Cytori Completes IDE Filing for Chronic Myocardial Ischemia ATHENA Trial of the Celution(R) System
(firmenpresse) - SAN DIEGO, CA -- (Marketwire) -- 12/19/11 -- Cytori Therapeutics (NASDAQ: CYTX) filed its Investigational Device Exemption (IDE) application to begin a clinical trial of the Company's Celution® System for chronic myocardial ischemia (CMI).
ATHENA is a device-based safety and feasibility trial (Phase I/II) to investigate the use of autologous, clinical-grade adipose tissue-derived stem and regenerative cells (ADRCs), processed at the point-of-care with Cytori's proprietary Celution® System. The submission initiates a review process with the FDA before approval is granted to begin the trial.
Previously, Cytori reported six and 18 month trial data from PRECISE, a European clinical trial for this same indication showing statistically significant improvement in cardiac functional capacity, which was incorporated into the US IDE filing. In addition, Cytori has applied to expand its Celution® System CE Mark to include no-option CMI claims in Europe based on this data. Cytori is also enrolling a European pivotal trial using the Celution® System for acute heart attacks.
No-option CMI is estimated to affect approximately 6% of all coronary heart disease patients worldwide. In the U.S., more than one million patients are in this class with an annual cost of more than $10 billion. CMI patients typically have undergone multiple revascularization procedures, may suffer from serious abnormal heart rhythms, and have few therapeutic options. One goal of cell therapy in CMI is to revive hibernating heart muscle, which is living tissue that is not contributing to the pumping action of the heart.
Cytori is a leader in providing patients and physicians around the world with medical technologies that harness the potential of adult regenerative cells from adipose tissue. The Celution® System family of medical devices and instruments is being sold into the European and Asian cosmetic and reconstructive surgery markets but is not yet available in the United States. Our StemSource® product line is sold globally for cell banking and research applications. Our PureGraft® products are available in North America and Europe for fat grafting procedures.
This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position, such as the successful initiation of an FDA review process to initiate a clinical trial of the Company's Celution® System for chronic myocardial ischemia, our efforts to expand our CE Mark, and our efforts to successfully revive hibernating heart muscle tissue. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks include clinical and regulatory uncertainties, such as those associated with the ATHENA clinical trial, including risks in the collection and results of clinical data, final clinical outcomes, dependence on third party performance, and other risks and uncertainties described under the "Risk Factors" in Cytori's Securities and Exchange Commission Filings. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.
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Tom Baker
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Megan McCormick
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Datum: 19.12.2011 - 07:00 Uhr
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