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SEC Comment Letter for Nuwellis, Inc. (NUWE) (CIK 0001506492) (NUWE) — Jan 6, 2012

Nuwellis, Inc. (NUWE) (CIK 0001506492)
Date: Jan. 6, 2012 · CIK: 0001506492 · Accession: 0000000000-12-001049

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File numbers found in text: 001-35312

Date
January 6, 2012
Author
Amanda Ravitz Assistant Director
Form
UPLOAD
Company
Nuwellis, Inc. (NUWE) (CIK 0001506492)

Letter

January 6, 2012 Via E-Mail Jeffrey Mathiesen Chief Financial Officer Sunshine Heart, Inc. 7651 Anagram Drive Eden Prairie, Minnesota 55344 Re: Sunshine Heart, Inc. Amendment No. 2 to Form 10 Filed December 29, 2011 File No. 001-35312

Dear Mr. Mathiesen: We have reviewed your filing and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by providing the requested information, or by advising us when you will provide the requested response. If you do not believe our comments apply to your facts and circumstances or do not believe an am endment is appropriate, please tell us why in your response. After reviewing any amendment to your filing and the information you provide in response to these comments, we ma y have additional comments. Clinical Development, page 2

1. We note your disclosure that you have not yet implanted any additional patients permitted by the FDA. Please revise to clarify whether you plan on implanting the 20 additional patients and adding the two centers , and if so, when you plan on doing so. Please also clarify if these additional patie nts and two centers would be part of the “pivotal trial.”

Manufacturers and Suppliers, page 3

2. We note your response to prior comment 5. Howe ver, given your disc losure that, in the short term, each of your suppliers is material to your operations, please tell us whether you have any agreements with your suppliers and if so, how these agreements are not material. In addition, please e xpand your risk factor disclosure to reflect your reliance on single source suppliers.

Jeffrey Mathiesen Sunshine Heart, Inc. January 6, 2012 Page 2

Executive Compensation, page 33

3. Please update your executive compensation di sclosure for the fiscal year ended December 31, 2011. 4. We note your response to prior comment 9. Plea se provide us with your analysis as to whether the company benchmarks the salaries of Dr. Peters and Debra Kridner. See Regulation S-K Compliance and Disclosure In terpretation 118.05. If the company does benchmark these salaries, please identify th e component companies that make up the compensation peer group and the basi s for selecting the peer group.

We urge all persons who are responsible for th e accuracy and adequacy of the disclosure in the filing to be certain that the filing include s the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules requir e. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In responding to our comments, please provi de a written statement from the company acknowledging that:  the company is responsible for the adequacy an d accuracy of the disclo sure in the filing;

 staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and

 the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federa l securities laws of the United States. You may contact David Burt on at (202) 551-3626 or L ynn Dicker, the accounting reviewer, at (202) 551-3616 if you have questions regarding comments on the financial statements and related matters. Please contact Allicia Lam at (202) 551-3316 or Daniel Morris, Special Counsel, at (202) 551- 3314 with any other questions.

Sincerely,
/s/ Daniel Morris for
Amanda Ravitz Assistant Director
cc (by e-mail): Matthew R. Kuhn -- Faegre & Benson LLP

Show Raw Text
January 6, 2012
 Via E-Mail

Jeffrey Mathiesen Chief Financial Officer Sunshine Heart, Inc. 7651 Anagram Drive Eden Prairie, Minnesota  55344
Re: Sunshine Heart, Inc.
 Amendment No. 2 to Form 10
Filed December 29, 2011 File No. 001-35312

Dear Mr. Mathiesen:
 We have reviewed your filing and have the following comments.  In some of our
comments, we may ask you to provide us with  information so we may better understand your
disclosure.
 Please respond to this letter by providing the requested information, or by advising us
when you will provide the requested response.  If you do not believe our comments apply to your
facts and circumstances or do not believe an am endment is appropriate, please tell us why in
your response.
 After reviewing any amendment to your filing and the information you provide in
response to these comments, we ma y have additional comments.
         Clinical Development, page 2

 1. We note your disclosure that you have not  yet implanted any additional patients
permitted by the FDA.  Please revise to clarify whether you plan on implanting the 20
additional patients and adding the two centers , and if so, when you plan on doing so.
Please also clarify if these additional patie nts and two centers would be part of the
“pivotal trial.”

Manufacturers and Suppliers, page 3

 2. We note your response to prior comment 5.  Howe ver, given your disc losure that, in the
short term, each of your suppliers is material  to your operations, please tell us whether
you have any agreements with your suppliers and if so, how these agreements are not
material.  In addition, please e xpand your risk factor disclosure  to reflect your reliance on
single source suppliers.

Jeffrey Mathiesen Sunshine Heart, Inc. January 6, 2012 Page 2

 Executive Compensation, page 33

 3. Please update your executive compensation di sclosure for the fiscal year ended
December 31, 2011.
 4. We note your response to prior comment 9.  Plea se provide us with your analysis as to
whether the company benchmarks the salaries  of Dr. Peters and Debra Kridner.  See
Regulation S-K Compliance and Disclosure In terpretation 118.05.  If the company does
benchmark these salaries, please identify th e component companies that make up the
compensation peer group and the basi s for selecting the peer group.

We urge all persons who are responsible for th e accuracy and adequacy of the disclosure
in the filing to be certain that the filing include s the information the Securities Exchange Act of
1934 and all applicable Exchange Act rules requir e.  Since the company and its management are
in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.
 In responding to our comments, please provi de a written statement from the company
acknowledging that:
 the company is responsible for the adequacy an d accuracy of the disclo sure in the filing;

 staff comments or changes to disclosure in response to staff comments do not foreclose
the Commission from taking any action with respect to the filing; and

 the company may not assert staff comments as  a defense in any proceeding initiated by
the Commission or any person under the federa l securities laws of  the United States.
 You may contact David Burt on at (202) 551-3626 or L ynn Dicker, the accounting
reviewer, at (202) 551-3616 if  you have questions regarding comments on the financial
statements and related matters.  Please contact Allicia Lam at (202) 551-3316 or Daniel Morris,
Special Counsel, at (202) 551- 3314 with any other questions.

Sincerely,
   /s/ Daniel Morris for
Amanda Ravitz Assistant Director
cc (by e-mail): Matthew R. Kuhn -- Faegre & Benson LLP