Dermatologic Surgery Journal Publishes Comparison of Global PMMA-Based Dermal Fillers Showing Superior Characteristics of ArteFill Microspheres
This newly published study evaluated five different PMMA products available over the past several years in the U.S. (one product), Europe (one product), Brazil (two products) and Canada (one product) for PMMA microsphere size and morphology using Scanning Electron Microscope (SEM) techniques. Each of the five products was evaluated with respect to PMMA microsphere size, homogeneity and surface characteristics. Results from the comparison show marked differences with respect to PMMA microsphere size and morphology. Products obtained from various markets outside the U.S. over time contained variable PMMA particle sizes with shape and surface irregularities, whereas the U.S. product, ArteFill, demonstrated round, smooth, uniformly sized particles.
The authors cite literature support for the premise that microsphere-containing products may have different safety profiles based on the composition, morphology and surface characteristics of the microspheres they contain. In particular, highly variable particle size, morphology and surface characteristics may impact particle migration and overall biocompatibility. In contrast, uniform PMMA particles are believed to be a critical component of a consistent filler product. A recent landmark study confirmed the excellent safety profile of ArteFill over a five-year period.
"In previous studies, the safety profile of microspheres has been correlated to particle size and morphology. This comparison shows that ArteFill's PMMA particles are smooth, round and uniformly sized, which is in stark contrast to many other PMMA based fillers reviewed," said Daniel Piacquadio, M.D., CEO of Therapeutics Inc. and co-author of the study. "We believe it's important for healthcare providers to recognize that all PMMA-based fillers are not created equal, and the safety profiles of products manufactured outside the U.S. may differ greatly from ArteFill's well established safety profile."
This comparison further validates that ArteFill, a third-generation PMMA filler, is in a class of its own," said Christopher J. Reinhard, Executive Chairman, Artes Medical. "ArteFill is made in our 39,000 square foot cGMP manufacturing facility in San Diego which includes class 100 clean rooms where we manufacture ArteFill to precise and exacting standards. Since commercial launch, more than 7,000 patients have chosen ArteFill for long-lasting correction of their smile line wrinkles. These patients have embraced ArteFill's unique ability to deliver immediate, natural results that truly stand the test of time, as evidenced by the five-year safety and efficacy study published in December 2007."
ArteFill is a unique dual-acting aesthetic injectable implant that provides both immediate and enduring cosmetic benefits. ArteFill consists of a proprietary combination of PMMA microspheres suspended in a carrier gel containing highly purified bovine collagen with 0.3 percent lidocaine. ArteFill visibly corrects the smile line by providing volume beneath the wrinkle, similar to other dermal fillers. Following injection, the PMMA microspheres, which are 30 to 50 microns in diameter and barely visible to the naked eye, reside at the injection site for persistent wrinkle correction. The Company believes that the uniformity of size, shape and surface area of each microsphere, taken together with manufacturing consistency, plays an important role in the safety and efficacy of PMMA-based products.
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 and Dr. Rhoda S. Narins, Past President of the American Society for Dermatologic Surgery, are co-leading a study evaluating 1,000 patients treated with ArteFill over the course of five years to further evaluate efficacy and safety. "Since its introduction to the market over a year ago, ArteFill has filled a void for a more enduring solution to smile line wrinkles," said Dr. Narins. "We look forward to results from the 1,000 patient clinical 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 PMMA microspheres in ArteFill are not absorbed by the body and therefore provide the first-of-its-kind long-lasting 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 publication 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 aesthetics company focused on developing, manufacturing and commercializing new and innovative medical aesthetic products including 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 contains 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 ability to timely raise additional funds to support its operations, its ability to manage its operating expenses, its reliance on its sole FDA-approved product, ArteFill, its limited experience in commercializing ArteFill, its future receipt of FDA approval to extend the efficacy period of ArteFill beyond six months and eliminate the skin test requirement, 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(R) and ArteFill(R) are registered trademarks of Artes Medical, Inc.
Posted: June 2008