Nuwellis Partner Gets ~$3M NIH Grant to Accelerate Vivian™ Pediatric CRRT

Rhea-AI Filing Summary

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.

Positive

• NIH grant of approximately $3 million supports development of a pediatric CRRT device (Vivian™), indicating external validation
• Funding targets core software and firmware, which could strengthen Nuwellis’ broader device platform and shared technology

Negative

• Grant awarded to development partner Koronis Biomedical Technologies Corporation (KBT), and the filing does not state the portion, if any, that Nuwellis will receive
• No timeline, milestones, or financial impact disclosed, so material effects on Nuwellis’ financials or product launch timing are unspecified

Insights

Financial Analyst

TL;DR: A ~ $3M NIH grant to the development partner helps advance a pediatric CRRT device and key software, reducing development funding risk.

The NIH award to KBT supports development of Vivian™, targeting patients under 20 kg, and invests in software/firmware that underpins Nuwellis’ device platform. For investors, the grant signals third‑party validation of the technology’s clinical and public‑health relevance and may lower aggregate program funding needs. The 8‑K does not disclose direct cash to Nuwellis, timelines, milestones, or clinical endpoints, so material financial effects on Nuwellis cannot be determined from this filing alone.

Industry Specialist (Medical Devices)

TL;DR: NIH backing of pediatric CRRT development is a favorable technical and regulatory signal for Vivian™ and related platform software.

NIH grants typically support rigorous development and can facilitate subsequent clinical studies and regulatory engagement. Funding focused on pediatric CRRT for patients under 20 kg addresses a specialized market with high unmet need, and advancing core software/firmware can provide reusable IP across products. The filing is concise and lacks details on scope, milestones, or whether KBT retains primary development responsibilities, so implications for product launch timing remain unclear.

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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 9, 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 9, 2025, Nuwellis, Inc. (the “Company”) announced that the National Institutes of Health (NIH) has awarded an approximately $3 million multi-year grant to its development partner, Koronis Biomedical Technologies Corporation (KBT). The NIH-supported program will accelerate Vivian™, Nuwellis’ dedicated pediatric continuous renal replacement therapy (CRRT) device in development for patients under 20 kilograms, and advance core software and firmware that strengthen the Company’s broader portfolio.

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 9, 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?

The company reported that the NIH awarded an approximately $3 million multi-year grant to its development partner Koronis Biomedical Technologies Corporation to advance the Vivian™ pediatric CRRT device and related software/firmware.

Who received the NIH grant mentioned in the filing?

The grant was awarded to Koronis Biomedical Technologies Corporation (KBT), identified as Nuwellis’ development partner.

What product does the NIH funding support?

The funding is intended to accelerate development of Vivian™, a pediatric continuous renal replacement therapy (CRRT) device for patients under 20 kilograms.

Does the 8-K state how the $3 million affects Nuwellis’ finances?

No. The filing does not disclose any direct cash to Nuwellis, allocations, timelines, milestones, or expected financial impact.

Will the grant advance other Nuwellis technologies?

According to the filing, the program will also advance core software and firmware that strengthen Nuwellis’ broader portfolio.