Sunshine Heart's C-Pulse Device Reaches Treatment Milestone for Heart Failure

Sunshine Heart's C-Pulse Device Reaches Treatment Milestone for Heart Failure

25 Patient-Years of Cumulative Utilization Across 25 Patients

EDEN PRAIRIE, Minn., June 18, 2013 (GLOBE NEWSWIRE) -- Sunshine Heart, Inc.
(Nasdaq:SSH) today announced a major milestone for its flagship C-Pulse
device. As of today, C-Pulse has been implanted in 25 patients in North
America and Germany, representing a cumulative 25 years of active C-Pulse
heart failure treatment, or over one billion inflation and deflation cycles.
The 25^th patient was implanted on June 14, 2013 at German Heart Institute –
Berlin (DHZB).

Of particular note, throughout decades of treatment, C-Pulse has never
recorded a neurologic event associated with the device, most commonly defined
as a stroke or transient ischemic attack (TIA). This neurological safety
profile represents a potential unique advantage of C-Pulse as the device does
not contact the blood stream nor require blood thinning agents. To date, no
other known cardiovascular blood contacting mechanical support devices have
shown these results in a published pilot or pivotal clinical trial.

The Company has recently reported an additional two patients have been
targeted for weaning from the technology in addition to two previously weaned
patients that were permanently disconnected from the device based upon
improvement in their heart failure symptoms.

C-Pulse is designed to treat Class III and ambulatory Class IV heart failure.
The device utilizes proven balloon counterpulsation technology to assist the
heart by reducing the workload of the left ventricle. The device may be
implanted via a minimally invasive surgical procedure, which is generally
performed in an hour. A pre-sutured cuff is placed around the ascending aorta,
outside the patient's bloodstream. This strategic placement of the device is a
likely contributor to the neurologic safety profile relative to competitive
devices, reducing the risk of stroke incidence and blood clotting. Additional
advantages of the device include a durable cuff, with zero cuff failures being
recorded in the North American feasibility and European post-market trials; as
well as the ability of patients to seamlessly disconnect (and re-connect) from
the device based on symptom improvement, further enhancing patients' quality
of life.

C-Pulse is currently being evaluated in a U.S. pivotal trial, COUNTER HF,
which will enroll a total of 388 patients. Two sites have been activated in
this trial with ten additional sites in the activation process. A European
post-market study of the device is also underway in Europe, which will include
50 patients based on a similar trial design. One site is currently activated
with two patients already implanted and three additional sites are now capable
of enrolling. C-Pulse achieved CE Mark certification in July, 2012 based upon
the results of its U.S. feasibility study, which concluded in 2011.

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
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 condition 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 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 November2012 to
initiate its pivotal trial. In July2012 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
February2012.

Forward-Looking Statements

Certain statements in this release 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 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 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 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.

CONTACT: 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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