SAN DIEGO, Sept. 18, 2012 - Suneva Medical, Inc., a privately-held aesthetics company, today announced that it has completed the enrollment and initial treatment of patients in its Phase III acne scar study. Touch-up treatments are expected to be completed by the end of September. This multi-center, prospective study is being conducted at 10 prestigious aesthetic medical practices in the U.S. and is investigating the efficacy of Artefill for the treatment of moderate to severe atrophic acne scars.
"We have reached yet another milestone in our pursuit of expanded indications for Artefill. If the study is successful and the FDA grants an approval for this indication, Artefill would be the only dermal filler approved and on the market for the treatment of acne scars. This represents a significant market opportunity for our growing aesthetics company and could expand the patient and physician audience for Artefill," commented Nick Teti, Chairman and CEO of Suneva Medical. He continued, "Acne scars have a profoundly negative impact on the millions of people that have been living with this condition. If approved, Artefill could truly help these affected people."
According to the American Academy of Dermatology, acne is the most common skin condition in the United States, affecting 40 to 50 million Americans at any one time. By mid-teens, more than 40 percent of adolescents have acne or acne scarring requiring treatment by a dermatologist.
"Patients have been eager to enroll in the study as they are seeking a new and long-lasting option to treat their acne scars. We are excited about the prospects for this dermal filler with this growing patient population," commented study investigator Ava Shamban, M.D.
Artefill is a long-lasting, dermal filler approved by the FDA in 2006 for the correction of the nasolabial folds commonly known as "smile lines." To date, approximately 50,000 patients have been treated with the product.
This announcement follows several significant corporate developments for Suneva Medical in recent months. As previously announced, the company acquired Refissa and its generic equivalent, the only tretinoin cream currently available with a .05% strength, emollient base and broad indication for fine facial lines, hyperpigmentation and tactile roughness. Suneva Medical also previously announced the official roll-out of ReGenica Skincare, a next generation, growth factor skincare line clinically proven to reduce the signs of aging.
PR Newswire