Nuwellis Inc 8-K Filings

Nuwellis, Inc. reported second quarter 2026 revenue of $2.0 million, up 14% from the prior-year quarter, driven by higher U.S. circuit and console sales and nine consoles sold versus three a year ago. Gross margin improved to 76% from 56%, reflecting prior pricing actions, favorable product mix, and the transition to contract manufacturing.

Operating expenses rose to $4.7 million, leading to a net loss of $4.8 million, a substantial improvement from a $12.6 million loss in the prior-year quarter, helped by a favorable $4.4 million change in warrant liabilities. For the first half, net loss was $9.4 million and net cash used in operations was $6.3 million. Cash and cash equivalents were $3.9 million at June 30, 2026; including recent financings and warrant exercises, the company raised $12.7 million in gross proceeds and states its cash runway extends through the second quarter of 2027. Total stockholders’ equity shifted to a deficit of $2.1 million as warrant liabilities increased to $7.0 million.

Nuwellis, Inc. completed a financing in which it sold 1,310,890 shares of common stock at $2.59 per share in a registered direct offering priced at-the-market under Nasdaq rules and issued matching warrants to purchase up to 1,310,890 shares at $2.59 in a concurrent private placement. These transactions, conducted under an effective Form S-3 shelf registration statement, closed on August 3, 2026 and are expected to generate approximately $3.4 million in gross proceeds before fees.

Ladenburg Thalmann acted as exclusive placement agent, earning a 9.0% cash fee on gross proceeds and receiving Placement Agent Warrants for 3.0% of the shares issued, with an exercise price of $4.2735 per share. Nuwellis agreed to limit additional equity issuances and new registration filings for five trading days after closing, to avoid Variable Rate Transactions for ninety days, and to file and maintain a resale registration statement for the warrant shares. The company also reported receiving $3.1 million from exercises of warrants issued in a June 2026 public offering.

Nuwellis, Inc. held a special stockholder meeting via live webcast on July 24, 2026. Stockholders representing 1,490,999 shares, or 46.20% of common shares outstanding as of the record date, were present in person or by proxy.

Stockholders voted on issuing common shares upon exercise of warrants from a June 8, 2026 financing and related repriced warrants, on authorizing a discretionary reverse stock split at a ratio between 1-for-5 and 1-for-70 to support continued Nasdaq listing requirements, and on allowing potential adjournments to solicit additional proxies. Proposal 1 received 477,084 votes for and 216,196 against; Proposal 2 received 1,172,689 for and 310,588 against; Proposal 3 received 1,235,430 for and 255,223 against.

Nuwellis, Inc. is implementing a 1-for-35 reverse stock split of its common stock. The company filed a Certificate of Amendment in Delaware to effect this change, following prior stockholder approval for a reverse split within a specified range.

The reverse split becomes effective at 5:00 p.m. Eastern Time on June 25, 2026, and NUWE shares will trade on a split-adjusted basis on the Nasdaq Capital Market starting June 26, 2026. Each block of 35 existing shares will convert into 1 share, while the par value remains unchanged.

Outstanding preferred stock, stock options, restricted stock units, warrants, and shares reserved under equity incentive plans will be adjusted proportionately. Fractional shares will be rounded down to the nearest whole share, with cash paid for the fractional remainder based on the Nasdaq closing price before effectiveness.

Nuwellis, Inc. announced a leadership change, with John L. Erb resigning as Chief Executive Officer effective June 30, 2026, while continuing as Chairman of the Board. The company states his resignation is not due to any dispute or disagreement over operations, policies, or practices.

Effective the same date, the board appointed Michael McCormick, age 65, as Chief Executive Officer, President, and director. He has consulted for Nuwellis since 2025 and previously served on its board. Under a new Employment Agreement, McCormick will receive a base salary of $431,100 and be eligible for annual incentive compensation targeted at 65% of base salary, plus a one-time equity grant to be determined.

Nuwellis, Inc. has closed a registered public offering generating gross proceeds of approximately $6.0 million before fees and expenses. The deal includes 1,903,338 shares of common stock and pre-funded warrants to purchase 18,096,662 shares, each sold with accompanying Series C and Series D warrants. The Series C warrants cover up to 60,000,000 shares and the Series D warrants up to 20,000,000 shares, all with a $0.30 exercise price and subject to stockholder approval and a reverse stock split. Nuwellis reports 12,750,321 shares of common stock issued and outstanding as of June 9, 2026 following exercises of pre-funded warrants.

Nuwellis, Inc. reported first quarter 2026 results that show stronger sales but continued losses. Revenue for the quarter was $2.4 million, up from $1.9 million a year earlier, a 26% increase driven by growth across Pediatric, Adult Heart Failure, and Critical Care categories and higher Aquadex system placements and utilization.

Gross margin improved to 70.1%, reflecting better pricing, product mix, and use of contract manufacturing. Operating expenses rose to about $6.0 million from $4.1 million, mainly from higher sales headcount and compensation, leading to a net loss attributable to common shareholders of roughly $4.3 million.

As of March 31, 2026, Nuwellis reported no debt and cash, cash equivalents, and restricted cash of about $2.2 million. During the quarter, the company raised approximately $4.4 million net from an offering of common stock and warrants, while using about $3.1 million of cash in operating activities.

Nuwellis, Inc. held its annual stockholder meeting where investors elected two Class I directors and approved the company’s auditor for 2026. Marty J. Emerson and David A. McDonald were elected to three-year terms ending at the 2029 annual meeting.

Stockholders also ratified Baker Tilly US, LLP as Nuwellis’ independent registered public accounting firm for the fiscal year ending December 31, 2026. A total of 1,078,020 common shares, representing approximately 43.81% of shares outstanding as of the record date, were represented virtually or by proxy.

Nuwellis, Inc. has settled a contract dispute with E.F. Hutton & Co. over an engagement letter related to registered securities offerings. Under a Settlement Agreement and Release dated April 24, 2026, Nuwellis agreed to pay $204,000 to Hutton within five days.

The agreement includes no admission of liability, mutual releases of all claims, and an obligation for Hutton to file a stipulation to dismiss the lawsuit with prejudice within two days after receiving the settlement payment.

Nuwellis, Inc. filed an amended current report to update an earlier disclosure about board resignations. This Amendment No. 1 adds as exhibits supplemental response letters from former directors Katharyn Field and Mika Grasso addressing the company’s initial description of their March 26, 2026 resignations.

The company states it does not agree with certain statements in these response letters and maintains that its original account in the initial filing is accurate. Nuwellis emphasizes that the resignation and response letters reflect only the former directors’ personal views and may conflict with management’s and the board’s views.

The company cautions that it does not take responsibility for the contents of the former directors’ letters and encourages stockholders and investors to rely on information in its official SEC reports, including its most recent annual and quarterly reports.

Nuwellis, Inc. has completed its previously announced acquisition of Rendiatech, Inc., an Israeli-based developer of automated kidney function monitoring technology. This technology is designed to support clinical decision-making for critically ill patients, potentially broadening Nuwellis’ clinical offerings in advanced patient monitoring.

Nuwellis, Inc. reported mixed fourth quarter and full year 2025 results. Q4 2025 revenue was $2.4 million, up 4% year over year and 9% sequentially, driven by stronger U.S. console sales and higher circuit pricing. Q4 gross margin improved to 68.2% from 58.4%, while operating loss was about $2.4 million, roughly flat with the prior-year quarter.

For full year 2025, revenue was $8.3 million, down 5% from 2024, with Heart Failure and Pediatrics growth offset by weaker Critical Care. Gross margin for the year was 62.0%. Net loss attributable to common shareholders was $17.5 million, including a $6.4 million non-cash warrant valuation expense and about $0.3 million of executive severance. As of December 31, 2025, Nuwellis had $1.2 million in cash, cash equivalents and restricted cash and no debt, after using $10.8 million of cash in operating activities and raising $6.9 million through equity financings during the year.

Nuwellis, Inc. entered a securities purchase agreement for a private placement of pre-funded and common stock warrants, raising approximately $3.1 million in gross proceeds to support working capital and general corporate purposes. The company also induced an investor to immediately exercise certain existing warrants at a reduced exercise price, generating approximately $2 million of additional gross proceeds and issuing new five-year common stock purchase warrants. As of January 29, 2026, Nuwellis had 1,686,892 shares of common stock outstanding.

Nuwellis agreed to acquire all shares of Rendiatech, Ltd., which holds assets from RenalSense’s bankruptcy, for a mix of cash, 150,000 Nuwellis shares, options to purchase 30,000 shares, additional deferred cash payments, and up to $2,000,000 in earn-out royalties tied to sales of kidney monitoring products. The transaction is subject to closing conditions, including Israeli tax approval. The company also appointed Carisa Schultz as Chief Financial Officer, effective February 2, 2026, with a base salary of $265,000 and eligibility for an annual bonus of up to 40% of base salary and standard change-in-control and indemnification protections.

Nuwellis, Inc. reported significant board changes. On January 21, 2026, directors Dave McDonald, Mike McCormick, and Dr. Maria Costanzo resigned from the board and all committees. The company states these resignations were not due to any disagreement over operations, policies, or practices, and the board size was reduced from six to five members.

Effective the same day, the board appointed Katharyn Field and Mika Grasso as Class I directors, with terms running until the 2026 annual meeting. The board determined both are independent under Nasdaq, internal policy, and SEC standards. Field is expected to join the Audit and Compensation Committees, while Grasso is expected to join the Audit and Nominating and Corporate Governance Committees.

Both new directors entered into Nuwellis’ standard indemnity agreement and are eligible under the Non-Employee Director Compensation Program. Each has agreed to resign if an investment of at least $5 million in the company’s equity securities is not made within 30 days of the filing of a related Form S-1 registration statement, or within 30 days of clearing any SEC comments on that filing.

Nuwellis, Inc. filed a report noting that on November 12, 2025 it released a press release with its financial results for the three and nine months ended September 30, 2025. The press release is included as Exhibit 99.1 and is incorporated by reference. The company states that this financial information is being furnished under Item 2.02 of Form 8-K, rather than filed, which limits how it is treated under certain securities law liability provisions.

Nuwellis, Inc. reported that its Chief Financial Officer, Robert B. Scott, has decided to resign, with his last day expected on or about October 24, 2025. The company states that his resignation is not due to any disagreement regarding operations, policies, or procedures, and it plans to begin a formal search for a new CFO.

To bridge the gap, the Board has appointed current President and Chief Executive Officer John L. Erb to also serve as interim Chief Financial Officer, interim Principal Financial Officer, and interim Principal Accounting Officer beginning on the separation date. Erb, who has long experience with Nuwellis and multiple medical device companies, will receive no additional compensation for these interim roles, and there are no special arrangements or related-party transactions tied to his appointment.

Nuwellis, Inc. filed a current report describing a clinical research update. On September 30, 2025, the company announced findings from the ULTRA-Peds registry, a multi-center observational study.

The registry examines real-world use of the company’s Aquadex System in children with acute kidney injury, fluid overload, or congenital kidney failure. The update focuses on clinical experience in pediatric patients rather than on financial or transactional developments.

Nuwellis, Inc. reported that the United States Patent and Trademark Office has issued U.S. Patent No. 12,415,021, dated September 16, 2025, based on Application No. 18/298,860.

The patent covers the use of one or more hemolysis sensors with extracorporeal blood filtration systems, including ultrafiltration therapy and continuous renal replacement therapy, to help detect and localize red blood cell destruction in or around the circuit.

This intellectual property is described as supporting Nuwellis’ pediatric device, Vivian, which is in development, as well as future platform innovation.

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. 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.

Nuwellis, Inc. reported that it has released its financial results for the three and six months ended June 30, 2025. The company furnished this update through a press release dated August 14, 2025, which is attached as Exhibit 99.1. The information was provided under a current report and is treated as furnished rather than filed under securities law, which affects how it is subject to certain legal liabilities.

Nuwellis, Inc. (NUWE) filed an 8-K to report that it has regained compliance with Nasdaq’s $1.00 minimum bid-price rule. On 18 Jun 2025 the company received a deficiency notice because its shares closed below $1.00 for 30 straight trading days and, due to recent reverse splits, NUWE was ineligible for the standard 180-day cure period. Nasdaq therefore set a delisting hearing for 12 Aug 2025.

On 22 Jul 2025 Nasdaq’s Office of General Counsel informed the company that the bid-price deficiency has been cured; consequently, the hearing was cancelled and NUWE’s common stock will continue trading on the Nasdaq Capital Market. The filing eliminates an immediate delisting threat but highlights prior share-price weakness that triggered the notice.

Nuwellis has received a delisting notice from Nasdaq on June 18, 2025, due to non-compliance with the minimum bid price requirement of $1.00 for 30 consecutive trading days. The company is not eligible for the standard compliance period due to previous reverse stock splits.

Key developments:

• Company executed a reverse stock split on June 27, 2024
• Shareholders approved a new reverse split ratio of 1-for-5 to 1-for-70 at May 20, 2025 annual meeting
• Board intends to implement another reverse stock split to regain compliance
• Company plans to request a hearing with Nasdaq Hearings Panel

Stock will remain listed on Nasdaq Capital Market pending the hearing outcome. However, there is no guarantee of continued listing or successful compliance restoration. This situation presents significant risks for investors, including potential delisting and further share dilution through another reverse split.