Welcome to our dedicated page for Nuwellis SEC filings (Ticker: NUWE), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
This page provides access to U.S. Securities and Exchange Commission (SEC) filings for Nuwellis, Inc. (Nasdaq: NUWE), a medical technology and medical device company focused on precision fluid management for patients with cardio-renal conditions and fluid overload. Through these filings, investors can review how Nuwellis reports its financial performance, material events, and key developments related to its Aquadex SmartFlow® ultrafiltration system and its Vivian™ pediatric continuous renal replacement therapy (CRRT) platform in development.
Current report filings (Form 8-K) for Nuwellis often cover topics such as quarterly financial results, changes in executive roles, new patents, NIH grant-supported programs, FDA 510(k) clearances for accessories like catheters, and at-the-market equity offering agreements. Some 8-K filings also reference press releases announcing clinical registry findings, such as the ULTRA-Peds pediatric Aquadex registry, or new intellectual property supporting pediatric safety features and hemolysis sensing in extracorporeal circuits.
Annual reports on Form 10-K and quarterly reports on Form 10-Q (when available) provide more detailed discussions of Nuwellis’ business, including its focus on fluid overload, its Aquadex SmartFlow system, development-stage technologies like Vivian, and its geographic footprint with headquarters in Minneapolis and a subsidiary in Ireland. These filings also describe risk factors, liquidity, capital-raising activities, and other information relevant to NUWE shareholders.
Stock Titan’s platform enhances these SEC documents with AI-powered summaries that explain the key points of lengthy filings, highlight important changes from prior periods, and help users quickly understand complex disclosures. Investors can also use this page to follow real-time updates as new Nuwellis filings are posted to EDGAR, including current reports, registration statements, and other material submissions related to NUWE.
Nuwellis (NUWE) filed its Q3 2025 10‑Q. Net sales were $2.217 million, down from $2.367 million a year ago, as lower console pricing and reduced international activity offset a 15% increase in circuit sales. Gross margin was 65.2% versus 70.0% last year. The company reported quarterly net income of $468,000, aided by a $3.161 million non‑cash gain from the change in fair value of warrant liabilities.
Year‑to‑date, net sales were $5.846 million versus $6.418 million and net loss was $15.099 million. Operating cash flow for the nine months was an outflow of $7.780 million. Cash and cash equivalents were $3.094 million as of September 30, 2025. Management states that existing capital resources are expected to support operations into the first quarter of 2026, while acknowledging “substantial doubt” about the ability to continue as a going concern.
During the quarter, Nuwellis closed a June public offering with approximately $5.0 million in gross proceeds, executed a 1‑for‑42 reverse stock split effective July 3, 2025, and launched an ATM program, selling 447,288 shares for about $1.9 million in net proceeds by September 30. The company exited selected international operations (with about $254,000 accrued for related obligations), terminated the REVERSE‑HF clinical trial (anticipated savings of approximately $4.0 million over 2.5 years), and transitioned manufacturing to KDI to streamline operations.
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.
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