Sunshine Heart Initiates Animal Study on Applicability of C-Pulse Technology in the Treatment of Pulmonary Arterial Hypertens...
September 21 2015 - 8:46PM
Sunshine Heart, Inc. (Nasdaq:SSH) announced today the commencement
of a collaborative effort with Dr. Mark Slaughter and the
University of Louisville to study the impact of the C-Pulse
technology on the pulmonary circulation and right heart,
specifically in the field of pulmonary hypertension and heart
failure.
Pulmonary arterial hypertension (PAH) is a debilitating
condition characterized by progressive increases in pulmonary
vascular resistance and loss of elasticity of the pulmonary artery
and large vessels. Patients with PAH suffer from poor quality of
life, shortness of breath and greatly reduced functional capacity
leading to right ventricular dysfunction and ultimately, right
heart failure. PAH afflicts approximately 200,000 patients
worldwide and places a significant burden on the healthcare system,
with limited treatment options available and 5 year survival rates
as low as 34%1. PAH and right heart failure are also commonly
associated with left heart failure. Approximately 50% of patients
with systolic heart failure or preserved ejection fraction heart
failure (HFpEF) have PAH with similar 5 year outcomes2. PAH and
right heart failure also continue to remain a significant risk in
the left ventricular assist device patient population3.These
studies hope to provide scientific rationale for a new application
of current C-Pulse therapy by leveraging the existing technology to
apply counterpulsation to the pulmonary artery in acute and chronic
animal preparations. Biochemical, neurohormonal and pressure-volume
data will be used to assess the effects of C-Pulse on pulmonary
circulation and right and left heart properties. A fully
implantable system may provide therapeutic options in HFpEF
population with PAH where there are currently no approved
treatments.
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 counter-pulsation 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 study, we also believe that some patients
treated with our C-Pulse System may 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.
1. D'Alonzo, GE et al. Ann Int Med
115: 342-349, 1991 2. Miller WL et al. JACC HF 1(4): 290-299, 2013;
Guazzi M. Circ. Heart Fail. 7: 367-377, 2014 3. MacGowan, GA and
Schueler, S. Curr Opin Cardiol 27(3); 296-300. 2012
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 study 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 study. 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 wholly owned subsidiaries in
Australia and Ireland. 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, our
expectations with respect to future clinical study activities and
results including patient enrollment in studies. These
forward-looking statements are subject to numerous risks and
uncertainties, including, without limitation, the possibility that
our clinical studies 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
Securities and Exchange Commission. 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:
Investor:
Candice Knoll
Blueprint Life Science Group
T: +1-415-375-3340 Ext. 4
Claudia Drayton
Chief Financial Officer
Sunshine Heart, Inc.
T: +1-952-345-4200
Media:
David Schull
Russo Partners
T: +1-212-845-4271
Christopher Hippolyte
Russo Partners
T: + 1-646-942-5634
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