Healthcare Industry News:  Dermal Filler 

Devices Dermatology

 News Release - March 21, 2007

Artes Medical Submits Five Year Artefill(R) Clinical Results to FDA

Study Demonstrates Continued Safety and Efficacy at the Five Year Mark in Patients Treated With the Only FDA-Approved Non-Resorbable Injectable Dermal Filler

SAN DIEGO--(HSMN NewsFeed)--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, has submitted the results of a 5-year efficacy and safety study of ArteFill® to the FDA in order to enhance product labeling. ArteFill® is the first and only non-resorbable injectable filler for the correction of wrinkles known as smile lines or nasolabial folds and was approved by the FDA in October 2006.

About ArteFill®

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.

The Company recently completed a 5-year follow-up study of 145 patients who were treated with ArteFill in the Company's U.S. clinical trial. In addition to demonstrating the safety profile of ArteFill, the study showed statistically significant (p less than 0.001) improvement in patient wrinkle correction 5 years after the patient's last ArteFill treatment, and a statistically significant (p less than 0.002) improvement in wrinkle correction at the 5-year point compared to the 6-month evaluation period. As part of the study, physician investigators and patients were asked to provide their assessment of ArteFill treatment. Over 90% of the physician assessments were either "completely successful" or "very successful"; and over 90% of the patient assessments were either "very satisfied" or "satisfied." The Company has submitted the data from the study to the FDA for review in order to enhance the product labeling for ArteFill.

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. Additional information about Artes Medical and ArteFill is available at www.artesmedical.com and www.artefill.com.

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 ability to receive FDA approval to claim that the aesthetic benefits of ArteFill extend 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® and ArteFill® are registered trademarks of Artes Medical, Inc.


Source: Artes Medical

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