximately $128,000.

 

During the year ended December 31, 2021, the Company converted $393,597 in principal and $100,152 in accrued but unpaid interest into 27,461,307 shares of common stock.

 

The gross amount of all convertible notes with variable conversion rates outstanding as of December 31, 2021, is $4,770,926, of which $4,770,926 are past maturity.

 

Former related-party notes

 

Notes payable to a former related party in the aggregate amount of $112,100 was outstanding at December 31, 2022, which are past maturity date. The notes bear interest between 10% and 12% per annum. During the year ended December 31, 2022, the Company paid total principal of $14,000 to this former related party. As of December 31, 2022, the Company had notes payable to related parties amounting to $112,100. Refer to Note 7– Related Party Transactions.

 

 

Notes payable to a former related party in the aggregate amount of $126,100 was outstanding at December 31, 2021, which are past maturity date. The notes bear interest between 10% and 12% per annum. During the year ended December 31, 2021, the Company paid total principal of $16,900 to this former related party.

 

Other notes

 

In October 2013, July 2014, October 2014 and August 2015, the Company initiated a series of private placements for up to $500,000, each, of financing by the issuance of notes payable at a minimum of $25,000, one unit. The notes bear interest at 10% per annum and were due and payable with accrued interest one year from issuance. During the years ended December 31, 2022, and 2021, the Company did not issue notes in connection with these private placements and did not repay any of these notes. As of December 31, 2022, and 2021, notes payable outstanding under these private placements are $624,903, all of which are past maturity.

 

Notes payable totaling $2,110,450 are secured by the intellectual property acquired from RGN including patents obtained in the acquisition.

 

Acquisition Payable

 

In connection with the Company’s acquisition of IPR in 2012, IPR recorded a $155,000 long-term acquisition payable for costs that were not paid at closing. This payable is non-interest bearing and IPR agreed to make payments up to 25% of the proceeds from any private placement or gross profits earned by IPR until the obligation is satisfied. The percentage of the proceeds to be paid is at the sole discretion of IPR’s Chief Executive Officer and the ex-Chief Executive Officer of the Company based on the liquidity of the Company.

 

There was no activity during the year ended December 31, 2022. During the year ended December 31, 2021, the Company issued 2,505,834 as extinguishment for $75,175 in principal and interest. The balance of the acquisition payable is $79,825, as of December 31, 2022 and 2021.

 

Effective Interest Rate

 

During the years ended December 31, 2022, and 2021, the Company’s effective interest rate was 18% and 12% respectively.

 

Note 5 - Shareholders’ Deficit

 

Preferred Stock

 

The Company has authorized 5,000,000 shares of preferred stock which have been designated as follows:

 

 

		Number of Shares Authorized				Number of Shares Outstanding at December 31, 2022				Par Value				Liquidation Value per Share
Series AA			1,000,000				25,000			$	0.0010				-
Preferred Series B			50,000				600			$	0.0001				100
Preferred Series C			8,000				738			$	0.0001				1,000
Preferred Series D			20,000				50			$	0.0001				1,000
Undesignated			3,922,000				-				-				-

 

 

Series AA Preferred Shares

 

On February 22, 2013, the Board of Directors of the Company authorized an amendment to the Company’s Articles of Incorporation, as amended (the “Articles of Incorporation”), in the form of a Certificate of Designation that authorized the issuance of up to one million (1,000,000) shares of a new series of preferred stock, par value $0.001 per share, designated “Series AA Super Voting Preferred Stock,” for which the board of directors established the rights, preferences and limitations thereof.

 

Each holder of outstanding shares of Series AA Super Voting Preferred Stock shall be entitled to one hundred thousand (100,000) votes for each share of Series AA Super Voting Preferred Stock held on the record date for the determination of stockholders entitled to vote at each meeting of stockholders of the Company. As of December 31, 2022 and 2021, there were 25,000 shares of Series AA Preferred stock outstanding.

 

Series B Convertible Preferred Stock

 

On February 7, 2017, the Company filed a certificate of designation for 50,000 shares of Series B Convertible Preferred Stock designated as Series B (“Series B”) which are authorized and convertible, at the option of the holder, commencing six months from the date of issuance into common shares and warrants. For each share of Series B, the holder, on conversion, shall receive the stated value ($100 per share) divided by 75% of the market price on the date of purchase of Series B and a three-year warrant exercisable into up to a like amount of common shares with an exercise price of 150% of the market price as defined in the Certificate of Designation. Dividends shall be paid only if dividends on the Company’s issued and outstanding Common Stock are paid, and the amount paid to the Series B holder will be as though the conversion shares had been issued. The Series B holders have no voting rights. Upon liquidation, the holder of Series B, shall be entitled to receive an amount equal to the stated value, $100 per share, plus any accrued and unpaid dividends thereon before any distribution is made to Series C Secured Redeemable Preferred Stock or common stockholders. There has been no activity during the years ended December 31, 2022 and 2021. As of December 31, 2022 and 2021, there were 600 shares of Series B outstanding.

 

Series C Secured Redeemable Preferred Stock

 

On December 22, 2017, the Company filed a certificate of designation for 8,000 shares of Series C Secured Redeemable Preferred Stock (“Series C”). Each share of the C Preferred is entitled to receive a $20.00 quarterly dividend commencing March 31, 2018, and each quarter thereafter and is to be redeemed for the stated value, $1,000 per share, plus accrued dividends in cash (i) at the Company’s option, commencing one year from issuance and (ii) mandatorily as of December 31, 2019. On January 29, 2020, the Company filed the amended and restated certificate of designation for its Series C Secured Redeemable Preferred Stock. The amendment changed the rights of the Series C by (a) removing the requirement to redeem the Series C, (b) removing the obligation to pay dividends on the Series C, (c) Allowing the holders of shares of Series C to convert the stated value of their shares into common stock of the Company at 75% of the closing price of such common stock on the day prior to the conversion. The Series C preferred does not have any rights to vote with the common stock. Upon liquidation, the holder of Series C, shall be entitled to receive an amount equal to the stated value, $1,000 per share, plus any accrued and unpaid dividends thereon before any distribution is made to common stockholders but after distributions are made to holders of Series B.

 

Management determined the fair value of the new instrument based on the guidance in ASC 820 Fair Value Measurement. Management concluded that the preferred stock should not be classified as a liability per the guidance in ASC 480 Distinguishing Liabilities from Equity even though the conversion would require the issuance of variable number of shares since such obligation is not unconditional. Management classified the Series C in permanent equity as of December 31, 2022 and 2021.

 

During the years ended December 31, 2022 and 2021, the Company converted 0 and 25 shares of Series C into 0 and 1,111,111 shares of common stock, respectively. As of December 31, 2022 and 2021, there were 738 shares of Series C outstanding, respectively.

 

 

Series D Convertible Preferred Stock

 

On November 11, 2019, the Company filed a certificate of designation for 20,000 shares of Series D Convertible Preferred Stock designated as Series D (“Series D”), which are authorized and convertible, at the option of the holder, at any time from the date of issuance, into shares of common shares. On or prior to August 1, 2020, for each share of Series D, the holder, on conversion, shall receive a number of common shares equal to 0.01% of the Company’s issued and outstanding shares on conversion date and for conversion on or after August 2, 2020, the holder shall receive conversion shares as though the conversion date was August 1, 2020, with no further adjustments for issuances by the Company of common stock after August 1, 2020, except for stock split or reverse stock splits of the common stock.

 

The Series D holders have no voting rights. Upon liquidation, the holder of Series D, shall be entitled to receive an amount equal to the stated value, $1,000 per share, plus any accrued and unpaid dividends thereon before any distribution is made to common stockholders.

 

In September 2022, the Company offered to each holder of Series D the opportunity to convert each share of Series D into 100,000 shares of the Company’s common stock at an effective conversion price of $0.01. In addition, the Company included a make whole provision, which assures each holder a 15% return on the resale, effectively potentially granting them additional common shares until the holder realizes a 15% return upon resale.

 

During the year ended December 31, 2022, the Company issued 25,500,000 shares of common stock upon conversion of 255 shares of Series D preferred stock, for a total value of $255,000. At December 31, 2022, based on the stock price, the value of these shares was in excess of the 15% guaranteed return.

 

As of December 31, 2022 and 2021, there were 50 and 305 shares of Series D outstanding, respectively.

 

Common Stock

 

Activity during the year ended December 31, 2022:

 

During the year ended December 31, 2022, the Company issued 25,850,000 shares of common stock for the conversion of $380,272 of principal notes and accrued interest in the amount of $136,728.

 

During the year ended December 31, 2022, the Company issued 2,428,777 shares of common stock pursuant to a make-whole provision from an April 2021 debt settlement with one investor.

 

During the year ended December 31, 2022, the Company issued 3,450,000 shares of common stock as commitment shares in connection with promissory notes.

 

During the year ended December 31, 2022, the Company issued 66,500,000 shares of common stock for services for total fair value of $1,316,900.

 

During the year ended December 31, 2022, the Company issued 25,500,000 shares of common stock in exchange for 255 shares of Series D Preferred, which resulted in an inducement loss of $200,932 recorded as a deemed dividend in the shareholders’ deficit as of December 31, 2022.

 

During the year ended December 31, 2022, the Company issued 3 units or 15,000,000 shares of common stock pursuant to a private placement for total net cash receipt of $142,000.

 

Activity during the year ended December 31, 2021:

 

During the year ended December 31, 2021, the Company issued 27,461,307 shares of common stock for the conversion of principal notes and accrued interest for aggregate fair value of issued common stock of $1,117,990.

 

During the year ended December 31, 2021, the Company issued 7,868,668 shares of common stock labeled as commitment shares in connection with the issuance of promissory notes for a total fair value of approximately $223,000.

 

During the year ended December 31, 2021, the Company issued 7,000,000 shares of common stock pursuant to securities purchase agreement for total consideration of $126,000.

 

 

During the year ended December 31, 2021, the Company issued 1,111,111 shares of common stock with a value of $33,333, related to the conversion of Series C.

 

During the year ended December 31, 2021, the Company issued 4,020,986 shares of common stock with a value of $142,424, related to the settlement of debts, of which 2,505,834 shares of common stock were issued with a fair value of $84,697 to a former related party.

 

During the year ended December 31, 2021, the Company issued 2,500,000 shares of common stock in connection with the consulting agreement, with a fair value of approximately $95,000.

 

Stock Options

 

During the year ended December 31, 2022, the Company executed an independent contractor agreement with the Company’s new President and Chief Commercial Officer of its medical division. Pursuant to this agreement, the Company granted 3,000,000 stock options to purchase an equivalent number of common stocks, with 250,000 options vesting each quarter with a term of 2 years from vesting and a strike price of $0.0076. The Company did not issue any stock options during the year ended December 31, 2021.

 

The Company cancelled 501,320 and 2,500,350 stock options during the years ended December 31, 2022 and 2021, respectively.

 

The Company did not recognize any share-based compensation expense for the years ended December 31, 2022 and 2021.

 

Stock option activity for the years ended December 31, 2022 and 2021, is as follows:

 

		Options				Weighted Average Exercise Price Per Share				Weighted Average Remaining Contractual Term (years)				Aggregate Intrinsic Value
Outstanding at December 31, 2020			3,014,080			$	0.37				1.67			$	-
Granted			-			$	-				-				-
Cancelled			(2,500,350	)		$	0.16				0.65				-
Exercised			-			$	-				-				-
Outstanding at December 31, 2021			513,730			$	1.43				0.76			$	-
Granted			3,000,000			$	0.0076				3.40				31,200
Cancelled			(501,320	)		$	0.18				-				-
Exercised			-			$	-
Outstanding at December 31, 2022			3,012,410			$	0.22				3.40			$	31,200
Exercisable at December 31, 2022			262,410			$	2.45				2.02			$	2,600

 

 

The balance of all stock options outstanding as of December 31, 2022, is as follows:

 

				Outstanding												Exercisable
								Weighted
								Average				Weighted								Weighted
Range of								Remaining				Average								Average
Exercise				Number				Contractual				Exercise				Number				Exercise
Prices				Outstanding				Life				Price				Exercisable				Price
	Options
$	54.00				11,750				4.30			$	54.00				11,750			$	54.00
$	11.60				660				-			$	11.60				660			$	11.60
$	0.0076				3,000,000				3.40			$	0.0076				250,000			$	0.0076
					3,012,410				3.40			$	0.22				262,410			$	0.22

 

Warrants

 

During the years ended December 31, 2022, and 2021, the Company did not issue any warrants.

 

A summary of the changes of the warrants during the years ended December 31, 2022 and 2021, are presented below:

 

		Outstanding Warrants
						Weighted Average
						Exercise Price
		Shares				Per Share
Outstanding at December 31, 2020			39,295			$	200.72
Granted			-			$	-
Cancelled			(17,095	)		$	384.39
Exercised			-			$	-
Outstanding at December 31, 2021			22,200			$	59.25
Granted			-			$	-
Cancelled			(20,200	)		$	60.17
Exercised			-			$	-
Outstanding at December 31, 2022			2,000			$	50.00
Exercisable at December 31, 2022			2,000			$	50.00

 

The balance of all warrants outstanding as of December 31, 2022, is as follows:

 

				Outstanding												Exercisable
								Weighted
								Average				Weighted								Weighted
Range of								Remaining				Average								Average
Exercise				Number				Contractual				Exercise				Number				Exercise
Prices				Outstanding				Life				Price				Exercisable				Price
	Warrants
$	50.00				2,000				0.22			$	50.00				2,000			$	50.00
					2,000				0.22			$	50.00				2,000			$	50.00

 

 

Note 6 – Related Party and former Related Parties Transactions

 

One executive officer, one former executive and one former operational manager of the Company have agreed to defer a portion of their compensation until cash flow improves. As of December 31, 2022, and 2021, the balances of their deferred compensation were $1,350,265 and $1,289,625, which reflects $300,000 accrual of deferred compensation in accordance with contractual arrangement, approximately $170,000 cash repayments of deferred compensation and $69,217 non-cash reduction pursuant to royalties charged to the former operational manager on SofPulse units during the year ended December 31, 2022, and $300,000 accrual of deferred compensation, $250,950 cash repayments during the year ended December 31, 2021. The royalty/licensing revenue recognized in 2022 was generated from the former operational manager who is developing business in Costa Rica and Mexico. In lieu of payment for the royalty/licensing, the former operational manager paid $44,406 directly to the Company’s vendor, and the deferred compensation due to him was reduced by $69,217.

 

During the year ended December 31, 2022, the Company issued 25,000,000 shares of common stock to a company controlled by the Company’s Chief Executive Officer with an estimated fair value of $550,000 for services.

 

During the year ended December 31, 2022, the Chief Executive Officer of the Company advanced $28,021 of funds to the Company of which $25,521 was repaid during the year 2022. During the year ended December 31, 2021, the Chief Executive Officer of the Company advanced $13,530 of funds to the Company of which $13,405 was repaid during the year 2021.

 

The balance of short-term advances due to one officer and executive of the Company at December 31, 2022 and 2021 was $2,625 and $125, respectively and is included in the Company’s accounts payable and accrued interest balance as of December 31, 2022 and 2021.

 

At December 31, 2022 and 2021, notes payable remain outstanding to the former President of the Company, in the amounts of $112,100 and $126,100, respectively. At December 31, 2022 and 2021, accrued interest on these notes payable totaled $80,034 and $67,787, respectively, and are included in accrued interest on the consolidated balance sheets.

 

Note 7 - Income taxes

 

The Company files income tax returns with the Internal Revenue Service (“IRS”) and various state jurisdictions. For jurisdictions in which tax filings are prepared, the Company is subject to income tax examinations by state tax authorities and federal tax authorities for all tax years.

 

The deferred tax assets are mainly comprised of net loss carryforwards. As of December 31, 2022 and 2021, the Company had approximately $33,000,000 and $28,000,000 of federal net operating loss carryforwards, respectively, that it can use to offset a certain amount of taxable income in the future. Some of these federal net operating loss carryforwards begin to expire in 2030. The resulting deferred tax asset is offset by a 100% valuation allowance due to the uncertainty of its realization. Utilization of these net operating losses could be limited under Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”), and similar state laws based on ownership changes and the value of the Company’s stock.

 

A reconciliation of the provision for income tax expense with the expected income tax computed by applying the federal statutory income tax rate to income before provision for income taxes was as follows for the years ended December 31, 2022 and 2021:

 

		2022				2021
Income tax computed at federal statutory rate			-21.0	%			-21.0	%
State taxes, net of federal benefit			-1.7	%			-7.0	%
Non-Deductible expenses			15.6	%			1.0	%
Change in valuation allowance			7.1	%			27.0	%
Total			0.0	%			0.0	%

 

The primary difference between income tax expense attributable to continuing operations and the amount of income tax expense that would result from applying domestic federal statutory rates to income before provision for income taxes relates to the change in the valuation allowance.

 

The Company has adopted the accounting standards that clarify the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements and prescribes a recognition threshold of more likely than not and a measurement process for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. In making this assessment, a company must determine whether it is more likely than not that a tax position will be sustained upon examination, based solely on the technical merits of the position, and must assume that the tax position will be examined by taxing authorities. Our policy is to include interest and penalties related to unrecognized tax benefits in income tax expense. Interest and penalties totaled $0 for the years ended December 31, 2022 and 2021.

 

 

Note 8 - Commitments and Contingencies

 

Legal matters

 

The Company is subject to certain legal proceedings, which it considers routine to its business activities. As of December 31, 2022, the Company believes, after consultation with legal counsel, that the ultimate outcome of such legal proceedings, whether individually or in the aggregate, is not likely to have a material adverse effect on the Company’s financial position, results of operations or liquidity.

 

Note 9 – Concentrations.

 

Sales

 

During the year ended December 31, 2022, we had two significant customers which accounted for 84% and 10% of direct sales. In addition, the Company generated all of its royalty/licensing revenue from one former related party.

 

During the year ended December 31, 2021, we had two significant customers which accounted for 28% and 25% of sales.

 

Supplier

 

We also have a single source for our bioelectric medical devices, which account for 100% of our sales. The interruption of products provided by this supplier would adversely affect our business and financial condition unless an alternative source of products could be found.

 

Accounts Receivable

 

At December 31, 2021, we had two customers which accounted for 67% of our accounts receivable balances. There are no accounts receivable balance as of December 31, 2022.

 

Note 10 - Subsequent Events.

 

Subsequent to December 31, 2022, the Company issued 5,000,000 shares of common stock following the conversion of 50 shares of Series D preferred stock.

 

Subsequent to December 31, 2022, the Company issued 6,500,000 shares of common stock pursuant to consulting agreements with an estimated fair value of $63,700.

 

Subsequent to December 31, 2022, the Company issued 22,500,000 shares of common stock pursuant to a private placement for $225,000 in cash.

 

Subsequent to December 31, 2022, the Company issued 10,900,000 shares of common stock for the conversion of $100,000 promissory note and $9,000 in accrued interest with one investor.

 

Subsequent to December 31, 2022, the Company issued 4,300,590 shares of common stock with a fair value of approximately $67,090 as settlement of a convertible note with an approximate carrying value of $209,300.

 

Subsequent to December 31, 2022, the Company issued 1,507,277 shares of common stock with a fair value of approximately $25,000 pursuant to a make good provision from a previously executed settlement agreement.

 

Subsequent to December 31, 2022, the Company issued 6,350,000 shares of common stock as additional consideration pursuant to a securities purchase agreement with estimated fair value of $50,000.

 

On March 29, 2023, the Company entered into a binding Letter of Intent (“LOI”) to spin off its current medical device division to an entity managed by Ira Weisberg, the Company’s President and Chief Commercial Officer of its medical division. Mr. Weisberg will be the future President and Chief Executive Officer of this newly formed entity.

 

Subsequent to December 31, 2022, the Company executed a Service-Disabled Veteran-Owned Small Business Government Reseller Agreement with Academy Medical, Inc. to distribute SofPulse® medical devices to ensure its availability to the Veteran Health Administration (“VHA”) and Department of Defense (DoD) contracts.

 

Subsequent to December 31,2022, the Board of director approved the issuance of 39,150,000 shares of common stock for past services with estimated fair value of approximately $552,000.

 

 

PART III Exhibits

 

EXHIBIT NUMBER		DESCRIPTION
1.1		Broker-Dealer Agreement, dated February 3, 2022, between the Company and Dalmore Group, LLC. Previously Filed.
1.2		Finder’s Fee Agreement, dated March 15, 2022, between the Company and J.H.Darbie & Co. Previously Filed
1.3		Amendment to Finder’s Fee Agreement dated June 7, 2023 between Company and J.H. Darbie & Co. Previously Filed
2.1		Share Exchange Agreement. Incorporated by reference to the current report on Form 8-K filed with the Securities and Exchange Commission on March 21, 2012. Incorporated by reference from exhibit 2.1 to our annual financial statements on Form 10-K filed with the SEC on May 4, 2020.
3.1		Articles of Incorporation. Incorporated by reference to the registration statement filed with the Securities and Exchange Commission on September 22, 2011.
3.2		By-Laws. Incorporated by reference to the registration statement filed with the Securities and Exchange Commission on September 22, 2011.
3.3		Agreement and Plan of Merger (Delaware reincorporation). Incorporated by reference to the registration statement filed with the Securities and Exchange Commission on September 22, 2011.
3.4		Certificate of Designation (Super AA Voting Preferred). Incorporated by reference to the Annual Report on Form 10-K for the year ended December 31, 2012
3.5		Articles of Amendment -Name Change. Incorporated by reference to Exhibit 3.1 to Form 8-K filed with the Securities and Exchange Commission on January 24, 2014.
3.6		Articles of Amendment – Increase Authorized Shares. Incorporated by reference to Exhibit 3.1 to Form 8-K filed with the Securities and Exchange Commission on January 24, 2014.
3.7		Articles of Amendment – Reverse Stock Split. Incorporated by reference to Exhibit 3.7 to Form S-1 amendment filed with the Securities and Exchange Commission on October 6, 2016.
3.8		Certificate of Designation Series B Preferred Stock. Incorporated by reference to Exhibit 3.1 to Current Report on Form 8-K filed with the Securities and Exchange Commission February 10, 2017.
3.9		Certificate of Designation Series C Preferred Stock. Incorporated by reference to Exhibit 10.4 to Current Report on Form 8-K filed with the Securities and Exchange Commission December 26, 2017.
3.10		Articles of Amendment Authorizing additional Shares. Incorporated by reference to Exhibit 3.1 to Form 8-K filed with the Securities and Exchange Commission on September 18, 2018.
4.1		Form of Subscription Agreement – Previously Filed
6.1		Investment Agreement by and between the Company and Azure Capital, dated as of December 31, 2018. Incorporated by reference to like numbered exhibit to Current Report on Form 8-k filed with the Securities Exchange Commission on January 3, 2018.
6.2		Registration Rights Agreement by and between the Company and Azure Capital, dated as of December 31, 2018. Incorporated by reference to like numbered exhibit to Current Report on Form 8-k filed with the Securities Exchange Commission on January 3, 2018.
6.3		Acquisition Agreement between the Company and We Heal Animals, Inc. Incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed November 19, 2013
6.4		Settlement and Mutual Release, effective November 22, 2018, between the Company and Rio Grande Neurosciences, LLC. Incorporation by reference to Exhibit 10.1 to current report on Form 8-K filed with the Securities and Exchange Commission on December 26, 2017.
6.5		Exchange Agreement dated as of November 30, 2018, between the Company and Eagle Equities, LLC. Incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed with the Securities Exchange Commission on December 7, 2018.
6.6		Secured $1,500,000 Convertible Promissory Note, dated as of November 30, 2018, issued by the Company and Eagle Equities, LLC. Incorporated by reference to Exhibit 10.2 to Current Report on Form 8-K filed with the Securities Exchange Commission on December 7, 2018.
11.1		Consent of Independent Public Accountants. Filed Herewith.
12.1		Opinion of Frank J. Hariton. Previously Filed

 

 

SIGNATURES

 

Pursuant to the requirements of Regulation A, the issuer certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form 1-A and has duly caused this Offering Statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Woodland Hills, California on August 25, 2023.

 

	Endonovo Therapeutics, Inc.
Dated: August 25, 2023	By:	/s/ Alan B. Collier
		Alan B. Collier
		Chief Executive Officer and Interim Chief Financial Officer and Principal Accounting Officer

 

This offering statement has been signed by the following persons in the capacities and on the dates indicated.

 

Signature		Title		Date
/s/ Alan B. Collier		Director		August 25, 2023
Name: Alan B. Collier

 

 

 

Exhibit 11.1

 

 

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