Sunshine Heart Receives 2012 Frost & Sullivan North American HeartFailure Treatment New Product Innovation Award for C-Pulse(R)
EDEN PRAIRIE, MN and SYDNEY, AUSTRALIA, Oct 23, 2012 (Menafn - MARKETWIRE via COMTEX) --Sunshine Heart, Inc. SSH (asx:SHC), a global medicaldevice company focused on innovative technologies for moderate heartfailure, today announced it has received the 2012 North AmericanHeart Failure Treatment New Product Innovation Award. This awardhighlights the innovation and potential value of Sunshine Heart'sflagship C-Pulse(R) Heart Assist System.
"Capable of delivering treatment without contact of blood, theimplantable C-Pulse Heart Assist system represents a truly novelapproach into the treatment paradigm for heart failure patients,"said Venkat Rajan, Industry Manager for Medical Devices at Frost &Sullivan.
Frost & Sullivan's "New Product Innovation Award" is presentedannually to the company that has demonstrated excellence in thefollowing categories: innovative element of the product, value addedfeatures/benefits, increased customer ROI and customeracquisition/penetration potential. Frost & Sullivan Best PracticesAwards recognize companies in a variety of regional and globalmarkets for demonstrating outstanding achievement and superiorperformance in areas such as leadership, technological innovation,customer service, and strategic product development. Industryanalysts compare market participants and measure performance throughin-depth interviews, analysis, and extensive secondary research inorder to identify best practices in the industry.
"We are honored to be recognized by Frost & Sullivan for ourinnovative progress toward the treatment of moderate to severe heartfailure," said Jim Yearick, Vice President of Marketing & Sales ofSunshine Heart. "As we continue to make great strides in thedevelopment and enhancement of our C-Pulse(R) system, we aim to bethe first effective treatment specific to Class III and ambulatoryClass IV heart failure. With our U.S. investigational device pivotaltrial on the immediate horizon, and having achieved CE Mark inAugust, we feel we are well on our way to addressing this key segmentof the heart failure population."
About Frost & Sullivan
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About the C-Pulse(R) Heart Assist System The C-Pulse Heart AssistSystem, or C-Pulse System, an investigational device in the UnitedStates, Canada and countries that do not recognize the CE markapproval, utilizes the scientific principles of intra-aortic ballooncounter-pulsation applied in an extra-aortic approach to assist theleft ventricle by reducing the workload required to pump bloodthroughout the body, while increasing blood flow to the coronaryarteries. Operating outside the patient's bloodstream, theextra-aortic approach of the C-Pulse technology offers greaterflexibility, allowing patients to safely disconnect to have intervalsof freedom to perform certain activities such as showering. TheC-Pulse System may help maintain the patient's current condition and,in some cases, reverse the heart failure process, thereby potentiallypreventing the need for later stage heart failure therapies, such asleft ventricular assist devices (LVADs), artificial hearts ortransplants.
Caution: Investigational device, limited by Federal (or UnitedStates) Law to Investigational use.
About Sunshine(R) Heart Sunshine Heart, Inc. SSH (asx:SHC) is an early-stage global medical device company committed to thecommercialization of the C-Pulse Heart Assist System, an implantable,non-blood contacting, heart assist therapy for the treatment ofmoderate to severe heart failure. The C-Pulse System can be implantedusing a minimally invasive procedure and is designed to relieve thesymptoms of heart failure through the use of counter-pulsationtechnology, which enables an increase in cardiac output, an increasein coronary blood flow and a reduction in the heart's pumping load.Sunshine Heart has completed an approved U.S. Food and DrugAdministration (FDA) feasibility clinical trial of the C-Pulse Systemand presented the results in November 2011. In March, 2012, the FDAnotified the company that it could move forward with aninvestigational device exemption (IDE) application. Sunshine Heartreceived conditional approval from the FDA in September 2012 toinitiate its pivotal trial. In July 2012 Sunshine Heart received CEMark for its C-Pulse System in Europe. Sunshine Heart is a Delawarecorporation headquartered in Minneapolis with a subsidiary presencein Australia. The company has been listed on the ASX since September2004 and on the NASDAQ since February 2012. For more information,please visit www.sunshineheart.com.
Forward-Looking Statements Certain statements in this report areforward-looking statements that are based on management's beliefs,assumptions and expectations and information currently available tomanagement. All statements that address future operating performance,events or developments that we expect or anticipate will occur in thefuture are forward-looking statements, including without limitation,our expectations with respect to product development,commercialization efforts and future clinical trial activities andresults. These forward-looking statements are subject to numerousrisks and uncertainties, including without limitation, thepossibility that our clinical trials do not meet their end-points orotherwise fail, that regulatory authorities do not accept ourapplication or approve the marketing of the C-Pulse Heart System, thepossibility we may be unable to raise the funds necessary for thedevelopment and commercialization of our products, that we may not beable to commercialize our products successfully in the EU and theother risk factors described under the caption "Risk Factors" andelsewhere in our filings with the U.S. Securities and ExchangeCommission (SEC) and ASX. You should not place undue reliance onforward-looking statements because they speak only as of the datewhen made and may turn out to be inaccurate. We do not assume anyobligation to publicly update or revise any forward-lookingstatements, whether as a result of new information, future events orotherwise. We may not actually achieve the plans, projections orexpectations disclosed in forward-looking statements, and actualresults, developments or events could differ materially from thosedisclosed in the forward-looking statements.
For further information, please contact:
Media:
Laura Landry
Blueprint Life Science Group
T: 1-415-375-3340
Investor:
Jeff Mathiesen
Chief Financial Officer
Sunshine Heart, Inc.
T: 1-952-345-4200
SOURCE: Sunshine Heart
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