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Artes Medical Begins Qualification of U.S. Manufacturing of ArteFill; Company Takes Significant Next Step toward Final FDA Approval (press release from Artes Medical, Inc.)
SAN DIEGO---April 27, 2005--Artes Medical Inc., a privately held specialty pharmaceutical
and medical device company, today announced it has begun qualification runs of its
flagship product, ArteFill(TM), at its newly completed commercial cGMP manufacturing
facility in San Diego. ArteFill is a permanent injectable wrinkle filler used to
correct smile lines or naso-labial folds. These qualification runs of ArteFill are a critical step in the final FDA approval process for Artes Medical. The FDA approvable letter, received by Artes Medical in January 2004, required this milestone to be achieved in order to complete the full FDA approval process. "Reaching this important milestone, we are now preparing for commercial manufacturing of ArteFill," said Dr. Stefan Lemperle, president and CEO of Artes Medical. "This represents the culmination of efforts of a talented team of employees, partners and contractors." ArteFill is a unique combination of homogeneous precision-filtered synthetic microspheres suspended in a solution of ultra-purified collagen and lidocaine to alleviate discomfort during injection. When ArteFill receives final FDA approval, it will be the first approved permanent injectable implant for the correction of naso-labial folds, stimulating the production of the patient's own collagen to provide a lasting effect. Over the last decade, Artecoll, ArteFill's predecessor, has been used in over 250,000 patients outside the United States to correct a wide variety of facial wrinkles and scars. Validation of the manufacturing processes for ArteFill and facilities inspection by the FDA are anticipated in summer 2005. Artes Medical is preparing for final FDA and commercial approval to occur early fall 2005. Artes Medical's new 35,000 sq. ft. manufacturing facility has 14,000 sq. ft of FDA compliant, cGMP cleanroom manufacturing suites, 15,000 sq. ft. of manufacturing support laboratories, and 6,000 sq. ft. of office space. The company plans to employ over 100 employees before the end of the year. Artes Medical will use its new facility to centralize worldwide manufacturing and distribution of ArteFill. About Artes Medical, Inc. Artes Medical helps physicians in the facial aesthetics market significantly improve patient outcomes through Aesthetic Tissue Engineering(TM) and partners with physicians to build their practices. The company's lead product is ArteFill(TM). ArteFill is a unique combination of precision filtered synthetic microspheres (20%) evenly suspended in Ultra-Purified Collagen(TM) (80%). After ArteFill is injected, the microscopic spheres stimulate the body's own natural collagen production to replace the purified collagen. The autologous collagen builds volume and encapsulates each permanent microscopic sphere to achieve enduring wrinkle correction. The ArteFill Progressive Enhancement Procedure(TM) allows for treatment in stages, giving patients the exact look they desire, and will only be available from Artes-certified physicians. ArteFill's pre-market approval application (PMA) received an approvable letter from the FDA in January 2004. Once ArteFill receives final approval, it will be the only FDA-approved permanent injectable implant for the treatment of smile lines or naso-labial folds on the market. Over the last decade, Artecoll, ArteFill's predecessor, has been used in over 250,000 patients outside the United States to correct a wide variety of facial wrinkles and scars. For more information about the company and its products, visit the company's website www.artesmedical.com . Artes Medical, Artecoll, ArteFill, Ultra-Purified Collagen and ArteFill Progressive Enhancement Procedure are trademarks of Artes Medical, Inc. Townsend Inc. for Artes Medical Inc. |
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