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Cytori rises on FDA clearance for fat graft device

March 17th, 2012 6:10 am

WASHINGTON (AP) -- Shares of Cytori Therapeutics Inc. jumped more than 10 percent Friday after the medical device maker said it received U.S. approval for a new version of its Puregraft system, which is used in cosmetic surgery.

Plastic surgeons use the device in fat grafting procedures that take fat from one part of the body and inject it into another. The device removes unwanted fluid, blood cells and debris from the fat and prepares it for grafting. Many procedures use fat from the thighs and abdomen to augment the breasts or face, aiming for a smoother, firmer look.

The latest version of the device can process 850 milligrams of fat, more than three times as much as the original Puregraft system approved in 2010. Plastic surgeons performed nearly 60,000 fat grafting procedures in the U.S. in 2010, according to industry figures

Shares of San Diego, Calif.-based Cytori rose 30 cents, or 10.6 percent, to close at $3.13.

Cytori has attracted attention from analysts for another device, called the Celution system, which some plastic surgeons have reportedly used to create fat grafts enhanced with adult stem cells. The device supposedly separates and purifies adult stem cells, which can then be mixed with fat grafts. Plastic surgeons in Los Angeles, Miami and elsewhere claim the so-called "stem cell facelift" creates a younger, healthier-looking physique than the incisions and implants associated with traditional surgery. But there are few studies to support such claims, and the Food and Drug Administration has not approved any therapies using stem cells for cosmetic use.

Early this year the two largest professional societies for plastic surgeons issued a joint statement calling on their members to avoid stem cell procedures. A review of the medical literature found little human data to support the benefits of injecting stem cells into patients, according to the statement from the American Society of Plastic Surgeons and the American Society for Aesthetic Plastic Surgery.

"The marketing and promotion of stem cell procedures in aesthetic surgery is not adequately supported by clinical evidence at this time," reads the joint statement, published in January.

"This is modern-day snake oil," said Dr. Felmont Eaves, president of the American Society of Plastic Surgeons, in an interview last year with the Associated Press. "It is the worst form of merchandising for a procedure that doesn't have scientific evidence to back it up."

Eaves pointed out that surgeons have been using fat grafts to plump up cheeks and breasts for decades. The practice has a mixed record of success, and has never eclipsed the more popular facelift and breast implant procedures.

"There's no evidence that going the extra step to create a stem cell version of this makes any difference," Eaves said.

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Cytori rises on FDA clearance for fat graft device

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