Artes Medical Names Greg J. Kricorian, M.D. as Its Chief Medical Officer.SAN DIEGO San Diego (săn dēā`gō), city (1990 pop. 1,110,549), seat of San Diego co., S Calif., on San Diego Bay; inc. 1850. San Diego includes the unincorporated communities of La Jolla and Spring Valley. Coronado is across the bay. -- Artes Medical, Inc. (Nasdaq:ARTE), a medical technology company focused on developing, manufacturing and commercializing a new category of aesthetic injectable in·ject·a·ble adj. Capable of being injected. Used of a drug. n. A drug or medicine that can be injected. 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 Not to be confused with Glass microphere. This article largely refers to micropheres or protein protocells as small spherical units postulated by some scientists as a key stage in the origin of life. 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 Valeant Pharmaceuticals International is a pharmaceutical company with activities spanning the drug discovery pipeline from target identification through clinical trials and commercialization. , a leading global specialty pharmaceutical company. Previously, Dr. Kricorian held positions of increasing responsibility at ICN ICN International Council of Nurses. Pharmaceuticals (now Valeant) and Dermatology Associates of San Diego, where he was a practicing physician focusing on aesthetic procedures, including dermal dermal /der·mal/ (der´mal) pertaining to the dermis or to the skin. der·mal or der·mic adj. Of or relating to the skin or dermis. fillers and conducted and published research studies in aesthetic dermatology. Dr. Kricorian received his Bachelor of Science Noun 1. Bachelor of Science - a bachelor's degree in science BS, SB bachelor's degree, baccalaureate - an academic degree conferred on someone who has successfully completed undergraduate studies in Biology from University of California, Los Angeles UCLA comprises the College of Letters and Science (the primary undergraduate college), seven professional schools, and five professional Health Science schools. Since 2001, UCLA has enrolled over 33,000 total students, and that number is steadily rising. ; his M.D. at Stanford University Stanford University, at Stanford, Calif.; coeducational; chartered 1885, opened 1891 as Leland Stanford Junior Univ. (still the legal name). The original campus was designed by Frederick Law Olmsted. David Starr Jordan was its first president. Medical School; and his Masters of Business Administration from the University of California, Los Angeles. Additionally, Dr. Kricorian received his Regulatory Affairs Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas: 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 FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. in October 2006 based on data from the Company's 12-month controlled, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , 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 Evaluation period The time interval over which funds assess a money manager's performance. 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 pretreatment, n the protocols required before beginning therapy, usually of a diagnostic nature; before treatment. pretreatment estimate, n See predetermination. 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 < 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 PMMA polymethyl methacrylate. , 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 United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. 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 ASAPS American Society for Aesthetic Plastic Surgery ASAPS Advanced Surveillance Acoustic Prediction System ASAPS Active Sonar Acquisition and Processing System . 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. 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. |
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