UNITED STATES

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

Date of Report (Date of earliest event reported): July 23, 2015

SUNSHINE HEART, INC.

(Exact Name of Registrant as Specified in its Charter)

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):

Item 7.01   Regulation FD Disclosure.

On July 23, 2015, Sunshine Heart, Inc. (“Sunshine Heart” or the “Company”) issued a press release regarding an update on the COUNTER HF study.  The COUNTER HF study is a prospective, randomized, multi-center, controlled study that evaluates the safety and efficacy of the C-Pulse system for the treatment of NYHA Class III and ambulatory Class IV heart failure. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

In accordance with General Instruction B.2 of Form 8-K, this information (including Exhibit 99.1) is furnished pursuant to Item 7.01 and shall not be deemed to be “filed” for the purpose of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. The information in this Item 7.01 of this Current Report on Form 8-K will not be deemed an admission as to the materiality of any information that is required to be disclosed solely by Regulation FD.

Item 8.01   Other Events.

On July 23, 2015, the Company announced that, since May 26, 2015, the date that the Food and Drug Administration approved resumption of patient enrollment in the COUNTER HF study, 12 sites have been reactivated, which is approximately half of all previously activated sites. Sunshine Heart expects the majority of sites to be reactivated by the end August. Also since May 26, 2015, two new patients have been enrolled. One of these patients was already reviewed by Sunshine Heart’s newly formed Physician Subject Selection Committee, and the first implant was scheduled for this morning.

Safe Harbor Statement

Certain statements in this current report are forward-looking statements that are based on management’s beliefs, assumptions, expectations, and information currently available to management. All statements that address future operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including, without limitation, our expectations with respect to future clinical study activities and results including patient enrollment in studies. These forward-looking statements are subject to numerous risks and uncertainties, including, without limitation, the possibility that our clinical studies do not meet their enrollment goals, meet their endpoints or otherwise fail, that regulatory authorities do not accept our application or approve the marketing of the C-Pulse System, the possibility that we may be unable to raise the funds necessary for the development and commercialization of our products, that we may not be able to commercialize our products successfully in the EU and the other risk factors described under the caption “Risk Factors” and elsewhere in our filings with the U.S. Securities and Exchange Commission. You should not place undue reliance on forward-looking statements because they speak only as of the date when made and may turn out to be inaccurate. We do not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. We may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements.

Item 9.01    Financial Statements and Exhibits.

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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.

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EXHIBIT INDEX

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Exhibit 99.1

Sunshine Heart Provides Update on COUNTER HF™ US Pivotal Study for

C-Pulse® Heart Assist System

Eden Prairie, MN: July 23, 2015: Sunshine Heart, Inc. (NASDAQ: SSH) announced today an update on its COUNTER HF™ US pivotal study for the C-Pulse Heart Assist System. COUNTER HF is a prospective, randomized, multi-center, controlled study evaluating the safety and efficacy of the C-Pulse system for the treatment of NYHA Class III and ambulatory Class IV heart failure. The study was temporarily paused this past March after the Company notified the FDA of four deaths in the treatment arm of the study. The deaths were adjudicated as not device or therapy related and as previously announced on May 26th, the FDA approved resumption of patient enrollment in the study.

“I’m pleased with the enthusiasm and speed at which sites are being reactivated. We witnessed genuine excitement for the study at our recent investigator meeting and are strongly encouraged by the momentum generated at many of our sites,” commented Dave Rosa, President and Chief Executive Officer of Sunshine Heart.

Immediately following the FDA’s decision to approve enrollment to continue the COUNTER HF’s study, Sunshine Heart distributed material to all sites with the necessary documentation in order to achieve site Investigational Review Board (IRB) approvals. Currently, 12 sites have been reactivated which is approximately half of all previously activated sites. Sunshine Heart expects the majority of sites to be reactivated by the end August. In addition, the Company is pleased to announce the enrollment of its first two patients since the resumption of the COUNTER HF study. One of these patients was already reviewed by Sunshine Heart’s newly formed Physician Subject Selection Committee. This process was handled efficiently and led to the first implant being scheduled for this morning.

About the COUNTER HF Study

COUNTER HF is a prospective, randomized, multi-center clinical study. It is being conducted by heart failure and cardiac surgeon specialists in the United States. It is expected to randomize 388 patients in up to 40 clinical sites. The purpose of the study is to determine whether the C-Pulse System is a safe and effective treatment for heart failure patients who meet the following key study qualifications:

·                  NYHA Class III or early Class IV heart failure*;

·                  Ejection fraction < 35% (measure of how well the heart pumps blood);

·                  Taking appropriate heart failure medications as prescribed by doctor; and

·                  Have been evaluated for cardiac resynchronization therapy with or without defibrillation (CRT, CRT-D) or implantable cardioverter defibrillator (ICD) therapy.

*New York Heart Class (NYHA) Class III or early Class IV: Very limited in daily activities or unable to do activities without discomfort. Become tired, short of breath, and have heart palpitations during physical activity. Note: Other qualifications apply and study doctors will determine who is eligible for the study.

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. Combined, these potential benefits may help sustain the patient’s current condition or, in some cases, reverse the heart failure process, thereby potentially preventing the need for later-stage heart failure devices, such as left ventricular assist devices (LVADs), artificial hearts or transplants. It may also provide relief from the symptoms of Class III and ambulatory Class IV heart failure and improve quality of life and cardiac function. Based on the results from our feasibility study, we also believe that some patients treated with our C-Pulse System may be able to stop using the device due to sustained improvement in their conditions as a result of the therapy.

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

About Sunshine® Heart

Sunshine Heart, Inc. (Nasdaq:SSH) is an early-stage medical device company focused on developing, manufacturing and commercializing the C-Pulse System for treatment of Class III and ambulatory Class IV heart failure. Sunshine Heart has completed an approved U.S. Food and Drug Administration (FDA) feasibility clinical study 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 unconditional approval from the FDA in November 2012 to initiate its pivotal study. 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 wholly owned subsidiaries in Australia and Ireland. The Company has been listed on the NASDAQ Capital Market since February 2012.

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