BioForm Inc. Release: Clinical Study Proves Radiesse(TM) Facial Filler Delivers Longer Lasting Correction Of Nasolabial Folds
ORLANDO, Fla., April 24 /PRNewswire/ -- Results of a clinical study released at an international meeting in Orlando today showed that Radiesse(TM), the next-generation facial filler for wrinkles and lines around the nose and mouth, was rated the most effective and longer lasting treatment to restore fullness and a youthful appearance for women and men.
Marion Moers-Carpi, M.D., a dermatologist from Munich, Germany, reported on a study comparing Radiesse, made of calcium hydroxylapatite, with Restylane(R) hyaluronic acid during the Annual Meeting of the American Society for Aesthetic Plastic Surgery (ASAPS) on April 21-26, 2006. The split-face study was designed to evaluate the long-term enhancement of the nasolabial folds (creases from the nose to the corners of the mouth) using Radiesse on one side and Restylane on the other.
"The results showed the aesthetic improvement of the nasolabial fold treated with Radiesse was significantly greater than the nasolabial fold treated with Restylane in 63 percent of patients at 6 months following the second injection," said Dr. Moers-Carpi. "In addition, patients needed approximately 30 percent less Radiesse than Restylane to achieve the superior results, making Radiesse a more cost effective treatment for the patient."
About the Study
Sixty patients were treated at two clinical sites in Germany and Spain in the summer of 2005. Patients had moderate to severe nasolabial folds as rated using a well accepted wrinkle scale. Subjects were randomized to receive Radiesse in one fold and Restylane in the other. Photography was performed prior to treatment and at each successive visit. The protocol called for two injection sessions three months apart to bring patients to optimal correction. The volume of material required in each fold was recorded at each injection. Blinded evaluators rated the nasolabial folds at three months and at six months after the second injection. The clinical study is ongoing for further follow-up to determine longevity of each treatment.
Key clinical results include: -- During the six-month evaluation, 63% of patients had significantly greater aesthetic improvement in the fold treated on the Radiesse side than on the Restylane side. Only 4% of patients had greater improvement on the Restylane side; while 33% had equal improvement on both sides. -- Approximately 30% less Radiesse than Restylane was needed to achieve optimal correction. -- Both products were safe and well tolerated, with no serious adverse events reported for either Radiesse or Restylane treatment. 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 and contour folds, depressions and defects of the facial area. Radiesse lasts twice as long as other commonly used fillers because Radiesse has advanced Microsphere Technology that stimulates the body to grow new collagen for natural, long-lasting results. It is marketed outside the U.S. for facial soft tissue augmentation and vocal fold augmentation ("VFA") and is approved in the U.S. for VFA and maxillofacial augmentation. 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 more than 200,000 procedures worldwide with an excellent safety record. Among the product's many advantages, Radiesse treatment allows steady growth of collagen matrix around the particles, produces immediate results, and is intended to last one year to 18 months. For more information on Radiesse, please visit: www.radiesse.com
About BioForm Medical, Inc.
BioForm Medical, Inc. is a privately-held medical device company developing and commercializing injectable implant products for soft tissue augmentation. Radiesse(TM) and Coaptite(R) have an extensive record of safe clinical use in a variety of applications. BioForm has initiated the PMA process with the U.S. Food and Drug Administration for Radiesse treatment of the nasolabial folds and facial lipoatrophy. Coaptite is sold outside of the U.S. to treat female stress urinary incontinence (SUI) and pediatric vesicoureteral reflux and recently received PMA approval for SUI in the U.S. For more information about BioForm, please visit the www.bioformmedical.com
Contact: NDTosk Communications, +1-847-920-9858, or nadinepr@bellsouth.net, for BioForm.
BioForm Medical, Inc.CONTACT: NDTosk Communications, +1-847-920-9858, ornadinepr@bellsouth.net, for BioForm