Leading U.S. Dermatologist Reports Positive Data On Artefill R
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Suneva Medical, a privately-held aesthetic medical device company, announced that Christopher B. Zachary, MBBS, FRCP, Professor and Chair, Department of Dermatology, University of California, Irvine, presented 18-month interim results from the prospective, open-label, five-year safety and patient satisfaction study on Artefill for nasolabial fold (NLF) correction. The data were presented at the Skin Disease Education Foundation's 34th Annual "Hawaii Dermatology Seminar" in Waikoloa, Hawaii February 14-19th.
Dr. Zachary commented, "The safety data presented at the Hawaii Dermatology Seminar should give aesthetic physicians some long awaited encouragement to view Artefill on its merits as a safe and long-lasting dermal filler. My own experience with Artefill as both a clinical investigator in the open-label, long-term safety study, and as a commercial user has been very positive."
The 23-center, prospective, open-label study consists of 1,008 patients who had no recent history of nasolabial fold correction. Patients received an initial treatment with Artefill, and up to two touch-ups after 30 and 60 days, until full correction was achieved. Potential adverse events and satisfaction data are reported by all patients at 2, 6, 12, 18, 24, 36, 48 and 60 months to assess the presence of or absence of adverse events, patient satisfaction, and any changes in health. Potential subject-reported AEs were followed up on and changes thought to be granulomas were biopsied and confirmed or ruled out by histology. All study patients will complete a final in-office visit at 60-months.
"The dermatology community continues to rally in support of Artefill and we believe that will only intensify as we report more supportive data from this long-term study," said Niv Caviar, President and Chief Executive Officer of Suneva Medical. "The data presented continues to validate what we hear consistently from our physician base, that Artefill is a great product with proven results which provides a wonderful solution for patients looking for a long-term treatment option for wrinkle correction."
Artefill is the first and only FDA-approved microsphere-enhanced dermal filler for the correction of nasolabial folds, better known as smile lines. Since Artefill was approved in 2006, over 20,000 patients have been treated successfully with very high satisfaction rates.
About Suneva Medical
Suneva Medical, Inc. is a medical technology company focused on developing, manufacturing and commercializing novel, differentiated aesthetic products for the dermatology, plastic and cosmetic surgery markets. The Company's lead product is Artefill®, the first and only microsphere-enhanced collagen filler for the correction of nasolabial folds, or smile lines.
Source: Suneva Medical
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