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

 

November 12, 2012

Date of report (Date of earliest event reported)

 

SUNSHINE HEART, INC.

(Exact Name of Registrant as Specified in its Charter)

 

Delaware

 

001-35312

 

68-0533453

(State of Incorporation)

 

(Commission File Number)

 

(I.R.S. Employer Identification No.)

 

12988 Valley View Road
Eden Prairie, Minnesota

 

55344

(Address of Principal Executive Offices)

 

(Zip Code)

 

(952) 345-4200

(Registrant’s Telephone Number, Including Area Code)

 

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

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 (see General Instruction A.2. below):

 

o    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 



 

Item 5.02                                           Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

 

Mark Harvey has resigned from our board of directors effective as of November 12, 2012.  Mr. Harvey served on our compensation committee.  Mr. Harvey’s resignation is not based on any disagreement with our company.

 

Item 9.01                                           Financial Statements and Exhibits.

 

(d) Exhibits

 

99.1   Press Release dated November 13, 2012.

 

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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.

 

 

SUNSHINE HEART, INC.

 

 

 

 

 

 

Date:  November 13, 2012

By:

/s/ Jeffrey Mathiesen

 

 

Jeffrey Mathiesen

 

 

Chief Financial Officer

 

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EXHIBIT INDEX

 

No.

 

Description

 

Manner of Filing

99.1

 

Press Release dated November 13, 2012.

 

Filed Electronically

 

4


Exhibit 99.1

 

 

Sunshine Heart Announces Resignation of Director

 

Eden Prairie, MN and Sydney, Australia: 13 November, 2012: Sunshine Heart, Inc. (NASDAQ: SSH; ASX: SHC), a global medical device company focused on innovative technologies for moderate heart failure, today announced that Mark Harvey has resigned from the Board of Directors.

 

Mark joined Sunshine Heart’s Board of Directors in November of 2011. His stepping down from the board coincides with Mark’s transition from CM Capital Investments, one of Sunshine Heart’s major investors. Mark has been a Partner with CM Capital since 2008.

 

“I leave at a time when Sunshine Heart is well positioned for its next stage of growth as C-pulse progresses towards commercialization through a pivotal trial in the U.S. and a post-market trial in Europe to gather additional safety and efficacy data.  C-pulse is a cutting edge product being advanced by a world class team. It has been a pleasure working with the Board and I extend my best wishes to everyone at Sunshine Heart,” said Mark Harvey.

 

“Mark played an integral role in guiding Sunshine Heart through a truly transformative period and the Company is better off today in large part to his contribution.  On behalf of the management team and Board, I extend to Mark sincere gratitude and best wishes for future endeavors,” commented Sunshine Heart’s Chairman, John Erb.

 

About the C-Pulse® Heart Assist System

 

The C-Pulse Heart Assist System, or C-Pulse System, an investigational device in the United States, Canada and countries that do not recognize the CE Mark approval, utilizes the scientific principles of intra-aortic balloon counter-pulsation applied in an extra-aortic approach to assist the left ventricle by reducing the workload required to pump blood throughout the body, while increasing blood flow to the coronary arteries.  Operating outside the patient’s bloodstream, the extra-aortic approach of the C-Pulse technology offers greater flexibility, allowing patients to safely disconnect to have intervals of freedom to perform certain activities such as showering.  The C-Pulse System may help maintain the patient’s current condition and, in some cases, reverse the heart failure process, thereby potentially preventing the need for later stage heart failure therapies, such as left ventricular assist devices (LVADs), artificial hearts or transplants.

 

Caution: Investigational device, limited by Federal (or United States) Law to Investigational use.

 

About Sunshine® Heart

 

Sunshine Heart, Inc. (NASDAQ: SSH / ASX: SHC) is an early-stage global medical device company committed to the commercialization of the C-Pulse System, an implantable, non-blood contacting, heart assist therapy for the treatment of moderate to severe heart failure.  The C-Pulse System can be implanted using a minimally invasive procedure and is designed to relieve the symptoms of heart failure through the use of counter-pulsation technology, which enables an increase in cardiac output, an increase in coronary blood flow and a reduction in the heart’s pumping load.  Sunshine Heart has completed an approved U.S. Food and Drug Administration (FDA) feasibility clinical trial of the C-Pulse System and presented the results in November 2011.  In March, 2012, the FDA notified the Company that it could move forward with an investigational device exemption (IDE) application.  Sunshine Heart received conditional approval from the FDA in September 2012 to initiate its pivotal trial.  In July 2012 Sunshine Heart received CE Mark approval for its C-Pulse System in Europe.  Sunshine Heart is a Delaware corporation headquartered in Minneapolis with a subsidiary presence in Australia.  The Company has been listed on the Australian Securities Exchange (ASX) since September 2004 and on the NASDAQ Capital Market since February 2012.  For more information, please visit www.sunshineheart.com.

 

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For further information, please contact:

 

Jeff Mathiesen
Chief Financial Officer
Sunshine Heart, Inc.
+1 952 345 4200