Cytori Therapeutics (CYTX) said the FDA approved its aesthetic body contouring device - PureGraft. The product will be available in the first quarter, but will be formally launched in May this year at the American Society of Aesthetic Plastic Surgeons, which estimates that over 46,000 fat grafting procedures were performed in the U.S. in 2008.
The device allows a patient's own fat tissue to be rapidly prepared in about 15 minutes for re-injection back into the same patient for aesthetic contouring and allows for cleaner grafting of the fat in less time than traditional methods.
The PureGraft will be sold in the U.S. directly by the company, as well as through select distribution partners on a non-exclusive basis.
Cytori is also seeking marketing approval for PureGraft in Europe, which is expected in the first half of 2010. In Europe, PureGraft will be sold as a standalone product as well as to complement Cytori's currently available autologous tissue processing system, the company noted.
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