Healthcare Industry News: Boston Scientific
News Release - June 16, 2014
Sunshine Heart Appoints Brian Brown as Senior Vice President of Operations and TechnologyEDEN PRAIRIE, Minn., June 16, 2014 -- (Healthcare Sales & Marketing Network) -- Sunshine Heart, Inc. (SSH) today announced the appointment of Brian Brown to the position of Senior Vice President of Operations and Technology. In this capacity, Mr. Brown will manage the Company's R & D program for its flagship C-Pulse(R) Heart Assist System, a medical device addressing Class III and ambulatory Class IV heart failure. Additionally, Mr. Brown will be responsible for operations inclusive of internal and contracted manufacturing.
Mr. Brown comes to Sunshine Heart after serving as R & D, Vice President Cardiovascular at Boston Scientific for the past 10 years. Prior to joining Boston Scientific in 1994, he held multiple engineering and managerial roles at SciMED Life Systems Inc., a developer and marketer of medical devices used principally to treat cardiovascular disease which was acquired by Boston Scientific.
"Brian brings a broad range of experiences covering all aspects of transforming new technologies into marketable products. His specific role in leading the technology transition from an early stage development company to one of the largest cardiovascular device corporations in the world is extremely valuable to an emerging company such as Sunshine Heart," said Dave Rosa, Chief Executive Officer of Sunshine Heart.
Mr. Brown has spent 24 years in the medical device industry including senior managerial roles at Boston Scientific where he most recently held the position of R & D, Vice President, Cardiovascular from 2004-2014, and SciMED Life Systems which was acquired by Boston Scientific in 1994. Boston Scientific is an international, publicly traded company headquartered in Boston, MA focused on the design, manufacture, and sale of minimally invasive medical devices in the areas of disposable devices (single use), permanent implants, and combination drug devices. The Interventional Cardiology business unit represents a $2B division of the company's greater than $7B of annual revenue. As R & D, VP of Cardiovascular, Brian directed the multisite worldwide research and development activities for the accelerated multi-billion dollar launches of implantable stents, drug delivery technologies, disposable catheters and adjunctive devices. Mandates typically evolved from early exploratory work, to technology development projects, to product commercialization, followed by line extensions or sustaining activities. Brian holds a Bachelor of Science, Mechanical Engineering with an emphasis on electro -mechanical automation from North Dakota State University.
About the C-Pulse(R) 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 study, 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 conditions as a result of the therapy.
Caution: Investigational device, limited by Federal (or United States) Law to Investigational use.
About Sunshine(R) Heart
Sunshine Heart, Inc. (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.
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.
Source: Sunshine Heart
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