SAN DIEGO, May 4 Suneva Medical, a privately-held aesthetic medical device company, today announced that Steven R. Cohen, M.D., F.A.C.S, Clinical Professor, University of California, San Diego and John H. Joseph, M.D., F.A.C.S, Assistant Clinical Professor, UCLA, presented interim results from the prospective, open-label, five-year safety study on Artefill for nasolabial fold (NLF) correction. The oral presentations took place at the American Society of Aesthetic Plastic Surgery's Aesthetic Meeting 2010 in Washington, D.C. and the American Academy of Facial Plastic & Reconstructive Surgery's International Symposium in Hollywood, FL, respectively.
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Dr. Cohen commented, "Artefill has consistently proven to be an effective, more permanent treatment option for smile lines. Our initial findings from this five-year study are consistent with the pivotal trial and show Artefill has a safety profile that appears to be similar to other dermal fillers on the market today."
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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.
Dr. Joseph added, "Patient satisfaction is critical to our success as surgeons. Our patients have been extremely pleased with the long-term benefits of Artefill and the interim trial results further support this, showing consistent and lasting high patient satisfaction ratings with the product."
About Artefill
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. For more information visit www.artefill.com.
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. For more information visit www.sunevamedical.com.
Contact: Kellie Walsh 914-315-6072 [email protected]
SOURCE Suneva Medical, Inc.
