Healthcare Industry News: Restylane
News Release - November 27, 2007
ArteFill in Head to Head Investigator-Initiated Study to Test Comparative Duration, Safety, and Patient Preference for Dermal Fillers for the Treatment of Smile LinesDr. Stacy Smith Launches Study to Compare ArteFill, Radiesse and Restylane, Other Studies Underway
SAN 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 “smile line” wrinkles, today announced that Dr. Stacy Smith, a leading San Diego based dermatologist, is conducting a head-to-head clinical study comparison of dermal fillers – ArteFill, Radiesse and Restylane. This 24 patient study will evaluate nasolabial fold, or smile line wrinkle, correction over a two year period.
Stacy R. Smith, MD, President, Therapeutics Clinical Research, Assistant Clinical Professor of Dermatology, University of California San Diego, Division of Dermatology, is conducting this “split-face” study whereby patients will receive ArteFill on one side of their face and will receive a temporary dermal filler, either Restylane or Radiesse on the other. Every three months, photographs will be taken to allow a blinded evaluation of the patients’ degree of wrinkle correction. Patients will also be asked to provide their assessment of wrinkle correction and level of satisfaction with the treatment on each side of their face. These patients will be followed for a total of two years and the possibility of announcing interim results will be assessed by Dr. Smith throughout the study. When one of the smile lines on the “temporary filler treated” side of their face returns to baseline, the patient will have the option to cross over and receive ArteFill.
Dr. Smith expects to enroll 24 patients by the end of March 2008. A patient satisfaction survey along with patient photos of the results are part of the study protocol. After study completion, these findings will be submitted and are expected to be published in a peer reviewed dermatology journal.
For more information on Dr. Smith or his study, please call (858) 571-6800 or visit www.therapeuticsresearch.com. Dr. Smith received a research grant from Artes Medical, Inc. to conduct this study.
Artes Medical is evaluating and anticipates awarding clinical research grants to other investigators for additional ArteFill studies. Press releases issued by physicians conducting clinical studies with research grants from Artes Medical will be posted on the Investor Relations section of our website at www.artesmedical.com under “Investigator-Initiated Studies.”
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 February 2007, the Company announced it 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." 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. 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 for Aesthetic Plastic Surgery, or ASAPS. 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, its future receipt of FDA approval to enhance the product label for ArteFill to extend the efficacy period of ArteFill 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 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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