[8-K] Nuwellis, Inc. Reports Material Event

Rhea-AI Filing Summary

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.

Positive

• Strategic expansion of Nuwellis’s technology platform beyond ultrafiltration to include continuous renal health monitoring
• Potential clinical benefit by providing clinicians earlier insight into fluid status and kidney function
• Clear timeline target with the parties anticipating a possible close in the fourth quarter of 2025, subject to approvals

Negative

• Non-binding letter of intent: transaction is not finalized and remains subject to due diligence and definitive agreements
• Conditional close dependent on final Board approval and unspecified closing conditions
• Forward-looking risks noted in the filing, including execution, financing, integration, regulatory, and clinical data uncertainties

Insights

M&A Specialist

TL;DR: Non-binding LOI signals strategic intent but deal economics and approvals remain uncertain.

The LOI for Rendiatech positions Nuwellis to broaden its product offering into continuous renal monitoring, which could create cross-selling opportunities with its existing ultrafiltration solutions. From an M&A execution perspective, the critical near-term items are diligence outcomes, valuation alignment, regulatory considerations for medical devices in target markets, and board sign-off. Until definitive agreements are executed and closing conditions are satisfied, the transaction risk remains elevated and impact on financials is indeterminate.

Medical Devices Analyst

TL;DR: The technology target complements clinical monitoring needs but clinical validation and commercialization paths matter most.

Rendiatech’s focus on real-time urine flow and acute kidney injury monitoring could materially enhance clinical decision-making when integrated with Nuwellis’s renal therapy solutions. However, material investor impact depends on the stage of Rendiatech’s clinical evidence, regulatory clearances, and how quickly the combined offering can be commercialized and adopted by clinicians. The filing does not provide details on product approvals, revenue, or integration plans, so clinical and commercial risks remain key.

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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): August 19, 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		55344
(Address of Principal Executive Offices)		(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 August 19, 2025, Nuwellis, Inc. (the “Company”) announced that it has entered into a non-binding letter of intent to acquire Rendiatech, Ltd., an Israeli-based medical device company specializing in real-time urine flow and acute kidney injury monitoring technologies.  The proposed acquisition is expected to support the Company’s strategy to expand its current technology platform beyond ultrafiltration by potentially adding continuous renal health monitoring technologies that provide clinicians with earlier insight into fluid status and kidney function. The parties are engaged in the due diligence process and should they agree to proceed, the transaction is anticipated to close in the fourth quarter of 2025, pending final Board approval and closing conditions.

Forward-Looking Statements

Certain statements in this Current Report on Form 8-K may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding the new market opportunities and anticipated growth in 2025 and beyond. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this Current Report on Form 8-K, including, without limitation, those risks associated with our ability to execute on our commercialization strategy, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. The Company does not assume any obligation to publicly update or revise any forward-looking statements, whether due to new information, future events or otherwise.

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: August 19, 2025	NUWELLIS, INC.
	By:	/s/ John L. Erb

	Name:	John L. Erb
	Title:	President and Chief Executive Officer

FAQ

What did Nuwellis (NUWE) announce in the 8-K?

Nuwellis announced it entered into a non-binding letter of intent to acquire Rendiatech, an Israeli medical device company focused on real-time urine flow and acute kidney injury monitoring technologies.

Is the acquisition of Rendiatech by NUWE finalized?

No; the filing states the LOI is non-binding, the parties are in due diligence, and the transaction is subject to definitive agreements, Board approval, and closing conditions.

When is the transaction expected to close if it proceeds?

The filing states the transaction is anticipated to close in the fourth quarter of 2025, contingent on final approvals and closing conditions.

What strategic benefit does Nuwellis say the acquisition would provide?

Nuwellis said the acquisition is expected to expand its platform beyond ultrafiltration by potentially adding continuous renal health monitoring technologies that give earlier insight into fluid status and kidney function.

What risks did Nuwellis disclose about the proposed acquisition?

The filing includes standard forward-looking disclosures citing risks such as execution, ability to raise funds, post-market clinical data collection, product benefits, commercialization, competition, intellectual property, and integration risks.