Cytori gets FDA OK to sell device to remove body fat and re-inject it in about 15 minutes

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 in what is called an autologous procedure. 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 autologous fat graft 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.

Cytori also makes products that are used in harvesting and researching adult stem cells taken from fat tissue. Analyst Stephen Brozak of WBB Securities said the stem cell and fat graft technologies could ultimately be combined to make an alternative to product silicone breast implants. He said plastic surgeons and clinicians would develop other uses on their own.

Brozak kept a “Strong Buy” rating on the stock. He expects the shares to rise to $12 within the next six months.

“This is a commercial beachhead for them with a system that allows for the introduction of their platform technology within the U.S.,” he said in a telephone interview.

In afternoon trading, shares of Cytori Therapeutics rose 93 cents, or 14.4 percent, to $7.41. Earlier the stock set an annual high of $7.78.