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:

☐
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 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
 
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 diagnosis​5,6  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  
 
v3.24.2
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
Newellis (NASDAQ:NUWE)
Historical Stock Chart
From Oct 2024 to Nov 2024 Click Here for more Newellis Charts.
Newellis (NASDAQ:NUWE)
Historical Stock Chart
From Nov 2023 to Nov 2024 Click Here for more Newellis Charts.