News Release
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Artes Medical's 5-Year Safety and Efficacy Data Presented at the American Society of Plastic Surgeons (ASPS) Conference |
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-- ArteFill(R) live injection demonstration at plastic surgery conference -- SAN DIEGO--(BUSINESS WIRE)--Oct. 31, 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 its participation at the recent American Society of Plastic Surgeons (ASPS) Conference on October 27-30, 2007 at the Baltimore Convention Center, in Baltimore, Maryland. This conference is a venue for plastic and reconstructive surgeons to learn about new products, procedures and cutting-edge technology from experts in their field. In the quest to eradicate the signs of aging, cosmetic plastic surgery patients continue to demand better, long lasting results with no downtime. ArteFill was presented
during the "Facial Rejuvenation Through the Combined Use of Dermal
Fillers and Injectables" course. This
scientific session included an update on the long-term safety and efficacy of
ArteFill and a live injection demonstration by
Steven R. Cohen, MD, Clinical Professor, Division of Plastic Surgery, "Dr. Cohen's live patient injection demonstrated the ease of use, excellent flow characteristics and the immediate natural look and feel of results that can be achieved with ArteFill. We often also have patients from our 5-year clinical trial attend our injection training sessions so physicians can observe the long-lasting effects, and the continuing attractive look and feel of the implant as the face ages naturally, over a number of years. This conference was an opportune setting for plastic surgeons to learn about ArteFill's long lasting results for the correction of smile lines," said Diane S. Goostree, President and Chief Executive Officer. 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 ArteFill persisted and showed statistically significant improvement compared to the wrinkle correction in the patients treated with the collagen control, who returned to their pretreatment status. The ArteFill patients were also evaluated one year after treatment, demonstrating continued safety and wrinkle correction. In February 2007, the Company announced it completed a 5-year follow-up
study of 145 patients who were treated with ArteFill in the Company's An ArteFill Skin Test is required before initial treatment. The most common adverse events associated with ArteFill treatment, similar to those observed with other dermal fillers, are lumpiness, persistent swelling or redness and increased sensitivity at the injection site. ArteFill is a proprietary formulation comprised
of polymethylmethacrylate, or PMMA, microspheres and bovine collagen, and is the only
PMMA-based injectable product that has been approved by the FDA for the treatment of facial
wrinkles. Artes Medical is the sole manufacturer of
ArteFill, which is only available in the About Artes Medical, Inc. Artes Medical is a medical technology company
focused on developing, manufacturing and commercializing a new category of
aesthetic injectable products for the dermatology
and plastic surgery markets. The Company's initial product, ArteFill, is being marketed to
men and women as a treatment option for the correction of nasolabial
folds. There were approximately two million dermal filler procedures in the Forward-Looking Statements This news release may contain forward-looking statements that are based on the Company's current beliefs and assumptions and on information currently available to its management. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. As a result of these risks, uncertainties and other factors, which include the Company's history of net losses, its reliance on its sole FDA-approved product, ArteFill, its limited experience in commercializing ArteFill, and its future receipt of FDA approval to enhance the product label for ArteFill to extend the efficacy period of ArteFill beyond six months, readers are cautioned not to place undue reliance on any forward-looking statements included in this press release. A more extensive set of risks and uncertainties is set forth in the Company's SEC filings available at www.sec.gov. These forward-looking statements represent beliefs and assumptions only as of the date of this news release, and the Company assumes no obligation to update these forward-looking statements publicly, even if new information becomes available in the future. Artes Medical(R) and ArteFill(R) are registered trademarks of Artes Medical, Inc. CONTACT: Investor Relations: SOURCE: Artes Medical, Inc. |
© 2007 Artes Medical, Inc.