NEW YORK, NY USA
– Success of Radiesse(TM) Facial Wasting Treatment Trial Means Potential Physical and Psychological Benefits for Many Infected With HIV
NEW YORK, March 22 /PRNewswire/ — Physicians from leading plastic surgery
and dermatology practices report positive results from HIV patients
participating in a clinical trial of Radiesse(TM) synthetic injectable implant
on facial wasting. The trial is intended to demonstrate the safety and
effectiveness of this widely used tissue augmentation therapy as a treatment
for the facial changes that socially stigmatize many HIV-infected patients.
Lipoatrophy, or facial wasting, is a condition caused by loss of fat
tissue under the skin of the cheeks resulting in a gaunt appearance. It is
often associated with the anti-retroviral therapies taken by HIV patients,
and, in some cases, is so severe that patients discontinue therapy. Radiesse,
developed by BioForm Medical, Inc., is being tested for restoration of facial
volume in patients with Lipoatrophy and to assess patient satisfaction and
improvement in quality of life. An estimated 150,000 to 350,000 patients may
benefit from such treatment.
“Facial wasting continues to have a debilitating effect on many HIV
patients’ appearance causing them to withdraw from normal social activities,”
stated Stacey L. Silvers, M.D., practicing facial plastic surgeon in New York,
N.Y. “This new application of Radiesse may provide an immediate and
potentially prolonged effect compared to other available treatments, resulting
in enhanced quality of life.”
The FDA has already approved Radiesse for vocal fold augmentation and
certain plastic surgery reconstruction applications. It is also being tested
in a trial for the treatment of nasolabial folds.
“I was interested in this study, because I knew of Radiesse’s success in
other tissue bulking uses, and I never questioned its safety,” added Silvers.
“I have found the end results more natural than any other injectable filler on
“This product has made a dramatic difference in my life,” noted one of Dr.
Silver’s patients. “Before participating in the trial, I had become less and
less social because of the hollow appearance of my face. Now I have new
confidence and a more positive outlook on life.”
“Radiesse seems to be a much-preferred treatment because of its longer
duration over currently available products,” commented Joseph Eviatar, M.D.,
F.A.C.S., of Chelsea Eye & Cosmetic Surgery Associates in New York, NY.
“Patients notice immediate results and require fewer treatments.”
Radiesse is composed of Calcium Hydroxylapatite (“CaHA”) microspheres in a
gel carrier. CaHA is a naturally occurring material in the body. “Because
Radiesse is natural in makeup, the product has been proven safe in many
applications and has been well received by patients who are reluctant to
inject non-natural products into their bodies,” added Eviatar.
BioForm Medical, Inc. is a privately held medical device company
developing and commercializing injectable implant products for soft and hard
tissue augmentation. The company is dedicated to improving patients’ lives by
providing high quality, innovative, safe and effective medical products for
use in the aesthetic plastic surgery and urology markets. The company’s
corporate headquarters are located in San Mateo, CA, and its R&D and
manufacturing facility is near Milwaukee, WI. For more information, please
SOURCE BioForm Medical, Inc.