Healthcare Industry News: Cytori Therapeutics
News Release - November 1, 2007
Cytori Receives European Approval for 2nd Generation Celution(TM) Stem & Regenerative Cell Processing SystemSAN DIEGO--(HSMN NewsFeed)--Cytori Therapeutics, Inc. (NASDAQ:CYTX ) received European approval - CE Mark - for the second generation Celution™ stem and regenerative cell processing system. The Celution™ System is the only device approved in Europe to extract and concentrate a patient’s own stem and regenerative cells from within fat tissue in order to be delivered back to the same patient in the same procedure. Fat tissue, known medically as adipose, is a rich, accessible, and non-embryonic source of stem and regenerative cells.
“With this approval, Cytori can begin targeted commercial introduction of the Celution™ System next year to select reconstructive surgeons in Europe,” said Christopher J. Calhoun, chief executive officer, Cytori Therapeutics. “In parallel, we will conduct our planned post-market studies of the Celution™ System for use in breast cancer reconstruction in order to drive market adoption and reimbursement.”
The Celution™ System was evaluated in an 11-patient investigator-initiated safety and feasibility study, designated as RESTORE I, conducted in Japan. This study investigated adipose-derived stem and regenerative cells extracted and processed with the Celution™ System to treat the complications of surgery and radiation damage following partial mastectomy for the treatment of breast cancer. Study results will be presented at the San Antonio Breast Cancer Symposium on December 15, 2007.
Based on preliminary results, Cytori is planning two clinical studies, designated as the RESTORE II and VENUS studies, which will further evaluate the use of adipose-derived stem and regenerative cells in breast reconstruction following partial mastectomy for the purpose of offering optimal reimbursement in Europe. RESTORE II will evaluate up to 70 patients at multiple European trial sites. VENUS will be a 20 patient single center study, adjunct to RESTORE II, in patients with more severe radiation damage and contour defects resulting from a partial mastectomy.
Adipose-derived stem and regenerative cells extracted with the Celution™ System are currently being investigated in Europe for the treatment of heart disease. A 36 patient clinical trial in chronic ischemia patients is underway and a 48 patient clinical trial in heart attack patients is planned to begin shortly.
Cytori Therapeutics is a global leader in the development of regenerative medicine products. The company is developing therapeutic applications for its Celution™ System to enable real-time regenerative cell therapy in conjunction with breast reconstruction surgery, cardiovascular disease, and other large unmet medical needs. The Company's StemSource™ Cell Bank, which is based on Cytori's innovative Celution™ System, will be commercialized in Japan starting in 2008 to hospitals and clinics to enable regenerative cell banking. www.cytoritx.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding events, trends and prospects of our business, which may affect our future operating results and financial position. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include our history of operating losses, the need for further financing, regulatory uncertainties, dependence on performance of third parties, and other risks and uncertainties described (under the heading "Risk Factors") in Cytori Therapeutics' Form 10-K annual report for the year ended December 31, 2006. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.
Source: Cytori Therapeutics
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