August 29, 2006 (AIDSmeds)—BioForm Medical, Inc. announced on August 24th that anadvisory committee to the U.S. Food and Drug Administration (FDA) hasrecommended 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.

Radiessecontains man-made (synthetic) calcium hydroxylapatite, a substancefound in bones and teeth. It is currently approved by the FDA forvarious uses in the United States, including orthopedic andreconstructive surgery and in dentistry. When it is injected into theskin, natural collagen forms around the calcium hydroxylapatite. Thiscauses the skin to thicken, which can be useful in terms of masking thehollows in the face area associated with lipoatrophy.

Radiesseis considered to be a temporary filler, meaning that its cosmeticbenefits decrease over time, usually within a few years of receivingthe injections. According to BioForm Medical, it has been used inhundreds of thousands of procedures worldwide with an excellent safetyrecord.

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

“The injectiontechnique is relatively simple,” explained Joseph Eviatar, MD, of NYUMedical School in New York and a Radiesse researcher. “What you injectis pretty much what you get. In other words, if you inject a certainvolume, that’s what you’ll see. You have to account for a little bit ofswelling, but you can inject it where you’d like it and the productpretty much stays there. It’s a soft and malleable product.”

StaceySilvers, MD, of Beth Israel Medical Center and another Radiesseresearcher, agreed with Dr. Eviatar. “We’ve been very happy with thisproduct in the study we’ve been participating in. The patients havealso been very pleased with it so far. In European studies, it has beensuggested that [Radiesse] is restorative for two to five years. Wehaven’t seen this – we’re seeing results lasting approximately a yearto a year and a half – but it’s one of the longest lasting fillers I’veseen.”

While the FDA is not required to agree with theadvisory committee’s recommendation, it usually does. With FDA approvalof the product for HIV-positive people with lipoatrophy, there will begreater access to the product through physicians and, with hope, abetter chance of insurance companies paying for the procedure.