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SEC Comment Letter for Nuwellis, Inc. (NUWE) (CIK 0001506492) (NUWE) — Dec 23, 2011

Nuwellis, Inc. (NUWE) (CIK 0001506492)
Date: Dec. 23, 2011 · CIK: 0001506492 · Accession: 0000000000-11-073648

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File numbers found in text: 001-35312

Date
December 23, 2011
Author
Daniel Morris
Form
UPLOAD
Company
Nuwellis, Inc. (NUWE) (CIK 0001506492)

Letter

December 23, 2011 Jeff Mathiesen Chief Financial Officer Sunshine Heart, Inc. 7651 Anagram Drive Eden Prairie, Minnesota Re: Sunshine Heart, Inc. Amendment No. 1 to Form 10 Filed December 16, 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 within ten business days by amending your filing, by providing the requested information, or by advi sing us when you will provide the requested response. If you do not believe our comments apply to your fact s and circumstances or do not believe an amendment is appropriate, pl ease 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.

Overview, page 1

1. We note your response to prior comment 10. Please revise the summary to include disclosure that all revenu e during 2009 and 2010 was deri ved from your feasibility clinical trials. Our Product, page 2

2. Expand your discussion of the adverse conse quences if your product is turned off for extended periods of time. In a ddition, please clarify whether us e of the product, including turning it off and on, requires a visit to a medical facility.

Jeff Mathiesen Sunshine Heart, Inc. December 23, 2011 Page 2

Clinical Development, page 2

3. We note your response to prior comment 6. Plea se revise the second- to-last paragraph of this section to disclose the anti cipated end date of the IDE study. Sales and Marketing, page 3

4. Please disclose the anticipated timetable for the expansion of your sales into Europe and throughout the world. Manufacturers and Suppliers, page 3

5. We note that you do not have any material l ong-term agreements with your suppliers. However, please revise to clarify wh ether you have any suppliers on which you materially rely. Competition, page 4

6. We note your response to prior comment 9. Plea se revise to disclose that the potential disadvantages of the C-Pulse System are not fully known.

Properties, page 27

7. We note your revised disclosure in this section. Please continue to provide updated disclosure with your subsequent amendments. In this regard, we note that you anticipate moving your operations in late December 2011. Summary Compensation Table, page 33

8. Given your disclosure in the last paragraph on page 33 that your employment agreement with Mr. Rosa provides for a salary of $250,000, please provide additional disclosure clarifying why the summary compensation ta ble indicates that Mr. Rosa received $280,000 in base salary in 2011. 9. We note your response to prior comment 15. With a view to disclosure, please describe for us the nature and extent of your chie f executive officer’s c onsultation of certain publicly available information. For instance, please tell us the type of information that the chief executive officer consulted and how this information served as a “reference point.” 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

Jeff Mathiesen Sunshine Heart, Inc. December 23, 2011 Page 3

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 Lynn Dicker at (202) 551-3616 if you have questions regarding comments on the fina ncial statements and related matters. Please contact Allicia Lam at (202) 551-3316 or Dani el 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
December 23, 2011
 Jeff Mathiesen Chief Financial Officer Sunshine Heart, Inc. 7651 Anagram Drive  Eden Prairie, Minnesota
Re: Sunshine Heart, Inc.
 Amendment No. 1 to Form 10
Filed December 16, 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 within ten business days by amending your filing, by
providing the requested information, or by advi sing us when you will provide the requested
response.  If you do not believe our comments apply to your fact s and circumstances or do not
believe an amendment is appropriate, pl ease 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.

Overview, page 1

 1. We note your response to prior comment 10. Please revise the summary to include
disclosure that all revenu e during 2009 and 2010 was deri ved from your feasibility
clinical trials.
 Our Product, page 2

 2. Expand your discussion of the adverse conse quences if your product is turned off for
extended periods of time. In a ddition, please clarify whether us e of the product, including
turning it off and on, requires a visit to a medical facility.

Jeff Mathiesen Sunshine Heart, Inc. December 23, 2011 Page 2

 Clinical Development, page 2

 3. We note your response to prior comment 6.  Plea se revise the second- to-last paragraph of
this section to disclose the anti cipated end date of the IDE study.
 Sales and Marketing, page 3

 4. Please disclose the anticipated timetable for the expansion of your sales into Europe and
throughout the world.
 Manufacturers and Suppliers, page 3

 5. We note that you do not have any material l ong-term agreements with your suppliers.
However, please revise to clarify wh ether you have any suppliers on which you
materially rely.
 Competition, page 4

 6. We note your response to prior comment 9.  Plea se revise to disclose that the potential
disadvantages of the C-Pulse System are not fully known.

Properties, page 27

 7. We note your revised disclosure in this section. Please continue  to provide updated
disclosure with your subsequent amendments.  In this regard, we note that you anticipate
moving your operations in  late December 2011.
 Summary Compensation Table, page 33

 8. Given your disclosure in the last paragraph on page 33 that  your employment agreement
with Mr. Rosa provides for a salary of  $250,000, please provide additional disclosure
clarifying why the summary compensation ta ble indicates that Mr. Rosa received
$280,000 in base salary in 2011.
9. We note your response to prior comment 15. With  a view to disclosure, please describe
for us the nature and extent of your chie f executive officer’s c onsultation of certain
publicly available information.  For instance, please tell us the type of information that
the chief executive officer consulted and how this information served as a “reference
point.”   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

Jeff Mathiesen Sunshine Heart, Inc. December 23, 2011 Page 3

 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 Lynn Dicker at (202) 551-3616 if
you have questions regarding comments on the fina ncial statements and related matters.  Please
contact Allicia Lam at (202) 551-3316 or Dani el 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