Suneva Medical, a privately-held aesthetic medical device company, today announced 18-month interim results from its prospective, open-label, five-year safety and patient satisfaction study on Artefill for nasolabial fold (NLF) correction. The study assessed adverse events with Artefill starting at 6-months post treatment. Initial results show the incidence of adverse events with Artefill compare favorably to the current label, and that the majority of patients (88%) reported a high satisfaction rating. Upon completion, this will be the largest and longest duration prospective U.S. clinical study of any dermal filler.
The data is being presented by study investigator W. Philip Werschler, M.D., FAAD, FAACS, Assistant Clinical Professor in Medicine/Dermatology at University of Washington, at the Advances in Cosmetic and Medical Dermatology's "Maui Derm 2010" Meeting taking place in Maui, Hawaii January 23-27th.
Dr. Werschler commented, "Our initial analysis is very encouraging as it further validates Artefill's strong safety profile and high level of patient satisfaction for long-term wrinkle correction. A granuloma incidence rate of less than 0.1% is also indicative of this and suggests Artefill is as safe as other dermal fillers, such as Juvederm and Restylane."
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 by phone (non-device related) and/or office visit and possible granulomas were analyzed by biopsy. All study patients will complete a final in-office visit at 60-months.
Niv Caviar, President and Chief Executive Officer of Suneva Medical commented, "These results are consistent with what we observed during the pivotal trial and further validate Artefill's role as a long-lasting filler in the aesthetic market. We look forward to reporting additional interim results later this year as more patients reach the two-year point."
SOURCE Suneva Medical, Inc.