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Artes Medical Names
Greg J. Kricorian, M.D. as Its Chief Medical
Officer |
SAN DIEGO--(BUSINESS WIRE)--July 17, 2007--Artes Medical, Inc. (Nasdaq:ARTE),
a medical technology company focused on developing, manufacturing and
commercializing a new category of aesthetic injectable
products for men and women, today announced the appointment of Greg J. Kricorian, M.D. to the newly created role of Chief
Medical Officer. Dr. Kricorian will
report to Artes Medical's President and Chief
Executive Officer, Diane S. Goostree, and will have
responsibility for the clinical development and medical affairs departments.
He will also chair the Company's Medical Advisory Board (MAB), and focus on
enhancing the Company's involvement in the medical community. He will play a
key role in Artes Medical's newly formed
wholly-owned subsidiary, Spheris Medical, Inc., which will focus on
developing and commercializing new and innovative medical applications based
on the Company's proprietary microsphere tissue
bulking technology. "Greg has significant experience in the
commercial development of dermatology products as well as in the design,
execution and management of clinical studies of innovative aesthetic
products," said Ms. Goostree.
"Additionally, his strong relationships with the medical community will
strengthen our management team as we move forward with our marketing launch
campaign for ArteFill(R)." Dr. Kricorian has
over 10 years experience in the clinical and business development of cosmetic
and aesthetic dermatology products. Prior to joining Artes
Medical, he served as Senior Director, Medical Affairs for Valeant
Pharmaceuticals International, a leading global
specialty pharmaceutical company. Previously, Dr. Kricorian
held positions of increasing responsibility at ICN Pharmaceuticals (now
Valeant) and Dermatology Associates of San Diego, where he was a practicing
physician focusing on aesthetic procedures, including dermal fillers and
conducted and published research studies in aesthetic dermatology. Dr. Kricorian received his Bachelor of Science in Biology
from About ArteFill(R) 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. The Company recently completed a 5-year
follow-up study of 145 patients who were treated with ArteFill
in the Company's In addition to demonstrating the safety
profile of ArteFill, the study showed statistically
significant (p less than 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." The Company has
submitted the data from the study to the FDA for review in order to enhance
the product labeling for ArteFill. 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 About Artes
Medical, Inc. Artes
Medical is a medical technology company focused on developing, manufacturing
and commercializing a new category of aesthetic injectable
products for the dermatology and plastic surgery markets. There were
approximately two million dermal filler procedures in the Forward-Looking Statements This news release may contain
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, its reliance on its sole FDA-approved
product, ArteFill, its limited experience in
commercializing ArteFill, and its future receipt of
FDA approval to enhance the product label for ArteFill
to extend the efficacy period of ArteFill beyond
six months, 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(R) and ArteFill(R) are registered
trademarks of Artes Medical, Inc. CONTACT: Schwartz Communications, Inc. |