Study participants will receive ArteFill injections into their facial wrinkles, known as nasolabial folds or smile lines, at up to twenty-five leading Dermatology and Plastic Surgery centers throughout the United States and Canada. The co-lead investigators are Steven R. Cohen, M.D., Clinical Professor, Division of Plastic Surgery, University of California, San Diego School of Medicine, and a Board Certified Plastic Surgeon; and Rhoda S. Narins, M.D., Past President of the American Society of Dermatologic Surgery and Clinical Professor of Dermatology at New York University Medical School, and a Board Certified Dermatologist, both leading dermal filler experts and members of the Artes Medical Advisory Board.

Participants will be assessed regarding long-term wrinkle correction and the safety profile of ArteFill over the five-year period. They will also be asked to rate their satisfaction with the treatment during this period. Previous patients have indicated very high levels of both short and long-term patient satisfaction ratings of over 90 percent in previous studies. Treatment will be according to the approved product labeling, and limited to the smile lines, which is the only indication approved by the FDA.

"A number of patients in our practice are asking for a longer lasting filler due to the time and cost associated with temporary filler injections. ArteFill represents a novel solution for those patients who don't want to return for repeat injections with temporary dermal fillers," said Dr. Cohen.

"With the expansion of the dermal filler category, evidence-based data remains vital in providing the key insights into a product's efficacy and safety. With this in mind, Artes has initiated this large multi-patient clinical trial to show that ArteFill's unique formulation, combined with its long-term efficacy and safety data, will meet patient expectations for a product with optimal and long-lasting results," said Dr. Narins.

Artes Medical previously announced in February 2007 that it completed an evaluation of 145 patients from the original ArteFill U.S. pivotal trial over a five-year period, and submitted this five-year safety and efficacy data to the FDA in March of 2007. The Company is in active discussions with the FDA regarding this retrospective analysis of its pivotal clinical trial data. These five-year results from the ArteFill pivotal trial have also been submitted and accepted for publication in the peer-reviewed journal Dermatologic Surgery, with publication expected by the end of this year.

"We are happy to announce the initiation and treatment of patients in this important post-marketing study with our final commercialized formulation, ArteFill," said Diane S. Goostree, President and Chief Executive Officer. "We are leading the way in the injectable aesthetics industry with long-term monitoring of dermal filler patients based upon our previous five-year assessment from our pivotal trial, and this new trial of 1000 new patients. No other company in our industry has generated this level of long-term safety and efficacy data with its dermal filler."

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 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.

In February 2007, the Company announced it completed a five-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 five years after the patient's last ArteFill treatment, and a statistically significant (p=0.002) improvement in wrinkle correction at the five-year point compared to the six-month evaluation period. As part of the study, physician investigators and patients were asked to provide their assessment of ArteFill treatment. Over 90 percent of the physician assessments were either "completely successful" or "very successful;" and over 90 percent of the patient assessments were either "very satisfied" or "satisfied." In March 2007, the Company submitted the data from the study to the FDA for review in order to enhance the product labeling for ArteFill.

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 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, 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 U.S. in 2006, an increase of 25 percent over the prior year, according to the American Society for Aesthetic Plastic Surgery, or ASAPS. 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 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:
Artes Medical, Inc.
Cheryl Monblatt Allen, 858-550-9999, callen@artesmedical.com or
Corporate Media: Schwartz Communications, Inc.
Brooke Chappell or Thea Lavin, 415-512-0770, artes@schwartz-pr.com

SOURCE: Artes Medical, Inc.