Artefill Inventor Debunks Myths about Much Anticipated Wrinkle Filler from Artes Medical at Plastic Surgery Conference.

Business Editors/Health/Medical Writers

SAN DIEGO--(BUSINESS WIRE)--May 23, 2003

Speaking at a conference of the American Society for Plastic Surgeons in Boston on Wednesday, Dr. Gottfried Lemperle, inventor of Artefill and chief scientific officer of San Diego-based Artes Medical, clarified how any unlikely side-effects from the only permanent wrinkle filler to go through U.S. clinical trials are easily treated and reversible.

"All complications -- should they occur -- can be solved within one to three months with simple shots of intralesional corticosteroids," said Dr. Lemperle, who has treated over three thousand patients with Artefill (known as Artecoll abroad) in a 10-year period. "Though Artefill is a permanent filler, its side effects are not necessarily permanent."

Speaking in a panel group entitled ""Fillers and Tissue Adhesives -- What's new -- what works," Dr. Lemperle challenged a spate of recent media reports and comments from doctors inexperienced with Artefill suggesting any potential problems with Artefill are permanent, irreversible and would require surgery for correction. "Surgical excision -- a procedure suggested by some doctors -- is never indicated for side-effects," stressed Dr. Lemperle.

In the panel presentation Dr. Lemperle also discussed the frequency of adverse events in the U.S. clinical trials. He said the trials showed that there were no more overall side-effects with Artefill than with bovine collagen, the control, and in fact had less severe problems overall than the already-approved filler. "The clinical study showed that Artefill is as safe and likely safer overall than collagen," he said.

Artefill already received a recommendation for approval from an FDA advisory panel in February and is estimated to have final FDA approval by summer's end. The Panel recommendation, which included conditions such as post-marketing follow-up, training of physicians and patient education, was that Artefill be approved for the treatment of facial wrinkles and other soft tissue contour deficiencies of comparable size such as acne scars and traumatic scars. Upon approval it will be the only approved permanent dermal filler in the United States for removal of wrinkles and scars.