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Artes Medical Announces Completion of Enrollment in 1,000 Patient Post-Marketing ArteFill Study

Posted on: Tuesday, 21 October 2008, 06:00 CDT

Artes Medical, Inc. (Nasdaq:ARTE), a medical aesthetics company, today announced that enrollment has been completed in the 1,000-patient post-marketing study required by the FDA. The study follows patients treated with ArteFill(R), the first and only FDA-approved non-resorbable dermal filler, for a five-year period.

The Company reported that 1,000 study participants have now been screened and entered into the study which includes a skin test, ArteFill injections and follow-up evaluations for safety and duration of treatment effects of their facial wrinkles, known as nasolabial folds or smile lines. All participants have been formally enrolled and skin tested with a few remaining participants scheduled to receive their Artefill injections within the coming weeks. Participants were enrolled at twenty-three leading Dermatology and Plastic Surgery centers throughout the United States. 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 in this study 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. In previous studies, patients have indicated very high levels of both short and long-term satisfaction, with ratings of over 90 percent. Treatment of the participants was done in accordance with the approved product labeling, and limited to the smile lines, which is the only indication approved by the FDA.

"We are pleased to announce the completion of patient enrollment in this important post-marketing study with our final ArteFill commercialized formulation," said Christopher J. Reinhard, Executive Chairman, Artes Medical. "In addition to assessing the safety and efficacy of ArteFill over a five-year period, this study provides us with an important opportunity to recruit key dermal filler opinion leaders from across the nation, increasing their familiarity with ArteFill and providing another pathway to deepen the use of ArteFill in clinical practice. 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, as well as this study of 1,000 new patients. No other company in our industry has generated this level of long-term safety and efficacy data with its dermal filler. As such, this study represents a large financial commitment for us. We have shipped $1.8 million of ArteFill to these clinical sites this year, including more than $500,000 this past quarter. We have a strong commitment to the completion of clinical studies involving the FDA as well as those that are conducted for strategic marketing purposes. This year, we will have spent over $3.9 million on clinical studies that include this 1,000 patient study, the skin test removal study and the support of physician-initiated clinical studies."

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 December 2007, the Company announced that ArteFill's 5-year safety and efficacy data was published in the peer-reviewed publication Dermatologic Surgery "Filler Issue." This publication addresses the robust, long-term, efficacy and safety profile of ArteFill. This 5-year follow-up study included 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 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 FDA is currently reviewing the data from the study in order to determine if it will 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, or any other PMMA-based dermal filler, outside the United States.

About Artes Medical, Inc.

Artes Medical is a medical aesthetics company focused on developing, manufacturing and commercializing a new category of injectable products for the dermatology and plastic surgery markets. The Company's flagship product, ArteFill, is being marketed to men and women as a long-lasting treatment option for the correction of nasolabial folds. The Company also markets Elevess(TM), the first FDA-approved hyaluronic acid-based wrinkle filler with lidocaine for patient comfort. Additional information about Artes Medical, ArteFill and Elevess is available at www.artesmedical.com, www.artefill.com and www.myelevess.com.

Forward-Looking Statements

This news release contains 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 and its need to raise additional funds to support its operations, its reliance on its sole FDA-approved product, ArteFill, its limited experience in commercializing ArteFill, its future receipt of FDA approval to extend the efficacy period of ArteFill beyond six months and eliminate the skin test requirement, and the risk that the Company's revenue projections may prove incorrect because of unexpected difficulty in generating sales and 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. All other trademarks, trade names and brand names referred to in this press release are the property of their respective owners.

Source: Business Wire

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