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(press release from Artes Medical, Inc.)
SAN DIEGO--Aug. 11, 2004--Artes Medical, Inc., a privately held specialty pharmaceutical and medical device company, announced today that it has filed a patent infringement complaint in the United States District Court for the Southern District of California against BioForm Medical, Inc. of San Mateo, California. The lawsuit seeks a preliminary and permanent injunction, treble damages, attorney's fees, costs and expenses against BioForm for the sale of its products. According to the allegations in the complaint, BioForm infringes U.S. Patent No. 5,344,452 through the manufacture and sale of its Radiesse FN and Radiance FN products, which are being used by doctors "off-label" to correct facial wrinkles and skin depressions. The '452 patent protects the microsphere technology used in Artes' product ArteFill(TM), the first permanent filler for correcting skin contour deficiencies. Artes received an approvable letter from the FDA for ArteFill in January 2004 and plans to begin marketing the product in early 2005. Artes Medical also filed a motion for preliminary injunction, asking the court to immediately enjoin BioForm from further manufacture, use, sales, or offers to sell its Radiance, Radiesse, and Coaptite product lines pending resolution of the lawsuit. A hearing is currently scheduled for September 10, 2004 on Artes' motion. "We are concerned about patients being treated for skin depressions, such as facial wrinkles, with products that have not gone through the rigors of an FDA clinical trial and are not specifically approved for such indications. Moreover, Artes has made substantial investments in research, development and U.S. clinical trials for its product aimed at treating skin depressions, ArteFill. Though litigation was not our first choice, we owe it to our shareholders to preserve their investment in our groundbreaking platform technology. We intend to enforce our patents vigorously," said Dr. Stefan Lemperle, co-founder and CEO of Artes Medical. About Artes Medical Artes Medical is a specialty pharmaceutical and medical device company focused on the development of new and innovative products for the Plastic Surgery and Dermatology markets. The company's lead product ArteFill(TM) is a unique permanent injectable dermal filler administered by company-trained Plastic Surgeons and Dermatologists for the treatment of facial wrinkles and scars. Artecoll(R), the predecessor product to ArteFill, has been used in over 250,000 patients in Europe, Canada, Mexico, South America and Asia since 1994. The company's product development is centered around its proprietary platform technology and formulations of injectable collagen and synthetic microspheres, which have potentially wide ranging applications as permanent bulking agents for soft tissue augmentation. ArteFill has been developed for the plastic surgery and dermatology market. In addition, the company is establishing strategic partnerships to commercialize the development of (1) ArteSeal to seal and restore spinal disc injuries and for other orthopaedic applications including non-surgical connective tissue repair; (2) ArteFlux as a soft tissue bulking agent for the treatment of gastro-esophageal reflux disease (GERD); and (3) ArteSure for the treatment of stress urinary incontinence (SUI). ArteFill has received an approvable letter from the FDA, following successful completion of company-sponsored U.S. clinical trials. The company is establishing a San Diego-based GMP manufacturing facility for the production of ArteFill and its portfolio of other development stage product candidates, including ArteSeal, ArteFlux and ArteSure. Artes Medical expects to begin marketing ArteFill to company-trained Plastic Surgeons and Dermatologists early next year. For more information about the company, technology platform
and product development activities, visit the company's website:
www.artesmedical.com Artes Medical, Inc. If You Found this Article Helpful You May Enjoy this article: New FDA-Approved Skin Fillers Changing the Face of Cosmetic Dermatology
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