Dermal FIller One Million Syringes of RADIESSE(r)

One Million Syringes of RADIESSE(r) Dermal Filler Have Been Shipped

Source: BioForm Medical, Inc.
One Million Syringes of RADIESSE(r) Dermal Filler Have Been Shipped
RADIESSE Dermal Filler Has Become One of the Leading Dermal Fillers Worldwide
SAN MATEO, Calif. and PARIS, Jan. 8, 2009 (GLOBE NEWSWIRE) -- BioForm Medical, Inc. (Nasdaq:BFRM) today announced, at a presentation at the 11th Annual Meeting of the International Master Course on Aging Skin (IMCAS), that it has shipped more than 1,000,000 syringes of RADIESSE(r) dermal filler worldwide since 2002. RADIESSE dermal filler has been available since 2002 for aesthetic uses in the Europe and for reconstructive and therapeutic uses in the United States. In 2006, BioForm Medical received U.S. Food and Drug Administration approval of RADIESSE dermal filler for facial aesthetics applications, and use of this product has rapidly expanded. RADIESSE dermal filler has demonstrated an excellent safety profile, comparable to short term hyaluronic acid products. RADIESSE dermal filler is also the only dermal filler to have demonstrated, in peer-reviewed studies, better aesthetic correction and higher patient satisfaction than Restylane(r) and Juvederm(r).


As of December 2008, BioForm Medical has supplied more than 1,000,000 syringes of RADIESSE dermal filler to approximately 10,000 medical and aesthetics practices worldwide. With the rapid adoption of this product, RADIESSE dermal filler has become one of the leading dermal fillers in the worldwide market. BioForm Medical believes that to date, RADIESSE dermal filler is the only dermal filler, other than collagen and hyaluronic acid, to reach this 1,000,000 syringe milestone.


Industry-Leading Peer Reviewed Publications with RADIESSE Dermal Filler
More than 60 published peer-reviewed scientific articles have demonstrated the utility of RADIESSE dermal filler. The studies and clinical publications collectively reporting on several-thousand-patient experience with RADIESSE dermal filler include: * 117-patient comparative study vs. Cosmoplast (human collagen) by Dr. Stacy Smith, Dr. Mariano Busso, Dr. Marla McClaren and Dr. Lawrence Bass published in the Journal of Dermatologic Surgery in December 2007, which supported FDA approval for fold and wrinkle treatment, showed superior performance of RADIESSE dermal filler vs. Cosmoplast on nearly every measure evaluated

* 60-patient split-face, blinded comparative study vs. Restylane by Dr. Marion Moers-Carpi and Dr. Jaime Tufet published in the Journal of Dermatologic Surgery in February 2008, which demonstrated more patients improved at 6 months and 9 months following treatment with RADIESSE dermal filler than with Restylane, and higher patient satisfaction with RADIESSE dermal filler than with Restylane

* 205-patient randomized, blinded comparative study vs. Juvederm and Perlane by Dr. Marion Moers-Carpi, Dr. Stephan Vogt, Dr. Begonia Santos, Dr. Jorge Planas, Dr. Sonia Vallve and David Howell, PhD published in the Journal of Dermatologic Surgery in December 2007, which demonstrated higher patient satisfaction and greater likelihood of patients to return if treated with RADIESSE dermal filler compared with Juvederm or Perlane

* 100-patient study treating patients with HIV-associated lipoatrophy by Dr. Stacey Silvers, Dr. Joseph Eviatar, Dr. Michael Echavez and Dr. Alexandra Pappas that demonstrated safety of treatment with up to 15 syringes of RADIESSE dermal filler, which was published in the Plastic and Reconstructive Surgery Journal in September 2006

* 1,000-patient clinical report of 4-year follow-up with RADIESSE dermal filler by Dr. Thomas Tzikas published in the Journal of Dermatologic Surgery in June 2008

* 58-patient radiographic and computed tomographic imaging study of RADIESSE dermal filler in nasolabial fold and HIV-associated lipoatrophy treatment by Dr. Alastair Carruthers, Dr. Jean Carruthers, Dr. Marc Liebeskind and Dr. Bruce Forster published in the Journal of Dermatologic Surgery in June 2008

* 24-patient, 26-month clinical report on nasal augmentation with RADIESSE dermal filler by Dr. Hilton Becker published in the Plastic and Reconstructive Surgery Journal in June 2008

* 5-patient clinical report to characterize new collagen formation following RADIESSE dermal filler treatment by Dr. Alexander Berlin, Dr. Mussarratt Hussain and Dr. David Goldberg published in the Journal of Dermatologic Surgery in June 2008

* An investigation of physical properties when RADIESSE dermal filler is mixed with lidocaine by Dr. Mariano Busso published in the Journal of Dermatologic Surgery in June 2008

* 19-patient clinical report on the use of RADIESSE dermal filler for mid-face volume loss by Dr. Kenneth Beer, Monica Yohn, RN and Dr. Joel Cohen published in the Journal of Drugs in Dermatology in April 2008

* 14-patient clinical report on nonsurgical rhinoplasty with RADIESSE dermal filler by Dr. Cameron Rokhsar and Dr. David Ciocon published in the Journal of Dermatologic Surgery in April 2008

* 113-patient clinical report on patient satisfaction outcomes with RADIESSE dermal filler from three physicians' practices by Dr. Neil Sadick, Dr. Bruce Katz and Dr. Deborshi Roy published in the Journal of Dermatologic Surgery in December 2007

* A clinical report on the use of RADIESSE dermal filler in hand augmentation by Dr. Mariano Busso and Dr. David Applebaum published in the Journal of Dermatologic Therapy in November 2007

* 13-patient clinical report on the use of RADIESSE dermal filler for the correction of post-rhinoplasty contour deficiencies by Dr. Howard Stupak, Dr. Thomas Moulthrop, Patricia Wheatley, RN, Allison Tauman, PharmD, and Dr. Calvin Johnson published in the
Archives of Facial Plastic Surgery in March 2007

* 22-patient, 12-18 month clinical report on the use of RADIESSE dermal filler for the correction of nasolabial fold depressions by Dr. Murad Alam and Dr. Simon Yoo published in the Journal of the American Academy of Dermatology in February 2007

* 139-patient clinical report on the use of RADIESSE dermal filler in multiple aesthetic indications by Dr. Silvia Cuevas, Dr. Maria Patricia Rivas, Dr. Sadegh Amini and Dr. Eduardo Weiss published in the American Journal of Cosmetic Surgery in October 2006

* 609-patient clinical report on the use of RADIESSE dermal filler in multiple aesthetic indications by Dr. David Jansen and Dr. Miles Graivier published in the Plastic and Reconstructive Surgery Journal in September 2006

* 40-patient, 18-month clinical report on the use of RADIESSE dermal filler by Dr. Patricio Jacovella, Dr. Claudia Peiretti, Dr. Diego Cunille, Dr. Mauricio Salzamendi and Dr. Sophia Asiu Schechtel published in the Plastic and Reconstructive Surgery Journal in September 2006

About RADIESSE Dermal Filler:
RADIESSE dermal filler is approved in the United States for the correction of moderate to severe facial folds and wrinkles, including nasolabial folds and for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with HIV. In Europe, RADIESSE dermal filler is CE-marked for plastic and reconstructive surgery, including deep and sub-dermal soft tissue augmentation of the facial area. We believe that the general advantages of RADIESSE dermal filler that have enabled the rapid uptake of the product include: excellent initial correction, durability of treatment of one year or longer in many patients, and the physical characteristics of holding shape and lifting tissues better than some filler materials. Procedural side effects from RADIESSE dermal filler injection are consistent with side effects commonly associated with injectable dermal filler treatments, and may include bruising, swelling, redness, pain, and itching. In most cases, these side effects go away within two weeks following treatment. There have been no reported long term adverse effects of RADIESSE dermal filler in the pivotal clinical studies conducted, and there have been no reports of delayed onset adverse events in these clinical studies.


About BioForm Medical, Inc.:
BioForm Medical, Inc. is a medical aesthetics company headquartered in San Mateo, California, developing products that enhance aesthetic procedures performed in dermatology and plastic surgery practices. BioForm Medical's lead product is RADIESSE(r) dermal filler, a long-lasting filler for use in facial aesthetics. BioForm Medical is developing several future aesthetics products, including a radiofrequency treatment to reduce nerve function in the forehead, a sclerotherapy treatment for spider veins, and a surgical adhesive for brow lifts. For more information about BioForm Medical, please visit http://www.bioform.com/.

RADIESSE(r) is a registered trademark of BioForm Medical, Inc. Restylane(r) is a registered trademark of HA North American Sales AB, a subsidiary of Medicis Pharmaceutical Corporation.
Juvederm(r) mark owned by Allergan Industrie SAS. CONTACT: BioForm Medical, Inc.
Adam Gridley, Senior Vice President, Corporate Development
650.286.4025
Keywords: MEDICAL, BIOTECHNOLOGY

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