FDA Approves Radiesse Treatment
FDA APPROVES RADIESSE® FACIAL FILLER FOR TWO NEW AESTHETIC INDICATIONS
Long-Lasting Filler from BioForm Medical Approved for Treatment of Facial Wrinkles and Folds; and for the Correction of HIV-Associated Facial Wasting
Seattle, WA — December 27, 2006. BioForm Medical, Inc., a privately-held medical aesthetics company, today announced that the U.S. Food and Drug Administration (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 (HIV).
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.
“Today’s FDA approval of Radiesse for use in facial aesthetic applications confirms our rigorous clinical findings that Radiesse is safe and effective for long-term facial aesthetic enhancement,” said Steven L. Basta, President and Chief Executive Officer of BioForm. “With its advanced calcium-based microsphere technology, Radiesse is the first facial cosmetic filler with a proven 12 month benefit in multiple clinical studies. Accordingly, Radiesse is raising the bar to become the new standard for the treatment of facial wrinkles and folds such as nasolabial folds.”
Radiesse is composed of calcium hydroxylapatite microspheres in a water-based gel carrier. Radiesse provides immediate improvement so a patient looks better the moment the product is injected. The calcium microsphere technology also enables the body to generate new collagen, providing longer lasting effects than other available fillers. Further, because Radiesse is a robust, full-bodied material, it provides physicians a superior level of control, predictability and finesse for facial applications.
Seattle Plastic Surgeon Dr. Stephen B. Anderson, of Anderson • Sobel Cosmetic Surgery, has been using Radiesse injections in his practice since early 2003. As one of the first cosmetic surgeons in the Seattle area approved to administer Radiesse injections, he is very experienced with the product and advanced techniques for treatment of facial wrinkles.
Dr. Anderson believes that comfort is key when treating patients with Radiesse. Injections done at his Seattle-area plastic surgery clinic offer the utmost in patient care and local anesthesia to minimize any discomfort.