Nuwellis (NASDAQ: NUWE) shares ULTRA-Peds Aquadex pediatric study data

Rhea-AI Filing Summary

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.

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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 30, 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 30, 2025, Nuwellis, Inc. announced findings from the ULTRA-Peds registry, a multi-center observational study examining the real-world use of the Aquadex System in children with acute kidney injury (AKI), fluid overload, or congenital kidney failure.

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 30, 2025	NUWELLIS, INC.
	By:	/s/ John L. Erb
	Name:	John L. Erb
	Title:	President and Chief Executive Officer

FAQ

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

Nuwellis reported that it announced findings from the ULTRA-Peds registry, a multi-center observational study of real-world Aquadex System use in children.

What is the ULTRA-Peds registry mentioned by Nuwellis (NUWE)?

The ULTRA-Peds registry is a multi-center observational study examining real-world use of the Aquadex System in pediatric patients.

Which conditions were studied in Nuwellis’ ULTRA-Peds registry?

The registry focuses on children with acute kidney injury, fluid overload, or congenital kidney failure treated with the Aquadex System.

What product is involved in the Nuwellis (NUWE) ULTRA-Peds study?

The study examines real-world use of Nuwellis’ Aquadex System in pediatric patients with serious kidney-related conditions.

Does this Nuwellis 8-K describe any major transactions or earnings changes?

No, the report centers on the announcement of clinical findings from the ULTRA-Peds registry, not on financial results or major transactions.