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Sunshine Heart, Inc. Announces First Patient Implanted in C-Pulse System European Post-Market Study

Sunshine Heart, Inc. Announces First Patient Implanted in C-Pulse System 
European Post-Market Study 
EDEN PRAIRIE, MN -- (Marketwired) -- 05/09/13 --  Sunshine Heart,
Inc. (NASDAQ: SSH) announced today the implant of the first patient
in the OPTIONS HF C-Pulse System Multicenter Study. The post market
study is intended to treat patients with moderate to severe heart
failure.  
The patient was implanted on May 7, 2013 at the German Heart
Institute - Berlin (DHZB), a leading international hospital dedicated
to the treatment of cardiovascular and thoracic diseases. In
particular, DHZB is focused on implantation of mechanical circulatory
support systems and for heart and lung transplantation. The procedure
was completed by Professor Roland Hetzer, Chairman of the Department
of Cardiothoracic and Vascular Surgery in cooperation with Dr. Holger
Hotz of Cardio Centrum Berlin. The implant utilized Sunshine Heart's
enhanced cuff, which is pre-sutured and pre-marked providing ease of
use for implanting surgeons.  
"We are extremely pleased to announce the implant of the first
patient at the German Heart Institute - Berlin in our European
multicenter post market study," said Dave Rosa, Sunshine Heart's
Chief Executive Officer. "In particular, we are encouraged to see
early success of our next generation cuff in its ability to improve
the ease of implant and allow for better predictability of proper
securement. We anticipate the activation of additional sites in the
coming months and look forward to updating the market with our
progress as enrollment proceeds." 
The World Heart Failure Society estimates that heart failure affects
over 16 million Europeans of all ages and is responsible for more
hospitalizations than all forms of cancer combined. The OPTIONS HF
study is structured to enroll a total of 50 patients with moderate to
severe heart failure at ten European centers. This study is designed
to provide additional clinical data to assist in publications and
reimbursement. The data being collected is similar to that which is
being collected in the U.S. pivotal trial.  
About the C-Pulse(R) 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
counterpulsation 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 trial, we also believe that some
patients treated with our C-Pulse System will 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(R) 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 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 unconditional approval
from the FDA in November 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 wholly owned subsidiary in Australia. The Company
has been listed on the NASDAQ Capital Market since February 2012.  
Forward-Looking Statements 
 Certain statements in this release are
forward-looking statements that are based on management's beliefs,
assumptions and 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 the net proceeds from the offering,
future clinical trial activities and results including patient
enrollment in trials. These forward-looking statements are subject to
numerous risks and uncertainties, including, without limitation, that
the net proceeds may be lower than we currently expect due to
increased offering expenses or otherwise, the possibility that our
clinical trials do not meet their enrollment goals, meet their
end-points 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 SEC. 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. 
For further information, please contact:  
Media: 
Laura Forman 
Blueprint Life Science Group 
T: +1-415-375-3340  
Investor: 
Jeff Mathiesen
Chief Financial Officer
Sunshine Heart, Inc.
T: +1-952-345-4200 
 
 
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