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): October 10, 2023
Nuwellis, Inc.
(Exact Name of Registrant as Specified in its Charter)
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Delaware
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001-35312
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No. 68-0533453
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(State or Other Jurisdiction of Incorporation or Organization)
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(Commission File Number)
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(I.R.S. Employer Identification No.)
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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:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Common Stock, par value $0.0001 per share
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NUWE
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Nasdaq Capital Market
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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:
☐
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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☐
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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☐
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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☐
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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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. ☐
On October 10, 2023, Nuwellis Inc. (the “Company”) issued a press release announcing that its distribution partner, SeaStar Medical Holding Corporation, a Delaware corporation (“SeaStar”),
received correspondence from the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (the “Agency”) indicating that the Agency
considers SeaStar’s Selective Cytopheretic Device Pediatric to be approvable under a Humanitarian Device Exemption for use in children weighing 10 kilograms or more with acute kidney injury and sepsis or a septic condition requiring continuous
kidney replacement therapy in the hospital intensive care unit. A copy of the press release is attached hereto as Exhibits 99.1 and is incorporated herein by reference.
This Current Report on Form 8-K and Exhibit 99.1 hereto contain forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. These forward looking statements are based on current expectations and assumptions and are not guarantees of future performance. Further, the forward-looking statements are subject to the limitations listed in Exhibit
99.1 and in the other reports of the Company filed with the Securities and Exchange Commission, including that actual events or results may differ materially from those in the forward-looking statements. 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.
| Item 9.01 |
Financial Statements and Exhibits.
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Exhibit
Number
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Exhibit Description
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Company Press Release dated October 10, 2023.
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104
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Cover Page Interactive Data File (embedded within Inline XBRL document).
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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.
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Date: October 10, 2023
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NUWELLIS, INC.
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By:
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/s/ Nestor Jaramillo, Jr
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Name:
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Nestor Jaramillo, Jr.
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Title:
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President and Chief Executive Officer
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