STOCK TITAN
  1. Home
  2. Sec-filings
  3. NUWE
  4. [8-K] Nuwellis, Inc. Reports Material Event

Nuwellis (NASDAQ: NUWE) gets half its revenue from pediatrics in $4.2B market

Filing Impact
(High)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Nuwellis, Inc. (NUWE) furnished an updated investor presentation outlining its Aquadex ultrafiltration platform and growth strategy. The company targets a U.S. clinical addressable market exceeding $4.2 billion across critical care, heart failure, pediatrics and fluid monitoring, with pediatrics representing about 50% of current revenues.

For the first half of 2026, Nuwellis reports 20% year‑over‑year revenue growth and second‑quarter 2026 gross margin of 76% versus 56% a year earlier, and states it has cash runway through 2Q27. Growth is broad‑based, with H1 revenue in pediatrics, critical care and heart failure up 29%, 28% and 27%, respectively. The company is pursuing pediatric expansion of Aquadex to patients ≥5 kg with an FDA submission anticipated by Q4 2026, and is developing new products including the ClarityPRIME smart fluid monitoring system, targeted for commercial launch in 2H 2027, and the Vivian pediatric renal support platform with an IDE submission expected in 2Q 2028.

Positive

  • 20% H1 2026 revenue growth versus the prior-year period, indicating expanding adoption of the Aquadex platform and related offerings.
  • Gross margin improved to 76% in 2Q 2026 from 56% in the year‑ago quarter, suggesting stronger unit economics and operating leverage.
  • Nuwellis cites a $4.2 billion U.S. clinical addressable market across critical care, heart failure, pediatrics and fluid monitoring, providing a large runway for potential future growth.
  • The company reports cash runway through 2Q 2027, supporting execution of its near‑term product and market expansion initiatives.

Negative

  • None.

Filing Explained

The update adds a conditional AtriAmp pilot and lists 2,102,300 warrants, but reports no exercise or new share issuance as of August 10.

Nuwellis used this Form 8-K to furnish an updated corporate presentation under Item 7.01, rather than report a completed financing or share issuance. The presentation describes an AtriAmp co-promotion pilot and U.S. distribution opportunity outside New York; any effect on existing common holders from the listed warrants and options remains contingent on exercise and issuance.

The presentation says the AtriAmp arrangement covers about 11 Western states, includes a six-month co-promotion pilot, and is subject to pre-established performance criteria. It does not state that the pilot has completed or that revenue from the arrangement has been received.

As of August 10, 2026, the capitalization table lists 3,647,264 common shares, 5,859 preferred shares, 2,102,300 warrants with a weighted-average exercise price of $10.66, and 1,722 options with a weighted-average exercise price of $72.89; its fully diluted figure is 5,757,145.

Issuing additional shares would reduce an existing holder’s percentage ownership absent offsetting changes, but this filing presents warrants and options as common equivalents and does not report their exercise or the resulting share issuance. The next specified checkpoints are the AtriAmp pilot’s performance evaluation and the company’s stated distribution milestones.

Item 7.01 Regulation FD Disclosure Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
H1 2026 revenue growth 20% year-over-year Revenue growth for the first half of 2026 versus prior-year period
2Q 2026 gross margin 76% Compared to 56% in the prior-year quarter
U.S. clinical addressable market $4.2 billion Total potential market across five segments for Nuwellis’ platform
Pediatric share of revenue 50% Portion of company revenues represented by pediatric patients
Fully diluted shares 5,757,145 Capitalization table as of August 10, 2026
Common stock outstanding 3,647,264 shares Common stock count as of August 10, 2026
Warrants outstanding 2,102,300 at $10.66 Warrants with weighted average exercise price of $10.66
Cash runway through 2Q 2027 Company-stated cash runway to support near-term initiatives
ultrafiltration medical
"Aquadex® is a clinically proven system for precise, predictable fluid removal"
Ultrafiltration is a process that separates small particles and liquids from larger molecules or substances using a filter with tiny pores. It is often used in water treatment and medical applications to remove impurities or excess fluids. For investors, understanding ultrafiltration is important because innovations or changes in this technology can impact industries focused on clean water, healthcare, and filtration products.
gross margin financial
"2Q26 gross margins improved to 76% compared to 56% in prior-year period"
Gross margin is the difference between how much money a company makes from selling its products and how much it costs to produce them, expressed as a percentage of sales. It shows how efficiently a company is turning sales into profit before other expenses like marketing or salaries. Higher gross margin means the company keeps more money from each sale, which is a good sign of financial health.
cash runway financial
"Cash runway through 2Q27 to implement near-term growth initiatives"
Cash runway is the amount of time a company can continue operating using its available cash before needing additional funding or generating enough revenue. It’s like a countdown showing how long a business can keep running with its current funds. Knowing the cash runway helps investors assess the company's financial health and whether it has enough resources to reach its goals or needs to find more support soon.
fully diluted financial
"Fully Diluted 5,757,145"
Fully diluted is the total number of a company's shares that would exist if every potential share from stock options, warrants, convertible debt and other claims were converted into common stock — like counting every reserved pizza slice as if everyone who could request one already had it. Investors use the fully diluted share count to see the realistic ownership picture and how those future claims could lower each shareholder’s percentage, earnings per share and implied valuation.
pediatric renal support platform medical
"Vivian as the next-generation pediatric renal support platform supporting patients"
510k submission regulatory
"FDA 510k submission for Pediatric indication expansion to 5kg"

FAQ

What did Nuwellis (NUWE) disclose in its latest 8-K?
Nuwellis (NUWE) furnished an updated corporate investor presentation highlighting its Aquadex ultrafiltration platform, financial performance, market opportunity, and product pipeline. The presentation, dated August 2026, was posted on the company’s website and attached as Exhibit 99.1.

What are the key financial highlights for NUWE in 1H 2026?
Nuwellis reports 20% year‑over‑year revenue growth in the first half of 2026 and 76% gross margin in 2Q 2026, up from 56% in the prior‑year quarter. The company also states it has cash runway through 2Q 2027.

How large is Nuwellis’ addressable market according to the presentation?
Nuwellis estimates its total U.S. clinical addressable market at over $4.2 billion, spanning critical care, inpatient and outpatient heart failure, pediatrics, and fluid monitoring segments, addressed by current Aquadex products and future pipeline offerings.

What portion of NUWE’s revenue currently comes from pediatric patients?
The presentation states that pediatric patients account for about 50% of Nuwellis’ revenues, with Aquadex adopted by leading children’s hospitals and installations in 47 U.S. children’s hospitals across NICUs, PICUs, and CVICUs.

What are the main upcoming regulatory and product milestones for NUWE?
Planned milestones include a Q4 2026 FDA 510(k) submission for Aquadex pediatric indication expansion to patients ≥5 kg, the 2H 2027 commercial launch of ClarityPRIME, and an IDE submission for the Vivian pediatric renal support system expected in 2Q 2028.

What is Nuwellis’ capital structure as of August 10, 2026?
As of August 10, 2026, Nuwellis lists 3,647,264 common shares, 5,859 preferred shares, 2,102,300 warrants with a weighted average exercise price of $10.66, and 1,722 options with a weighted average exercise price of $72.89, for 5,757,145 fully diluted shares.

AI-generated analysis. How Rhea-AI works. Not financial advice.

Understanding 8-K Material Events →
See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google
Add on Google
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 8-K

Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 25, 2026

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

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. ☐

Item 7.01
Regulation FD Disclosure.

On August 25, 2026, 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 presentations, investor 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”) and is incorporated herein by reference.

Information contained on or accessible through any website reference in the corporate presentation is not part of, or incorporated by reference in, this Report, and the inclusion of such website addresses in this Report by incorporation by reference of the corporate presentation is as inactive textual references only.

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.

Forward-Looking Statements

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 August 25, 2026
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: August 25, 2026
NUWELLIS, INC.
   
 
By:
/S/ Michael K. McCormick
     
 
Name:
Michael K. McCormick
 
Title:
President and Chief Executive Officer


Exhibit 99.1

 August 2026  INVESTOR PRESENTATION  NASDQ: NUWE 
 
 Forward-Looking Statements  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, 2025 and subsequent Quarterly Reports on Form 10-Q. 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 
 
 Investment Highlights  3  Best-in-class ultrafiltration technology   Aquadex® is a clinically proven system for precise, predictable fluid removal reducing readmissions and improving outcomes   Streamlined solution that is cost-effective, workflow-friendly, and backed by comprehensive clinical support  Expanding our platform into new indications and leveraging our commercial infrastructure through partnerships   Planned label expansion and new products in development broaden our offering  Partnerships that leverage sales team and expand our cardiorenal solutions  Addressing a large and growing market opportunity   Total platform potential opportunity exceeds $4.2 billion in the U.S.  Accelerating growth in pediatric care   Adopted by leading children’s hospitals  Pediatrics patients represents 50% of revenues  Improving financial metrics with revenue growth and expanding margins   1H26 revenue growth of 20% over prior-year period  2Q26 gross margins improved to 76% compared to 56% in prior-year period  Cash runway through 2Q27 to implement near-term growth initiatives      See Appendix for Market Opportunity sources. 
 
 Fluid Overload Drives Mortality and Hospitalizations  4  Higher ICU Mortality  Fluid overload is associated with significantly increased 90-day mortality in critically ill ICU patients2  Increased Pediatric Mortality  Fluid overload is linked to substantially higher mortality in critically ill children3-4  Key driver of hospitalizations   ~90% of HF hospitalizations are associated with symptoms of fluid overload5  Critical Care  Pediatric  Heart Failure  Fluid Overload is a leading cause of costly hospital readmission post 30 days following cardiac surgery1  1. Iribarne A, et al. Ann Thorac Surg. 2014; 98(4): 1274-80. 2. Vaara ST et al. Crit Care.2012; 16: 1-11. 3 Sutherland SM, et al. Am J Kidney Disease. 2010; 5(2): 316-25. 4 Gillespie RS, et al. Ped Nephro. 2004; 19(12): 1394-99. 5 Costanzo MR, et al. JACC. 2017 May 16;69(19):2428-2445.  
 
 A $4.2B U.S. Clinical Addressable Market Opportunity   5  Nuwellis current platform and future products collectively address an enormous market opportunity across five segments  Critical Care  Inpatient HF  Outpatient HF  Pediatrics  Fluid Monitoring  Sources: See Appendix  $900MMarket  $1BMarket  $770MMarket  $160MMarket  $1.4BMarket 
 
 6  Our Solution  Aquadex®A clinically proven therapy for precise, predictable fluid removal1  Low-volume ultrafiltration designed for critically ill patients  Allows controlled fluid removal when diuretics fail  Adopted in ICU, cardiac surgery, and pediatric critical care programs  1Pinney, S et. al., J AM Coll Cardiol HF, 2025, ISSN 2213-1779 https://doi.org/10.1016/j.jchf.2024.11.018 
 
 Aquadex System: Predictable and Precise Fluid Removal  Filtered blood returns to the patient via the infusion line  5  Blood is taken from the patient via the withdrawal line using proprietary catheter 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 the filter membrane using negative pressure  Hematocrit sensor monitors preset hematocrit limits  3  Ultrafiltration pump can pull 0-500 ml of fluid per hour  4  7 
 
 Aquadex System: High-Margin Recurring Revenue Model  8  Flexible acquisition models: purchase, lease or rental  Increasing utilization as adoption spreads  One-time CapEx purchase  Price point:   high-value  Single-use for every treatment  High-margin   Aquadex Console Capital Equipment  Disposables Recurring Revenue 
 
 Why Hospitals Are Adopting Precision Fluid Management  9  Mortality  Acute Kidney Injury Risk (AKI)  Readmissions  Pediatrics  Fluid overload > 5% body-weight gain is associated with significantly higher mortality across ICU cohorts.1  Postoperative AKI drives higher mortality and longer ICU/PICU stays.2  In HF & CV surgery, persistent fluid overload at discharge predicts unplanned readmission within 30 days of discharge.3  Aquadex’s low priming blood volume (35 ml) can mitigate complications of other therapies used in children with AKI or ESKD.4   1Messmer AS, Zingg C, Müller M, Gerber JL, Schefold JC, Pfortmueller CA. Fluid overload and mortality in adult critical care patients: A systematic review and meta-analysis of observational studies. Crit Care Med. 2020;48(12):1862–1870 2McIlroy DR, Engelman DT, Shaw AD, et al. Perioperative Quality Initiative (POQI) and Enhanced Recovery After Surgery (ERAS) Cardiac Society Joint Consensus Statement on Adult Cardiac Surgery–Associated Acute Kidney Injury (CSA-AKI) 3Abraham WT, Adamson PB, Bourge RC, et al. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: A randomized controlled trial. Lancet. 2011;377(9766):658–666 4Menon S, Broderick J, Munshi R, et al. Kidney Support in Children using an Ultrafiltration Device: A Multicenter, Retrospective Study. Clin J Am Soc Nephrol. 2019;14(10):1432-1440. doi:10.2215/CJN.03240319 
 
 Commercial Execution Demonstrating Broad-Based Growth  10  Broad Clinical Coverage  Pediatric - 29% growth* Pediatric Nephrology & Critical Care  Critical Care – 28% growth* ICU/Intensivists & Cardiac Surgery  Heart Failure – 27% growth* Heart failure Cardiology  *H1 revenue growth YOY  Complex Therapy Sales Capability  Experienced sales and clinical teams  Expertise navigating multi-department adoption  Ability to establish new therapy programs  Performance  20% H1 revenue growth vs prior year  72% gross margin up from 56% prior year  ~135 active hospital accounts, including leading U.S. academic hospitals and Centers of Excellence 
 
 11  Providers are increasingly seeking out Aquadex for use with children, validating both the clinical demand and the growing commercial footprint in pediatric centers  Expansion of Aquadex labelled weight indication to > 5kg to facilitate broader adoption  Development of Vivian as the next-generation pediatric renal support platform supporting patients as small as 2.5kg  Pediatric Adoption Validates Both the Market Need and the Pathway for a Dedicated Solution  Installations in 47 Leading U.S. Children’s Hospitals  Integrated Into NICUs, PICUs, and CVICUs   Sustained Utilization Growth  Establishing a significant pediatric footprint with substantial opportunity for expansion  Providing precise, gentle fluid removal for critically ill children who require controlled ultrafiltration  Signaling increasing clinical reliance and expanding need across pediatric care teams  Future Pediatric Product Offering to Address Major Unmet Need 
 
 Aquadex Pediatric Growth Expansion  12  Successfully completed FDA pre-submission meeting for proposed Aquadex label expansion to pediatric patients ≥5 kg  Proposed expansion supported by:  Established body of published pediatric clinical experience  Real-world utilization at leading pediatric centers  Growing physician adoption in patients weighing 5–20 kg  Strategic impact:   Addresses significant unmet need for controlled fluid management in low-weight pediatric patients   Expands long-term pediatric market opportunity  Company anticipates FDA submission by year-end 2026 
 
 Critical Care: Addressing Fluid Overload Following Cardiac Surgery  13  The ProblemCardiac surgery can require significant fluid administration, contributing to post-operative fluid overload1  1 DeVore A, et al. Curr Treat Opts Cardiovasc Med. 2014; 16(2):283. 2 Bundgaard-Nielsen M, et al. Acta Anaesthesiol Scand 2009; 53:843-851. 3 Wiedemann HP, et al. N Engl J Med. 2006, 354:2564-75. 4 Stein A, et al. Critical Care. 2012; 16(R99):1-9. 5 Miller TE, et al. Can J Anesthes. 2015; 62:158-68.  Aquadex SolutionSimple, predictable fluid removal when precise volume management is needed  Clinical ValueReduces time to be extubated2,3  Shortens time in post op care and ICU length of stay3,4  Improves outcomes2-5  28%Growth H1 over prior year 
 
 Heart Failure: Breaking the Cycle of Fluid Overload and Readmission  14  The Problem  Persistent congestion drives repeat hospitalization  Aquadex Solution  Precise, predictable fluid removal – for patients with fluid overload when diuretics are inadequate  60% Reduction in HF Events at 30 days – Adjustable ultrafiltration vs. adjustable IV diuretics6  27% H1 2026 Growth – Heart Failure revenue vs prior year  1Gheorghiade M, et al. Eur Heart J Suppl. 2005; 7:B13-9. 2Premier Applied Sciences Database. 3Costanzo MR, et al. J Am Coll Cardiol. 2017, May 16; 69(19):2428-2445.   4Emani S, et al. (2012) Poster from The 16th Annual Scientific Meeting of HFSA. 5Chung ES, O’Brien TM, et al. Korean Circ J. 2014; 44(3):151-61. ⁶ Pinney SP, DeVita MV, Redfors B, et al. Ultrafiltration for Management of Decompensated Heart Failure: A Reappraisal of AVOID-HF. JACC Heart Fail. 2025;13(4):657-659.  
 
 Expanding Beyond Fluid Removal into Critical Care Solutions  15  Current Commercial Engine  Near-term Expansion  Long-term Pediatric Upside  Leveraging our ICU & pediatric commercial infrastructure to expand into adjacent monitoring and therapy markets  ClarityPRIME  Precision fluid removal platform deployed across ICU and pediatric centers  Co-Promotion and Distribution for AtriAmp® Cardiac Rhythm Monitoring  Enhancing capabilities with SmartView, High Flow and multiple filters   Automated urine output and electrolyte monitoring for critical care  Next-generation pediatric renal support platform  *ClarityPRIME is currently under development and is not FDA cleared. 
 
 R&D Expanding Aquadex Capabilities to Extend Platform Use  16  SmartView Provides Real-time Insights  Expanding Filtration Range Built For High Flow  Multiple Filters For Critical Care  Optimizes therapy and supports decisions  Seamlessly integrated with EMR and hospital systems  Simplifies workflows and improves productivity  Operating range expanded from to 100 mL/min (from 40 mL/min )  Improves filtration efficiency and extends filter life  Reduces consumable use and procedural costs  Performs in high pressure critical care settings, including ECMO  Adapted to run adsorption and other modality filters  Applications include drug overdose/poisoning, chemotherapy filtration, autoimmune disease, sepsis  Unlocks new solutions for critical care  More Capability. More Filters. More Patients. Same Trusted Aquadex Platform. 
 
 17  Introducing  Vivian™Developing our dedicated pediatric solution  Currently in development and supported by a $3M NIH grant.  Ultra-low ECV (29–67 mL) for neonatal + small-child CRRT  Engineered for patients as small as 2.5kg with unique Hematocrit and SVO2 sensor safety features  Integrated UF, CVVH, and CVVHD therapies in one platform  *Vivian is currently under development and is not FDA cleared. 
 
 ClarityPRIME* Systems Expands Nuwellis into Smart Fluid Monitoring  18  Addresses A Critical Need in Cardiac Surgery & Critical Care  Enters a High-growth, Underpenetrated Market  Fits Directly Into Our Existing Sales Channel  Real-time urine output and electrolyte data are essential for early detection of AKI.  Targets the emerging automated urine monitoring segment within the broader urinalysis and critical care monitoring market.  RMS price point ($2,500 console; $60–80 kits) aligns with Aquadex’s critical care sales and our common call point.  Commercial Launch Expected in 2H 2027  1  2  3  *ClarityPRIME is currently under development and is not FDA cleared. 
 
 Co-Promotion and Distribution Agreements withfor AtriAmp® Cardiac Rhythm Monitoring  19  Ability to expand revenue per customer by leveraging critical-care commercial infrastructure  FDA cleared, sterile, single-patient-use device for adult and pediatric patients with temporary epicardial pacing wires  Improved atrial signal visibility supports faster, more accurate identification of post-operative arrhythmias   Enables more informed clinical decision-making  AtriAmp® Agreement Value Drivers  Leverages existing sales infrastructure  Deepens customer relationships with complementary product supported by same commercial and clinical team  Recurring disposable revenue with limited incremental investment  Exclusive Distribution Opportunity  U.S. rights (ex-NY) · Recurring product revenue  Performance Criteria  Pre-established milestones evaluated  6-Month Co-Promotion Pilot  ~11 Western states · Current sales team 
 
 Strategy Drives Growth with Operating Discipline  Drive physician adoption within new and existing hospitals  Expand label to pediatric patients > 5kg  Enhance system with workflow improvements and data integration  Recent acquisition extends cardiorenal platform  Clarity PRIME targeted launch in 2027  Ability to leverage existing sales channel  Recent announcement with Atrility Medical  Strategic fit with pediatric and critical care franchise  Continue to drive revenue growth (1H26 revenue growth of 20%)  Expand grow margins (2Q26 gross margins of 76% vs. 56% in 2Q25)  Expect further operating leverage as recurring utilization continues to scale   Develop Vivian CRRT system for pediatric patients > 2.5kg  IDE submission with the the FDA expected in 2Q 2028  20  Increase Aquadex Market Penetration  Develop and Market New Products in Cardiorenal Care  Pursue Select Distribution Partnerships to Leverage Commercial Infrastructure  Improve Operating Leverage  Execute Long-Term Portfolio Vision 
 
 Target Milestones  21  Target Date  Milestone  Q3 2026  Publication of ULTRA-Peds data  Q4 2026  FDA 510k submission for Pediatric indication expansion to 5kg (from 20kg)  Q4 2026  Additional strategic partnership/distribution agreements  H1 2027  Launch of SmartView for Aquadex  H2 2027  Launch of expanded high flow range for Aquadex  H2 2027  Clarity PRIME commercial launch  Q4 2027 / Q1 2028  Launch of multiple filters for Aquadex 
 
 Nuwellis Leadership Team  22  Over 200 years of combined experience in clinical practice and the medical device industry, including major tenures at J&J, Boston Scientific, Medtronic, and Abbott/St. Jude Medical  Ryan Marthaler  Vice President of Product Marketing and Business Development  Betsy Riemenschneider  Regional Vice President of Sales  Carisa Schultz  Chief Financial Officer  Kelsey Newell  Senior Director of Medical Affairs  Neil Ayotte  Sr. Vice President,   General Counsel & Compliance Officer  Kim Anderson  Vice President of Operations  Scott Campbell  Regional Vice President of Sales  David Lerner  Vice President of Research and Development  Mike McCormick  President and CEO 
 
 Financial Highlights  23  Capitalization  as of August 10, 2026  Common Equivalents  Common Stock  3,647,264  Preferred Stock*  5,859  Warrants (weighted avg. exercise price: $10.66)  2,102,300  Options (weighted avg. exercise price: $72.89)  1,722  Fully Diluted  5,757,145  H1 2026 Revenue Growth  +20% YoY  Q2 2026 Gross Margin  76% versus 55%   in year-ago period  * See SEC filings for Preferred Stock terms and anti-dilution provisions. 
 
 Contact Details  Investor & Media Relations:  CORE IRYvonne Briggs  ir@nuwellis.com  Media Inquiries:  CORE PRKati Waldenburg media@nuwellis.com 
 
 Appendix  Market Size Sources  Heart Failure – Inpatient  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  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  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  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  25 
 

Source: View Original Filing on SEC EDGAR

Filing Exhibits & Attachments

4 documents

Press Releases

Other Documents