Cytori Therapeutics (CYTX) said that the FDA has granted the company 510(k) marketing clearance for its PureGraft System. Cytori will now launch the first and only device in the United States cleared for aesthetic body contouring using autologous fat. PureGraft allows a patient's own fat tissue to rapidly be prepared in about 15 minutes for re-injection back into the same patient for aesthetic contouring. PureGraft is able to prepare both small and large volumes of fat grafting tissue ranging from 50 mL to 250 mL.
PureGraft will be sold in the United States directly by Cytori as well as through select distribution partners on a non-exclusive basis. The product will be available in the first quarter of 2010 and will be formally launched at the American Society of Aesthetic Plastic Surgeons in May 2010.
Cytori is also seeking marketing approval (CE Mark certification) for PureGraft in Europe, which is expected in the first half of 2010. In Europe, PureGraft, in addition to being sold as a standalone product, will be used to complement Cytori's currently available autologous tissue processing system as a means to expand the potential number of clinical applications.
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