Healthcare Industry News: Cytori Therapeutics
News Release - December 12, 2007
Cytori Therapeutics Receives FDA 510(k) Clearance for the Cytori Fat Transfer SystemSAN DIEGO--(HSMN NewsFeed)--Cytori Therapeutics (NASDAQ:CYTX ) received 510(k) regulatory clearance from the Food and Drug Administration's Center for Devices and Radiological Health (CDRH) for the Cytori Autologous Fat Transfer (AFT) System. This system may be used to harvest, filter, and transfer a patient’s own adipose (fat) tissue from one part of a patient’s body to another at the point-of-care in the same surgical procedure.
“This is an important regulatory clearance toward a more comprehensive adipose tissue processing system,” said Christopher J. Calhoun, chief executive officer of Cytori. “The key attribute of this device is its ability to optimize the preparation of adipose tissue before it is transferred back into the patient.”
The Cytori AFT System is intended for use in the following surgical specialties when the aspiration of soft tissue is desired: plastic and reconstructive surgery, general surgery, neurosurgery, gastrointestinal surgery, urological surgery, orthopedic surgery, gynecological surgery, thoracic surgery and laparoscopic surgery.
Cytori Therapeutics’ (NASDAQ:CYTX ) goal is to be the global leader in regenerative medicine. The company is dedicated to providing patients with new options for reconstructive surgery, developing treatments for cardiovascular disease, and banking patients’ adult stem and regenerative cells. To reach its goal, Cytori is developing its innovative Celution™ System to separate and concentrate a patient’s own adult stem and regenerative cells from adipose (fat) tissue for these cells to be delivered back to the patient during the same surgical procedure. The Celution™ System will be introduced in 2008 in Europe for reconstructive surgery and launched in Japan for cryopreserving a patient’s own stem and regenerative cells. Clinical trials are ongoing or planned in cardiovascular disease, spinal disc degeneration, gastrointestinal disorders, and other unmet medical needs. 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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