Health & Fitness
Tue, August 10, 2010Mon, August 9, 2010Fri, August 6, 2010Thu, August 5, 2010Wed, August 4, 2010Tue, August 3, 2010Mon, August 2, 2010Fri, July 30, 2010Thu, July 29, 2010Wed, July 28, 2010Tue, July 27, 2010Mon, July 26, 2010Fri, July 23, 2010Thu, July 22, 2010Wed, July 21, 2010Tue, July 20, 2010Mon, July 19, 2010Cytoria?s PureGrafta" System Receives European Approval for Fat Grafting Procedures
Published in Health and Fitness on Thursday, July 29th 2010 at 5:12 GMT by Market Wire
SAN DIEGO--([ BUSINESS WIRE ])--Cytori Therapeutics (NASDAQ: CYTX) has received European (CE Mark) approval for the PureGrafta" 250/PURE System for autologous fat grafting procedures, allowing Cytori to immediately commercialize the PureGrafta" product line to physicians in Europe. PureGrafta" will be sold as both a standalone product and as a complement to Cytoria™s Celution® 800/CRS System in Europe.
"The addition of PureGrafta" to our product portfolio allows us to offer a broad spectrum of autologous fat grafting technologies in Europe. In addition to Celution® System, which enables cell-enriched fat grafting procedures, PureGrafta" fulfills the need for high quality, sterile tissue for fat grafting procedures, including body contouring"
The PureGrafta" System is an optimized tissue processing technology that is positioned at the forefront of the emerging fat grafting trend in the cosmetic and reconstructive surgery market. PureGrafta" replaces current non-standardized methods of graft preparation. Used independently, PureGrafta" rapidly and reliably produces optimal graft tissue for use in autologous fat grafting procedures. In combination with the Celution® 800/CRS, PureGrafta" lowers processing times and increases processing volumes, improving the utility and efficiency of Cytoria™s core product for soft tissue applications.
aThe addition of PureGrafta" to our product portfolio allows us to offer a broad spectrum of autologous fat grafting technologies in Europe. In addition to Celution® System, which enables cell-enriched fat grafting procedures, PureGrafta" fulfills the need for high quality, sterile tissue for fat grafting procedures, including body contouring,a said Eric Daniels, M.D., Cytoria™s Managing Director in Europe and the Middle East.
Cytori will immediately begin commercializing PureGrafta" in Europe, through a combination of direct sales and distributors. In addition to the 27 countries of the EU, the CE Mark is followed by eight other countries and facilitates additional registrations around the world.
The PureGrafta" System sets a new standard for fat graft processing with its membrane-based tissue filtration combined with speed, simplicity, safety and precision. The PureGrafta" technology takes only 15 minutes to purify a fat graft ranging from 50 to 250 mL, removing excess and unwanted fluid, lipid, blood cells and debris in a controllable manner. The consumable-based system, used within the sterile field, adialyzesa off everything but the purified fat tissue without centrifugation or other methods. The ease of use and simplicity of this innovative system sets it apart from other traditional fat grafting methods.
The PureGrafta" 250/PURE System received 510(k) marketing clearance for aesthetic body contouring from the U.S. FDA in January of this year. The product was formally launched at the meeting of the American Society of Aesthetic Plastic Surgeons in April 2010. In addition, Cytori received a Canadian medical device license for PureGrafta" in March 2010.
For more information, visit [ www.puregraft.com ].
About Cytori
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. [ www.cytori.com ]
Cautionary Statement Regarding Forward-Looking Statements
This communication includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including, but not limited to, those regarding the potential market for PureGrafta" in Europe, 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 the challenges inherent in convincing physicians and patients to adopt the new technology, creating and implementing a successful marketing and sales strategy, as well as our history of operating losses, regulatory uncertainties, dependence on third party performance, and other risks and uncertainties described under the "Risk Factors" in Cytori's Securities and Exchange Filings, including its annual report on Form 10-K for the year ended December 31, 2008. Cytori assumes no responsibility to update or revise any forward-looking statements contained in this press release to reflect events, trends or circumstances after the date of this press release.
