Sunshine Heart Receives FDA Approval for Interim Analysis of U.S. Pivotal Trial of C-Pulse(R) Heart Assist System
February 25 2015 - 4:30AM
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
CHF Solutions (NASDAQ:CHFS)
Historical Stock Chart
From Apr 2024 to May 2024
CHF Solutions (NASDAQ:CHFS)
Historical Stock Chart
From May 2023 to May 2024