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RADIESSE® 18-MONTH HIV FACIAL LIPOATROPHY CLINICAL STUDY

Trial Background:

• A multi-site, clinical study examining the safety and efficacy of RADIESSE injections for restorative treatment of HIV-associated Facial Lipoatrophy.
• Conducted by BioForm Medical, a privately-held medical device company specializing in injectable products for soft tissue augmentation.
• Trial conducted under an Investigational Device Exemption (IDE) granted by the FDA.

Trial Design:

• Conducted at three medical centers in the United States, including two centers in New York City and one in San Francisco.
• 100 patients with HIV-associated Facial Lipoatrophy were enrolled in the trial.
• All study patients received an injection of RADIESSE filler during initial visit and were seen one month later for touch-up injections as necessary.
• Additional follow-up injections were conducted at six months. Follow-up appointments where photos were taken, were performed at months twelve and eighteen. (Note: No injections were given at these appointments.) Injections were given at 18 months, after evaluations.

Key Findings:

• Patients were scored by their physician for improved appearance using the Global Aesthetic Improvement Scale (GAIS). Findings at twelve and eighteen months after treatment with RADIESSE dermal filler showed:
  
  Facial Lipoatrophy Effectiveness GAIS Results

• 100% of Patients Improved Through 12 Months
• 90% of Patients Maintain Improvement Through 18 Months

• During the study, patients were asked how treatment with RADIESSE dermal filler had affected their quality of life. Summary patient responses were:

• RADIESSE dermal filler was safe and well tolerated, with no serious device-related adverse events reported.
• No granulomas or nodules were reported.
• In all 100 patients, RADIESSE dermal filler was proven safe for injection.
  

Current Indications:

RADIESSE dermal filler is also indicated in the United States for the following:

• Correction of Nasolabial Folds
• Oral/Maxillofacial Defects
• Vocal Fold Insufficiency
• Radiographic Tissue Marking

Other Clinical Publications:

Broder, KW and Cohen, SR. “An overview of permanent and semipermanent fillers” Plast Reconstructive Surg 2006 Sep;118(3 Suppl):7S-14S.

Burroughs, JR, Anderson, RL, and McCann, JD. “Expanding roles for dermal fillers lead to better outcomes, satisfied patients” Cosmetic Surgery Times 2006; 6:10-17.

Busso, Mariano and Karlsberg, Peter L. “Cheek augmentation and rejuvenation using Radiesse” Cosmetic Dermatology, 2006; 19 (9): 583-588.

Comite, Stephen L, Liu, Judy F, Balasubramanian, Suprina and Christian, Marisa A. “Treatment of HIV-associated Facial Lipoatrophy with Radiance FN™ (Radiesse)”
Dermatology Online Journal 2004;10(2):2.
http://dermatology.cdlib.org/102/therapy/HIV/comite.html

Elson, Melvin L. “Radiesse: A fresh look at fillers” Cosmetic Dermatology 2006; 19(2):111-112.

Felderman, Lenora I. “Radiesse for facial rejuvenation” Cosmetic Dermatology 2005; 18(12):823-826.

Funt, David K. “Volumetrics - Facial fillers are essential for harmony” Healthy Aging, [In Press].
Goldberg, David J. “Acne scar correction using Radiesse, injectable calcium hydroxylapatite in a carrier-based gel” J Cosmetic Laser Ther, [In Press].

Jansen, David J. and Graivier, Miles H. “Evaluation of a calcium hydroxylapatite-based implant (Radiesse) for facial soft tissue augmentation” Plast Reconstructive Surg 2006 Sep;118(3 Suppl):22S-30S, discussion 31S-33S.

Jacovella PF, Peiretti CB, Cunille D, Salzamendi M and Schechtel SA. “Patient satisfaction and longevity of Radiesse (calcium hydroxylapatite) as a facial soft tissue filler in adult females and adult males” Plast Reconstructive Surg 2006 Sep;118(3 Suppl):15S-21S.

Kanchwala, Suhail K, Holloway, Lisa and Bucky, Louis P. “Reliable soft tissue augmentation: A clinical comparison of injectable soft-tissue fillers for facial-volume augmentation” Annals of Plastic Surgery 2005; 55:30-35.

Marmur, ES, Phelps, R. and Goldberg, DJ. “Clinical, histologic and electron microscopic findings after injection of a calcium hydroxylapatite filler” J Cosmetic Laser Ther 2004; 6:223-226.

Nyte, Christopher P, DO “Spreader Graft Injection with Calcium Hydroxylapatite: A Nonsurgical Technique for Internal Nasal Valve Collapse” Laryngoscope 2006: 116 (7): 1291-1292. .

Roy, Deborshi, Lack, Edward, Sadick, Neil S, Bosniak, Stephen L, Cantisano-Zilkha, Marian and Zdinak, Lisa “Midface lift with Radiesse: A minimal puncture technique” Dermatol Surg, [In Press].

Silvers, Stacy L, Eviatar, Joseph A, Echavez, Michael I, and Pappas, Alexandra L. “Prospective open label 18-month trial of calcium hydroxylapatite (Radiesse) for facial soft tissue augmentation in patients with HIV-associated lipoatrophy: One year durability” Plast Reconstructive Surg, 2006 Sep;118(3 Suppl):34S-45S.

Tzikas, Thomas L. “Evaluation of Radiance FN soft tissue filler for facial soft tissue augmentation” Arch Facial Plast Surg 2004; 6:234-239.

Werschler, William P. “Radiesse and other soft tissue fillers: Right products, right place, right time” Aesthetics Trends Tech, Summer 2006; 5(4).

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