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): May 31, 2024
 
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)

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

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))

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 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.
 
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.
 
Item 9.01
Financial Statements and Exhibits.

(d)
Exhibits

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

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]