We recently announced interim results from a long-term safety and patient satisfaction study on Artefill, the first and only FDA-approved microsphere-enhanced dermal filler for the correction of smile lines. 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.
FOR IMMEDIATE RELEASE
Suneva Medical Announces Positive Interim Data from Five-Year Safety and Patient Satisfaction Study on Artefill®
Study Suggests Artefill Is As Safe as Other Dermal Fillers for Nasolabial Fold Correction
Data Presented at Maui Derm 2010 Meeting
MAUI, HAWAII -- January 25, 2010 – 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.”
Artefill is the first and only FDA-approved microsphere-enhanced collagen 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. For more information visit www.artefill.com <http://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