Form 8-K/A - Current report: [Amend]

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K/A

(Amendment No. 1)

Current Report Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): July 16, 2024

Nuwellis, Inc.

(Exact Name of Registrant as Specified in its Charter)

Delaware	001-35312	No. 68-0533453
(State or Other Jurisdiction of Incorporation or Organization)	(Commission File Number)	(I.R.S. Employer Identification No.)

12988 Valley View Road, Eden Prairie, MN 55344

(Address of Principal Executive Offices) (Zip Code)

(952) 345-4200

(Registrant’s Telephone Number, Including Area Code)

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, par value $0.0001 per share	NUWE	Nasdaq Capital Market

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:

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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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. ☐

Explanatory Note

This Current Report on Form 8-K/A (the “Amendment”) amends the Current Report on Form 8-K (the “Original Report”) of the Company (as defined below) filed on July 17, 2024. The sole purpose of this Amendment is to provide an updated version of the corporate presentation furnished as Exhibit 99.1 thereto. The updated corporate presentation is furnished as Exhibit 99.1 hereto and replaces and supersedes Exhibit 99.1 to the Original Report in its entirety. No other revisions have been made to the Original Report, and other than mentioned in the foregoing sentence, this Amendment does not amend, update, or change any other items or disclosures contained in the Original Report.

Item 8.01.

Other Events.

Corporate Presentation

On July 17, 2024, Nuwellis, Inc. (the “Company”) posted an updated corporate presentation to its website at https://ir.nuwellis.com/, which the Company may use from time to time in communications with potential investors or conferences. A copy of the corporate presentation is attached as Exhibit 99.1 to this Current Report on Form 8-K (this “Report”).

Exhibit 99.1 hereto contains forward-looking statements within the meaning of the federal securities laws. These forward-looking statements are based on current expectations and are not guarantees of future performance. Further, the forward-looking statements are subject to the limitations listed in Exhibit 99.1 and in the other reports of the Company filed with the U.S. Securities and Exchange Commission (“SEC”), including that actual events or results may differ materially from those in the forward-looking statements.

Risk Factor Update

On May 8, 2024, the Company filed its Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 (the “Form 10-Q”) with the SEC. This Report is being filed in part to revise Item 1A to include the risk factor included below.

Except as described below, no other changes have been made to the Form 10-Q, and this Report does not otherwise amend, update or change the financial statements or other disclosures in the Form 10-Q. This Report speaks as of the filing date of the Form 10-Q and does not (i) reflect events, results or developments that occurred or facts that became known after the filing date of the Form 10-Q or (ii) modify or update those disclosures affected by subsequent events, results, developments or facts. Among other things, forward-looking statements made in the Form 10-Q have not been revised to reflect events, results or developments that occurred or facts that became known to us after the date of the Form 10-Q, and such statements should be read in conjunction with our filings with the SEC subsequent to the Form 10-Q. This Report should be read in conjunction with the Company’s other filings with the SEC subsequent to May 8, 2024.

If we fail to comply with federal and state laws regarding off-label use of our products, we could face substantial civil and criminal penalties and our business, financial condition, results of operations, and prospects could be adversely affected.

Healthcare professionals may choose to use and prescribe medical devices for uses that are not described in the product’s labeling and for uses that differ from those tested in clinical trials and approved or authorized by the regulatory authorities. Medical device companies, however, are prohibited from marketing and promoting products for indications and uses that are not specifically approved or authorized by FDA. Such “off-label” uses are common on the medical world and often are appropriate treatments for some patients. Regulatory authorities in the U.S. generally do not restrict or regulate the treatment choices of healthcare professionals. Regulatory authorities do, however, restrict communications by companies concerning off-label uses of their products. Any FDA approval or marketing authorization that we have or may obtain in the future permits us to promote the subject medical device only for the specific use(s) cleared, approved, certified or otherwise authorized. We are prohibited from marketing or promoting any medical devices for off-label use.

Notwithstanding the regulatory restrictions on off-label promotion, the FDA and other regulatory authorities allow companies to engage in truthful, non-misleading, and non-promotional speech concerning their products. Accordingly, we engage in medical education activities and communicate with healthcare professionals about many aspects of our products and clinical trials. In addition, we are aware that the Aquadex System, which is cleared by FDA solely for use in adults and pediatric patients weighing 20 kg or more, is being used off-label uses to treat patients who weigh under 20 kg, including being modified by children’s hospitals so that it can provide dialysis to neonates and other premature infants who were born either without kidneys or without normal kidney function. These patients typically have very few other treatment options given the large extracorporeal blood volume required by standard dialysis machines, the need for blood priming of the dialysis circuit and the use of large catheters.

Although we believe that all of our communications regarding off-label uses are in compliance with the relevant regulatory requirements, the FDA or another regulatory authority may disagree, and characterize such communications as marketing and promotion of an off-label use.

If the FDA determines that we have marketed or promoted our products for off-label use by us or our commercial partners, it could request that we or our commercial partners modify those promotional materials. We also could be subject to regulatory or enforcement actions, including the issuance of an untitled letters or warning letters, injunctions, seizures, civil fines and criminal penalties.

In addition to FDA, we may be subject to significant enforcement actions from other federal and state enforcement authorities, such as the Department of Justice and the Office of the Inspector General of the Department of Health and Human Services, if they consider our communications, including promotional and training materials, to constitute promotion of an uncleared, uncertified or unapproved use of a medical device. In the U.S., engaging in the impermissible promotion of our products, following approval, for off-label uses can also subject us to false claims and other litigation under federal and state statutes, including fraud and abuse and consumer protection laws, which can lead to civil and criminal penalties and fines, agreements with governmental authorities that materially restrict the manner in which we promote or distribute therapeutic products and do business through, for example, corporate integrity agreements, suspension or exclusion from participation in federal and state healthcare programs, and debarment from government contracts and refusal of future orders under existing contracts. These laws include the federal False Claims Act, which allows any individual to bring a lawsuit against a company on behalf of the federal government alleging submission of false or fraudulent claims or causing others to present such false or fraudulent claims, for payment by a federal program such as Medicare or Medicaid. If the government decides to intervene and prevails in the lawsuit, the individual will share in the proceeds from any fines or settlement funds. If the government declines to intervene, the individual may pursue the case alone. Many False Claims Act lawsuits against, and preceding investigations of, manufacturers of healthcare products are brought every year, leading to several substantial civil and criminal settlements related to off-label uses. In addition, False Claims Act lawsuits may expose manufacturers to follow-on claims by private payors based on fraudulent marketing practices. This growth in litigation has increased the risk that a company will have to defend a false claim action, pay settlement fines or restitution, as well as criminal and civil penalties, agree to comply with burdensome reporting and compliance obligations, and be excluded from Medicare, Medicaid, or other federal and state healthcare programs. If we or our collaborators do not lawfully promote our approved products, we may become subject to such investigations and litigation and, if we do not successfully defend against such actions, those actions may have a material adverse effect on our business, financial condition, results of operations and prospects.

Additionally, we must have adequate substantiation for the claims we make for our products and services. If any of our claims are determined to be false, misleading or deceptive, our products and services could be considered misbranded under the FDCA or in violation of the Federal Trade Commission Act. We could also face lawsuits from our competitors under the Lanham Act alleging that our marketing materials are false or misleading.

Foreign jurisdictions have their own laws and regulations concerning medical devices, including marketing authorizations and certifications, communications about off-label uses, and substantiation of advertising and promotional claims. Failure to comply with those laws and regulations could result in actions against us, including fines, penalties and exclusion from the market. Any such actions could adversely affect our ability to market new products and services or continue to market existing products and services in those jurisdictions.

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number		Exhibit Description
99.1		Corporate Presentation, dated July 17, 2024
104		Cover Page Interactive Data File (embedded within Inline XBRL document).

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: July 17, 2024	NUWELLIS, INC.

	By:	/s/ Nestor Jaramillo, Jr
	Name:	Nestor Jaramillo, Jr.
	Title:	President and Chief Executive Officer

Exhibit 99.1

July 2024 Investor Presentation

Aquadex FlexFlow® and Aquadex SmartFlow® are registered trademarks of Nuwellis, Inc. Aquadex ® is a trademark of Nuwellis, Inc. Safe Harbor Statement Financial and Statistical DataThis presentation also contains estimates and other statistical data made by independent parties and by us relating to market shares and other data about our industry. These data involve a number of assumptions and limitations and have not been reviewed or audited by our independent registered accounting firm. You are cautioned not to give undue weight to such estimates. In addition, projections, assumptions and estimates of our future performance and future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk. Neither we nor our advisors or representatives makes any representations as to the accuracy or completeness of that data or undertake to update such data after the date of this presentation. TrademarksThe trademarks included herein are the property of the owners thereof and are used for reference purposes only. Such use should not be construed as an endorsement of such products. Additional InformationYou should read the documents that we have filed with the SEC for more complete information about us. We encourage you to read such documents in full for more detailed information, statistics, reports and clinical trials referenced in this presentation. You may access these documents for free by visiting EDGAR on the SEC website at http://www.sec.gov. Forward Looking StatementThis presentation contains forward‐looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities and Exchange Act, as amended regarding our plans, expectations, beliefs, estimates, goals and outlook for the future that are intended to be covered by the Private Securities Litigation Reform Act of 1995. Except for statements of historical fact, all forward‐looking statements are management’s present expectations and are not guarantees of future events and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results to differ materially from those expressed in, or implied by, such forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “could,” “would,” “should,” “plan,” “predict,” “potential,” “project,” “promising,” “expect,” “estimate,” “anticipate,” “intend,” “goal,” “strategy,” “milestone,” and similar expressions and variations thereof. Various factors could cause actual results to differ materially from these statements including our ability to execute on our commercial strategy and to grow our Aquadex® business, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, our clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our expectations regarding anticipated synergies with and benefits of the Aquadex business, our business strategy, market size, potential growth opportunities and the other risks set forth under the caption “Risk Factors” and elsewhere in our periodic and other reports filed with the U.S. Securities and Exchange Commission (“SEC”), including our Annual Report on Form 10‐K for the fiscal year ended December 31, 2023 and subsequent reports. We are providing this information as of the date of this presentation, and we undertake no obligation to update any forward-looking statements contained in this presentation as a result of new information, future events or otherwise. Although the Company believes that the forward‐looking statements are reasonable and based on information currently available, it can give no assurances that the Company’s expectations are correct. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

Overview The Problem: Fluid Overload The Market Opportunity Nuwellis Solutions Market Validation Growth Strategy Financial Snapshot Team

4 Our Mission Nuwellis is dedicated to transforming the lives of patients suffering from Fluid Overload through science, collaboration, and innovation.

The ProblemFluid Overload presents a significant public health challenge that impacts both patient outcomes and hospital resources.

What is Hypervolemia (Fluid Overload)? Hypervolemia is an excess of fluid in the bloodstream, vital organs and interstitial space that results in an array of patient symptoms Tiredness Shortness of breath Pulmonary edema (excess fluid in lungs) Swelling in ankles and legs Coughing Pleural effusion (excess fluid around lungs) Swelling in abdomen (ascites) Pumping action of the heart grows weaker

6.7 million US adults with Heart Failure and ~50% will die within five years of their diagnosis5,6 8 Days Average HF Length of Stay2 $24,027 Total True Inpatient Cost per Encounter2 Long Lengths of Stay & High Costs of Care 90% of Heart Failure (HF) hospitalizations are due to signs and symptoms of Fluid Overload1 Unresolved congestion Poor clinical outcomes1 High Readmission Rates Related Costs/Penalties $24,027 Non-reimbursable cost estimate for readmission encounter2 Opportunity Cost of occupied bed of ALL Medicare reimbursements4 Up to 3% 24% 30-Day Readmission rate1 50% 90-Day Readmission rate1 Low Reimbursement $8,2833 $15,744 Loss per visit DRG 291 DRG 292 $5,7083 $18,319 Loss per visit DRG 293 $3,9013 $20,126 Loss per visit High Loss per HF Hospitalization The Healthcare Burden of Heart Failure/Fluid Overload With Fluid Overload as a leading cause of HF readmissions, it also presents a considerable economic burden on hospitals PATIENT HOSPITAL Over 1 million HF hospitalizations occur annually in the US1 Efficacy of diuretic use in HF & CV surgery patients 10-40%5 are refractory 68%5 show sub-optimal response Decompensated HF admission drives economic loss per admission High readmission rates lead to Medicare penalties4 1. Costanzo MR, et al. J Am Coll Cardiol. 2017 May 16;69(19):2428-2445. 2. From Premier Applied Sciences database. 3. 2021 DRG National Average Payment Table Update 4. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/Readmissions-Reduction-Program 5. Testani, Circ Heart Failure, 2016;9:e002370. 6. Kazory A, Sgarabotto L, Ronco C: Extracorporeal Ultrafiltration for Acute Heart Failure. Cardiorenal Med 2023;13:1-8. doi: 10.1159/000527204

The market faces an urgent challenge as three patient categories grapple with the debilitating impact of Fluid Overload across multiple hospital specialty units Fluid Overload is a leading cause of hospital readmission post 30 days following cardiac surgery2 1. Costanzo MR, et al. JACC. 2017 May 16;69(19):2428-2445. 2. Iribarne A, et al. Ann Thorac Surg. 2014; 98(4): 1274-80. 3. Vaara ST et al. Crit Care.2012; 16: 1-11. 4. Sutherland SM, et al. Am J Kidney Disease. 2010; 5(2): 316-25. 5. Gillespie RS, et al. Ped Nephro. 2004; 19(12): 1394-99. For critically ill patients in the ICU, Fluid Overload was associated with a markedly increased risk for 90-day mortality3 In pediatric patients, Fluid Overload is associated with significant increases in mortality4-5 90% of all heart failure hospitalizations are due to symptoms of Fluid Overload 1 Heart Failure Critical Care Pediatric

Diuretics, the current standard of care, have significant limitations leaving a gap in clinical care Diuretics provide insufficient symptom relief and are associated with in hospital worsening heart failure and increased mortality after discharge1 1. Costanzo MR, et al. JACC. 2017;69(19)2428-2445. 2. Felker MG & Mentz RJ. JACC. 2012;59(24):2145-53. 3. Al‐Naher et al. Br J Clin Pharmacol. 2018 Jan; 84(1): 5–17. 4. Butler J et al. Am Heart J. 2004 Feb;147(2):331-8. 5. Testani JM, et al. Circ Heart Fail. 2016;9(1):e002370. 6. Kazory et al. Cardiorenal Med 2023;13:1-8. doi: 10.1159/000527204. High risk of readmissions 1 Long-term use of diuretics is associated with kidney damage1-4 Efficacy of diuretic use in HF & CV surgery patients 10-40%5 have poor diuretic response 68%5 show sub-optimal response “Diuretic resistance has been a well-known challenge in the care of these patients, and not surprisingly is tied to worse prognosis.”6 “Extracorporeal Ultrafiltration for Acute Heart Failure” Cardiorenal Medicine Journal

Market OpportunityAcross our three strategic patient categories, we have an enormous opportunity to improve outcomes for Fluid Overload patients across multiple hospital specialty units.

1. See Appendix. 2. Approved for use in pediatric patients weighing 20 kg or more. With a large and expanding addressable market, Nuwellis stands at the forefront of a transformative healthcare opportunity Outpatient market opportunity adds $0.5B+ to addressable market (heart failure and advanced liver disease) $1B Market1 ~30% of current Nuwellis sales Heart Failure $900M Market1 ~40% of current Nuwellis sales Critical Care $130M Market1 ~30% of current Nuwellis sales Pediatric $2B+ TAM

Differentiated SolutionsNuwellis is a different company today

Aquadex represent our foundation, positioning the company to effectively address significant market opportunities Collaborations Patent Portfolio Products Console Circuit Peripheral Access Accuracy & Safety Guided Therapy Robust clinical foundation reinforces strategic technology expansion and collaboration

Our hero therapy: Aquadex®A clinically superior solution for Fluid Overload The only device of its kind in the market

Filtered blood returns to the patient via the infusion line 5 Blood is taken from the patient via the withdrawal line using proprietary catheters technology 1 The blood is pushed through the filter by the blood pump (0-40 ml per minute) 2 The ultrafiltration pump withdraws fluid across filter membrane using negative pressure Hematocrit sensor monitors preset hematocrit limits 3 Ultrafiltration pump can pull 0-500 ml of fluid per hour 4 How the Aquadex system works Predictable and precise fluid removal

At a Recent Late Breaking Clinical Trials, Significant Reduction in HF Events and HF Hospitalization at 30 Days Presented at THT 2024 in early March, a re-appraisal of a 224-patients randomized controlled trial (AVOID-HF) demonstrated statistically significance reductions at 30 days. THT Boston 2024 – Featured Late-Breaking Clinical Science Abstract III – Aquapheresis for Management of Decompensated Heart Failure: A Re-appraisal of AVOID-HF

Aquadex Reintroduced in 2016 An estimated 25,700 patients treated across all three of our customer categories9 From proprietary technology to unmatched advantages in Fluid Overload therapy, Aquadex has the potential to be the standard of care for diuretic resistant patients Product Strategy & Differentiation More effective in decongesting resulting in stabilized or improved cardiac hemodynamics2-5 Easier to set-up than CRRT; built-in Hematocrit sensor allows real-time measurement of blood volume changes Designed for multiple settings: ICU, Stepdown Unit, Telemetry Unit, HF Floor, and Outpatient – versus ICU only for CRRT Predictably removes excess isotonic fluid (water and sodium)8 No significant changes to kidney function1 A proven and predictable solution for Fluid Overload. 1.74 fewer hospitalizations1 At one year after Aquadex therapy treatment, compared to 2.14 before treatment Compared to the 24% national average at 30 days1 12.4% readmission rate Over $2B addressable market 1. Watson R et al. J Cardiac Fail. 2020; 26(10): s56. 2. Kiziltepe, U, et al. Ann Thorac Surg. 2001;71(2): 684-93. 3. Sahoo, TK, et al. Indian J Thorac Cardiovas Surg. 2007;23(2): 116-24. 4. Boga et al. Perfusion. 2000;15:143-50. 5. Onoe et al. Perfusion. 2001;16:37-42.65. 6. Costanzo MR et al. JACC. 2005; 46(11); 2457-51. 7. Costanzo, et. al., ISPOR 23rd Annual Int’l Mtg., May 19-23, 2018, Baltimore, MD, USA. 8. Kazory A, Sgarabotto L, Ronco C: Extracorporeal Ultrafiltration for Acute Heart Failure. Cardiorenal Med 2023;13:1-8. doi: 10.1159/000527204. 9. Utilization figures are based upon Company estimates, including certain good faith assumptions of the number of blood circuits used per adult and per pediatric procedures, such that patients served equals total number of units sold divided by a per procedure estimate of circuit used per adult and pediatric patients. Reduces length of hospital stay when initiated early, resulting in average savings of $3,975 (14%)6-7 $3,975 in average savings

Coming soon: Vivian™Our pediatric solution On track for H1 2027 launch

Received 510(k) and launched commerciallyin Q1 2020. We’ve seen a steady increase in our pediatric business, providing patients with high mortality an opportunity at life1 1. Source: Menon S, et al. CJSN, 2019; 14: 1432-40. Aquadex is currently cleared for use in pediatric patients weighing 20 kg or more. Attributes Group 1: <10kg Group 2: 10-20kg Group 3: >20kg # of Patients N = 72 N = 13 N = 34 Primary disease 43% kidney 29% cardiac 54% kidney 31%other 38% kidney 28% cardiac Survival at end of treatment (Aquadex) 43 (60%) 13 (100%) 33 (97%) Group 1 patients traditionally do not receive any kind of therapy “For our babies born with diseased or absent kidneys, Aquadex has given them a chance at life because in the past, there were no options to treat these patients.” Kara Short MSN, CRNP, NICU nurse practitioner at Alabama Children’s Hospital Improved patient survival at end of treatment 4-10 circuits/pts 3-6 consoles per hospital Pediatrics represents a $130M TAM

1. Sutherland SM, et al. American Journal of Kidney Diseases, vol. 55, no. 2, pp. 316-325, February 2010, 2. Gillespie RS, et al. Pediatric Nephrology, vol. 19, no. 12, pp. 1394-1399, December 2004., 3. Menon S, et al. CJSAN, vol 14, October 2019. Introducing Vivian™ Launch best-in-class pediatric CRRT system, H1 2027 Early feedback from pediatric nephrologists: “This will be a game-changer for us.” Nuwellis Pediatric Advisory Board member Product Strategy & Differentiation Integrates Ultrafiltration with Hemofiltration and Hemodialysis capabilities Expected broadest weight indication: 2.5 kg + Safety features: lowest extracorporeal blood volume; built-in hematocrit sensor Clinician-driven UX design Product name: “Viv” Latin root means life; Vivian – Lady of the Lake in King Arthur, allusion to Land of 10,000 Lakes Therapy to fill crucial gaps, offering a lifeline to critically ill neonates and children Ultrafiltration Hemofiltration Hemodialysis 8.5x mortality Fluid Overload drives pediatric morbidity and mortality risk in critically ill patients Children with >20% fluid overload had an odds ratio for mortality of 8.5 compared to children with <20% FO 1,2 Providing renal support and hemodynamic stability can be life-saving 60% survival to end therapy In patients <20 kg who primarily received Slow Continuous Ultrafiltration (SCUF)3 $130m addressable pediatric market

External Pump Detection Hemolysis/Blood Leak Detector Accounting for Density Auto Clamp Transport Mode Self-loading/Self-emptying Bags Open vs. Closed Loop Filter Clotting Prevention Source LineConnection Peripheral Flow Improvements Dual LumenCatheter Plasma and Blood Volume Measurement Physiological Parameters Guidance Console Circuit Peripheral Access Accuracy & Safety Guided Therapy We are keenly focused on developing novel technology with a strong IP portfolio Robust and evolving portfolio of patents circling the technology 16 Nuwellis patent applications (US & EU) in addition to licensed IP from Baxter Wide technology scope coverage 13 issued patents with protection to 2043

Strategic CollaborationsOur collaborations with DaVita and SeaStar are expanding market access, bolstering technology offerings, and accelerating Nuwellis growth trajectory.

In June of 2023, we launched a supply and collaboration agreement with DaVita to expand the access of Aquadex therapy for heart failure 790+ hospital partnerships1 2,500+ clinic1 11.6B in revenue in 20221 65,000+ employees1 1. Used with permission from DaVita 77% survival rate1 At day 60 At day 60 NO dialysis dependency2 2x length of stay in ICU for patients with AKI (8 days vs. 4 days) as ICU patients without AKI3 SeaStar distribution and licensing agreement to offers a new Selective Cytopheretic Device (SCD-PED) for pediatric patients with AKI 1) Use of the Selective Cytopheretic Device to Support Critically Ill Children Requiring Continuous Renal Replacement Therapy: A Probable Benefit-Risk Assessment Stuart L. Goldstein, Nicholas J. Ollberding, David J. Askenazi, Rajit K. Basu, David T. Selewski, Kelli . Krallman, Lenar Yessayan, H. David HumesmedRxiv 2023.08.22.23294378; doi: https://doi.org/10.1101/2023.08.22.23294378 2) SL Goldstein et al.: The Selective Cytopheretic Device in Children; Kidney International Reports (2021) 3) De Zan F, Amigoni A, Pozzato R, Pettenazzo A, Murer L, Vidal E. Acute Kidney Injury in Critically Ill Children: A Retrospective Analysis of Risk Factors. Blood Purif. 2020;49(1-2):1-7. doi: 10.1159/000502081. Epub 2019 Aug 5. PMID: 31382259.

Financial Snapshot Key Milestones Executive TeamInvestment Highlights

With a track record of revenue growth, we believe our strategy will lead to continued revenue growth Annual Revenue ($000) Cash $1.4 million as of Mar 31, 2024 NO Debt Capitalization Table as of June 30th, 2024

Enroll 80th patient in REVERSE-HF clinical trial Execute DaVita Supply & Collaboration agreement FDA 510(k) clearance of 12cm dual-lumen length catheter (dELC) Completion of DaVita pilot program Commercial launch of SeaStar’s SCD for pediatric AKI Branded Quelimmune* IDE Anticipated approval for Vivian™ Launch DaVita pilot program Key milestones Legend: Clinical Milestone Commercial Milestone Product Milestone Partnership/Acquisition Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Enrollment completion REVERSE-HF clinical trial 2023 2025 2024 On May 20, 2024, SeaStar sent a notice alleging that Nuwellis has breached its license and distribution agreement with SeaStar. Nuwellis believes that the alleged breach allegation is without merit and that Nuwellis has fully complied with the terms of the license and distribution agreement. Nonetheless, the license and distribution agreement provides Nuwellis with a ninety-day cure period. As of the date hereof, SeaStar has honored Nuwellis’ most recent purchase orders under the license and distribution agreement.

Our diverse leadership team boasts extensive industry experience and a successful history of commercialization Seasoned Leadership: Over 200 years’ ofcollective experience in clinical practice and the medical device industry, with significant tenures at industry leaders such as Medtronic, Boston Scientific, and Abbott/St. Jude Medical. Commercialization Prowess: Demonstrated success in commercializing various therapies, showcasing the team's ability to bring innovative medical devices to market effectively. Strategic Industry Involvement: In-depth industry knowledge and strategic insights gained from working with major players in the medical device sector. Adaptive Management: Dynamic management style with a history of successfully navigating challenges and adapting to evolving market dynamics. Innovative Contribution: Track record of contributing to the growth and success of previous ventures through innovation and product development. Nestor Jaramillo, Jr. President & Chief Executive Officer John Kowalczyk Senior Vice President of Sales & Marketing John Jefferies, M.D. Chief Medical Officer Megan Cotts VP of Clinical Research and Reimbursement Rob Scott Chief Financial Officer Neil P. Ayotte General Counsel, SVP & Chief Compliance Officer Sandra Eayrs Chief Human Resources Officer

Investment Highlights $2B+ TAM Positive ROI Clinical Evidence Scalable Consumables Commercial Infrastructure Product Pipeline Leadership Team $2B+ and growing addressable market in critical need Attractive clinical + economic benefits to hospitals and healthcare system Robust body of clinical evidence demonstrating the success of our products Scalable consumables driven growth Commercial infrastructure leverage Novel product pipeline along with an expanding IP Portfolio for continued expansion Highly experienced leadership perfectly positioned to drive our growth strategy We’re confident that the key catalysts we will pursue in 2024 should support a valuation of 3-5x revenue.

Thank you!

Appendix

DaVita pilot to commercialization In June of 2023, we launched a supply and collaboration agreement with DaVita to expand the access of Aquadex therapy for Fluid Overload patients 790+ hospital partnerships1 2,500+ clinic1 11.6B in revenue in 20221 65,000+ employees1 Collaboration Strategy Pilot Aquadex to treat adult patients with congestive heart failure in select U.S. markets Offer Aquadex to patients across a network of hospitals and outpatient clinics Enable accelerated commercial expansion of Aquadex Provides DaVita the option to acquire up to 19.9% of Nuwellis Expected Collaboration Benefits Improved patient outcomes and lower long-term cost of care for hospitals and health care system Reduce related healthcare costs for providers and payers Accelerated Aquadex market penetration Provides DaVita with a new therapy offering 1. Used with permission from DaVita

SeaStar Distribution and Licensing Agreement Collaboration Strategy Launch market-first SCD-PED device (2024) Offer new product to existing Nuwellis pediatric customers Develop relationships at new pediatric accounts to support Vivian launch in 2027 Explore Nuwellis manufacturing viability for SCD Strengthen Nuwellis pediatric product portfolio Expected Collaboration Benefits New revenue stream Therapeutic diversification Strong strategic fit with Vivian SeaStar distribution and licensing agreement offers a new Selective Cytopheretic Device (SCD-PED) for pediatric patients with AKI 77% survival rate1 At day 60 At day 60 NO dialysis dependency2 2x length of stay in ICU for patients with AKI 1) Use of the Selective Cytopheretic Device to Support Critically Ill Children Requiring Continuous Renal Replacement Therapy: A Probable Benefit-Risk Assessment Stuart L. Goldstein, Nicholas J. Ollberding, David J. Askenazi, Rajit K. Basu, David T. Selewski, Kelli . Krallman, Lenar Yessayan, H. David HumesmedRxiv 2023.08.22.23294378; doi: https://doi.org/10.1101/2023.08.22.23294378 2) SL Goldstein et al.: The Selective Cytopheretic Device in Children; Kidney International Reports (2021) 3) De Zan F, Amigoni A, Pozzato R, Pettenazzo A, Murer L, Vidal E. Acute Kidney Injury in Critically Ill Children: A Retrospective Analysis of Risk Factors. Blood Purif. 2020;49(1-2):1-7. doi: 10.1159/000502081. Epub 2019 Aug 5. PMID: 31382259. (8 days vs. 4 days) as ICU patients without AKI3

Market ValidationReal-world testimonials and clinical studies provide meaningful validation for Nuwellis' products.

Abington Hospital Jefferson Health Retrospective, single center analysis 334 consecutive acutely decompensated heart failure patients Cohort of patients in study were sicker than those in other clinical trials Treated with adjustable-rate UF using Aquadex Weight loss due to fluid removal Unchanged kidney function 1. Watson R et al. J Cardiac Fail. 2020; 26(10): s56. 2. Costanzo MR, et al. JACC. 2017 May 16;69(19):2428-2445. Ultrafiltration: Positive ROI, clinical and economic benefits 10-Year, real-world experience with ultrafiltration1 81% reduction in heart failure hospitalizations per year HF Hospitalizations Average 2.14 hospitalizations per year before Aquadex Ultrafiltration 1 Year after Aquadex ultrafiltration Average 0.4 hospitalizations 12.4% at 30 days 14.9% at 90 days 27.3% at 1 year National Average 24% at 30 days2 50% at 6 months Hospital Readmissions Significant quality of life improvement for the patients as well as savings to the healthcare system and to the individual hospitals Newly published

“Extracorporeal ultrafiltration has emerged as an option to overcome shortcomings of diuretics” Predictable, adjustable, and more efficient fluid removal with ultrafiltration compared to diuretics Applicability in other clinical settings, such as cardiac surgery, burn and other specialty units Potential to expand use of ultrafiltration into outpatient centers and other ambulatory settings “Extracorporeal Ultrafiltration for Acute Heart Failure” Cardiorenal Medicine Journal Pooled data from seven randomized controlled trials of ultrafiltration, 771 patient participants Kazory A, Sgarabotto L, Ronco C: Extracorporeal Ultrafiltration for Acute Heart Failure. Cardiorenal Med 2023;13:1-8. doi: 10.1159/000527204. Peer-reviewed publication advocates for early clinical application of ultrafiltration in diuretic resistant patients Diuretic shortcomings leave a gap in clinical care “The efficacy of diuretics gradually decreases as (heart failure) progresses in a significance subset of patients.”“Diuretic resistance has been a well-known challenge in the care of these patients, and not surprisingly is tied to worse prognosis.”

With 15 sites and 125 patients enrolled, we are in the midst of executing our REVERSE-HF Clinical Study with Aquadex Planning + Enrollment Execution Analysis + Publication Protocol design based on AVOID-HF trial Target 20 sites Goal; enroll 372 patients by end of 2024 16 sites activated 80 patients enrolled at end of 2023 Interim analysis at 80% enrollment Final analysis and publication H2 2025 Ongoing REVERSE-HF randomized controlled trial to support driving ultrafiltration to standard of care As of July 12, 2023

Growth StrategyWe aim to achieve sustainable expansion and market leadership through strategic growth plans and tactics.

Our strategic growth plan emphasizes four key efforts 1 2 3 4 We’ve structured our sales and marketing team to ensure seamless execution

Document and Entity Information	Jul. 16, 2024
Cover [Abstract]
Document Type	8-K/A
Amendment Flag	false
Document Period End Date	Jul. 16, 2024
Entity File Number	001-35312
Entity Registrant Name	Nuwellis, Inc.
Entity Central Index Key	0001506492
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	68-0533453
Entity Address, Address Line One	12988 Valley View Road
Entity Address, City or Town	Eden Prairie
Entity Address, State or Province	MN
Entity Address, Postal Zip Code	55344
City Area Code	952
Local Phone Number	345-4200
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	NUWE
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false