Radiesse Approved for HIV Lipoatrophy

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December 27, 2006

Radiesse Approved for HIV Lipoatrophy

by Tim Horn

BioForm Medical, Inc. announced on December 27 that the U.S. Food and

Drug Administration (FDA) has approved Radiesse® for use in the

correction of lipoatrophy of the face associated with HIV treatment.

It is the second FDA-approved 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 was previously 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.

FDA approval was based on an August 24 recommendation from the

agency's General and Plastic Surgery Devices Advisory panel. The

panel's independent experts, reviewing a pre-market approval

application for the product, agreed that Radiesse is safe and

effective as an injectable device for the correction of facial

lipoatrophy in people with HIV. Radiesse was also approved by the FDA

as a filler material to cosmetically correct facial lines and

wrinkles such as nasolabial folds.

" The injection technique is relatively simple, " explains ph

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, agrees 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. "

Now that the FDA has approved Radiesse, it is hoped that there will

be greater access to the product through physicians and a better

chance of insurance companies paying for the procedure.

Source:

BioForm Medical, Inc.