SOURCE: Sunshine Heart Inc.

Sunshine Heart Inc.

December 02, 2010 17:51 ET

Sunshine Heart Successfully Completes $9.5 Million Capital Raising With Close of Non-Renounceable Rights Offer

Cash to Continue Rapid Advance of Commercial and Regulatory Programs

SYDNEY, AUSTRALIA--(Marketwire - December 2, 2010) -  Sunshine Heart Inc. (ASX: SHC), a global medical device company focused on innovative technologies for moderate to severe heart failure, today announced the successful completion of its non-renounceable rights issue to existing shareholders, raising a total of A$9.5 million.

88 per cent of entitlements were taken up under the rights issue including the shortfall facility, leaving 44,761,462 shares unsubscribed.

The rights issue follows the Company's recent successful placement to US institutional investors raising A$3.7 million (announced 16 September 2010), bringing the total proceeds to A$13.2 million before deducting fees and expenses.

Majority Australian shareholders, GBS Venture Partners and CM Capital, both continued their strong support for the Company, taking up their full entitlements and also some of the shortfall, for an aggregate amount of $6.6 million

Sunshine Heart Chief Executive Officer Dave Rosa said, "We are delighted to have such strong support from existing shareholders and welcome new US institutional investors during this exciting and pivotal period for Sunshine Heart."

The capital will be used to fund the key activities of the Company. The most important of these is to advance the regulatory trials in the US by completing the current 20-patient feasibility trial and six-month patient follow up, then preparing the application for the larger FDA pivotal trial which is the precursor for marketing approval in the USA. The Company expects to have approval for this trial and to start implants during 2011.

The money will also be used to apply for CE Mark approval in 2011 which will allow the C-Pulse heart assist device to be marketed in Europe and parts of Asia.

The Company will continue its development of a new, single unit C-Pulse driver as well as introducing product changes to facilitate minimally invasive implant procedures.

The successful US placement was managed by specialist healthcare investment firm Summer Street Research Partners Inc. The non-renounceable rights issue was managed by RBS Morgans in Australia.

About Sunshine Heart Inc.
Sunshine Heart Inc. (ASX: SHC), a global medical device company focused on innovative technologies for the treatment of moderate heart failure, is commercializing the C-Pulse® Heart Assist System, a minimally invasive, implantable, non-blood contacting, heart assist therapy for the treatment of moderate heart failure. The C-Pulse System is designed to relieve the symptoms of heart failure through the use of counterpulsation technology which enables an increase in cardiac output, an increase in coronary blood flow and a reduction in the heart's pumping load. The Company has received approval from the US Food and Drug Administration (FDA) to conduct a 20-patient U.S. feasibility clinical trial with the C-Pulse System and the study has achieved eighty percent enrolment as of November 2010. Sunshine Heart, Inc. is a Delaware-based Corporation headquartered in Minneapolis with a subsidiary presence in Australia.

About the C-Pulse® Heart Assist System
The C-Pulse Heart Assist System uses proprietary balloon counterpulsation technology to increase the amount of blood pumped by the heart and to reduce the workload on the heart. The C-Pulse System is implanted in the patient's chest through a sternotomy or through a small incision when performed as a minimally invasively procedure. During the procedure, there is no need to place the patient on a heart-lung machine as the patient's heart remains beating continuously. 

Once implanted, the C-Pulse cuff is positioned on the outside of the patient's ascending aorta above the aortic valve. An ECG sense lead is then attached to the heart to determine timing for cuff inflation and deflation in synchronization with the heartbeat. The C-Pulse cuff and lead are connected to a single line that is run through the abdomen to connect to a power driver outside the body. Because the C-Pulse System remains outside the blood system, there is potentially less risk of blood clots and stroke in comparison to other mechanical devices, such as left ventricle assist devices (LVADs).

This press release contains forward-looking statements that are based on current management expectations. These statements may differ materially from actual future events or results due to certain risks and uncertainties from time to time in the Company's filings with the Australian Securities Exchange. The shares of Sunshine Heart have not been registered under the Securities Act of 1933 (US Securities Act) and may not be offered, sold or delivered in the United States, or to, or for the account or benefit of, any US Person, as such term is defined in Regulation S of the US Securities Act. In addition, hedging transactions with regard to the shares may not be conducted unless in accordance with the US Securities Act.

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