Suneva Medical has released 12-month follow-up data from its pivotal acne scar investigational study evaluating the safety and efficacy of its dermal filler ArteFill to treat acne scars. The treatment as performed in the study was shown to be safe and well tolerated at 12 months. Any treatment-related adverse events were expected, predominantly mild and resolved in a short period of time.
Cross-over controls in the randomized, double-blinded, multi-center study are currently being monitored for 12-month safety data. 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 Pearl Grimes, MD, 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."
The company also announced that it recently raised $35 million in debt and equity capital. The new capital was structured to be comprised of a growth-capital term loan, a working capital facility, and a Series B equity round financing of $20 million.
Polaris Partners led the Series B round, with an affiliate of HealthCare Royalty Partners ("HC Royalty") providing the growth-capital term loan and also participating in the Series B round, which includes up-front and product-related milestone investments. Comerica Bank provided the working capital facility.
"In a short time, we have put Suneva on the path toward success by growing the core business, investing in innovative product research, and working strategically with the right partners,” said Nicholas L. Teti, Jr., chairman and CEO of Suneva Medical. “This funding is a vote of confidence in the Suneva team and strategy, giving us the financial platform upon which to execute our vision to build a profitable and dynamic aesthetics company."