Sunshine Heart Announces Collaboration With Minnesota-Based Minnetronix For
Its C-Pulse(R) Fully Implantable System
EDEN PRAIRIE, Minn., Aug. 12, 2013 (GLOBE NEWSWIRE) -- Sunshine Heart, Inc.
(Nasdaq:SSH) announced today a collaboration with St. Paul-based Minnetronix®
for a transcutaneous energy transfer ("TET") system to power the Company's
fully-implantable C-Pulse device under development. Minnetronix is a leader in
med-device engineering, providing design and manufacturing support for many of
the world's largest medtech companies.
A TET system enables power transfer across the skin without direct electrical
connectivity utilizing time varying magnetic fields. TET is used to power
implanted devices, such as heart assist devices, artificial hearts and
electrical stimulators. The agreement leverages Minnetronix's existing TET
technology and includes milestone payments due to Minnetronix prior to U.S.
regulatory approval for the fully-implantable C-Pulse system.
"We are pleased to have entered into our second partnership with Minnetronix,"
said Dave Rosa, CEO of Sunshine Heart. "Currently, they are the supplier of
our second generation C-Pulse driver and we have been pleased with the
quality, responsiveness and service they have provided. We look forward to
closely partnering with them for our TET system for our fully implantable
"Minnetronix is very excited to collaborate with Sunshine Heart on their fully
implantable heart assist system," said Rich Nazarian, President and CEO of
Minnetronix. "Sunshine Heart's novel technology represents the next generation
in chronic circulatory support devices and holds great promise for less
invasive and more effective treatment of congestive heart failure."
Sunshine Heart initiated its COUNTER HF^™ U.S. pivotal trial for its C-Pulse
system earlier this year. As announced on August 7, 2013 in conjunction with
its second quarter earnings release, the Company intends to initiate animal
studies for its fully-implantable pump in the fourth quarter of this year. The
C-Pulse device is also in an ongoing OPTIONS HF European post-market study.
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
About Sunshine^® Heart
Sunshine Heart, Inc. (Nasdaq:SSH) is a 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 February2012.
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.
Blueprint Life Science Group
Chief Financial Officer
Sunshine Heart, Inc.
Sunshine Heart logo
Press spacebar to pause and continue. Press esc to stop.