SAN MATEO, Calif. -- BioForm Medical to File Radiesse(TM) for Facial Soft Tissue Approval
BioForm Medical, Inc., announced today that 100% of patients enrolled in a clinical study of Radiesse(TM) to correct facial wasting reported a significant improvement in their appearance at 12 months post treatment. The results of the landmark study showed that one year after initial treatment 84% of patients were Very Much Improved or Much Improved according to the Global Aesthetic Improvement Scale (GAIS) and the remaining 16% were rated as Improved. The research findings were published in a special supplement of the September 2005 issue of "Plastic Surgery Journal."
Facial wasting is a common problem for HIV patients treated with highly active antiretroviral therapy (HAART). The condition gives patients a "hollowed-out" look and is a visible sign that they have HIV.
"Our study results demonstrate the long-lasting benefits of Radiesse to achieve dramatic improvements in the appearance of facial wasting," noted clinical investigator Joseph A. Eviatar, MD, FACS, a prominent plastic surgeon and surgical director of Chelsea Eye and Cosmetic Surgery Associates in New York, NY. "This improvement, which generally lasts one to two years, favorably impacts these patients' quality of life without subjecting them to an invasive procedure."
Further, Quality of Life data collected at 12-months follow-up indicated that 100% of patients found that Radiesse treatment had been beneficial. Additionally, 99% of patients said they were more confident about their appearance after treatment with Radiesse and would recommend treatment to others.
No serious adverse events were reported in the study.
The multi-site study was conducted by BioForm under an Investigational Device Exemption (IDE) for marketing clearance of Radiesse to assess the safety and efficacy of Radiesse injections for restorative treatment of HIV-associated facial lipoatrophy. One hundred patients were enrolled at three sites: two centers in New York City and one in San Francisco.
All study patients received an injection of Radiesse, a new augmenting and contouring substance, during their initial visit. Patients were seen one month following their initial visit and given a second touch up injection if required for optimal correction. Follow-up visits were conducted at three and six months, measured from the first date of treatment if no touch-up injection was received, or from the date of the touch-up injection if one was received.
"Facial wasting has a devastating effect on the self-esteem of patients because of the stigma attached to it. I had one patient who was so concerned about how he looked that he stuffed cotton balls in his mouth to make his cheeks look more full," said Dr. Stacey Silvers, lead investigator and executive partner, Madison ENT & Facial Plastic Surgery in New York, NY. "I have been treating people with this condition for eight years and find that Radiesse provides consistently excellent results."
The study results were presented at the recent meetings of the American Society of Plastic Surgery (ASPS) and American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS).
"I had been on HIV medications for some time and was doing great. My prognosis was good and I didn't feel sick. The problem was that anyone on the street could tell I had HIV. I didn't want to go out of the house, and basically lived the life of a hermit," said a patient in the study. "After I had treatment with Radiesse I couldn't believe the difference. I felt like I had finally won the war against HIV because I looked as healthy as I felt."
Manufactured and distributed in the U.S. 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. Composed of tiny, smooth calcium hydroxylapatite (CaHA) particles suspended in a water-based gel carrier, Radiesse(TM) has been proven safe and biocompatible in numerous soft tissue applications. It has been used in more than 100,000 procedures worldwide with an excellent safety record. Among the product's many advantages, Radiesse treatment allows steady growth of collagen matrix, produces virtually instant results and lasts one to three years.
About BioForm Medical, Inc.
Headquartered in San Mateo, CA, BioForm Medical, Inc., is a privately-held medical device company developing and commercializing injectable implant products for soft and hard tissue augmentation and topical preparations for dermatological conditions. The Company is dedicated to improving patients' lives by providing high quality, innovative, safe and effective medical products for use in the plastic surgery, dermatology, urology, and ENT markets. For more information, please visit www.radiesse.com.
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