SUNEVA MEDICAL ANNOUNCES 12-MONTH SAFETY RESULTS FROM PIVOTAL ARTEFILL® ACNE SCAR INVESTIGATIONAL CLINICAL STUDY
Dermal Filler Appears to be a Safe Treatment for Acne Scars
SANTA BARBARA, Calif. (Jan. 7, 2014)—Suneva Medical Inc., a privately-held aesthetics company, today announced the 12-month follow-up data from its randomized, double-blinded, multi-center, Pivotal acne scar investigational study evaluating the safety and efficacy of ArteFill®, a dermal filler, to treat acne scars. The study treatment was shown to be safe and well-tolerated in study subjects at 12 months. Any treatment-related adverse events were expected, predominantly mild, and resolved in a short period of time.
Cross-over control subjects are currently being monitored for 12 month safety. Once final safety results across the entire study population are available, Suneva plans to submit a premarket approval (PMA) supplement with the goal of receiving FDA approval for the treatment of atrophic facial scars such as acne scars. The study already met its primary efficacy endpoint at six months in which subjects treated with Artefill demonstrated a statistically significant higher response rate in scar correction compared to subjects treated with saline control.
“The effective treatment of acne scars represent a huge unmet clinical need,” said Dr. Pearl Grimes, a Principal Investigator in the study, and Director of the Vitiligo & Pigmentation Institute of Southern California. “The results I was able to achieve in my study patients were remarkable and I look forward to the day when I can offer this treatment to my acne scar patients as an FDA-approved product.”
Nicholas L. Teti Jr., Chairman and Chief Executive Officer of Suneva Medical said, “In reviewing the 12-month follow-up safety results we have even more enthusiasm that ArteFill can offer hope for the millions of patients who suffer from acne scars today.”
ArteFill is a dermal filler approved by the U.S. Food and Drug Administration in 2006 for the correction of the nasolabial folds commonly known as “smile lines.”
About Suneva Medical, Inc.
Suneva Medical, Inc. is a privately-held aesthetics company focused on developing, manufacturing and commercializing novel, differentiated products for the general dermatology and aesthetic markets. The Company currently markets ArteFill® in the U.S., Korea, Singapore; Refissa® and ReGenica® in the U.S. and Bellafill™ in Canada. ReGenica® is a trademark of Histogen, Inc., exclusively licensed to Suneva Medical, Inc.