Nuwellis, Inc. Files 8-K for Material Definitive Agreement

TL;DR

Nuwellis (NUWE) filed an 8-K on 5/31 for a material agreement - big news pending.

AI Summary

Nuwellis, Inc. announced on May 31, 2024, that it entered into a Material Definitive Agreement. The company, formerly known as CHF Solutions, Inc. and Sunshine Heart, Inc., is incorporated in Delaware and headquartered in Eden Prairie, MN. This filing is a current report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.

Why It Matters

This 8-K filing indicates a significant contractual development for Nuwellis, Inc., which could impact its business operations and financial standing.

Risk Assessment

Risk Level: medium — Material Definitive Agreements can introduce new risks or opportunities that are not yet fully understood by the market.

Key Players & Entities

• Nuwellis, Inc. (company) — Registrant
• May 31, 2024 (date) — Date of earliest event reported
• CHF Solutions, Inc. (company) — Former company name
• Sunshine Heart, Inc. (company) — Former company name
• Delaware (jurisdiction) — State of Incorporation
• Eden Prairie, MN (location) — Principal Executive Offices
• 952-345-4200 (phone_number) — Registrant's Telephone Number

FAQ

Key Financial Figures

• $0.0001 — ich registered Common Stock, par value $0.0001 per share NUWE Nasdaq Capital Marke

Filing Documents

• ef20030547_8k.htm (8-K) — 30KB
• ef20030547_ex10-1.htm (EX-10.1) — 12KB
• ef20030547_ex99-1.htm (EX-99.1) — 10KB
• image0.jpg (GRAPHIC) — 19KB
• 0001140361-24-029069.txt ( ) — 219KB
• nuwe-20240531.xsd (EX-101.SCH) — 4KB
• nuwe-20240531_lab.xml (EX-101.LAB) — 21KB
• nuwe-20240531_pre.xml (EX-101.PRE) — 16KB
• ef20030547_8k_htm.xml (XML) — 4KB

01

Item 1.01 Entry into a Material Definitive Agreement. On May 31, 2024, Nuwellis, Inc. (the " Company ") entered into a first amendment (the " Amendment ") to the Supply and Collaboration Agreement (the " Supply Agreement ") with DaVita Inc., a Delaware corporation (" DaVita "), dated June 19, 2023, pursuant to which DaVita will pilot the Aquadex ultrafiltration therapy system to treat adult patients with congestive heart failure and related conditions within select U.S. markets . Pursuant to the Supply Agreement, the pilot program launched at the end of the third quarter of 2023 and extended through the earlier of (i) the treatment of not less than 150 patients or (ii) December 31, 2023 (the " Pilot Term "); provided however, that DaVita could extend the Pilot Term until May 31, 2024 upon written notice to the Company, which such extension was requested (the " Pilot "). The Amendment modified Section 2.1(a) of the Supply Agreement to extend the term of the Pilot through the earlier of (i) the treatment of not less than 150 patents or (ii) August 31, 2024. Except as expressly set forth in the Amendment, the terms of the Supply Agreement remain unchanged and in full force and effect. The foregoing description of the Amendment does not purport to be complete and is qualified in its entirety by reference to the full text of the Amendment, which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.

01

Item 8.01 Other Events. On June 6, 2024, the Company issued a press release announcing the Amendment disclosed herein. A copy of the press release is furnished herewith as Exhibit 99.1 hereto and incorporated herein by reference.

Financial Statements and Exhibits

Financial Statements and Exhibits. (d) Exhibits Exhibit Number Exhibit Description 10.1 First Amendment to Supply and Collaboration Agreement dated as of May 31, 2024 by and between the Company and DaVita Inc. 99.1 Press Release, dated June 6, 2024 104 Cover Page Interactive Data File (embedded within Inline XBRL document).

SIGNATURES

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: June 6, 2024 NUWELLIS, INC. By: /s/ Nestor Jaramillo, Jr Name: Nestor Jaramillo, Jr. Title: President and Chief Executive Officer [Signature Page to First Amendment]

View Full Filing

View this 8-K filing on SEC EDGAR