August 29, 2006

Second Facial Filler for HIV Lipoatrophy Receives Approval Recommendation

August 29, 2006 (AIDSmeds)—BioForm Medical, Inc. announced on August 24th that an advisory committee to the U.S. Food and Drug Administration (FDA) has recommended the approval of Radiesse™ for use in the correction of lipoatrophy (loss of fat) of the face associated with HIV treatment. If approved, it will be the second FDA-screened facial filler for this condition, following the approval of Dermik's Sculptra® in August 2004.

Radiesse contains man-made (synthetic) calcium hydroxylapatite, a substance found in bones and teeth. It is currently approved by the FDA for various uses in the United States, including orthopedic and reconstructive surgery and in dentistry. When it is injected into the skin, natural collagen forms around the calcium hydroxylapatite. This causes the skin to thicken, which can be useful in terms of masking the hollows in the face area associated with lipoatrophy.

Radiesse is considered to be a temporary filler, meaning that its cosmetic benefits decrease over time, usually within a few years of receiving the injections. According to BioForm Medical, it has been used in hundreds of thousands of procedures worldwide with an excellent safety record.

The General and Plastic Surgery Devices Advisory Panel recommended approval of Radiesse following the review of data from a pre-market approval application (PMA) for the product to be used as an injectable device intended for use in the correction of facial lipoatrophy in people with HIV. Radiesse was also recommended for approval to be used as a filler material to correct facial lines and wrinkles such as nasolabial folds.

"The injection technique is relatively simple," explained Joseph Eviatar, MD, of NYU Medical School in New York and a Radiesse researcher. "What you inject is pretty much what you get. In other words, if you inject a certain volume, that's what you'll see. You have to account for a little bit of swelling, but you can inject it where you'd like it and the product pretty much stays there. It's a soft and malleable product."

Stacey Silvers, MD, of Beth Israel Medical Center and another Radiesse researcher, agreed with Dr. Eviatar. "We've been very happy with this product in the study we've been participating in. The patients have also been very pleased with it so far. In European studies, it has been suggested that [Radiesse] is restorative for two to five years. We haven't seen this – we're seeing results lasting approximately a year to a year and a half – but it's one of the longest lasting fillers I've seen."

While the FDA is not required to agree with the advisory committee's recommendation, it usually does. With FDA approval of the product for HIV-positive people with lipoatrophy, there will be greater access to the product through physicians and, with hope, a better chance of insurance companies paying for the procedure.