Cytori Therapeutics Inc. (CYTX) said it has gotten approval from the Food and Drug Administration to sell what it calls the first device in the U.S. cleared for using a patient’s own fat for cosmetic purposes.

Shares rose 15.7% premarket to $7.50.

Cytori’s PureGraft system allows a patient’s own fat tissue to be prepared in approximately 15 minutes for re-injection for so-called aesthetic contouring. President Marc Hedrick said using a person’s own fat for grafting “can improve efficiencies in the operating room, decrease surgery time and, by being able to process greater volumes, to include large defects.”

The approval was done under the FDA’s abbreviated review process for devices that are judged similar to existing products. It is expected to become available in the U.S. this quarter, while approval from European regulators is anticipated by midyear.

Citing the American Society of Plastic Surgeons, Cytori said more than 46,000 fat-grafting procedures were done in the U.S. last year.

The company has been in the red as it continues to develop products, though it does have several items on the market now. Its stock through Thursday doubled since early October amid optimism about Cytori’s fat-grafting efforts.

-By Kevin Kingsbury, Dow Jones Newswires; 212-416-2354; kevin.kingsbury@dowjones.com

If you enjoyed this post then Subscribe to Savvy Investor via RSS