Healthcare Industry News: Dermal Filler
News Release - July 17, 2007
Artes Medical Names Greg J. Kricorian, M.D. as Its Chief Medical OfficerSAN DIEGO--(HSMN NewsFeed)--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®."
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 University of California, Los Angeles; his M.D. at Stanford University Medical School; and his Masters of Business Administration from the University of California, Los Angeles. Additionally, Dr. Kricorian received his Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society.
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 U.S. clinical trial.
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 United States through our Company, and we have not entered into distribution or licensing arrangements with any third party for the distribution or sale of ArteFill outside the United States.
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 U.S. in 2006, an increase of 25% over the prior year, according to the American Society of Aesthetic Plastic Surgeons, or ASAPS. The Company's initial product, ArteFill, is being marketed to men and women as a treatment option for the correction of nasolabial folds. Additional information about Artes Medical and ArteFill is available at www.artesmedical.com and www.artefill.com.
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® and ArteFill® are registered trademarks of Artes Medical, Inc.
Source: Artes Medical
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