FDAnews
www.fdanews.com/articles/90177-radiesse-approved-for-two-new-aesthetic-indications

RADIESSE APPROVED FOR TWO NEW AESTHETIC INDICATIONS

December 27, 2006

BioForm Medical Dec. 27 announced that the FDA approved Radiesse, the next-generation cosmetic dermal filler, for the long-lasting correction of moderate to severe facial wrinkles and folds such as nasolabial folds. Radiesse also received a second FDA approval for the long-lasting correction of facial fat loss (lipoatrophy) in people with human immunodeficiency virus.

Radiesse is the first filler with advanced calcium-based microsphere technology that not only provides volume replacement to wrinkles, folds and sunken depressions but also stimulates the body to produce new collagen. This unique action restores the fullness and contours of a youthful, healthy appearance with sustained results that last an average of one year or more.

"With its advanced calcium-based microsphere technology, Radiesse is the first facial cosmetic filler with a proven 12 month benefit in multiple clinical studies," said Steven L. Basta, president and CEO of BioForm.

Radiesse is composed of calcium hydroxylapatite microspheres in a water-based gel carrier. The calcium microsphere technology enables the body to generate new collagen, providing longer lasting effects than other available fillers.