Nuwellis (NUWE) awarded U.S. patent supporting Vivian pediatric device

Rhea-AI Filing Summary

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.

8-K Event Classification

Item 8.01 — Other Events

1 item

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Understanding 8-K Material Events →

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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): September 18, 2025

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 (Address of Principal Executive Offices) 55344
(Zip Code)

(952) 345-4200

(Registrant’s Telephone Number, Including Area Code)

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

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))

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 Capital Market

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 8.01. Other Events.

On September 18, 2025, Nuwellis, Inc. (the “Company”) announced that the United States Patent and Trademark Office has issued U.S. Patent No. 12,415,021 on September 16, 2025, based on Application No. 18/298,860. The patent relates to the use of one or more hemolysis sensors with extracorporeal blood filtration systems—such as ultrafiltration therapy and continuous renal replacement therapy (CRRT)—to help detect and localize red blood cell destruction occurring within or around the circuit. The intellectual property supports the Company’s pediatric device, Vivian, in development and future platform innovation.

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: September 18, 2025	NUWELLIS, INC.
	By:	/s/ John L. Erb
	Name:	John L. Erb
	Title:	President and Chief Executive Officer

FAQ

What did Nuwellis (NUWE) disclose in this 8-K filing?

Nuwellis disclosed that the U.S. Patent and Trademark Office issued U.S. Patent No. 12,415,021 covering hemolysis sensor use in extracorporeal blood filtration systems.

What technology is covered by Nuwellis new patent?

The patent relates to using one or more hemolysis sensors with extracorporeal blood filtration systems to help detect and localize red blood cell destruction within or around the circuit.

How does the new patent relate to Nuwellis (NUWE) products?

The intellectual property is stated to support Nuwellis pediatric device, Vivian, which is in development, and to support future platform innovation.

When was Nuwellis patent issued by the USPTO?

The United States Patent and Trademark Office issued U.S. Patent No. 12,415,021 on September 16, 2025.

Which therapies are mentioned in connection with Nuwellis patent?

The patent is described as applying to extracorporeal blood filtration systems, including ultrafiltration therapy and continuous renal replacement therapy (CRRT).

Who signed the Nuwellis (NUWE) 8-K related to the patent?

The report was signed on behalf of Nuwellis, Inc. by John L. Erb, President and Chief Executive Officer.