Nuwellis Inc SEC Filings

Nuwellis announced that the National Institutes of Health awarded an approximately $3 million multi-year grant to Koronis Biomedical Technologies Corporation (KBT), its development partner. The NIH funding is directed to accelerate Vivian™, the pediatric continuous renal replacement therapy (CRRT) device in development for patients under 20 kilograms, and to advance core software and firmware that support Nuwellis’ broader device portfolio. The filing states the award aims to speed development of the pediatric product and strengthen underlying technology, but does not specify how funds will be allocated between KBT and Nuwellis or any timeline or financial impact on Nuwellis’ statements.

Nuwellis, Inc. filed a Form 8-K reporting that it entered into an At The Market Offering Agreement with Ladenburg Thalmann & Co. Inc. dated September 3, 2025. The filing lists an opinion and consent from Honigman LLP as exhibits. The document indicates the company has established a mechanism to offer its common stock (NUWE) into the market under the agreement, and the related legal opinion and consent are included as exhibits.

Nuwellis, Inc. has filed a prospectus supplement to offer up to $4,650,000 of common stock in an at-the-market program with Ladenburg Thalmann & Co. Inc., which may act as agent or principal and receive commissions of up to 3.0% of gross sales. The filing states there is no escrow arrangement and the agent will be deemed an underwriter for Securities Act purposes with customary indemnification rights.

The company discloses corporate and capital information: common stock trades on Nasdaq under NUWE, last reported sale price was $5.18 on August 28, 2025, and public float computed on July 16, 2025 was $13,977,751 based on 876,348 non-affiliate shares at $15.95. The prospectus reports 902,665 shares outstanding as of August 8, 2025 and lists various dilutive instruments including warrants and convertible preferred shares. Auditors Baker Tilly included an explanatory paragraph regarding the company's ability to continue as a going concern. The company also disclosed a non-binding LOI to acquire Rendiatech, Ltd., with a potential close in the fourth quarter of 2025 pending board approval and closing conditions.

Nuwellis, Inc. announced it received U.S. Food and Drug Administration 510(k) clearance for a new size of its Dual Lumen Extended Length Catheter (dELC). The filing is brief and states the clearance date as August 21, 2025. This indicates the company added a cleared product variant to its U.S. regulatory portfolio, which may support future clinical use and commercial availability of the dELC family.

The 8-K does not disclose pricing, launch timing, shipment volumes, or expected revenue impact. Investors should note this is a regulatory clearance for a device size variant rather than a new device model and the company provided no operational or financial details in the filing.

Nuwellis announced a non-binding letter of intent to acquire Rendiatech, Ltd., an Israeli medical device company focused on real-time urine flow and acute kidney injury monitoring technologies. The proposed deal is described as supporting Nuwellis’s aim to expand its platform beyond ultrafiltration by potentially adding continuous renal health monitoring that can give clinicians earlier insight into fluid status and kidney function. The parties are conducting due diligence and, if they agree to proceed, the company expects the transaction to close in the fourth quarter of 2025, subject to final board approval and closing conditions. The filing also includes standard forward-looking statement disclosures noting risks such as execution, financing, integration, and other uncertainties.