FDA-Approved Device to Help Surgeons’ Efficiency, Cytori Says

San Diego-based regenerative medicine company Cytori Therapeutics Inc. said Jan. 8 that it received U.S. regulatory clearance to market its PureGraft system, a bedside device capable of removing, purifying and re-injecting a patient’s fat tissue in about 15 minutes.

Shares of Cytori, which have traded between $1.42 and $7.78 in the past 52 weeks, closed up 12 percent at $7.26 that day. The stock is listed under the symbol CYTX on Nasdaq.

Cytori, which has built a business out of tools used for harvesting adult stem cells, said the latest regulatory decision positions it as the only company with an FDA-approved device that can perform cosmetic body contouring procedures using a patient’s own fat.

The company said it will begin marketing PureGraft to plastic and reconstructive surgeons in the United States in the first quarter of the year. It said it will formally introduce the product in April at the American Society for Aesthetic Plastic Surgery’s annual meeting.

Dr. Marc Hedrick, Cytori’s president, who first discovered useful applications for adult stem cells harvested from leftover liposuction fat while at UCLA, said the product offers physicians improved efficiencies in the operating room and decreased surgery time.

More than 46,000 fat grafting procedures were performed in the U.S. in 2008, according to the most recent data by the American Society of Plastic Surgeons.

Cytori said it is also seeking European regulatory clearance to market the device overseas, with an answer anticipated in the first quarter.

By HEATHER CHAMBERS

January 18, 2010 San Diego Business Journal