Healthcare Industry News: Dermal Filler
News Release - December 10, 2007
Dermatologic Surgery Journal Publishes Landmark Study Showing Positive Five-Year Effects of ArteFill for Smile LinesSAN DIEGO--(HSMN NewsFeed)--Artes Medical, Inc. (Nasdaq:ARTE ), a medical technology company whose product ArteFill® is the first and only FDA-approved non-resorbable injectable Dermal Filler for the correction of nasolabial fold or “smile line” wrinkles, today announced the publication of positive data from a long-term safety and efficacy study of ArteFill in the December Filler Issue of Dermatologic Surgery, a peer-reviewed publication of the American Society for Dermatologic Surgery. The study is available at http://delivery.sheridan.com/index.php?ID=blk/BLK_130959_CP.
Results from the study, led by Steven R. Cohen, MD, Clinical Professor, Division of Plastic Surgery, University of California, San Diego School of Medicine, showcase the safety and aesthetic outcomes over a five-year period in patients treated with ArteFill for nasolabial fold wrinkles. This 5-year follow-up study evaluated 145 patients who were treated with ArteFill in Artes Medical’s U.S. pivotal clinical trial. In addition to demonstrating the safety profile of ArteFill, the study showed statistically significant (p<0.001) improvement in patient wrinkle correction 5 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.
The published article states the safety profile of the product is consistent with that of other temporary Dermal Fillers. This comparison, however does not take into account the potential increased safety risks resulting from the multiple injection treatments required by other Dermal Fillers to achieve a similar 5 year correction as demonstrated in the study.
In addition, as a part of this study, physician investigators and patients were asked to provide their assessment of ArteFill treatment over the five year period. 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." Artes Medical submitted the data from the study to the FDA for review in order to enhance the product labeling for ArteFill and is in active discussions with the FDA regarding this retrospective analysis of its pivotal clinical trial data.
"The data presented in this article represents the most comprehensive study of a Dermal Filler product to date and provides important safety and efficacy data of ArteFill at five years after injection," said Dr. Cohen. "The study confirms the safety profile of ArteFill in patients five years after treatment and demonstrates that ArteFill continues to provide optimal wrinkle correction over time. Because of ArteFill's unique non-resorbable nature, which utilizes a microsphere support structure under the wrinkle to provide a truly long-lasting correction, it is now becoming an important complement to other non-invasive dermatological procedures and will increasingly be used in association with a wide variety of plastic surgery procedures. We're pleased that the American Society for Dermatologic Surgery (ASDS) has published this data in its peer-reviewed academic journal, providing clinically validated insights into ArteFill's highly differentiated performance when compared to the published clinical trial results of the traditional temporary Dermal Fillers."
“ArteFill is a product that is in a class of its own, as no other filler on the market to date has been proven to last beyond a year, let alone demonstrates a continued statistically significant improvement in wrinkle correction five years following treatment,” said Diane S. Goostree, President and Chief Executive Officer, Artes Medical. “Since our February ArteFill market launch, physicians have treated thousands of patients and based on patients from our long-term study, ArteFill has provided truly long-lasting wrinkle correction that beautifully integrates under the skin of a patient’s face, is undetectable to touch and feel and gracefully improves and enhances the aging face as time marches on.”
ArteFill Clinical Evaluation Continues
Artes Medical supports continued evaluation of long-term safety and efficacy of all Dermal Fillers, and is leading the way with ArteFill through additional research. Dr. Steven R. Cohen, along with Dr. Rhoda S. Narins, Past President of the American Society for Dermatologic Surgery, are also co-leading a study that will evaluate 1,000 patients treated with ArteFill over the course of the next five years to further evaluate efficacy and safety. “Since its introduction to the market nearly a year ago, ArteFill has filled a void for a more enduring solution to smile line wrinkles,” said Dr. Narins. “We’re very encouraged by the data released today in Dermatologic Surgery Journal and look forward to results from the 1,000 patient study.”
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 six 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.
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 Artes Medical, and Artes Medical has not entered into distribution or licensing arrangements with any third party for the distribution or sale of ArteFill, or any other PMMA-based Dermal Filler, 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. 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 Artes Medical’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 Artes Medical’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 Artes Medical’s history of net losses, its reliance on its sole FDA-approved product, ArteFill, its limited experience in commercializing ArteFill, its ability to receive FDA approval to claim that the aesthetic benefits of ArteFill extend beyond six months and delays in the market acceptance of ArteFill, 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 Artes Medical’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 Artes Medical 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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