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): September 16, 2014
SUNSHINE HEART, INC.
(Exact Name of Registrant as Specified in its Charter)
Delaware (State or other jurisdiction of
incorporation) | | 001-35312 (Commission File No.) | | 68-0533453 (IRS 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 7.01 Regulation FD Disclosure.
On September 16, 2014, Sunshine Heart, Inc. (“Sunshine Heart” or the “Company”) announced that follow-up data from six patients implanted with the C-Pulse® Heart Assist System at St. Luke’s Hospital — Mid America Heart Institute, as part of a FDA approved, North American Feasibility Trial, will presented by Dr. Sanjeev Aggarwal, MD, Director of Mechanical Circulatory Support at Saint Luke’s Mid America Heart Institute. Prior to his clinical presentation at TCT Conference, Dr. Aggarwal will present these case studies and a COUNTER HF study update to the investment community at Sunshine Heart’s fourth annual analyst and investor breakfast that begins at 7:00am (EDT) at the Grand Hyatt Washington on September 16, 2014. Dr. Christopher Bowles, PhD, Royal Brompton and Harefield NHS Foundation Trust and Imperial College London, and Dr. William E. Cohn, MD, Texas Heart Institute, will also present at the breakfast. Following the event, the presentations will be available on the investor section of the Sunshine Heart website at http://ir.sunshineheart.com/index.cfm.
Limitation of Incorporation by Reference
In accordance with General Instruction B.2. of Form 8-K, this information including Exhibits 99.1, 99.2, 99.3 and 99.4, 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 9.01 Financial Statements and Exhibits.
Exhibit No. | | Description |
99.1 | | Press Release - Sunshine Heart to Provide Case Studies from North American Feasibility Trial and Updates on OPTIONS HF and COUNTER HF™ at 2014 Transcatheter Cardiovascular Therapeutics (TCT) Conference |
99.2 | | Presentation - Dr. Sanjeev Aggarwal, Director of Mechanical Circulatory Support at St. Luke’s Mid America Heart Institute |
99.3 | | Presentation - Christopher Bowles, PhD, Artificial Heart Specialist at Royal Brompton and Harefield NHS Foundation Trust & Imperial College London |
99.4 | | Presentation - Dr. William E. Cohn, Director of Minimally Invasive Surgical Technology at Texas Heart Institute at St. Luke’s Medical Center |
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.
Dated: September 16, 2014 | | SUNSHINE HEART, INC. |
| | |
| By: | /S/ JEFFREY S. MATHIESEN |
| Name: | Jeffrey S. Mathiesen |
| Title: | Chief Financial Officer |
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EXHIBIT INDEX
Exhibit No. | | Description |
99.1 | | Press Release - Sunshine Heart to Provide Clinical Updates from the North American Feasibility Study and OPTIONS HF European Post-Market Study at 2014 Transcatheter Cardiovascular Therapeutics (TCT) Conference |
99.2 | | Presentation - Dr. Sanjeev Aggarwal, Director of Mechanical Circulatory Support at St. Luke’s Mid America Heart Institute |
99.3 | | Presentation - Christopher Bowles, PhD, Artificial Heart Specialist at Royal Brompton and Harefield NHS Foundation Trust & Imperial College London |
99.4 | | Presentation - Dr. William E. Cohn, Director of Minimally Invasive Surgical Technology at Texas Heart Institute at St. Luke’s Medical Center |
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