Cytori gets FDA approval for PureGraft system
SAN DIEGO_Cytori Therapeutics Inc. said Friday it received approval to sell its PureGraft system, which can remove fat tissue from a patient and prepare it for re-injection in about 15 minutes.
Cytori said PureGraft is the only Food and Drug Administration-approved device that can perform cosmetic "body contouring" procedures using a patient's own fat. It will start marketing PureGraft in the first quarter of this year, with a formal launch scheduled for May at the American Society of Aesthetic Plastic Surgeons.
PureGraft is designed to quickly remove anesthetics, lipids, and medical fluids from fat that has been removed by liposuction. That makes it easier to reuse the fat and measure it before it is re-injected. Cytori Chief Financial Officer Mark Saad said the system should make the procedures less expensive as well.
He said there hasn't been a single product that removes and purifies fat like PureGraft does. Instead, surgeons have had to do the work manually or use multiple products.
The San Diego company said the system can be used for small and large volumes of fat. The company said more than 46,000 fat regrafting procedures were performed in the U.S. in 2008. Cytori has also applied for marketing approval in the European Union, and said it expects to gain it in the first half of this year.
In morning trading, shares of Cytori Therapeutics rose $1.17, or 18.1 percent, to $7.65. The stock set an annual high of $7.78.