Sunshine Heart to Appear on Bloomberg Television's Taking Stock
February 05 2014 - 5:15AM
Sunshine Heart, Inc. (Nasdaq:SSH) today announced that Chief
Executive Officer, Dave Rosa, will be featured on Bloomberg
Television's Taking Stock on Wednesday, February 5, 2014 at 5:00 pm
EST. Hosted by Bloomberg anchor Pimm Fox, Taking Stock is a daily
investment-focused program featuring conversations with leading
Wall Street analysts, fund managers and CEOs, offering insight into
company news, market and trading strategies across equities, fixed
income, commodities, and currencies. Following the segment, a link
to a recording of the program will be posted to the investor page
of Sunshine Heart's website at: http://ir.sunshineheart.com.
The segment will focus on Sunshine Heart's C-Pulse Heart Assist
System, an investigational device designed to treat clinical
symptoms associated with Class III and ambulatory Class IV heart
failure. The device is currently used in an ongoing U.S. randomized
controlled clinical trial, COUNTER HF™; as well as in a post-market
study throughout Europe, OPTIONS HF. Sunshine Heart received CE
Mark certification for its C-Pulse device in the EU in July of
2012. The device can be implanted via a minimally invasive
procedure or a full sternotomy. Operating outside the patient's
bloodstream, the extra-aortic approach of C-Pulse offers
significant potential safety advantages to existing therapies, as
well as greater flexibility, allowing patients to have intervals of
freedom to disconnect from the device. A fully implantable device
is currently under development, with a chronic animal trial
successfully completed with the device showing a comparable level
of support to the first generation C-Pulse system.
As previously announced, Sunshine Heart plans to release its
fourth quarter and full year 2013 audited results in early March of
2014.
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
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,
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, 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, 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: Investor:
Laura Forman
Blueprint Life Science Group
T: +1-415-375-3340
Jeff Mathiesen
Chief Financial Officer
Sunshine Heart, Inc.
T: +1-952-345-4200
Media:
David Schull
Russo Partners
T: +1-212-845-4271
Andreas Marathis
Russo Partners
T: +1-212-845-4235
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