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