Sunshine Heart Receives FDA Approval for Interim Analysis of U.S. Pivotal Trial of C-Pulse(R) Heart Assist System
(Thomson Reuters ONE) -
EDEN PRAIRIE, Minn., Feb. 25, 2015 (GLOBE NEWSWIRE) -- Sunshine Heart, Inc.
(Nasdaq:SSH) today announced it has received unconditional approval from the FDA
to conduct an interim analysis of COUNTER HF, the Company's U.S. pivotal study.
The COUNTER HF study is a prospective, randomized, multi-center, controlled
study that evaluates the safety and efficacy of the C-Pulse system for the
treatment of NYHA Class III and ambulatory Class IV heart failure. Integral to
the COUNTER HF study is the assessment of C-Pulse's unique balloon
counterpulsation treatment designed to improve heart function and reduce re-
hospitalizations due to worsening heart failure.
"Today's announcement is a significant achievement for the company as it offers
the potential to dramatically reduce the development timeline for this important
solution for heart failure. The FDA decision to approve this interim analysis is
not only unconditional but also arrives earlier than the originally anticipated
timeframe of end Q1 2015. We are grateful for the FDA's rapid response to our
submission and look forward to working with the Agency through the balance of
the COUNTER HF study and on the development of the next generation, fully
implantable C-Pulse system," commented Dave Rosa, President and Chief Executive
Officer of Sunshine Heart.
A key potential benefit of conducting the analysis is the prospect of reducing
the overall duration of the study should COUNTER HF meet the higher statistical
threshold of the interim analysis. The study is a prospective, randomized,
multi-center clinical trial. It is being conducted by heart failure and cardiac
surgeon specialists in the United States. It is expected to randomize 388
patients in up to 40 clinical sites. The purpose of the study is to determine
whether the C-Pulse System is a safe and effective treatment for heart failure
patients who meet the following key study qualifications:
* NYHA Class III or early Class IV heart failure*;
* Ejection fraction < / = 35% (measure of how well the heart pumps blood);
* Taking appropriate heart failure medications as prescribed by doctor; and
* Have been evaluated for cardiac resynchronization therapy with or without
defibrillation (CRT, CRT-D) or implantable cardioverter defibrillator (ICD)
therapy.
*New York Heart Class (NYHA) Class III or early Class IV: Very limited in daily
activities or unable to do activities without discomfort. Become tired, short of
breath, and have heart palpitations during physical activity. Note: Other
qualifications apply and study doctors will determine who is eligible for the
study.
Individuals who are interested in learning more about the trial and if they
might qualify for the study can visit www.HFClinicalStudy.com or call
1-888-978-8391.
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.
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 U.S. 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. 105
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
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Sunshine Heart, Inc. via GlobeNewswire
[HUG#1897015]
Unternehmensinformation / Kurzprofil:
Datum: 25.02.2015 - 11:30 Uhr
Sprache: Deutsch
News-ID 374024
Anzahl Zeichen: 8546
contact information:
Town:
Minnesota
Kategorie:
Business News
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