Artes Medical Obtains ISO 13485:2003 Quality System Certification; Quality System Certificate First Step to CE-Marking and Canadian CMDCAS Approvals

Business Wire, Jan 5, 2006

SAN DIEGO -- Artes Medical, a fully-integrated medical technology company focused on the development, manufacture and commercialization of a new category of permanent injectable aesthetic products, today announced it has received a quality system certificate demonstrating compliance with ISO 13485:2003, the internationally recognized quality system standard for medical device manufacturers. E[acute accent]Artes Medical joins the ranks of internationally renowned medical device manufacturers who have obtained ISO 13485:2003 quality system certificates. ISO 13485:2003 specifies quality management system requirements for an organization to demonstrate its ability to consistently provide products and services at the highest level of quality. The ISO 13485:2003 certificate is the first step towards demonstrating compliance with appropriate medical device regulatory and statutory requirements for CE-marking in the European Union and for Canadian approval. E[acute accent]"The quality policy for Artes Medical is to strive for continuous improvements in all of our business practices. Obtaining this ISO 13485:2003 quality system certificate is a major achievement for the company. Artes has shown a commitment to the highest standard of quality for our customers and the desire to advance our systems, processes and products to the next level," said Stefan Lemperle, M.D., President and CEO of Artes Medical. "We plan to apply for CE-marking for Europe and Canadian CMDCAS approval in early 2006." E[acute accent]Developed by the International Organization for Standardization, ISO 13485:2003 is a stand-alone medical device quality system standard especially intended for the medical device industry focusing on regulatory quality system requirements.

E[acute accent]About Artes Medical, Inc.

E[acute accent]Artes Medical is a fully-integrated medical technology company focused on the development, manufacture and commercialization of a new category of injectable aesthetic products for the dermatology and plastic surgery markets. The company's lead product ArteFill(R) is based on the company's proprietary Aesthetic Tissue Engineering(TM) platform from which other products will be developed. E[acute accent]ArteFill is a unique combination of Precision-Filtered Microspheres(TM) evenly suspended in Purified Bovine Collagen(TM). ArteFill stimulates the body's own natural collagen production to build volume and achieve enduring wrinkle correction. ArteFill's pre-market approval application (PMA) has been deemed approvable by the FDA. Once ArteFill receives final approval, it will be the first and only FDA-approved permanent injectable micro-implant for the treatment of facial wrinkles known as smile lines or nasolabial folds. E[acute accent]Based in San Diego, Calif., Artes Medical was founded in 1999 and is privately-held. Additional information about the Company and its products are available at www.artesmedical.com. Artes Medical and ArteFill, are registered trademarks of Artes Medical, Inc.