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): January 9, 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:

☐	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))

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 January 8, 2024. The sole purpose of this Amendment is to provide an updated version of the investor presentation furnished as Exhibit 99.1 thereto. The updated investor 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 8-K/A does not amend, update, or change any other items or disclosures contained in the Original Report.

Item 7.01

Regulation FD Disclosure.

On January 9, 2024, Nuwellis, Inc. (the “Company”) posted an updated corporate presentation to its website at ir.nuwellis.com, which the Company may use from time to time in communications or conferences. A copy of the corporate presentation is attached as Exhibit 99.1 to this Current Report on Form 8-K (this “Report”).

The information in this Report, including Exhibit 99.1 hereto, 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 (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing. The Company’s submission of this Report shall not be deemed an admission as to the materiality of any information required to be disclosed solely to satisfy the requirements of Regulation FD.

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 Securities and Exchange Commission, including that actual events or results may differ materially from those in the forward-looking statements.

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits

Number		Description
99.1		Corporate Presentation, dated January 9, 2024
104		Interactive Data File (embedded within the 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: January 9, 2024	NUWELLIS, INC.

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

Exhibit 99.1

Aquadex FlexFlow® and Aquadex SmartFlow® are registered trademarks of Nuwellis, Inc. Aquadex ® is a trademark of Nuwellis, Inc. Safe Harbor Statement Financial and Statistical Data This 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. Trademarks The 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 Information You 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 Statement This 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, 2022 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. 2 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc.

Overview 2 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc. The Problem: Fluid Overload The Market Opportunity Nuwellis Solutions Market Validation Growth Strategy Financial Snapshot Team

Nuwellis, Inc. 4 Our Mission 4 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis is dedicated to transforming the lives of patients suffering from Fluid Overload through science, collaboration, and innovation.

The Problem Fluid Overload presents a significant public health challenge that impacts both patient outcomes and hospital resources. 5 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc.

What is Fluid Overload? Fluid Overload 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 5 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc. 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

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 the 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. Fluid Overload is the leading cause of death for critically ill patients in the ICU within 90 days3 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 5 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc.

6.5 million US adults with Heart Failure and 40-45% will die within five years of their diagnosis6 With Fluid Overload as the leading cause of HF hospitalization, it also presents a considerable economic burden on hospitals 10 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc. 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 ~$16K loss per admission3 Non‐reimbursed 30‐day readmissions can cost up to $15.2M annually2 High readmission rates lead to Medicare penalties4 The Healthcare Burden of Heart Failure/Fluid Overload 90% of Heart Failure (HF) hospitalizations are due to signs and symptoms of Fluid Overload1 Unresolved Poor clinical congestion outcomes1 Long Lengths of Stay & High Costs of Care 8.3 Days $24,027 Average HF Length of Stay2 Total True Inpatient Cost per Encounter2 Low Reimbursement High Loss per HF Hospitalization DRG 291 DRG 292 DRG 293 $8,2833 $5,7083 $3,9013 $20,126 $18,319 Loss per visit $15,744 Loss per visit Loss per visit High Readmission Rates Related Costs/Penalties 24% $24,027 30‐Day Readmission rate1 Non‐reimbursable cost estimate for readmission encounter2 Opportunity Cost of occupied bed 50% Up to 3% 90‐Day Readmission rate1 of ALL Medicare reimbursements4 . 4. https://www.cms.gov/Medicare/Medicare‐Fee‐for‐Service‐ 1. Costanzo MR, et al. J Am Coll Cardiol. 2017 May 16;69(19):2428‐2445. 2. From Premier Applied Sciences database. 3. Reimbursement estimates from MCRA 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

Nearly 1 of 5 patients who undergo cardiac surgery require readmission Source: Iribarne A, et al. Ann Thorac Surg. 2014 Oct; 98(4): 1274-80. 1. Vaara ST et al. Crit Care.2012; 16: 1-11. 2. Pradeep, A. et al. HSR Proc IC and Car An. 2010 Mar; 2(4): 287-296. 3. Costanzo MR, et al. J Am Coll Cardiol. 2017 May 16;69(19):2428- 2445. 10 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc. In a multi‐center study, volume overload was among the top 3 most prevalent causes for first readmission within 30 days and beyond 30 days Fluid overload is the leading cause of death for critically ill patients in the ICU within 90 days1 Excess fluid following cardiac surgery leads to three‐fold increase in mortality at 90 days2 90% of heart failure hospitalizations are due to signs and symptoms of fluid overload3

Pediatric patients that experience Fluid Overload are vulnerable and have an increased mortality rate 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. Salahuddin et al. BMC Nephrology; 2017:18:45. 4. Raina, R et al. Frontiers in Pediatrics. Vol 6, Article 306. Oct 2018. 5. Wang S, et al. Perfusion., vol. 27, no. 5, pp. 438‐46, Sep 2012. 6. Askenazi D, et al. Pediatr Nephrol., vol. 31, no. 5, pp. 853‐860, May 2016. 7. Chakravarti S, et al. Pediatr Rep., vol. 8, no. 2, p. 6596, 23 Jun 2016. 8. Raina R, et al. PLoS ONE, vol. 12, no. 5, p. e0178233, 30 May 2017. In a pediatric study, a 3% increase in mortality was observed for every 1% increase in fluid overload1,2 Children with more than 20% FO had an odds ratio for mortality of 8.5 compared with children with less than 20% FO.1,2 FO is an independent risk factor for acute kidney injury in critically ill patients3,4 Diuretics and adult CRRT devices can be poorly tolerated by pediatric patients 5‐8 10 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc.

Diuretics, the current standard of care, have significant limitations leaving a gap in clinical care 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. Diuretics do not remove sodium predictably, which causes fluid retention 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 11 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc. Diuretics provide insufficient symptom relief and are associated with worsening heart failure and increased mortality after discharge1 “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

$2B+ Addressable Market Opportunity Across our three strategic patient categories, we have an enormous opportunity to improve outcomes for Fluid Overload patients across multiple hospital specialty units. 11 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc.

See Appendix. 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 sales Heart Failure $900M Market1 ~40% of current sales Critical Care $130M Market1 ~30% of current sales Pediatric $2B+ TAM 11 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc.

Near-term opportunities (U.S.) Mid to Long-term opportunities (U.S.) In addition to the ongoing pediatric and HF segments, we will expand our use cases to address new critical care needs 1. Derived from: https://www.grandviewresearch.com/industry‐analysis/coronary‐artery‐bypass‐graft‐cabg‐market and growth rate from: https://www.hcup‐us.ahrq.gov/reports/statbriefs/sb171‐Operating‐Room‐Procedure‐Trends.pdf. 2. Derived from: https://www.healthline.com/health/liver‐transplant‐survival and this for growth rate: https://www.marketwatch.com/press‐release/organ‐transplantation‐market‐size‐to‐grow‐at‐934‐cagr‐during‐the‐forecast‐period‐of‐2022‐2027‐100‐report‐pages‐2022‐09‐23. 3. Derived from: https://www.grandviewresearch.com/industry‐analysis/ventricular‐assist‐devices‐market ($600m estimated market in 2018 / Avg cost per procedure of $200k = 3k procedures) and growth rate from same source. 4. Derived from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6557150/. 5. Derived from: https://www.ncbi.nlm.nih.gov/pubmed/25291348. 6. Derived from: https://www.uclahealth.org/medical‐services/heart/ecmo/research/statistics and growth rate from same source. 7. AKI in Hospitalized Children: Epidemiology and Clinical Associations in a National Cohort, Sutherland. 8. Costanzo MR, et al. J Am Coll Cardiol. 2017 May 16;69(19):2428‐2445. Cardiac Surgery 550,000 patients/year1 Liver Transplants 12,000 patients/year2 VAD 6,000 patients/year3 Sepsis 1.8M patients/year4 Advanced Liver Disease 700,000 patients/year5 Adult ECMO 15,000 patients/year6 Pediatric Patients 16,000 patients/year7 Heart Failure Patients 360,000 patients/year8 14 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc.

Differentiated Solutions Nuwellis has been in the business of fluid management since 2016, and we’re only getting started. 14 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc.

We have strategically built a robust foundation, positioning the company to effectively address a significant market opportunity Collaborations Patent Portfolio Products Console Circuit Peripheral Access Accuracy & Safety Guided Therapy Robust clinical foundation reinforces strategic technology expansion and collaboration 14 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc.

Aquadex A proven and predictable solution for Fluid Overload. 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 Product Strategy & Differentiation More effective in decongesting resulting in stabilized or improved cardiac hemodynamics2‐5 Easier to set‐up than CRRT with a higher, 4:1 nurse to patient monitoring ratio; 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 1 81% hospitalization reduction Compared to diuretics than the national average at 30 days1 48% lower readmission 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 14 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc.

Filtered blood returns to the patient via the infusion line 5 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 Predictable and precise fluid removal 1 Blood is taken from the patient via the withdrawal line 14 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc. How the Aquadex system works

While the competitive landscape does address Fluid Overload, Aquadex is the only device in the market that gently and predictably removes fluid Potential for more timely/effective treatment (UF) with Aquadex More flexible and predictable treatment (UF) with Aquadex Draw less blood, more predictably with Aquadex Indicated for use in hospital, ambulatory, and physician office; Aquadex, with a flow rate of up to 40 ml/minute and 35ml extracorporeal volume, removes isotonic fluid Heart Failure Critical Care Pediatric 14 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc.

$1.1 $1.8 $2.1 $2.7 2019 2020 2021 2022 Pediatric Revenue ($M) Received 510(k) and launched commercially in 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 circuits/pts 3-6 consoles per hospital 14 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc. Pediatrics represents a $130M TAM 4-10

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, 1H 2025 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 14 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc. 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 66% survival to end therapy Providing renal support and hemodynamic stability can be life‐saving 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 14 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc. Transport Mode Self‐loading/ Self‐emptying Bags Open vs. Closed Loop Filter Clotting Prevention Source Line Connection Peripheral Flow Improvements Dual Lumen Catheter 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 16 novel patents with protection to 2043+ Robust and evolving portfolio of patents circling the technology 21 Nuwellis patent applications (US & EU) in addition to licensed IP from Baxter 1 pending patent application, expected to issue January 9, 2024 Wide technology scope coverage

Strategic Collaborations Our collaborations with DaVita and SeaStar are expanding market access, bolstering technology offerings, and accelerating Nuwellis growth trajectory. 14 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc.

DaVita pilot to commercialization 900+ hospital partnerships1 2,500+ clinic1 6,500+ employees1 In June of 2023, we launched a supply and collaboration agreement with DaVita to expand the access of Aquadex therapy for Fluid Overload patients Collaboration Strategy 11.6B in revenue in 20221 1. Used with permission from DaVita Pilot Aquadex to treat adult patients with congestive heart 14 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc. 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

SeaStar Distribution and Licensing Agreement 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 2025 Explore Nuwellis manufacturing viability for SCD Strengthen Nuwellis pediatric product portfolio SeaStar offers a new Selective Cytopheretic Device (SCD‐PED) for pediatric patients with AKI Collaboration Strategy Expected Collaboration Benefits New revenue stream Therapeutic diversification Strong strategic fit with Vivian 77% mortality reduction1 14 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc. At day 60 NO dialysis dependency2 At day 60 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

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 14 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc.

“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.” 30 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc.

With over 16 sites and 80+ 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 30 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc. 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 December 31, 2023

Growth Strategy We aim to achieve sustainable expansion and market leadership through strategic growth plans and tactics. 30 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc.

Our strategic growth plan emphasizes four key efforts Grow Utilization increase the number of circuits per console Grow Penetration increase the number of consoles per hospital Grow number of New Accounts Initiate New Indications 1 30 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc. 2 3 4 We’ve structured our sales and marketing team to ensure seamless execution

We will implement tactics aligned to our growth plan to drive revenue for 2024 to 2026, focusing on sales and marketing efforts Execute Strategies CV Surgery / CC / HF / Peds Physical presence and productive days readmission Leverage Proforma and Evidence to drive earlier intervention for diuretic resistance or Invest in Highest Opportunity Territories Build 2:1 CES to AM ratio Penetration / Growth Drivers Drive utilization across multiple departments and customer categories Build Pediatric presence for Vivian and Aquadex coexistence Drive Therapy Adoption and New Indications Maximize Go To Market Model Leverage DaVita footprints, network, contracts and resources Grow Organically with direct team Leverage SeaStar as revenue driver Add additional indirect distribution partnerships Leverage DaVita and SeaStar Partnerships Successful DaVita pilot leads to broader adoption Solution to nursing or hospital capital shortage SeaStar drives revenue while building relationships for Vivian opportunity Outpatient Reimbursement 1. Leverage outpatient reimbursement data for improved coverage 2. Explore and drive Apheresis APC code change 3. Continue to drive Category III CPT Code (0692T) 30 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc.

Financial Snapshot Nuwellis forecasts a financially robust future, aligning our funding ask with our strategic growth plan. 30 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc.

With a track record of consistent financial success, we're confident that our growth strategy will lead to meaningful revenue expansion Annual Revenue ($000) $5,511 $4,998 $8,543 $7,921 $7,441 2018 2019 2020 2021 2022 CASH $4.9 million as of Sept 30, 2023 NO DEBT 30 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc.

Our 2023 quarterly results reflect improving operational efficiencies ($000) $3,000 $2,500 $2,000 $1,500 $1,000 $500 $‐ Q1 2023 Q2 2023 Q3 2023 Revenue $8,000 $7,000 $6,000 $5,000 $4,000 $3,000 $2,000 Q1 2023 Q2 2023 Q3 2023 Operating Expense $‐ $(1,000) $(2,000) $(3,000) $(4,000) $(5,000) $(6,000) $(7,000) Q1 2023 Q2 2023 Q3 2023 Net Loss We’ve increased revenue and become more efficient in spend, resulting in a decrease in net loss 30 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc. Unaudited *

Enroll 80th patient in REVERSE‐HF clinical trial Execute DaVita Supply & Collaboration agreement FDA 510(k) clearance of 12cm dual‐lumen length catheter (dELC) Anticipated IDE approval for Vivian™ Commercial introduction of SCD for pediatric AKI following HDE approval (pending) Completion of DaVita pilot program Launch DaVita pilot program Key milestones Legend: Clinical Milestone Commercial Milestone Product Milestone Partnership/Acquisition 2023 30 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc. 2024E 2025E Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Commercial Launch best‐ in‐class pediatric CRRT system Reimbursement for outpatient to triple current payment level

Our diverse leadership team boasts extensive industry experience and a successful history of commercialization Seasoned Leadership: Over 200 years' collective 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 Vitaliy Epshteyn Senior Vice President of Operations, Engineering & QA/RA John Jefferies, M.D. Chief Medical Officer Megan Catts Vice President of Clinical Research and Reimbursement Rob Scott Chief Financial Officer 30 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc.

Investment Highlights 30 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc. $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.

History of Nuwellis: from restart to growth ACT I 2017‐2019 ACT III 2022‐2023 ACT IV 2024‐2026 Establish Company Vision, Direction, Strategy Set the Stage for Faster Growth Execute Repurchased assets from Baxter and transferred manufacturing to Eden Prairie Committed the organization to the Vision: Be the standard of care to treat Fluid Overload early in care continuum Direction: Established three patient categories: Heart Failure, Critical Care via CVS, and Pediatric Strategy: Re‐brand, the “New Well is” Nuwellis; Build clinical evidence pipeline, establish sales and marketing Supply and collaboration agreement with DaVita Exclusive license and distribution agreement with SeaStar for the pediatric SCD device Right sized the sales organization to become more efficient in growing the tnc. OApril27, 2021, HF Solutions announced a name change to Nuwellis, Inc. to reflect its expansion to include critical care and pediatrics applications Currently, Nuwellis has approximately 60 full‐time employees as of December 31, 2023

1. Pinney S et al Poster presented HFSA Annual Meeting 2022. 2. Haas D et al. Ten year real world experience with ultrafiltration for the management of acute decompensated heart failure. American Heart Journal, 2022. 3. Beckles DL et al. The Use of Simple Ultrafiltration Technology as a Fluid Management Strategy for High‐Risk Coronary Artery Bypass Grafting Surgery. J Cardiac Surg, 2022. DOI: 10.1111/jocs.16867 4. Sutherland SM, Davis AS, Powell D, Tanaka J, Woo M, Josephs S, Wong CJ. Kidney Replacement Therapy in Low Birth Weight Preterm Newborns. Pediatrics. 2022 Sep 1;150(3):e2022056570. doi: 10.1542/peds.2022‐056570. PMID: 35945293. 5. Engelman DT, Shaw AD. A Turnkey Order Set for Prevention of Cardiac Surgery‐Associated Acute Kidney Injury. 223 Jan 1 The Annals of Thoracic Ongoing REVERSE‐HF randomized controlled trial to support driving ultrafiltration to standard of care Growing body of clinical evidence; Advocating for medical society guidelines and improved provider reimbursement

Selling strategy & account targeting tools GOAL: Increase total number of active accounts & drive utilization 1. Top 10 Accounts: Maintain 3. Identify: New Accounts 2. 11-30 Accounts: Pull-through Use Top 10 Account Analysis to plan support activities to ensure these accounts maintain current levels of utilization or grow. Leverage success across IDN healthcare system Use 11‐30 Account Analysis to plan launch/support activities to ensure good on‐boarding/on‐going experiences and pull‐through Expand within the Account to new Rxers, Departments and Specialties Use Account Targeting Tool to help identify new accounts to focus selling efforts on greatest/most‐sustainable opportunities and markets (incl. Premier) Standardize across IDNs. CES / AM Responsibility CES Responsibility AM Responsibility 30 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc.

REVERSE-HF Activated Study Sites & Enrollment Site Activation Date Northwell Health, Lennox Hill Hospital 20 May 2022 Abington Memorial Hospital 11 Aug 2022 University of California, San Francisco (UCSF) 06 Sep 2022 BayCare Healthcare Systems (Morton Plant) 13 Sep 2022 San Diego Cardiac Center 02 Nov 2022 Jackson Madison County General Hospital 12 Dec 2022 Baylor Scott & White (Temple) 12 Dec 2022 Ohio State University 22 Dec 2022 University of Kentucky 13 Jan 2023 Banner University Medical Center 13 Apr 2023 Mount Sinai Hospital 02 Jun 2023 Long Beach Memorial 11 Sep 2023 Sentara 20 Sep 2023 Mount Sinai Morningside 09 Oct 2023 Christ Hospital 20 Nov 2023 Henry Ford SIV scheduled 25 Jan 2023 30 | FOR INVESTOR PURPOSES ONLY: NOT R PRODUCT PROMOTION ©2024 Nuwellis, Inc. 11 patient is a screen failure 21 patient was withdrawn prior to randomization Closing St Joe’s – PI left institution 1 2

Market size sources 30 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc. Heart Failure – Inpatient ($1B+) Incidence of HF: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5494150/ Annual HF Hospitalizations: Costanzo MR, et al. J Am Coll Cardiol. 2017 May 16;69(19):2428‐2445 Insufficient diuretic response: https://www.ahajournals.org/doi/10.1161/CIRCHEARTFAILURE.115.002370?url_ver=Z39.88‐ 2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed Heart Failure – Outpatient ($0.5B+) Incidence of HF: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5494150/ Annual HF Hospitalizations: Costanzo MR, et al. J Am Coll Cardiol. 2017 May 16;69(19):2428‐2445 Diuretic resistance rate: https://www.ahajournals.org/doi/10.1161/CIRCHEARTFAILURE.115.002370?url_ver=Z39.88‐ 2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed Critical Care ($900m) VADs: https://www.grandviewresearch.com/industry‐analysis/ventricular‐assist‐devices‐market CABG: https://www.grandviewresearch.com/industry‐analysis/coronary‐artery‐bypass‐graft‐cabg‐market Valves: https://idataresearch.com/over‐182000‐heart‐valve‐replacements‐per‐year‐in‐the‐united‐states/ Liver Transplants: https://www.healthline.com/health/liver‐transplant‐survival Liver Disease: https://www.ncbi.nlm.nih.gov/pubmed/25291348 Kidney Disease: https://www.kidney.org/news/newsroom/factsheets/KidneyDiseaseBasics Sepsis: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6557150/ ECMO: https://www.uclahealth.org/medical‐services/heart/ecmo/research/statistics Pediatrics ($130m) Renal Replacement/AKI: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3789331/#:~:text=The%20hospitalized%20population%20at%20risk,are%20shown%20in%20Table%201 Heart Disease: https://www.cdc.gov/ncbddd/heartdefects/data.html#:~:text=Congenital%20heart%20defects%20are%20conditions,the%20United%20States%20each%20year Pediatric Transplantations: https://www.organdonor.gov/about/donors/child‐infant.html Pediatric ECMO: https://www.ncbi.nlm.nih.gov/pubmed/23246046

Document and Entity Information	Jan. 09, 2024
Cover [Abstract]
Document Type	8-K/A
Amendment Flag	false
Document Period End Date	Jan. 09, 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