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Form 8-K

sec.gov

8-K — Nuwellis, Inc.

Accession: 0001140361-26-034367

Filed: 2026-08-26

Period: 2026-08-25

CIK: 0001506492

SIC: 3845 (ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — ef20081099_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (ef20081099_ex99-1.htm)

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8-K

8-K (Primary)

Filename: ef20081099_8k.htm · Sequence: 1

false000150649200015064922026-08-252026-08-25

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

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: ef20081099_ex99-1.htm · Sequence: 2

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

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