Healthcare Industry News: Dermal Filler
News Release - April 14, 2008
Artes Medical Reports Over Seven Thousand Patients Treated with ArteFill since February 2007 Product LaunchSAN 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 folds also known as “smile line” wrinkles, today reported that dermatologists, plastic surgeons and cosmetic surgeons are actively integrating ArteFill into their practices and estimates that over 7,000 patients have been treated with the enduring solution, ArteFill, since the product launch in February 2007.
According to John H. Joseph, M.D., a leading Beverly Hills facial plastic surgeon and Assistant Clinical Professor, Department of Head and Neck Surgery, University of California, Los Angeles, “The current state of aesthetic surgery requires the use of a broad array of new technologies to enable us to achieve the natural and refreshed long-term facial rejuvenation our patient’s desire. Aesthetic surgical procedures and techniques are an important foundation of my practice; however, we accent, enhance and refine our results with the use of Dermal Fillers. ArteFill’s unique non-resorbable nature provides a permanent support for the long-lasting wrinkle correction my patient’s desire. I have treated over 100 patients since ArteFill became available last year and have seen exceptional results with no complications.”
One of the largest ArteFill users in the country, San Diego-based cosmetic surgeon, Sassan Alavi, M.D., Medical Director for the Center for Cosmetic Surgery, San Diego, California stated, “Many patients come to my practice looking to improve the appearance of their smile lines, seeking a longer-term result than they have obtained previously. In the past we have used temporary wrinkle treatments; however, many of my patients desire long-term aesthetic improvement and are not satisfied with the required repeat maintenance with temporary wrinkle treatments. To address this wide-spread patient interest in obtaining long-term results, we rapidly integrated ArteFill into our medical practice. I am quite pleased with the excellent wrinkle correction and strong safety profile of ArteFill, and my patients express high levels of satisfaction with this enduring product.”
Since market launch one year ago the Company has trained over 1,200 board certified dermatologists, plastic surgeons, and cosmetic surgeons on the use of ArteFill. The Company launched a new advertising campaign with consumer-friendly print ads in many large metropolitan regions and cities including New York, Baltimore, Los Angeles, San Francisco, Miami, San Diego and Dallas. Additionally, the Company recently announced the launch of ArteFill.com the consumer-website, http://www.artefill.com/consumer, which includes testimonials from clinical trial patients treated over eight years ago, a before and after photo gallery of ArteFill patients, and a consumer video educating patients on the use of ArteFill.
“In the last twelve months since the ArteFill market launch, we have seen dermatologists and plastic surgeons actively incorporate ArteFill into their injectable aesthetic medical practice. Their ArteFill experiences are further supported by the 5-year safety and efficacy data reported in the peer-reviewed journal publication Dermatologic Surgery issued in December 2007. Now that we are moving forward into our consumer marketing phase, we are pleased that new patients are responding positively to our newly initiated consumer marketing programs. We are excited that physicians are continuing to establish ArteFill as an important element of their medical practice and those patients who have been treated love the natural look and feel of the long-lasting aesthetic results,” said Diane S. Goostree, President and Chief Executive Officer.
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 journal 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 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". In March 2007, the Company 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 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 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 and its need to raise additional funds to support its operations, its reliance on its sole FDA-approved product, ArteFill, its limited experience in commercializing ArteFill, its future receipt of FDA approval to enhance the product label for ArteFill to extend the efficacy period of ArteFill beyond six months, and the risk that the Company's revenue projections may prove incorrect because of unexpected difficulty in generating sales and 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 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. All other trademarks referred to in this press release are the property of their respective owners.
Source: Artes Medical
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