Suneva Medical to Pursue Expanded Indications for Artefill® with Launch of Phase III Acne Scar Study
SAN DIEGO, CA – January 11, 2012 – Suneva Medical, a privately-held aesthetic medical device company, today announced that it is launching a multi-center study to investigate the efficacy of Artefill for the treatment of acne scars. The 150-patient prospective study is being conducted at 10 centers throughout the U.S. and will enroll its first patient by February.
“Acne can have lasting effects on a patient’s self-esteem, especially when we are limited in our ability to permanently treat the resulting scars,” said study investigator Ava Shamban, M.D. “Artefill is a great solution for my regular filler patients who want to correct facial wrinkles with natural, long-lasting results and we are optimistic about its effectiveness with this new patient population.”
According to the American Dermatology Association, acne is the most common skin disorder in the United States, affecting 40 million to 50 million Americans. By mid-teens, more than 40 percent of adolescents have acne or acne scarring, which requires treatment by a dermatologist. Studies have reported the incidence of acne scarring in the general population to be 1 to 11 percent 1.
“Acne scarring impacts patients both physically and emotionally as it’s a direct reminder of the issues that affected them during their earlier years. However, there is no permanent solution on the market today to address this widespread cosmetic issue. We believe Artefill’s unique composition may provide these patients a real solution for what many thought would be a lifelong problem,” commented Nicholas Teti, Chairman and CEO of Suneva Medical. He continued, “We are pleased to be working with a strong and prominent group of investigators on this trial as we look to expand the indications for Artefill.”
Approved in 2006, Artefill is a long-lasting, dermal filler. It is composed of bovine collagen and unique microspheres and includes lidocaine for improved patient comfort. This distinct formulation offers patients long-lasting wrinkle correction. To date over 30,000 patients have been treated.
Patients interested in additional information about this trial may visit www.clinicaltrials.gov.
1 Cunliffe WJ, Gould DJ. Prevalence of facial acne vulgaris in late adolescence and in adults. Br Med J. 1979;1(6171): 1109-1110. Goulden V, Stables GI, Cunliffe WJ. Prevalence of facial acne in adults. J Am Acad Dermatol. 1999:41:577-580.
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 long-lasting injectable product is marketed as Artefill® in the U.S. and Bellafill™ in Canada to correct facial wrinkles. For more information visit www.sunevamedical.com/old or Artefill.com.
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