FDA Approves ArteFill
FDA Approves ArteFill as the First Non-Resorbable Injectable Wrinkle Filler to Correct Smile Lines
Artes Medical Announces FDA Approval for ArteFill as the First Non-Resorbable Injectable Wrinkle Filler to Correct Smile Lines
SAN DIEGO, October 30, 2006 - Artes Medical, Inc., a medical technology company focused on developing, manufacturing and commercializing a new category of aesthetic injectable products for men and women, today announced the United States Food and Drug Administration’s approval of ArteFill. ArteFill is the first and only non-resorbable aesthetic injectable implant approved by the FDA. The product is indicated for the correction of facial wrinkles known as nasolabial folds, or smile lines. Unlike existing dermal fillers that are completely metabolized by the body, ArteFill represents the first product in a new category of non-resorbable dermal fillers providing a permanent support structure for enduring wrinkle correction. Artes Medical intends to begin marketing and selling ArteFill to dermatologists, plastic surgeons and cosmetic surgeons in the U.S. through the Company’s direct sales force.
"We are pleased to introduce ArteFill, a uniquely-designed product, for the expanding aesthetic market," said Diane S. Goostree, President of Artes Medical. "Based on ArteFill’s proven results and high level of patient satisfaction observed in our clinical trials, ArteFill addresses the unmet patient demand for enduring wrinkle correction."
ArteFill contains a proprietary combination of ArteFill Precision-Filtered Microspheres(TM) suspended in a carrier gel containing purified bovine collagen. Artes Medical produces the microspheres from one of the most commonly used synthetic implant materials in medicine, polymethylmethacrylate (PMMA). The size of the microspheres is strictly regulated to help ensure consistent and safe results. The microspheres are 30 to 50 microns in size, barely visible to the naked eye. Artes Medical produces the purified collagen gel in accordance with both FDA and USDA guidelines. After ArteFill is injected into a patient’s smile line, the microspheres provide a permanent support structure beneath the skin to support the wrinkle and to prevent further wrinkling.
"For the first time, U.S. consumers have an FDA-approved, non-resorbable aesthetic injectable product available that is designed to provide correction for smile lines, the primary external sign of facial aging," said Stefan M. Lemperle, MD, a founder of Artes Medical.
The Company manufactures ArteFill at its fully integrated, cGMP compliant, dedicated facility located in San Diego, California.
ArteFill is indicated for the correction of facial wrinkles known as nasolabial folds or smile lines. An ArteFill Skin Test is required before initial treatment. The most common adverse events associated with ArteFill injections, similar to those observed with other dermal fillers, are lumpiness, persistent swelling or redness and increased sensitivity at the injection site. For more information on ArteFill, including complete product information, visit www.artefill.com. Artes Medical intends to offer a comprehensive training program to dermatologists, plastic surgeons and cosmetic surgeons. The goal of the training program is to maximize patient and physician satisfaction with ArteFill by fostering consistent and high-quality treatments. ArteFill and the ArteFill Skin Test are expected to be available in the U.S. in the next 45 to 60 days.
U.S. Clinical Study
The FDA approval of ArteFill was based on data from the Company’s 12-month, controlled, randomized, double-masked, prospective, multi-center U.S. clinical trial. Patients treated with ArteFill (n=251) showed significantly greater and persistent improvement compared to those treated with the collagen control (Zyplast). At the 6 month evaluation, which was the primary efficacy evaluation period, the wrinkle correction in the patients treated with ArteFill persisted, while the patients treated with the collagen control returned to their pretreatment status. The safety profiles for ArteFill and the collagen control group were comparable. ArteFill patients were also evaluated one year after treatment, demonstrating continued safety and wrinkle correction. Based on our clinical data, the FDA approved ArteFill as a safe and effective non-resorbable injectable implant for the correction of nasolabial folds in men and women.
Source: Artes Medical, Inc.
Posted: October 2006