Artes Medical's 5-Year Safety and Efficacy Data Presented at the American Academy of Dermatology Conference
Mark G. Rubin, MD, Assistant Clinical Professor of Dermatology, University of California, San Diego, Division of Dermatology, presented data from a 5-year safety and efficacy study of ArteFill in the "Soft Tissue Augmentation" session. The data presented was published in the December 2007 Filler Issue of Dermatologic Surgery, a peer-reviewed publication of the American Society for Dermatologic Surgery. Dr. Rubin also discussed his views and experience in using ArteFill in his clinical practice over the last year.
Additionally, a live ArteFill injection demonstration was performed by Rhoda S. Narins, M.D., Past President of the American Society for Dermatologic Surgery and Clinical Professor of Dermatology at New York University Medical School. Dr. Narins' demonstration using ArteFill in the nasolabial folds during the "The State of the Art of Aesthetic Dermatology" session illustrated the ease of use of ArteFill for the correction of smile lines.
"We are pleased to participate in this year's AAD meeting. ArteFill, is in a class of its own, as no other filler on the market to date has demonstrated a continued wrinkle correction five years following treatment," said Diane S. Goostree, President and Chief Executive Officer, Artes Medical. "Since the ArteFill market launch one year ago, physicians have treated thousands of patients. Both physicians and patients have reported that ArteFill provides a beautiful and natural look and feel in the patient's face as the product provides long-term wrinkle correction."
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 six 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.
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 United States through Artes Medical, and Artes Medical has not entered into distribution or licensing arrangements with any third party for the distribution or sale of ArteFill, or any other PMMA-based dermal filler, outside the United States.
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(R), is being marketed to men and women as a treatment option for the correction of nasolabial folds. Additional information about Artes Medical and ArteFill is available at www.artesmedical.com and www.artefill.com.
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, its ability to receive FDA approval to claim that the aesthetic benefits of ArteFill extend beyond six months and delays in the market acceptance of ArteFill, 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.
Posted: February 2008