Artes Medical Announces Completion of Enrollment and Treatment in ArteFill Skin Test Study
15 Ottobre 2008 - 1:15PM
Business Wire
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
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