Healthcare Industry News: Hyaluronic Acid
News Release - May 9, 2008
Artes Medical Reports Strong Consumer Interest, Rapid Patient Enrollment and Positive Feedback in Largest U.S. Dermal Filler Clinical StudyOver 7,000 Patients Treated With ArteFill Since Launch in 2007 With No Serious Adverse Effects Reported; Research Shows High Patient and Physician Satisfaction
SAN DIEGO--(HSMN NewsFeed)--Artes Medical, Inc. (Nasdaq:ARTE ) today reported strong consumer interest, rapid patient enrollment and positive feedback in what it believes is the largest US-based post-marketing safety and efficacy study in the dermal filler industry. The Company said that the study, which was initiated in late 2007, has enrolled over 700 patients through April. Enrollment is expected to ultimately reach 1,000 patients. Feedback from both physicians and patients to date has been very positive, with high levels of interest from consumers to participate in the study.
Artes Medical, Inc. is 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.
Also, in April of this year, Artes Medical announced that over 7000 patients had been treated with ArteFill since its launch in February 2007. The Company said it was pleased to report that independent market research has indicated a high level of physician and patient satisfaction. The Company said, to date, no serious adverse events have been reported to the Company.
“Artes Medical is the only dermal filler company that has completed a 5-year safety and efficacy study, showing continued wrinkle correction with its product -- ArteFill -- over a 5 year period with a positive safety profile,” said Diane Goostree, Artes Medical President and Chief Executive Officer. “These data were published in the peer-reviewed journal Dermatologic Surgery in December 2007 and were submitted to the FDA for review for possible incorporation into product labeling.”
Ms. Goostree added, “It is unfortunate that Dr. Arnold Klein, a dermatologist in Los Angeles, California, recently made unsubstantiated and misleading statements about the safety of ArteFill that we feel we must correct,” she said. “While we encourage open discourse among physicians relating to injectable aesthetic products, Dr. Klein’s statements and allegations relating to ArteFill have no basis in fact.”
“We were informed recently that Dr. Klein, without any substantiation, told the Los Angeles County Coroner’s office during the course of the Coroner’s investigation, that ArteFill was used on the decedent. Dr. Klein attempted to implicate ArteFill in the death of the decedent. We were also told that Dr. Klein made statements to the Coroner’s office that bovine-derived substances could cause immune dysfunction of the lung,” Ms. Goostree said.
The Company immediately investigated Dr. Klein’s assertions, which included interviewing both the Los Angeles County Coroner’s office and the physician who treated the decedent with aesthetic injectable products. From the investigation, the Company determined that what Dr. Klein has alleged has no basis in fact. The Company learned that the patient in question died of unknown causes and that the patient had not been treated with ArteFill. Artes Medical was informed by the treating physician that the physician had never injected ArteFill into the decedent; but rather had treated the decedent with Botox® and a Hyaluronic Acid dermal filler. This information is consistent with the Company’s customer records, as Artes Medical sells ArteFill only to trained physicians, and has never sold ArteFill to the decedent’s treating physician. As a result of this investigation, the Company has determined that ArteFill was not injected into the decedent, and therefore was not a cause or contributing factor in the death of this patient.
Bovine collagen has been used safely in over 500,000 patients since it was approved by the FDA in 1981 and is a component of Zyderm®, Zyplast®, and ArteFill. Bovine collagen is sold in more than 60 countries around the world. Dr. Klein has himself used bovine collagen fillers extensively on patients for more than twenty years.
Years of testing show that ArteFill is a safe and effective product that meets all rigorous FDA requirements.
“Our 5-year data and physician and patient experience since launch confirm ArteFill’s strong efficacy in wrinkle correction, and excellent safety profile,” Ms. Goostree said. “Both the doctors and patients who use it are very pleased with its safety and results. We are disappointed that Dr. Klein inserted himself into a private matter involving the Los Angeles County Coroner’s Office and attempted to discredit Artes Medical and its product ArteFill through the use of false and misleading information.”
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. 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.
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<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. The Company has also submitted the data to the FDA for review in order to enhance the product labeling for ArteFill.
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 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 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 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® and ArteFill® are registered trademarks of Artes Medical, Inc. All other trademarks, trade names and brand names referred to in this press release are the property of their respective owners.
Source: Artes Medical
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