Healthcare Industry News: Cytori Therapeutics
News Release - July 29, 2010
Cytori's PureGraft System Receives European Approval for Fat Grafting ProceduresSAN DIEGO--(HSMN NewsFeed)--Cytori Therapeutics (NASDAQ: CYTX ) has received European (CE Mark) approval for the PureGraft™ 250/PURE System for autologous fat grafting procedures, allowing Cytori to immediately commercialize the PureGraft™ product line to physicians in Europe. PureGraft™ will be sold as both a standalone product and as a complement to Cytori’s Celution® 800/CRS System in Europe.
The PureGraft™ 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. PureGraft™ replaces current non-standardized methods of graft preparation. Used independently, PureGraft™ rapidly and reliably produces optimal graft tissue for use in autologous fat grafting procedures. In combination with the Celution® 800/CRS, PureGraft™ lowers processing times and increases processing volumes, improving the utility and efficiency of Cytori’s core product for soft tissue applications.
“The addition of PureGraft™ 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, PureGraft™ fulfills the need for high quality, sterile tissue for fat grafting procedures, including body contouring,” said Eric Daniels, M.D., Cytori’s Managing Director in Europe and the Middle East.
Cytori will immediately begin commercializing PureGraft™ 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 PureGraft™ System sets a new standard for fat graft processing with its membrane-based tissue filtration combined with speed, simplicity, safety and precision. The PureGraft™ 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, “dialyzes” 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 PureGraft™ 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 PureGraft™ in March 2010.
For more information, visit www.puregraft.com.
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 PureGraft™ 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.
Source: Cytori Therapeutics
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