Artes Medical Announces Completion of Enrollment in 1,000 Patient Post-Marketing ArteFill Study
21 Octubre 2008 - 5:00AM
Business Wire
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�, 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� 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
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