BioForm Inc. Release: Radiesse(TM) Receives Facial Aesthetics Approval In Canada
Published: Nov 10, 2005
SAN MATEO, Calif. and MONTREAL, Nov. 10 /PRNewswire/ -- BioForm Medical, Inc. ("BioForm"), the makers of Radiesse(TM), announced today that it has received approval from Health Canada to market Radiesse(TM) in Canada for facial aesthetics. Canderm Pharma Inc. ("Canderm"), a leading Canadian dermatology and facial aesthetics company, will be the exclusive distributor for Radiesse in Canada and will launch Radiesse to its customers in the coming weeks.
"We are very excited to offer Canadian physicians and their patients the first long lasting non- permanent filler for non-surgical facial contouring," stated Barry Vogel, President of Canderm.
"This is another important milestone for Radiesse as we continue to grow our share in the world-wide filler market," stated Steven L. Basta, President and CEO of BioForm. "We are fortunate to have Canderm as our partner. As a leader in the Canadian facial aesthetics market, Canderm is positioned to successfully communicate the positive attributes of Radiesse and to provide patients and physicians with a new alternative for long-lasting aesthetic augmentation."
Manufactured and distributed worldwide 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. Radiesse is marketed in Canada and other countries outside of the U.S. for facial soft tissue augmentation and vocal fold augmentation ("VFA") and is approved in the U.S. for VFA and maxillofacial augmentation. Composed of smooth calcium hydroxylapatite ("CaHA") particles suspended in a gel carrier, Radiesse has been demonstrated to be safe and biocompatible in numerous soft tissue applications. It has been used in more than 150,000 procedures worldwide with an excellent safety record. Among the product's many advantages, Radiesse treatment allows steady growth of collagen matrix around the particles, produces immediate results, and is intended to last one to three years.
In the U.S., BioForm recently filed a Pre-Market Approval ("PMA") application for soft-tissue augmentation for the treatment of facial lipoatrophy approval following clinical study results that demonstrated 100% of patients enrolled reported a significant improvement in their appearance at 12 months post treatment. BioForm also recently announced positive results from a multi-center, pivotal study using Radiesse for the treatment of nasolabial folds and the Company plans to file an additional PMA for this aesthetic application shortly. For more information, please visit www.radiesse.com.
Canderm Pharma specializes in the business of providing innovative skin rejuvenation technologies that deliver visible results. The Company uniquely possesses a proven track record of over 50 year's of responsiveness, expertise and successful marketing of skin care products and technologies to both physician and consumer markets. One of Canderm's flagship products Alyria, available exclusively in doctors' offices across North America, offers the most advanced technology and patented delivery systems found in facial creams today. Canderm continues to focus its efforts on acquisitions to its anti-aging portfolio of both facial and body enhancement technologies. For more information about the company and our products, visit www.canderm.com or www.alyria-med.com.
About BioForm Medical, Inc.
BioForm Medical, Inc. is a privately-held medical device company developing and commercializing injectable implant products for soft tissue augmentation. Radiesse(TM) and Coaptite(R) have an extensive record of safe clinical use in a variety of applications. Radiesse is marketed outside of the U.S. for facial soft tissue augmentation and vocal fold augmentation ("VFA") and is approved in the U.S. for VFA and maxillofacial augmentation. BioForm has recently completed two clinical trials evaluating Radiesse for nasolabial folds and facial lipoatrophy in the U.S., and has initiated the PMA process with the FDA for these indications. Coaptite is sold outside of the U.S. to treat female stress urinary incontinence ("SUI") and pediatric vesicoureteral reflux and is under PMA review for SUI in the U.S. For more information about BioForm, please visit the Company's website at www.bioformmedical.com.
CONTACT: Can Gumus, Corporate Development Analyst of BioForm, +1-650-286-4000; or Jennifer Preiato, Manager, Public Relations of Canderm, +1-514-334-3835, ext. 111.BioForm Medical, Inc.
CONTACT: Can Gumus, Corporate Development Analyst of BioForm,+1-650-286-4000; or Jennifer Preiato, Manager, Public Relations of Canderm,+1-514-334-3835, ext. 111