Suneva Medical Inc., a San Diego-based aesthetics company, announced that the U.S. Food and Drug Administration (FDA) has approved its dermal filler, Bellafill, for the treatment of acne scars.
Acne is the most common skin disorder in the country, affecting tens of millions of people in the United States, according to the American Academy of Dermatology. Severe acne can lead to scarring.
Bellafill has now been proven to be safe and effective for the correction of moderate to severe facial acne scars on the cheek in patients over the age of 21 years.
"The results of this rigorous clinical study prove that Bellafill reduces the appearance of acne scars, providing a solution to this widespread skin condition that previously had limited treatment choices,” said Nicholas L. Teti, Jr., chairman and chief executive officer at Suneva Medical. "Bellafill can have a transformational effect on a patient's appearance and, in turn, we hope an improvement in quality of life."
Dr. Ava Shamban, assistant clinical professor of dermatology at the University of California, Los Angeles, was an investigator in an independent Bellafill acne study, according to a recent Suneva press release.
"In the dermatology field, we regularly see patients who live with the burden of acne scarring - a physical and emotional burden that leads many to feel depressed, less energetic and less social,” Shamban said. “With Bellafill, we have a tremendous opportunity to remedy acne scars and help patients live a happier, healthy life. The level of acne scar correction Bellafill achieves is truly impressive and I greatly look forward to using this proven treatment option with patients."