SAN MATEO, Calif., Aug. 24 /PRNewswire/ -- BioForm Medical, Inc. announced today that the U.S. Food and Drug Administration’s (FDA) General and Plastic Surgery Devices Advisory Panel has recommended the approval of Radiesse, a next-generation soft tissue augmentation product, for use as a filler material to restore soft tissue facial contours such as nasolabial folds and for use in the correction of lipoatrophy of the face associated with HIV therapy.
The Panel recommended approval of Radiesse with conditions in both indications following the review of data from a premarket approval application (PMA) for Radiesse to be used as an injectable device intended for use in the correction of facial lipoatrophy associated with HIV therapy; and a second PMA for Radiesse to be used as a filler material to correct facial lines and wrinkles such as nasolabial folds. 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.
Based on the Panel’s recommendation, Radiesse will be considered for approval by the FDA.
About Radiesse
Manufactured and distributed worldwide by BioForm Medical, Inc., Radiesse 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. Composed of smooth calcium hydroxylapatite (CaHA) particles suspended in a gel carrier, Radiesse has been demonstrated to be safe and biocompatible in numerous soft tissue applications. It has been used in hundreds of thousands of procedures worldwide with an excellent safety record. For more information on Radiesse, please visit www.radiesse.com .
About BioForm Medical, Inc.
BioForm Medical, Inc. is a privately-held medical device company that develops and commercializes injectable implant products for soft tissue augmentation. For more information about BioForm, please visit www.bioformmedical.com .
CONTACT: Adam Gridley 650-286-4025 (Office) Corporate Development BioForm Medical, Inc.
Nadine Tosk NDTosk Communications for BioForm Medical, Inc. 847-920-9858 nadinepr@bellsouth.net
Source: BioForm Medical, Inc
