1,000,000 Syringes of Radiesse Shipped Worldwide
0SAN MATEO, Calif. and PARIS, (GLOBE NEWSWIRE) — BioForm Medical, Inc. today announced, at a presentation at the 11th Annual Meeting of the International Master Course on Aging Skin (IMCAS), that it has shipped more than 1,000,000 syringes of RADIESSE dermal filler worldwide since 2002. RADIESSE dermal filler has been available since 2002 for aesthetic uses in the Europe and for reconstructive and therapeutic uses in the United States. In 2006, BioForm Medical received U.S. Food and Drug Administration approval of RADIESSE dermal filler for facial aesthetics applications, and use of this product has rapidly expanded. RADIESSE dermal filler has demonstrated an excellent safety profile, comparable to short term hyaluronic acid products. RADIESSE dermal filler is also the only dermal filler to have demonstrated, in peer-reviewed studies, better aesthetic correction and higher patient satisfaction than Restylane(r) and Juvederm(r).
As of December 2008, BioForm Medical has supplied more than 1,000,000 syringes of RADIESSE dermal filler to approximately 10,000 medical and aesthetics practices worldwide. With the rapid adoption of this product, RADIESSE dermal filler has become one of the leading dermal fillers in the worldwide market. BioForm Medical believes that to date, RADIESSE dermal filler is the only dermal filler, other than collagen and hyaluronic acid, to reach this 1,000,000 syringe milestone.
About RADIESSE Dermal Filler:
RADIESSE dermal filler is approved in the United States for the correction of moderate to severe facial folds and wrinkles, including nasolabial folds and for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with HIV. In Europe, RADIESSE dermal filler is CE-marked for plastic and reconstructive surgery, including deep and sub-dermal soft tissue augmentation of the facial area. We believe that the general advantages of RADIESSE dermal filler that have enabled the rapid uptake of the product include: excellent initial correction, durability of treatment of one year or longer in many patients, and the physical characteristics of holding shape and lifting tissues better than some filler materials. Procedural side effects from RADIESSE dermal filler injection are consistent with side effects commonly associated with injectable dermal filler treatments, and may include bruising, swelling, redness, pain, and itching. In most cases, these side effects go away within two weeks following treatment. There have been no reported long term adverse effects of RADIESSE dermal filler in the pivotal clinical studies conducted, and there have been no reports of delayed onset adverse events in clinical studies.