Non-resorbable Injectable Dermal Filler For The Correction Of Wrinkles - Completion Of Enrollment And Treatment In ArteFill Skin Test Study

Main Category: Cosmetic Medicine / Plastic Surgery
Also Included In: Dermatology;  Clinical Trials / Drug Trials
Article Date: 16 Oct 2008 - 7:00 PDT

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Artes Medical, Inc. (Nasdaq:ARTE), a medical aesthetics company, today announced completion of the enrollment and treatment of patients in the ArteFill® Skin Test study.

The Company reports that 498 study participants are enrolled in the study and have received ArteFill Skin Test injections. The lead investigator in the study is David Wilson, M.D., of The Education and Research Foundation in Lynchburg, VA.

Each participant in the study received the ArteFill Skin Test and was assessed for a positive hypersensitivity reaction to the skin test. Any adverse events were also collected. The primary endpoint of the study is the Investigator's clinical determination of a positive skin test reaction with histopathology verification. In addition, subjects will have serum antibody levels against bovine collagen evaluated prior to and after treatment in this study.

"We are pleased to announce the completion of enrollment and treatment of patients in this important study," said Christopher J. Reinhard, Executive Chairman, Artes Medical. "Once all of the data has been fully analyzed, we will determine the appropriate next steps. Positive safety data from this study will be used to support a regulatory submission seeking an amendment to the ArteFill product usage labeling to remove the pre-treatment collagen skin test requirement."

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 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<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."

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™, 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 respectively.

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® and ArteFill® are registered trademarks of Artes Medical, Inc. Elevess is a trademark of Anika Therapeutics. All other trademarks, trade names and brand names referred to in this press release are the property of their respective owners

News Source
Cheryl Monblatt
Artes Medical, Inc.