SAN DIEGO--(BUSINESS WIRE)--Apr 17, 2007 - Artes Medical, Inc.
(Nasdaq:ARTE), a medical technology company focused on developing,
manufacturing and commercializing a new category of aesthetic
injectable products for men and women, today announced that the
final 5-year safety and efficacy data for ArteFill(R), the
Company's FDA-approved non-resorbable injectable dermal filler will
be presented at the national meeting of the American Society for
Aesthetic Plastic Surgery (ASAPS) on April 20, 2007 in New York
City by Steven R. Cohen, MD, FACS, Clinical Professor, Division of
Plastic Surgery, University of California, San Diego, School of
Medicine and lead ArteFill clinical investigator. The session will
also include a live patient workshop to demonstrate the proper
techniques in the treatment of nasolabial folds (smile lines).
The 5-year clinical data represents the culmination of a
significant follow-up study of 145 patients who were treated with
ArteFill in the Company's U.S. clinical trial. The Company has
submitted the data to the FDA in order to enhance the product
labeling of ArteFill.
About ArteFill(R)
ArteFill is the first and only FDA-approved non-resorbable
injectable dermal filler for the correction of wrinkles known as
smile lines or nasolabial folds. The unique microspheres in
ArteFill are not absorbed by the body and therefore provide the
first-of-its-kind permanent support for long-lasting wrinkle
correction in one to two treatments.
ArteFill was approved by the FDA in October 2006 based on data
from the Company's 12-month controlled, randomized, double-masked,
multi-center U.S. clinical trial, which compared outcomes for
patients treated with ArteFill with those of patients treated with
the leading bovine collagen-based filler. At the 6-month
evaluation, which was the primary efficacy evaluation period for
the clinical trial, the wrinkle correction in patients treated with
Arte
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