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New Study Confirms Radiesse(TM) Injectable Filler Provides Long-Term Improvement of Vocal Fold Insufficiency; New Generation Augmentation Treatment Offers Renewed Hope for Patients Suffering from Common Voice-Altering Conditions.

SAN MATEO, Calif. -- Anyone who has ever had laryngitis knows how frustrating it is to lose your voice. Even in today's world of email and text messaging, communicating through oral speech is still essential. But while laryngitis is only a temporary condition, increasing numbers of individuals face a more serious form of voice loss known as Vocal Fold Insufficiency - a medical condition in which one or both vocal folds (or cords) lack the physical capacity to vibrate properly. The result is poor voice quality that severely compromises a person's quality of life -- from performing a job and earning a livelihood to parenting and enjoying fulfilled relationships.

In the past, vocal fold insufficiency was often undertreated because patients mistook the condition as a normal sign of aging or didn't want to undergo invasive surgery to correct the problem. But now, new scientific data from a rigorous clinical study using calcium hydroxylapatite (CaHA), an innovative augmenting agent trademarked Radiesse finds that 94% of study patients with vocal fold insufficiency showed improvement in their voice quality six months after treatment.

Lead investigator and voice specialist Clark A. Rosen, M.D., presented his research findings on this non-invasive treatment at the annual meeting of the American Association of Otolaryngology-ENT in Los Angeles on September 28, 2005.

The multi-center, open-label, prospective clinical study is the largest of its kind in the field of voice disorders. More than 100 patients were enrolled with each patient serving as his or her own control. Voice-related outcome measures were collected for pre-injection and at one, three and six months post-injection. Dr. Rosen reported that "results in this large patient cohort demonstrated excellent clinical outcomes, indicating that CaHA is a valuable injectable material for glottal incompetence up to the 6-month time point."

"Most people take their voice for granted until it breaks down, like their car. But verbal communication is easily one of the top three major determinants of our quality of life," said the director of the University of Pittsburgh Voice Center. "Until Radiesse was introduced, there really wasn't a good, long-lasting injectable substance to correct vocal problems. As a physician, it's exciting to provide a safe and efficacious procedure that allows us to treat a lot more patients who shied away from surgical therapy in the past."

In the study, 36 patients received Radiesse for paralysis of the vocal folds, in which one of the vocal cords doesn't move to meet the middle opening between the two vocal folds. Typically, paralysis of the vocal folds results from a medical condition such as lung cancer or neck or chest surgery. The other 30 patients were treated with Radiesse for glottal incompetence, a medical condition where the two vocal cords move but are thin and weak and don't meet together to close the middle opening completely. Glottal incompetence usually occurs due to muscle damage or muscle loss associated with aging.

All patients received one treatment with Radiesse, which was injected into the affected vocal fold to modify the larynx and cause the vocal folds to meet at midline. Twenty-eight patients were treated in the physician's office under local anesthesia and with the throat numbed. The other 24 patients were treated in a hospital operating room and were sedated under general anesthesia.

At six months, 85% of the study patients reported high satisfaction and good to great improvement of voice quality. No permanent adverse complications were observed.

About Radiesse

Manufactured and distributed in the U.S. by BioForm Medical, Inc., Radiesse is an injectable filler used in various cosmetic, reconstructive and ENT applications to augment and contour folds, depressions and vocal fold defects of the facial area. Composed of tiny, smooth calcium hydroxylapatite (CaHA) particles suspended in a water-based gel carrier, Radiesse has been proven safe and biocompatible in numerous soft tissue applications. 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 the www.radiesse.com.
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Publication:Business Wire
Date:Sep 29, 2005
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