Nuwellis, Inc. — Regulatory Filings 2017

Apr 6, 2017

S-1/A 1 a2231719zs-1a.htm S-1/A QuickLinks -- Click here to rapidly navigate through this document

COMMAND=ADD_BASECOLOR,"#000000" COMMAND=ADD_DEFAULTFONT,"font-family:times;" COMMAND=ADD_TABLESHADECOLOR,"#CCEEFF" COMMAND=ADD_STABLERULES,"border-bottom:solid #000000 1.0pt;" COMMAND=ADD_DTABLERULES,"border-bottom:double #000000 2.25pt;" COMMAND=ADD_SCRTABLERULES,"border-bottom:solid #000000 1.0pt;margin-bottom:0pt;" COMMAND=ADD_DCRTABLERULES,"border-bottom:double #000000 2.25pt;margin-bottom:0pt;" As filed with the Securities and Exchange Commission on April 6, 2017

Registration No. 333-216841

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549

COMMAND=ADD_LINERULETXT,NOSHADE COLOR="#000000" SIZE="1.0PT" WIDTH="25%" ALIGN="CENTER" COMMAND=ADDING_LINEBREAK

Amendment No. 3 to

FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933

COMMAND=ADD_LINERULETXT,NOSHADE COLOR="#000000" SIZE="1.0PT" WIDTH="25%" ALIGN="CENTER" COMMAND=ADDING_LINEBREAK

SUNSHINE HEART, INC. (Exact name of registrant as specified in its charter)

COMMAND=ADD_LINERULETXT,NOSHADE COLOR="#000000" SIZE="1.0PT" WIDTH="25%" ALIGN="CENTER" COMMAND=ADDING_LINEBREAK

User-specified TAGGED TABLE

Delaware (State of Incorporation) 3845 (Primary Standard Industrial Classification Code Number) 68-0533453 (I.R.S. Employer Identification Number)

end of user-specified TAGGED TABLE

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)

COMMAND=ADD_LINERULETXT,NOSHADE COLOR="#000000" SIZE="1.0PT" WIDTH="25%" ALIGN="CENTER" COMMAND=ADDING_LINEBREAK

John Erb Chief Executive Officer Sunshine Heart, 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)

COMMAND=ADD_LINERULETXT,NOSHADE COLOR="#000000" SIZE="1.0PT" WIDTH="25%" ALIGN="CENTER" COMMAND=ADDING_LINEBREAK

User-specified TAGGED TABLE

Copies to:
Phillip D. Torrence, Esq. Meredith Ervine, Esq. Honigman Miller Schwartz and Cohn LLP 350 East Michigan Avenue, Suite 300 Kalamazoo, MI 49007 Tel: (269) 337-7700 Fax: (269) 337-7703	Joseph A. Smith Michael F. Nertney Ellenoff Grossman & Schole LLP 1345 Avenue of the Americas New York, NY 10105-0302 Tel: (212) 370-1300 Fax: (212) 401-4741

end of user-specified TAGGED TABLE

COMMAND=ADD_LINERULETXT,NOSHADE COLOR="#000000" SIZE="1.0PT" WIDTH="25%" ALIGN="CENTER" COMMAND=ADDING_LINEBREAK

Approximate date of commencement of proposed sale to the public: From time to time after this Registration Statement becomes effective.

If any 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: ý

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. o

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. o

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. o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a small reporting company. See definitions of "large accelerated filer," "accelerated filer," and "smaller reporting company" in Rule 12b-2 of the Exchange Act. (Check one):

COMMAND=ADD_TABLEWIDTH,"100%" User-specified TAGGED TABLE

Large accelerated filer o Accelerated filer o Non-accelerated filer o (Do not check if a smaller reporting company) Smaller reporting company ý

end of user-specified TAGGED TABLE

COMMAND=ADD_LINERULETXT,NOSHADE COLOR="#000000" SIZE="1.0PT" WIDTH="25%" ALIGN="CENTER" COMMAND=ADDING_LINEBREAK

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 Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

BLANK LINE TO FORCE PARA

ZEQ.=1,SEQ=1,EFW="2231719",CP="SUNSHINE HEART, INC.",DN="1",CHK=328767,FOLIO='blank',FILE='DISK121:[17ZAY1.17ZAY78901]BA78901A.;26',USER='CHE108077',CD=';6-APR-2017;02:03' THIS IS THE END OF A COMPOSITION COMPONENT

COMMAND=ADD_BASECOLOR,"#000000" COMMAND=ADD_DEFAULTFONT,"font-family:times;" COMMAND=ADD_TABLESHADECOLOR,"#CCEEFF" COMMAND=ADD_STABLERULES,"border-bottom:solid #000000 1.0pt;" COMMAND=ADD_DTABLERULES,"border-bottom:double #000000 2.25pt;" COMMAND=ADD_SCRTABLERULES,"border-bottom:solid #000000 1.0pt;margin-bottom:0pt;" COMMAND=ADD_DCRTABLERULES,"border-bottom:double #000000 2.25pt;margin-bottom:0pt;"

TOC_END

EXPLANATORY NOTE: We are filing this Amendment No. 3 (this "Amendment") to our Registration Statement on Form S-1, which was originally filed with the Securities and Exchange Commission on March 20, 2017 and has been previously amended by Amendment Nos. 1 and 2 thereto (as so amended, the "Registration Statement"), solely to include an updated Exhibit 5.1. No other information in the Registration Statement, including the prospectus that forms a part thereof, is being modified. Accordingly, this Amendment consists only of the facing page, this explanatory note, Part II of the Registration Statement, the signature page to the Registration Statement, the Exhibit Index, and Exhibit 5.1 filed herewith. The prospectus that forms a part of the Registration Statement is unchanged and has therefore been omitted from this filing.

PART II

INFORMATION NOT REQUIRED IN PROSPECTUS

Item 13. Other Expenses of Issuance and Distribution.

The following table sets forth the estimated costs and expenses to be incurred in connection with the issuance and distribution of the securities registered under this Registration Statement. All amounts are estimates except the Securities and Exchange Commission registration fee.

COMMAND=ADD_TABLEWIDTH,"100%" User-specified TAGGED TABLE

	Amount to be Paid
SEC registration fee	$ 1,910
FINRA filing fee	$ 3,000
Legal fees and expenses	$ 100,000
Printing expenses	$ 15,000
Accountant's fees and expenses	$ 50,000
Transfer agent and registrar fees	$ 5,000
Miscellaneous expenses	$ 10,090
Total	$ 185,000

end of user-specified TAGGED TABLE

Item 14. Indemnification of Directors and Officers.

Our certificate of incorporation and bylaws provide that each person who was or is made a party or is threatened to be made a party to or is otherwise involved (including, without limitation, as a witness) in any action, suit or proceeding, whether civil, criminal, administrative or investigative, by reason of the fact that he or she is or was a director or an officer of Sunshine Heart, Inc. or is or was serving at our request as a director, officer, or trustee of another corporation, or of a partnership, joint venture, trust or other enterprise, including service with respect to an employee benefit plan, whether the basis of such proceeding is alleged action in an official capacity as a director, officer or trustee or in any other capacity while serving as a director, officer or trustee, shall be indemnified and held harmless by us to the fullest extent authorized by the Delaware General Corporation Law, as amended (the "DGCL"), against all expense, liability and loss (including attorneys' fees, judgments, fines, ERISA excise taxes or penalties and amounts paid in settlement) reasonably incurred or suffered by such.

Section 145 of the DGCL permits a corporation to indemnify any director or officer of the corporation against expenses (including attorney's fees), judgments, fines and amounts paid in settlement actually and reasonably incurred in connection with any action, suit or proceeding brought by reason of the fact that such person is or was a director or officer of the corporation, if such person acted in good faith and in a manner that he or she reasonably believed to be in, or not opposed to, the best interests of the corporation, and, with respect to any criminal action or proceeding, if he or she had no reason to believe his or her conduct was unlawful. In a derivative action, (i.e., one brought by or on behalf of the corporation), indemnification may be provided only for expenses actually and reasonably incurred by any director or officer in connection with the defense or settlement of such an action or suit if such person acted in good faith and in a manner that he or she reasonably believed to be in, or not opposed to, the best interests of the corporation, except that no indemnification shall be provided if such person shall have been adjudged to be liable to the corporation, unless and only to the

ZEQ.=1,SEQ=2,EFW="2231719",CP="SUNSHINE HEART, INC.",DN="1",CHK=906193,FOLIO='blank',FILE='DISK121:[17ZAY1.17ZAY78901]JA78901A.;19',USER='JKEENE',CD=';6-APR-2017;09:34'

extent that the court in which the action or suit was brought shall determine that the defendant is fairly and reasonably entitled to indemnity for such expenses despite such adjudication of liability.

Pursuant to Section 102(b)(7) of the DGCL, our certificate of incorporation eliminates the liability of a director to us or our stockholders for monetary damages for such a breach of fiduciary duty as a director, except for liabilities arising:

We carry insurance policies insuring our directors and officers against certain liabilities that they may incur in their capacities as directors and officers.

The Company has entered into indemnification agreements with each of its directors and executive officers. Pursuant to the indemnification agreements, the Company agrees to hold harmless and indemnify its directors and executive officers to the fullest extent authorized or permitted by the provisions of the Company's certificate of incorporation and bylaws and the DGCL, including for any amounts that such director or officer becomes obligated to pay because of any claim to which such director or officer is made or threatened to be made a party, witness or participant, by reason of such director's or officer's service as a director, officer, employee or other agent of the Company.

There are certain exceptions from the Company's obligation to indemnify its directors and executive officers pursuant to the indemnification agreements, including for "short-swing" profit claims under Section 16(b) of the Exchange Act, losses that result from conduct that is established by a final judgment as knowingly fraudulent or deliberately dishonest or that constituted willful misconduct, or that constituted a breach of the duty of loyalty to the Company or resulted in any improper personal profit or advantage, where payment is actually made to a director or officer under an insurance policy, indemnity clause, bylaw or agreement, except in respect of any excess beyond payment under such insurance, clause, bylaw or agreement, for indemnification which is not lawful, or in connection with any proceeding initiated by such director or officer, or any proceeding against the Company or its directors, officers, employees or other agents, unless (i) such indemnification is expressly required to be made by law, (ii) the proceeding was authorized by the board of directors of the Company, (iii) such indemnification is provided by the Company, in its sole discretion, pursuant to the powers vested in the Company under the DGCL, or (iv) the proceeding is initiated to enforce a claim for indemnification pursuant to the indemnification agreement.

All agreements and obligations of the Company contained in the indemnification agreements shall continue during the period when the director or officer who is a party to an indemnification agreement is a director, officer, employee or other agent of the Company (or is or is serving at the request of the Company as a director, officer, employee or other agent of another corporation, partnership, joint venture, trust, employee benefit plan or other enterprise) and shall continue thereafter so long as such director or officer shall be subject to any possible claim or threatened, pending or completed action, suit or proceeding, whether civil, criminal, arbitrational, administrative or investigative. In addition, the indemnification agreements provide for partial indemnification and advance of expenses.

Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to our directors, officers or controlling persons pursuant to the foregoing provisions, or otherwise, we have been advised that in the opinion of the Securities and Exchange Commission this indemnification is against public policy as expressed in the Securities Act, and is, therefore, unenforceable.

ZEQ.=2,SEQ=3,EFW="2231719",CP="SUNSHINE HEART, INC.",DN="1",CHK=90774,FOLIO='blank',FILE='DISK121:[17ZAY1.17ZAY78901]JA78901A.;19',USER='JKEENE',CD=';6-APR-2017;09:34'

Item 15. Recent Sales of Unregistered Securities.

The following sets forth information regarding all unregistered securities sold by the registrant in the three years preceding the date of this registration statement. This information has been retroactively adjusted to reflect the reverse stock split for all periods presented.

ZEQ.=3,SEQ=4,EFW="2231719",CP="SUNSHINE HEART, INC.",DN="1",CHK=841068,FOLIO='blank',FILE='DISK121:[17ZAY1.17ZAY78901]JA78901A.;19',USER='JKEENE',CD=';6-APR-2017;09:34'

ZEQ.=4,SEQ=5,EFW="2231719",CP="SUNSHINE HEART, INC.",DN="1",CHK=173017,FOLIO='blank',FILE='DISK121:[17ZAY1.17ZAY78901]JA78901A.;19',USER='JKEENE',CD=';6-APR-2017;09:34'

THIS IS THE END OF A COMPOSITION COMPONENT

COMMAND=ADD_BASECOLOR,"#000000" COMMAND=ADD_DEFAULTFONT,"font-family:times;" COMMAND=ADD_TABLESHADECOLOR,"#CCEEFF" COMMAND=ADD_STABLERULES,"border-bottom:solid #000000 1.0pt;" COMMAND=ADD_DTABLERULES,"border-bottom:double #000000 2.25pt;" COMMAND=ADD_SCRTABLERULES,"border-bottom:solid #000000 1.0pt;margin-bottom:0pt;" COMMAND=ADD_DCRTABLERULES,"border-bottom:double #000000 2.25pt;margin-bottom:0pt;"

TOC_END

Item 16. Exhibits and Financial Statement Schedules.

The following exhibits are included as part of this Form S-1.

EXHIBIT INDEX

COMMAND=ADD_TABLEWIDTH,"140%" User-specified TAGGED TABLE

Exhibit Number	Exhibit Description	Incorporated By Reference — Form	File Number	Date of First Filing	Exhibit Number
1.1	Form of Underwriting Agreement.	S-1	333-216841	April 4, 2017	1.1
2.1	Asset Purchase Agreement between Sunshine Heart, Inc. and Gambro UF Solutions, Inc. dated August 5, 2016.	8-K	001-35312	August 8, 2016	2.1
3.1	Fourth Amended and Restated Certificate of Incorporation	10	001-35312	February 1, 2012	3.1
3.2	Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation	8-K	001-35312	January 13, 2017	3.1
3.3	Amended and Restated Bylaws	10	001-35312	September 30, 2011	3.2
3.4	Form of Certificate of Designation of Series A Junior Participating Preferred Stock	8-K	001-35312	June 14,2013	3.1
3.5	Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock.	8-K	001-35312	July 25, 2016	3.1
3.6	Certificate of Designation of Preferences, Rights and Limitations of Series B-1 Convertible Preferred Stock.	8-K	001-35312	November 3, 2016	3.1
3.7	Certificate of Designation of Preferences, Rights and Limitations of Series C Convertible Preferred Stock.	8-K	001-35312	November 3, 2016	3.2
3.8	Certificate of Designation of Preferences, Rights and Limitations of Series D Convertible Preferred Stock.	8-K	001-35312	November 3, 2016	3.3
3.9	Form of Certificate of Designation of Preferences, Rights and Limitations of Series E Convertible Preferred Stock.	S-1	333-216841	April 4, 2017	3.9
4.1	Warrant to Purchase Stock, dated February 18, 2015, issued to Silicon Valley Bank	8-K	001-35312	February 19, 2015	4.1

end of user-specified TAGGED TABLE

ZEQ.=1,SEQ=6,EFW="2231719",CP="SUNSHINE HEART, INC.",DN="1",CHK=736008,FOLIO='blank',FILE='DISK121:[17ZAY1.17ZAY78901]JC78901A.;24',USER='JKEENE',CD=';6-APR-2017;09:35'

COMMAND=ADD_TABLEWIDTH,"140%" User-specified TAGGED TABLE

Exhibit Number	Exhibit Description	Incorporated By Reference — Form	File Number	Date of First Filing	Exhibit Number	Filed Herewith
4.2	Warrant to Purchase Stock, dated February 18, 2015, issued to Life Science Loans, LLC	8-K	001-35312	February 19, 2015	4.2
4.3	Form of common stock Purchase Warrant issued pursuant to the Securities Purchase Agreement, dated July 20, 2016, among the Company and the purchasers signatory thereto.	8-K	001-35312	July 22, 2016	4.3
4.4	Form of common stock Purchase Warrant issued to Northland Securities, Inc.	8-K	001-35312	July 22, 2016	4.3
4.5	Registration Rights Agreement between Sunshine Heart, Inc. and Gambro UF Solutions, Inc. dated August 5, 2016	8-K	001-35312	August 8, 2016	4.1
4.6	Form of common stock Purchase Warrant issued pursuant to the Securities Purchase Agreement, dated October 30, 2016, among the Company and the purchasers signatory thereto.	8-K	001-35312	October 31, 2016	4.1
4.7	Form of Common Stock Purchase Warrant issued pursuant to the Letter Agreement between the Company and the purchasers signatory thereto, dated February 15, 2017.	8-K	001-35312	February 16, 2017	4.1
4.8	Form of Warrant to purchase shares of common stock.	S-1	333-216841	April 4, 2017	4.8
5.1	Opinion of Honigman Miller Schwartz and Cohn LLP.					X
10.1	Securities Purchase Agreement, dated July 20, 2016 among the Company and the purchasers signatory thereto.	8-K	001-35312	July 22, 2016	10.1
10.2	Patent License Agreement between Sunshine Heart, Inc. and Gambro UF Solutions, Inc. dated August 5, 2016.	8-K	001-35312	August 8, 2016	10.1
10.3	Loan and Security Agreement between Sunshine Heart, Inc. and Silicon Valley Bank dated August 5, 2016.	8-K	001-35312	August 8, 2016	10.2

end of user-specified TAGGED TABLE

ZEQ.=2,SEQ=7,EFW="2231719",CP="SUNSHINE HEART, INC.",DN="1",CHK=617137,FOLIO='blank',FILE='DISK121:[17ZAY1.17ZAY78901]JC78901A.;24',USER='JKEENE',CD=';6-APR-2017;09:35'

COMMAND=ADD_TABLEWIDTH,"140%" User-specified TAGGED TABLE

Exhibit Number	Exhibit Description	Incorporated By Reference — Form	File Number	Date of First Filing	Exhibit Number
10.4	Amended and Restated 2002 Stock Plan†	10	001-35312	December 16, 2011	10.2
10.5	Form of Notice of Stock Option Grant and Option Agreement for Amended and Restated 2002 Stock Plan†	10	001-35312	September 30, 2011	10.3
10.6	Second Amended and Restated 2011 Equity Incentive Plan, as amended†	14A	001-35312	July 27, 2012	App. A
10.7	Form of Stock Option Grant Notice and Option Agreement for 2011 Equity Incentive Plan†	10	001-35312	September 30, 2011	10.5
10.8	Form of Stock Option Grant Notice and Option Agreement (Senior Management) for 2011 Equity Incentive Plan†	10	001-35312	September 30, 2011	10.6
10.9	Form of Stock Option Grant Notice and Option Agreement (Director) for 2011 Equity Incentive Plan†	8-K	001-35312	September 18, 2012	10.1
10.10	Form of Stock Grant Notice and Award Agreement for 2011 Equity Incentive Plan†	8-K	001-35312	September 10, 2013	10.1
10.11	Form of Restricted Stock Unit Grant Notice and Agreement for 2011 Equity Incentive Plan†	8-K	001-35312	September 10, 2013	10.2
10.12	2013 Non-Employee Directors' Equity Incentive Plan†	14A	001-35312	April 5, 2013	App. A
10.13	Form of Stock Option Grant Notice and Option Agreement for 2013 Non-Employee Directors' Equity Incentive Plan†	10-K	001-35312	March 20, 2014	10.10
10.14	Form of Restricted Stock Unit Award Grant Notice and Agreement for 2013 Non-Employee Directors' Equity Incentive Plan†	10-K	001-35312	March 20, 2014	10.11
10.15	New-Hire Equity Incentive Plan†	10-Q	001-35312	August 8, 2013	10.1
10.16	First Amendment to New-Hire Equity Incentive Plan†	10-Q	001-35312	November 12, 2013	10.1
10.17	Second Amendment to New-Hire Equity Incentive Plan†	10-Q	333-202904	March 20, 2015	10.1

end of user-specified TAGGED TABLE

ZEQ.=3,SEQ=8,EFW="2231719",CP="SUNSHINE HEART, INC.",DN="1",CHK=523557,FOLIO='blank',FILE='DISK121:[17ZAY1.17ZAY78901]JC78901A.;24',USER='JKEENE',CD=';6-APR-2017;09:35'

COMMAND=ADD_TABLEWIDTH,"140%" User-specified TAGGED TABLE

Exhibit Number	Exhibit Description	Incorporated By Reference — Form	File Number	Date of First Filing	Exhibit Number
10.18	Form of Stock Option Grant Notice and Option Agreement for New-Hire Equity Incentive Plan†	10-K	001-35312	March 20, 2014	10.14
10.19	Form of Indemnity Agreement for the Company's executive officers and directors†	10	001-35312	September 30, 2011	10.1
10.20	Form of Change in Control Agreement for the Company's executive officers†	10-K	001-35312	March 20, 2015	10.16
10.21	Non-Employee Director Compensation Policy†	10-Q	001-35312	August 8, 2013	10.2
10.22	Executive Employment Agreement dated February 6, 2013 by and between the Company and David A. Rosa†	8-K	001-35312	February 6, 2013	10.1
10.23	Lease Agreement dated October 21, 2011 by and between the Company and Silver Prairie Crossroads, LLC	10	001-35312	December 16, 2011	10.18
10.24	Sales Agreement dated March 21, 2014 by and between the Company and Cowen and Company, LLC	S-3	333-194731	March 21, 2014	1.2
10.25	Loan and Security Agreement between the Company and Silicon Valley Bank dated February 18, 2015	8-K	001-35312	February 19, 2015	10.1
10.26	First Amendment to Loan and Security Agreement between the Company and Silicon Valley Bank dated December 8, 2015	8-K	001-35312	December 9, 2015	99.1
10.27	Second Amendment to Lease, dated as of April 20, 2015, by and between the Company and Capital Partners Industrial Fund I, LLLP dba Prairie Crossroads Business Center	8-K	001-35312	April 23, 2015	10.1
10.28	Termination and Release Agreement dated January 1, 2015 by and between the Company and William S. Peters†	10-Q	001-35312	May 7, 2015	10.2

end of user-specified TAGGED TABLE

ZEQ.=4,SEQ=9,EFW="2231719",CP="SUNSHINE HEART, INC.",DN="1",CHK=632962,FOLIO='blank',FILE='DISK121:[17ZAY1.17ZAY78901]JC78901A.;24',USER='JKEENE',CD=';6-APR-2017;09:35'

COMMAND=ADD_TABLEWIDTH,"140%" User-specified TAGGED TABLE

Exhibit Number	Exhibit Description	Incorporated By Reference — Form	File Number	Date of First Filing	Exhibit Number	Filed Herewith
10.29	Separation and Release Agreement dated June 19, 2015 by and between the Company and Kimberly A. Oleson†	10-Q	001-35312	August 5, 2015	10.2
10.30	Separation and Release Agreement between the Company and David A. Rosa, dated November 30, 2015†	8-K	001-35312	November 30, 2015	99.1
10.31	Executive Employment Agreement between Sunshine Heart, Inc. and John L. Erb, dated March 1, 2016†	8-K	001-35312	March 2, 2016	10.1
10.32	Separation and Release Agreement by and between Sunshine Heart, Inc. and Brian J. Brown, dated February 3, 2016†	10-Q	001-35312	May 5, 2015	10.2
10.33	Separation and Release Agreement by and between Sunshine Heart, Inc. and Debra Kridner, dated January 24, 2016†	10-Q	001-35312	May 5, 2016	10.3
10.34	Third Amendment to the Sunshine Heart, Inc. New-Hire Equity Incentive Plan†	S-8	333-210215	March 15, 2016	99.1
10.35	Claudia Drayton Retention Bonus Letter, dated as of December 12, 2016†	8-K	001-35312	December 16, 2016	10.1
10.36	Molly Wade Retention Bonus Letter, dated as of December 12, 2016†	10-K	001-35312	March 8, 2017	10.33
10.37	Letter Agreement dated February 15, 2017 among the Company, Sabby Volatility Warrant Master Fund, Ltd. and Sabby Healthcare Master Fund, Ltd.	8-K	003-35312	February 16, 2017	10.1
21	List of Subsidiaries	10-K	001-35312	March 8, 2017	21
23.1	Consent of Independent Registered Public Accounting Firm	S-1	333-216841	April 4, 2017	23.1
23.2	Consent of Honigman Miller Schwartz & Cohn LLP					Included in Exhibit 5.1
24.1	Power of Attorney	S-1	333-216841	March 20, 2017	24.1

end of user-specified TAGGED TABLE COMMAND=ADD_LINERULETXT,NOSHADE COLOR="#000000" SIZE="1.0PT" WIDTH="26%" ALIGN="LEFT"

† Indicates management compensatory plan, contract or arrangement.

ZEQ.=5,SEQ=10,EFW="2231719",CP="SUNSHINE HEART, INC.",DN="1",CHK=610896,FOLIO='blank',FILE='DISK121:[17ZAY1.17ZAY78901]JC78901A.;24',USER='JKEENE',CD=';6-APR-2017;09:35' THIS IS THE END OF A COMPOSITION COMPONENT

COMMAND=ADD_BASECOLOR,"#000000" COMMAND=ADD_DEFAULTFONT,"font-family:times;" COMMAND=ADD_TABLESHADECOLOR,"#CCEEFF" COMMAND=ADD_STABLERULES,"border-bottom:solid #000000 1.0pt;" COMMAND=ADD_DTABLERULES,"border-bottom:double #000000 2.25pt;" COMMAND=ADD_SCRTABLERULES,"border-bottom:solid #000000 1.0pt;margin-bottom:0pt;" COMMAND=ADD_DCRTABLERULES,"border-bottom:double #000000 2.25pt;margin-bottom:0pt;"

TOC_END

Item 17. Undertakings.

The undersigned registrant hereby undertakes that, for the purpose of determining any liability under the Securities Act of 1933, as amended, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

The undersigned registrant hereby undertakes to remove from registration by means of a post-effective amendment any of the securities being registered that remain unsold at the termination of the offering.

The undersigned registrant hereby undertakes that, for the purposes of determining liability to any purchaser, if the registrant is subject to Rule 430C, each prospectus filed pursuant to Rule 424(b) as part of a registration statement relating to an offering, other than registration statements relying on Rule 430B or other than prospectuses filed in reliance on Rule 430A, shall be deemed to be part of and included in the registration statement as of the date it is first used after effectiveness. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such first use, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such date of first use.

The undersigned registrant hereby undertakes that, for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial distribution of the securities:

The undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:

Insofar as indemnification for liabilities arising under the Securities Act of 1933, as amended, may be permitted to directors, officers and controlling persons of the undersigned registrant according the foregoing provisions, or otherwise, the undersigned registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the Registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act of 1933, as amended, and will be governed by the final adjudication of such issue.

ZEQ.=1,SEQ=11,EFW="2231719",CP="SUNSHINE HEART, INC.",DN="1",CHK=414865,FOLIO='blank',FILE='DISK121:[17ZAY1.17ZAY78901]JE78901A.;5',USER='CHE108077',CD=';6-APR-2017;02:11'

The undersigned registrant hereby undertakes that, for purposes of determining any liability under the Securities Act of 1933, each filing of the registrant's annual report pursuant to section 13(a) or section 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit plan's annual report pursuant to section 15(d) of the Securities Exchange Act of 1934) that is incorporated by reference in the registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

ZEQ.=2,SEQ=12,EFW="2231719",CP="SUNSHINE HEART, INC.",DN="1",CHK=723846,FOLIO='blank',FILE='DISK121:[17ZAY1.17ZAY78901]JE78901A.;5',USER='CHE108077',CD=';6-APR-2017;02:11' THIS IS THE END OF A COMPOSITION COMPONENT

COMMAND=ADD_BASECOLOR,"#000000" COMMAND=ADD_DEFAULTFONT,"font-family:times;" COMMAND=ADD_TABLESHADECOLOR,"#CCEEFF" COMMAND=ADD_STABLERULES,"border-bottom:solid #000000 1.0pt;" COMMAND=ADD_DTABLERULES,"border-bottom:double #000000 2.25pt;" COMMAND=ADD_SCRTABLERULES,"border-bottom:solid #000000 1.0pt;margin-bottom:0pt;" COMMAND=ADD_DCRTABLERULES,"border-bottom:double #000000 2.25pt;margin-bottom:0pt;"

TOC_END

SIGNATURES

Pursuant to the requirements of the Securities Act of 1933, the registrant has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized in the City of Eden Prairie, State of Minnesota, on this 6th day of April, 2017.

COMMAND=ADD_TABLEWIDTH,"100%" User-specified TAGGED TABLE

SUNSHINE HEART, INC.
By:	/s/ JOHN L. ERB John L. Erb Chief Executive Officer and Chairman of the Board

end of user-specified TAGGED TABLE

Pursuant to the requirements of the Securities Act of 1933, this registration statement has been signed by the following persons in the capacities and on the dates indicated.

COMMAND=ADD_TABLEWIDTH,"100%" User-specified TAGGED TABLE

Signature		Date
/s/ JOHN L. ERB John L. Erb	Chief Executive Officer and Chairman of the Board	April 6, 2017
/s/ CLAUDIA DRAYTON Claudia Drayton	Chief Financial Officer	April 6, 2017
* Steve Brandt	Director	April 6, 2017
* Matthew Likens	Director	April 6, 2017
* Jon W. Salveson	Director	April 6, 2017
* Gregory Waller	Director	April 6, 2017
* Warren Watson	Director	April 6, 2017
*By:	/s/ JOHN L. ERB John L. Erb Attorney-in-fact

end of user-specified TAGGED TABLE

ZEQ.=1,SEQ=13,EFW="2231719",CP="SUNSHINE HEART, INC.",DN="1",CHK=355903,FOLIO='blank',FILE='DISK121:[17ZAY1.17ZAY78901]JG78901A.;19',USER='CHE108077',CD=';6-APR-2017;02:11' THIS IS THE END OF A COMPOSITION COMPONENT

COMMAND=ADD_BASECOLOR,"#000000" COMMAND=ADD_DEFAULTFONT,"font-family:times;" COMMAND=ADD_TABLESHADECOLOR,"#CCEEFF" COMMAND=ADD_STABLERULES,"border-bottom:solid #000000 1.0pt;" COMMAND=ADD_DTABLERULES,"border-bottom:double #000000 2.25pt;" COMMAND=ADD_SCRTABLERULES,"border-bottom:solid #000000 1.0pt;margin-bottom:0pt;" COMMAND=ADD_DCRTABLERULES,"border-bottom:double #000000 2.25pt;margin-bottom:0pt;"

TOC_END

EXHIBIT INDEX

COMMAND=ADD_TABLEWIDTH,"140%" User-specified TAGGED TABLE

Exhibit Number	Exhibit Description	Incorporated By Reference — Form	File Number	Date of First Filing	Exhibit Number
1.1	Form of Underwriting Agreement.	S-1	333-216841	April 4, 2017	1.1
2.1	Asset Purchase Agreement between Sunshine Heart, Inc. and Gambro UF Solutions, Inc. dated August 5, 2016.	8-K	001-35312	August 8, 2016	2.1
3.1	Fourth Amended and Restated Certificate of Incorporation	10	001-35312	February 1, 2012	3.1
3.2	Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation	8-K	001-35312	January 13, 2017	3.1
3.3	Amended and Restated Bylaws	10	001-35312	September 30, 2011	3.2
3.4	Form of Certificate of Designation of Series A Junior Participating Preferred Stock	8-K	001-35312	June 14,2013	3.1
3.5	Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock.	8-K	001-35312	July 25, 2016	3.1
3.6	Certificate of Designation of Preferences, Rights and Limitations of Series B-1 Convertible Preferred Stock.	8-K	001-35312	November 3, 2016	3.1
3.7	Certificate of Designation of Preferences, Rights and Limitations of Series C Convertible Preferred Stock.	8-K	001-35312	November 3, 2016	3.2
3.8	Certificate of Designation of Preferences, Rights and Limitations of Series D Convertible Preferred Stock.	8-K	001-35312	November 3, 2016	3.3
3.9	Form of Certificate of Designation of Preferences, Rights and Limitations of Series E Convertible Preferred Stock.	S-1	333-216841	April 4, 2017	3.9
4.1	Warrant to Purchase Stock, dated February 18, 2015, issued to Silicon Valley Bank	8-K	001-35312	February 19, 2015	4.1
4.2	Warrant to Purchase Stock, dated February 18, 2015, issued to Life Science Loans, LLC	8-K	001-35312	February 19, 2015	4.2

end of user-specified TAGGED TABLE

ZEQ.=1,SEQ=14,EFW="2231719",CP="SUNSHINE HEART, INC.",DN="1",CHK=944778,FOLIO='blank',FILE='DISK121:[17ZAY1.17ZAY78901]JI78901A.;21',USER='JKEENE',CD=';6-APR-2017;09:36'

COMMAND=ADD_TABLEWIDTH,"140%" User-specified TAGGED TABLE

Exhibit Number	Exhibit Description	Incorporated By Reference — Form	File Number	Date of First Filing	Exhibit Number	Filed Herewith
4.3	Form of common stock Purchase Warrant issued pursuant to the Securities Purchase Agreement, dated July 20, 2016, among the Company and the purchasers signatory thereto.	8-K	001-35312	July 22, 2016	4.3
4.4	Form of common stock Purchase Warrant issued to Northland Securities, Inc.	8-K	001-35312	July 22, 2016	4.3
4.5	Registration Rights Agreement between Sunshine Heart, Inc. and Gambro UF Solutions, Inc. dated August 5, 2016	8-K	001-35312	August 8, 2016	4.1
4.6	Form of common stock Purchase Warrant issued pursuant to the Securities Purchase Agreement, dated October 30, 2016, among the Company and the purchasers signatory thereto.	8-K	001-35312	October 31, 2016	4.1
4.7	Form of Common Stock Purchase Warrant issued pursuant to the Letter Agreement between the Company and the purchasers signatory thereto, dated February 15, 2017.	8-K	001-35312	February 16, 2017	4.1
4.8	Form of Warrant to purchase shares of common stock.	S-1	333-216841	April 4, 2017	4.8
5.1	Opinion of Honigman Miller Schwartz and Cohn LLP.					X
10.1	Securities Purchase Agreement, dated July 20, 2016 among the Company and the purchasers signatory thereto.	8-K	001-35312	July 22, 2016	10.1
10.2	Patent License Agreement between Sunshine Heart, Inc. and Gambro UF Solutions, Inc. dated August 5, 2016.	8-K	001-35312	August 8, 2016	10.1
10.3	Loan and Security Agreement between Sunshine Heart, Inc. and Silicon Valley Bank dated August 5, 2016.	8-K	001-35312	August 8, 2016	10.2
10.4	Amended and Restated 2002 Stock Plan†	10	001-35312	December 16, 2011	10.2
10.5	Form of Notice of Stock Option Grant and Option Agreement for Amended and Restated 2002 Stock Plan†	10	001-35312	September 30, 2011	10.3

end of user-specified TAGGED TABLE

ZEQ.=2,SEQ=15,EFW="2231719",CP="SUNSHINE HEART, INC.",DN="1",CHK=131020,FOLIO='blank',FILE='DISK121:[17ZAY1.17ZAY78901]JI78901A.;21',USER='JKEENE',CD=';6-APR-2017;09:36'

COMMAND=ADD_TABLEWIDTH,"140%" User-specified TAGGED TABLE

Exhibit Number	Exhibit Description	Incorporated By Reference — Form	File Number	Date of First Filing	Exhibit Number
10.6	Second Amended and Restated 2011 Equity Incentive Plan, as amended†	14A	001-35312	July 27, 2012	App. A
10.7	Form of Stock Option Grant Notice and Option Agreement for 2011 Equity Incentive Plan †	10	001-35312	September 30, 2011	10.5
10.8	Form of Stock Option Grant Notice and Option Agreement (Senior Management) for 2011 Equity Incentive Plan†	10	001-35312	September 30, 2011	10.6
10.9	Form of Stock Option Grant Notice and Option Agreement (Director) for 2011 Equity Incentive Plan†	8-K	001-35312	September 18, 2012	10.1
10.10	Form of Stock Grant Notice and Award Agreement for 2011 Equity Incentive Plan†	8-K	001-35312	September 10, 2013	10.1
10.11	Form of Restricted Stock Unit Grant Notice and Agreement for 2011 Equity Incentive Plan†	8-K	001-35312	September 10, 2013	10.2
10.12	2013 Non-Employee Directors' Equity Incentive Plan†	14A	001-35312	April 5, 2013	App. A
10.13	Form of Stock Option Grant Notice and Option Agreement for 2013 Non-Employee Directors' Equity Incentive Plan†	10-K	001-35312	March 20, 2014	10.10
10.14	Form of Restricted Stock Unit Award Grant Notice and Agreement for 2013 Non-Employee Directors' Equity Incentive Plan†	10-K	001-35312	March 20, 2014	10.11
10.15	New-Hire Equity Incentive Plan†	10-Q	001-35312	August 8, 2013	10.1
10.16	First Amendment to New-Hire Equity Incentive Plan†	10-Q	001-35312	November 12, 2013	10.1
10.17	Second Amendment to New-Hire Equity Incentive Plan†	10-Q	333-202904	March 20, 2015	10.1
10.18	Form of Stock Option Grant Notice and Option Agreement for New-Hire Equity Incentive Plan†	10-K	001-35312	March 20, 2014	10.14
10.19	Form of Indemnity Agreement for the Company's executive officers and directors†	10	001-35312	September 30, 2011	10.1

end of user-specified TAGGED TABLE

ZEQ.=3,SEQ=16,EFW="2231719",CP="SUNSHINE HEART, INC.",DN="1",CHK=620145,FOLIO='blank',FILE='DISK121:[17ZAY1.17ZAY78901]JI78901A.;21',USER='JKEENE',CD=';6-APR-2017;09:36'

COMMAND=ADD_TABLEWIDTH,"140%" User-specified TAGGED TABLE

Exhibit Number	Exhibit Description	Incorporated By Reference — Form	File Number	Date of First Filing	Exhibit Number
10.20	Form of Change in Control Agreement for the Company's executive officers†	10-K	001-35312	March 20, 2015	10.16
10.21	Non-Employee Director Compensation Policy†	10-Q	001-35312	August 8, 2013	10.2
10.22	Executive Employment Agreement dated February 6, 2013 by and between the Company and David A. Rosa†	8-K	001-35312	February 6, 2013	10.1
10.23	Lease Agreement dated October 21, 2011 by and between the Company and Silver Prairie Crossroads, LLC	10	001-35312	December 16, 2011	10.18
10.24	Sales Agreement dated March 21, 2014 by and between the Company and Cowen and Company, LLC	S-3	333-194731	March 21, 2014	1.2
10.25	Loan and Security Agreement between the Company and Silicon Valley Bank dated February 18, 2015	8-K	001-35312	February 19, 2015	10.1
10.26	First Amendment to Loan and Security Agreement between the Company and Silicon Valley Bank dated December 8, 2015	8-K	001-35312	December 9, 2015	99.1
10.27	Second Amendment to Lease, dated as of April 20, 2015, by and between the Company and Capital Partners Industrial Fund I, LLLP dba Prairie Crossroads Business Center	8-K	001-35312	April 23, 2015	10.1
10.28	Termination and Release Agreement dated January 1, 2015 by and between the Company and William S. Peters†	10-Q	001-35312	May 7, 2015	10.2
10.29	Separation and Release Agreement dated June 19, 2015 by and between the Company and Kimberly A. Oleson†	10-Q	001-35312	August 5, 2015	10.2
10.30	Separation and Release Agreement between the Company and David A. Rosa, dated November 30, 2015†	8-K	001-35312	November 30, 2015	99.1

end of user-specified TAGGED TABLE

ZEQ.=4,SEQ=17,EFW="2231719",CP="SUNSHINE HEART, INC.",DN="1",CHK=477169,FOLIO='blank',FILE='DISK121:[17ZAY1.17ZAY78901]JI78901A.;21',USER='JKEENE',CD=';6-APR-2017;09:36'

COMMAND=ADD_TABLEWIDTH,"140%" User-specified TAGGED TABLE

Exhibit Number	Exhibit Description	Incorporated By Reference — Form	File Number	Date of First Filing	Exhibit Number	Filed Herewith
10.31	Executive Employment Agreement between Sunshine Heart, Inc. and John L. Erb, dated March 1, 2016†	8-K	001-35312	March 2, 2016	10.1
10.32	Separation and Release Agreement by and between Sunshine Heart, Inc. and Brian J. Brown, dated February 3, 2016†	10-Q	001-35312	May 5, 2015	10.2
10.33	Separation and Release Agreement by and between Sunshine Heart, Inc. and Debra Kridner, dated January 24, 2016†	10-Q	001-35312	May 5, 2016	10.3
10.34	Third Amendment to the Sunshine Heart, Inc. New-Hire Equity Incentive Plan †	S-8	333-210215	March 15, 2016	99.1
10.35	Claudia Drayton Retention Bonus Letter, dated as of December 12, 2016†	8-K	001-35312	December 16, 2016	10.1
10.36	Molly Wade Retention Bonus Letter, dated as of December 12, 2016†	10-K	001-35312	March 8, 2017	10.33
10.37	Letter Agreement dated February 15, 2017 among the Company, Sabby Volatility Warrant Master Fund, Ltd. and Sabby Healthcare Master Fund, Ltd.	8-K	003-35312	February 16, 2017	10.1
21	List of Subsidiaries	10-K	001-35312	March 8, 2017	21
23.1	Consent of Independent Registered Public Accounting Firm	S-1	333-216841	April 4, 2017	23.1
23.2	Consent of Honigman Miller Schwartz & Cohn LLP					Included in Exhibit 5.1
24.1	Power of Attorney	S-1	333-216841	March 20, 2017	24.1

end of user-specified TAGGED TABLE COMMAND=ADD_LINERULETXT,NOSHADE COLOR="#000000" SIZE="1.0PT" WIDTH="26%" ALIGN="LEFT"

† Indicates management compensatory plan, contract or arrangement.

ZEQ.=5,SEQ=18,EFW="2231719",CP="SUNSHINE HEART, INC.",DN="1",CHK=471883,FOLIO='blank',FILE='DISK121:[17ZAY1.17ZAY78901]JI78901A.;21',USER='JKEENE',CD=';6-APR-2017;09:36' THIS IS THE END OF A COMPOSITION COMPONENT

QuickLinks

TOC_BEGIN PART II INFORMATION NOT REQUIRED IN PROSPECTUS

TOC_BEGIN

EXHIBIT INDEX TOC_BEGIN

TOC_BEGIN SIGNATURES TOC_BEGIN EXHIBIT INDEX SEQ=,FILE='QUICKLINK',USER=CMATTI,SEQ=,EFW="2231719",CP="SUNSHINE HEART, INC.",DN="1" TOCEXISTFLAG