SAN DIEGO, Jul 28, 2008 (BUSINESS WIRE) -- Artes Medical, Inc. today reported that demand for its flagship product ArteFill(R) continues to grow, estimating that more than 10,000 patients have been treated since its launch in February 2007. ArteFill, the first and only FDA-approved non-resorbable injectable dermal filler, provides patients and doctors with a long-lasting solution for the correction of nasolabial folds, or "smile line" wrinkles.
"A growing number of my patients are looking for a simple, one-time treatment for their wrinkles that provides long-lasting results," said Dr. Benjamin Raab, dermatologist and director of the Center for Cosmetic Skin Surgery in Naperville, Illinois. "ArteFill is the ideal filler for these patients. It provides immediate wrinkle correction that looks and feels natural, and its unique, non-resorbable nature means treatment effects can be measured in years instead of months. I have treated nearly 150 patients with ArteFill with no adverse events, and my patients and I are extremely satisfied with the results."
Unlike other dermal fillers, ArteFill contains unique microspheres that are not absorbed by the body. As a result, ArteFill provides the support skin needs for long-lasting correction, with a safety profile similar to that of temporary fillers. A study supporting the safety and efficacy of ArteFill over five years was recently published in Dermatologic Surgery, a peer-reviewed publication of the American Society for Dermatologic Surgery.
"With over ten thousand ArteFill patients treated, we have reached another important benchmark in our commercial launch. We are pleased that more and more patients are realizing that ArteFill is truly in a class by itself as the first and only FDA-approved non-resorbable dermal filler for the safe and long-lasting correction of their wrinkles," said Christopher J. Reinhard, executive chairman for Artes Medical. "Physicians continue to integrate ArteFill into their practices at an accelerating rate and they are reporting excellent results relating to smile line correction and patient satisfaction. We believe that these strong clinical outcomes, combined with our increased sales force, national consumer marketing initiatives and practice development activities, have positioned ArteFill with the potential to achieve even greater levels of success in the future. We look forward to treating the next ten thousand patients with ArteFill."
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 PMMA microspheres in ArteFill are not absorbed by the body and therefore provide the first-of-its-kind support for long-lasting 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 aesthetics 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.
Forward-Looking Statements
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 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. All other trademarks referred to in this press release are the property of their respective owners.
SOURCE: Artes Medical, Inc.
