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Sunshine Heart to Provide Summary of Initial OPTIONS HF Data and Additional Clinical Updates at 2013 Transcatheter



Sunshine Heart to Provide Summary of Initial OPTIONS HF Data and Additional
Clinical Updates at 2013 Transcatheter Cardiovascular Therapeutics Analyst
Event

EDEN PRAIRIE, Minn., Oct. 29, 2013 (GLOBE NEWSWIRE) -- Sunshine Heart, Inc.
(Nasdaq:SSH) announced today that the initial C-Pulse^® System patient data of
its ongoing OPTIONS HF EU trial, will be presented by Professor Thomas
Krabatsch, Director of Mechanical Circulatory Support at the German Heart
Institute, Berlin to the investment community at Sunshine Heart's third annual
analyst breakfast event, held this morning at 7:30 a.m. PDT at the W Hotel San
Francisco. As announced on October 22, 2013, the event also includes
presentations from Dr. Andrew Kao, Associate Professor of Medicine at the
University of Missouri-Kansas City; as well as Dr. William Cohn, Director of
Minimally Invasive Surgical Technology of Texas Heart Institute. Following the
event, the presentations and audio will be available on the investor section
of the Sunshine Heart website at: http://ir.sunshineheart.com/index.cfm.

Initiated in February, 2013, the OPTIONS HF study is a post-market,
multi-center, prospective, open label study that will include 50 patients in
up to ten European centers. The study is designed to observe clinical outcomes
of heart failure patients treated with the C-Pulse system concurrent with the
Company's COUNTER HF™ US pivotal trial. The primary endpoint is identical to
the COUNTER HF trial as it evaluates rate of re-hospitalization due to
worsening heart failure and heart failure related death.

On October 28^th, Professor Krabatsch, with cooperation from Dr. Holger Hotz
at Cardio Centrum Berlin, presented initial OPTIONS HF study data on patients
implanted at the German Heart Center, Berlin at the 2013 TCT conference as
part of Session III: LVAD's for "Less Sick Patients." Data presented included
15 cumulative days of C-Pulse therapy across five individual patients, four of
which remain on C-Pulse therapy. An additional two patients have been
implanted at other centers and are not included in this presentation. As
presented by Dr. Krabatsch, the four patients on C-Pulse therapy range from 51
to 63 years of age, and include three patients classified as NYHA Class III
and one classified as NYHA ambulatory Class IV. All four patients are
currently at home with the device. Early results indicate that surgical
implantation without cardiopulmonary bypass was successful in all patients
with no reports of stroke, myocardial infarction, major bleeding or infection
(exit site or otherwise) due to the device.  In addition, there have been no
re-hospitalizations due to worsening heart failure or heart failure related
death, which is the primary endpoint in the U.S. COUNTER HF trial. High
compliance ( > 90%) has been reported thus far, with patients disconnecting
only for battery charge or showering. In addition, patients and physicians
report high satisfaction with the device. Dr. Krabatsch also summarized
results from two specific trial patients, presented earlier this year at ESAIO
in Scotland on September 13, 2013. Data included encouraging improvement
across both patients within left and right ventricle ejection fraction, and
one patient reported improving from NYHA Class III heart failure at baseline
to NYHA Class II after just six weeks on the device. The same patient reported
a 74% increase in observed six minute walk score at six weeks, improving to
418m from 240m at baseline. Further information will be available during the
Company's third quarter earnings call on November 11^th at 9:00 a.m. EST.

Dr. Kao's presentation provides data from a single center, St. Luke's Mid
America Heart Institute. The Company had previously announced that two
patients from the U.S. North American Feasibility study had been fully weaned
from the device. Dr. Kao's presentation profiles three additional patients
implanted with the C-Pulse device from the feasibility trial as well. Two of
the patients have now been successfully weaned from the device following
significant improvements in both heart failure NYHA classification, ejection
fractions, and heart failure related symptoms; while a third patient is in the
process of being weaned. Patient profiles include C-Pulse usage and key heart
failure metrics along the progression of treatment, as well as individual
lessons learned from each patient. The Company will not allow weaning in the
U.S. COUNTER HF trial to prevent any impact on the clinical results. 

Dr. William Cohn's presentation unveils the most recent advancements in the
developing C-Pulse fully-implantable system, including system design,
capabilities and upcoming test plans. The device will be non-blood contacting
and non-obligatory, providing the patient with active inflation without the
necessity for an implanted battery. In addition, the system will also
eliminate the exit site, as well as percutaneous lead and associated infection
risks.

Sunshine Heart will release its third quarter operating results and clinical
trial update before the market open on November 11, 2013. Subsequent to the
quarterly release, the Company will host a conference call at 9:00 a.m. EST.

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. 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 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 European Union 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: Media:
         Laura Forman
         Blueprint Life Science Group
         T: +1-415-375-3340
        
         Investor:
         Jeff Mathiesen
         Chief Financial Officer
         Sunshine Heart, Inc.
         T: +1-952-345-4200

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