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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date
of Report (Date of earliest event reported): January 16, 2025
| SANARA
MEDTECH INC. |
| (Exact
name of registrant as specified in its charter) |
| Texas |
|
001-39678 |
|
59-2219994 |
| (State
or other jurisdiction of |
|
(Commission |
|
(IRS
Employer |
| incorporation) |
|
File
Number) |
|
Identification
No.) |
1200
Summit Avenue, Suite 414
Fort
Worth, Texas |
|
76102 |
| (Address
of principal executive offices) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: (817) 529-2300
(Former
name or former address, if changed since last report)
Not
Applicable
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions (see General Instruction A.2. below):
| |
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
|
| |
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
|
| |
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
|
| |
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
| Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
| Common
Stock, $0.001 par value |
|
SMTI |
|
The
Nasdaq Capital Market |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item
1.01 | Entry
into a Material Definitive Agreement. |
The
information set forth in Item 8.01 regarding the Subscription Agreement (defined below) is incorporated by reference into this Item 1.01.
| Item
7.01 | Regulation
FD Disclosure. |
On
January 21, 2025, Sanara MedTech Inc., a Texas corporation (the “Company”), issued a press release announcing the License
Agreement (defined below) and Subscription Agreement. A copy of the press release is furnished as Exhibit 99.1 to this Current Report
on Form 8-K and is incorporated by reference herein.
The
information included under Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.1) is furnished pursuant to Item 7.01 and
shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (“Exchange
Act”), or otherwise be subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any
filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof and regardless
of any general incorporation language in such filing.
Licensing
and Distribution Agreement
On
January 16, 2025 (the “Execution Date”), the Company entered into a Licensing and Distribution Agreement (the “License
Agreement”), by and between the Company and Biomimetic Innovation Limited, a privately-held medical device company headquartered
in Shannon, Co. Clare Ireland (“BMI”), pursuant to which the Company acquired the exclusive U.S. marketing, sales and distribution
rights to OsStic® Synthetic Injectable Structural Bio-Adhesive Bone Void Filler (“OsStic”), as well as an
adjunctive internal fixation technology featuring novel delivery to promote targeted application of OsStic (“ARC” and together
with OsStic, the “Products”), for use in the treatment of a wound or injury caused by a traumatic incident.
Pursuant
to the License Agreement, the Company was appointed by BMI as the exclusive distributor to promote, market, offer to sell, transfer,
distribute and sell the Products for trauma indications inside the United States and its territories for an initial five-year term, which
term may be automatically renewed for successive two-year periods at the Company’s discretion, provided that the Company is in
compliance with its obligations thereunder (the “Term”). From the Execution Date until October 13, 2025, the Company has
an exclusive option to negotiate exclusive distribution rights for the Products in additional fields and/or additional territories on
substantially the same terms as those set forth in the License Agreement.
The
License Agreement requires that the Company pay BMI quarterly royalties (the “Quarterly Royalties”) based on a percentage
of the Net Sales Value (as defined in the License Agreement) of the Products during the Term, with the applicable percentage of the Net
Sales Value for OsStic being in the mid-single digit range. Pursuant to the License Agreement, the Company and BMI agreed to negotiate
the applicable percentage of the Net Sales Value for ARC at a future date. The License Agreement also requires that the Company pay BMI
minimum royalty payments being in the low to mid six figure range for the first, second and third years, respectively, following the
receipt of first regulatory approval for the marketing and sale of a Product.
The
License Agreement contains customary termination rights for both the Company and BMI, including, among others, the ability by either
party to terminate the License Agreement if an event of default (as defined in the License Agreement) occurs and is occurring and the
affected party provides written notice of such termination to the other party. Pursuant to the License Agreement, the Company is also
entitled to terminate the License Agreement for any reason after the achievement of the Milestones (defined below), provided that
the Company provide BMI with 90 days’ prior written notice of termination.
The
License Agreement contains customary representations, warranties and obligations of the parties, including, among others, certain confidentiality,
non-competition and non-solicitation covenants. The parties each have customary indemnification obligations and rights under the terms
of the License Agreement, including with respect to breaches of certain representations and warranties and failure to observe and perform
certain covenants.
Subscription
and Shareholders’ Agreement
In
connection with the License Agreement, on the Execution Date, the Company entered into a Share Subscription and Shareholders’ Agreement
(the “Subscription Agreement”), by and among the Company, The Russell Revocable Living Trust, BMI and the existing shareholders
of BMI, pursuant to which the Company agreed to contribute up to approximately €8.0 million to BMI through a series of capital contributions
in exchange for an aggregate of 16,460 ordinary shares of BMI, constituting approximately 12.5% of the outstanding equity of BMI as of
the Execution Date. The Company made an initial cash investment totaling approximately €3.0 million on the Execution Date, and the
Company’s previously announced convertible loan to BMI was converted into €1.0 million of equity in BMI. Pursuant to the Subscription
Agreement, the remaining €4.0 million contribution is due upon the achievement of certain development, clinical and regulatory milestones
(the “Milestones”).
Pursuant
to the Subscription Agreement, so long as the Company holds a five percent ownership interest or greater in BMI, the Company is entitled
to have one person appointed to BMI’s board of directors. The Company’s initial investment of approximately €4.0 million
caused the Company to exceed the five percent ownership interest threshold in BMI, and as a result the Company’s Chief Corporate
Development & Strategy Officer, Tyler Palmer, has been nominated and appointed to BMI’s board of directors. In addition, the
Company has the right to send one non-voting observer to attend meetings of the BMI board of directors, regardless of the Company’s
ownership interest level. The Company’s capital contributions must be used to fund the development and commercialization of the
Products, and the Company has certain veto and consent rights to further protect the Company’s investment in BMI and to support
its ability to successfully market and sell the Products.
The
foregoing description of the Subscription Agreement does not purport to be complete and is qualified in its entirety to the complete
text of the Subscription Agreement, a copy of which will be filed with the Company’s next Quarterly Report on Form 10-Q.
| Item
9.01 | Financial
Statements and Exhibits. |
(d)
Exhibits
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
| Date: |
January
22, 2025 |
|
|
| |
|
|
|
| |
|
Sanara
MedTech Inc. |
| |
|
|
|
| |
|
By: |
/s/
Michael D. McNeil |
| |
|
Name: |
Michael D.
McNeil |
| |
|
Title: |
Chief
Accounting Officer and Chief Administrative Officer |
Exhibit
99.1
Sanara
MedTech Inc. Announces Exclusive License and Distribution Agreement with, and Minority Investment in, Biomimetic Innovations Ltd
OsStic®
and related technologies represent differentiated solutions that address an estimated 100,000+ procedures in the U.S. annually(1);
arrangement leverages Sanara’s existing call points and commercial infrastructure, and complements Sanara’s existing surgical
portfolio
FORT
WORTH, TX, January 21, 2025 (GLOBE NEWSWIRE) – Sanara MedTech Inc. Based in Fort Worth, Texas, Sanara MedTech Inc. (“Sanara,”
the “Company,” “we,” “our” or “us”) (Nasdaq: SMTI), a medical technology company focused
on developing and commercializing transformative technologies to improve clinical outcomes and reduce healthcare expenditures in the
surgical, chronic wound and skincare markets, announced today the execution of an exclusive license and distribution agreement (the “License
and Distribution Agreement”) with Biomimetic Innovations Ltd (“Biomimetic Innovations” or “BMI”), a privately-held
medical device company headquartered in Shannon, Ireland. In tandem, Sanara agreed to contribute up to €8.0 million in cash to BMI
in exchange for approximately 12.5% of BMI’s outstanding equity. Sanara made an initial cash investment totaling €4.0 million,
including €1.0 million of converting debt. The remaining €4.0 million contribution is due upon the achievement of certain development,
clinical and regulatory milestones.
Under
the terms of the License and Distribution Agreement, Sanara has acquired the exclusive U.S. marketing, sales, and distribution rights
to OsStic® Synthetic Injectable Structural Bio-Adhesive Bone Void Filler (“OsStic”), as well as a hardware
agnostic adjunctive internal fixation technology featuring novel delivery to promote targeted application of OsStic, for use in fracture
management. The License and Distribution Agreement is for an initial five-year period, with the option to automatically renew for successive
two-year periods at Sanara’s discretion.
OsStic
was granted a Breakthrough Device Designation by the U.S. Food and Drug Administration (“FDA” or the “Agency”)
on December 10, 2023, with proposed indications for use as a “structural, mechanically enhanced bioadhesive for reduction, provisional
fixation, or void filling of periarticular fractures or defects to enhance structural stability where standard fixation alone cannot
provide sufficient support for functional mobilization.” Breakthrough Device Designation is granted to medical devices that provide
for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.
“We
are excited to announce this strategic agreement and investment in Biomimetic Innovations,” said Ron Nixon, Sanara’s Executive
Chairman and CEO. “OsStic offers a truly differentiated solution, designed to enhance the fracture repair process. We believe OsStic
represents a compelling treatment option for the more than 100,000 periarticular fractures that occur in the U.S. annually.”
Mr.
Nixon continued: “Leveraging the receipt of FDA Breakthrough Device Designation for OsStic, BMI is engaging with the Agency in
pursuit of U.S. regulatory clearance. We look forward to introducing this innovative surgical solution to the U.S. market, which we anticipate
in the first quarter of 2027. Importantly, we expect OsStic and related delivery technologies to complement our existing surgical product
portfolio, as we continue our focus on enhancing patient outcomes, improving healthcare providers’ surgical experience, and reducing
the total cost of care.”
Dr.
Thomas Russell, Chief Medical Officer of PBC Biomed (an affiliate of BMI), stated, “While traditional calcium phosphate bone substitute
materials offer basic bone void filling properties, they are limited in their ability to fully integrate with the bone and ultimately
do not provide the adequate mechanical support to assist fracture repair. OsStic sets a new standard with its innovative formulation.
Unlike conventional materials, OsStic is engineered to optimize fluidic dispersion into bone defects, interdigitate with the surrounding
boney structure, and firmly adhere to bone surfaces. These properties provide exceptional structural integrity and mechanically enhanced
bioadhesion, making OsStic uniquely suited for reducing periarticular fractures, achieving provisional fixation, and filling voids. As
the first calcium phosphate-based synthetic technology to address all three critical clinical needs, OsStic offers an unparalleled solution
for preserving joint congruency and improving patient outcomes.”
Paul
Burke, Managing Partner of PBC Biomed Ltd and acting CEO of Biomimetic Innovations stated, “Our goal is to ‘enhance patient
wellness’ using disruptive medical innovations. With its market expertise, sales and distribution network, and existing customer
relationships, Sanara represents an ideal partner to commercialize our innovative technologies. Together, we look forward to bringing
transformative solutions to market that enhance the surgeon’s treatment approach and improve patient outcomes.”
| (1) | National
Library of Medicine, BMI and Sanara company estimates. |
About
Biomimetic Innovations Ltd and PBC Biomed
Biomimetic
Innovations Ltd is an affiliate of PBC Biomed, a medical device company involved in design, development and manufacturing. PBC Biomed
partners with medical device, biologic, pharmaceutical and combination product innovators to accelerate their technology through the
product lifecycle stages. The company offers regulatory, clinical, quality assurance and commercial support, and facilitates the design,
development and validation of medical devices, biologics, and combination products. PBC Biomed’s ISO 13485 facilities and ISO 9001
certified processes enable the company to perform clean room manufacturing, packing and sterilization for a range of medical device products.
The company is headquartered in Shannon, Ireland, with offices in Memphis, Tennessee and Chamonix, France. PBC Biomed has a track record
in developing and commercializing new technologies, bringing the N-Force Fixation/iN3 Cement to market through its affiliate company,
CelgenTek Innovations (acquired by Zimmer Biomet in 2016), and more recently bringing ReFeel® to market as a nerve regeneration
solution, with partner company Mochida Pharmaceuticals Ltd (Japan). For more information, please visit pbcbiomed.com and pbcbiomed.com/affiliates/biomimeticinnovations/.
About
Sanara MedTech Inc.
Sanara
MedTech Inc. is a medical technology company focused on developing and commercializing transformative technologies to improve clinical
outcomes and reduce healthcare expenditures in the surgical, chronic wound and skincare markets. The Company markets, distributes and
develops surgical, wound and skincare products for use by physicians and clinicians in hospitals, clinics and all post-acute care settings
and offers wound care and dermatology virtual consultation services via telemedicine. Sanara’s products are primarily sold in the
North American advanced wound care and surgical tissue repair markets. Sanara markets and distributes CellerateRX® Surgical
Activated Collagen, FORTIFY TRG® Tissue Repair Graft and FORTIFY FLOWABLE® Extracellular Matrix as well
as a portfolio of advanced biologic products focusing on ACTIGEN™ Verified Inductive Bone Matrix, ALLOCYTE® Plus
Advanced Viable Bone Matrix, BiFORM® Bioactive Moldable Matrix, TEXAGEN® Amniotic Membrane Allograft, and
BIASURGE® Advanced Surgical Solution to the surgical market. In addition, the following products are sold in the wound
care market: BIAKŌS® Antimicrobial Skin and Wound Cleanser, BIAKŌS® Antimicrobial Wound Gel,
and BIAKŌS® Antimicrobial Skin and Wound Irrigation Solution. Sanara’s pipeline also contains potentially
transformative product candidates for mitigation of opportunistic pathogens and biofilm, wound re-epithelialization and closure, necrotic
tissue debridement and cell compatible substrates. The Company believes it has the ability to drive its pipeline from concept to preclinical
and clinical development while meeting quality and regulatory requirements. Sanara is constantly seeking long-term strategic partnerships
with a focus on products that improve outcomes at a lower overall cost. For more information, please visit sanaramedtech.com.
Information
about Forward-Looking Statements
The
statements in this press release that do not constitute historical facts are “forward-looking statements,” within the meaning
of and subject to the safe harbor created by the Private Securities Litigation Reform Act of 1995. These statements may be identified
by terms such as “aims,” “anticipates,” “believes,” contemplates,” “continue,”
“could,” “estimates,” “expect,” “forecast,” “guidance,” “intends,”
“may,” “plans,” “possible,” “potential,” “predicts,” “preliminary,”
“projects,” “seeks,” “should,” “targets,” “will” or “would,”
or the negatives of these terms, variations of these terms or other similar expressions. These forward-looking statements include, among
others, statements regarding the Company’s arrangement with BMI and the integration of BMI’s OsStic and related technologies
into the Company’s product and service offerings, the timing of the introduction of OsStic and related technologies to the U.S.
market, the Company’s business strategy and mission, the development of new products, the timing of commercialization of the Company’s
products, the regulatory approval process and expansion of the Company’s business in telehealth and wound care. These items involve
risks, contingencies and uncertainties such as uncertainties associated with the development and process for obtaining regulatory approval
for new products and OsStic and related technologies, the Company’s ability to build out its executive team, the Company’s
ability to identify and effectively utilize the net proceeds of its term loan to support the Company’s growth initiatives, the
extent of product demand, market and customer acceptance, the effect of economic conditions, competition, pricing, uncertainties associated
with the development and process for obtaining regulatory approval for new products, the ability to consummate and integrate acquisitions,
and other risks, contingencies and uncertainties detailed in the Company’s SEC filings, which could cause the Company’s actual
operating results, performance or business plans or prospects to differ materially from those expressed in, or implied by these statements.
All
forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation to revise any of
these statements to reflect the future circumstances or the occurrence of unanticipated events, except as required by applicable securities
laws.
Investor
Relations Contact:
Jack
Powell or Mike Piccinino, CFA
ICR
Healthcare
IR@sanaramedtech.com
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Sanara MedTech (NASDAQ:SMTI)
過去 株価チャート
から 1 2025 まで 2 2025
Sanara MedTech (NASDAQ:SMTI)
過去 株価チャート
から 2 2024 まで 2 2025
