S-1 1 ny20073226x1_s1.htm S-1

As filed with the Securities and Exchange Commission on May 22, 2026

Registration No. 333-

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM S-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

Nuwellis, Inc.

(Exact name of registrant as specified in its charter)

12988 Valley View Road

Eden Prairie, Minnesota 55344

(952) 345-4200

(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices)

John L. Erb

Chief Executive Officer

Nuwellis, Inc.

12988 Valley View Road

Eden Prairie, Minnesota 55344

(952) 345-4200

(Name, Address, Including Zip Code, and Telephone Number, Including Area Code, of Agent for Service)

Copies to:


Phillip D. Torrence, Esq. Jessica M. Herron, Esq. N. Danny Shulman, Esq. Michael J. Rosenberg, Esq. Honigman LLP 650 Trade Centre Way, Suite 200 Kalamazoo, Michigan 49002 Tel: (269) 337-7700 Fax: (269) 337-7703	Neil P. Ayotte Senior Vice President, General Counsel, Secretary and Chief Compliance Officer Nuwellis, Inc. 12988 Valley View Road Eden Prairie, Minnesota 55344 Tel: (952) 345-4200	Michael F. Nertney, Esq. Ellenoff Grossman & Schole LLP 1345 Avenue of the Americas New York, New York 10105 Tel: (212) 370-1300 Fax: (212) 401-4741

Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of this registration statement.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. ☒

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act:


Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		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 7(a)(2)(B) of the Securities Act. ☐

The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective on such date as the Commission acting pursuant to said Section 8(a), may determine.


	Per Share and Accompanying Common Warrants	Per Pre-Funded Warrant and Accompanying Common Warrants	Total(2)
Public offering price(1)	$	$	$
Placement Agent Fees(1)	$	$	$
Proceeds to us (before expenses)	$	$	$


ABOUT THIS PROSPECTUS			1
PROSPECTUS SUMMARY			2
SUMMARY OF RISK FACTORS			6
RISK FACTORS			6
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS			33
USE OF PROCEEDS			34
DILUTION			37
CAPITALIZATION			35
PRINCIPAL STOCKHOLDERS			39
DESCRIPTION OF CAPITAL STOCK			40
DESCRIPTION OF SECURITIES WE ARE OFFERING			45
PLAN OF DISTRIBUTION			49
MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES			53
LEGAL MATTERS			60
EXPERTS			60
WHERE YOU CAN FIND ADDITIONAL INFORMATION			60
INFORMATION INCORPORATED BY REFERENCE			61


	As of March 31, 2026
In thousands, except share and per share data	Actual	As Adjusted
Cash and cash equivalents	$2,083	6,483
Mezzanine Equity:
Series J convertible preferred stock, par value $0.0001 per share; authorized 600,000 shares, issued and outstanding 147 and 137 shares, actual and as adjusted, respectively	8	8
Stockholders’ equity:
Series A junior participating preferred stock as of March 31, 2026 and December 31, 2025, par value $0.0001 per share; authorized 30,000 shares, none outstanding	—	—
Series F convertible preferred stock as of March 31, 2026 and December 31, 2025, par value $0.0001 per share; authorized 18,000 shares, issued and outstanding 27 and 127 shares, respectively	—	—
Series F-1 convertible preferred stock as of March 31, 2026 and December 31, 2025, par value $0.0001 per share; authorized 100 shares, issued and outstanding 34 and 34 shares, respectively	—	—
Preferred stock, par value $0.0001 per share; 39,352,000 shares authorized, none outstanding, actual and as adjusted	—	—
Common stock, par value $0.0001 per share; 100,000,000 shares authorized, 2,635,718 and 7,490,087 shares issued and outstanding actual and as adjusted, respectively	—	—
Additional paid-in capital	323,506	327,906
Accumulated deficit	(320,853)	(320,853)
Total stockholders’ equity	$2,661	7,061


Assumed public offering price per share of common stock and accompanying common warrants		$1.03
Net tangible book value per share as of March 31, 2026	$0.97
Decrease in net tangible book value per share attributable to new investors in this offering	$0.04
As adjusted net tangible book value per share after giving effect to this offering		$0.93
Dilution per share to new investors participating in this offering		$0.10


Executive Officers, Directors and Greater than 5% Stockholders	Number of Shares Beneficially Owned	Percent Ownership Prior to the Offering
John L. Erb⁽¹⁾	42,893	1.6%
Archelle Georgiou, M.D.	1,547	*
Martin Emerson	1,124	*
Gregory D. Waller	1,541	*
David McDonald	1,547	*
Robert B. Scott	—	*
Nestor Jaramillo, Jr.	—	*
Carisa Schultz	—	*
Neil P. Ayotte	3	*
All current executive officers and directors as a group (7 persons)	48,655	1.8%


	Per Share and Accompanying Common Warrants	Per Pre-Funded Warrant and Accompanying Common Warrants	Total
Public offering price	$	$	$
Placement agent fees	$	$	$
Proceeds to us, before expenses	$	$	$

(State or Other Jurisdiction of
Incorporation or Organization)

(Primary Standard Industrial
Classification Code Number)

(I.R.S. Employer
Identification Number)

SEC Form S-1 filed by Nuwellis Inc.