BioForm Medical, Inc.'s Radiesse®: Recommended for Approval by FDA Advisory Panel for Two Facial Aesthetic Applications

Filed in archive Diagnostics , Treatment on August 31, 2006

Last week, BioForm Medical, Inc. announced that Radiesse® (a next-generation soft tissue augmentation product) has been recommended for approval (with conditions) by the USFDA's General and Plastic Surgery Devices Advisory Panel for the following indications:

1) Radiesse® is to be used as an injectable device intended for use in the correction of facial lipoatrophy associated with HIV therapy
2) Radiesse® is to be used as a filler material to correct facial lines and wrinkles such as nasolabial folds

BioForm Medical, Inc.'s Radiesse® is the first filler to obtain concurrent positive recommendations for use in two facial aesthetic applications.

"We are pleased with the Panel's decision to recommend the approval of Radiesse® with conditions. We now look forward to working with the FDA in the next stage of this process," said Steven L. Basta, President and Chief Executive Officer of BioForm.

Radiesse® will now be considered for approval by the USFDA based on the Panel's recommendation.

Radiesse®, manufactured and distributed worldwide by BioForm Medical, Inc., is an injectable filler used in various cosmetic, reconstructive and therapeutic applications to augment soft tissue and contour folds, depressions and defects of the facial area. This product is composed of smooth calcium hydroxylapatite (CaHA) particles suspended in a gel carrier and has been demonstrated to be safe and biocompatible in numerous soft tissue applications.

Radiesse® has been used in hundreds of thousands of procedures worldwide with an excellent safety record.

Read the full press release ( a pdf file).