Suneva Medical: Bellafill Study is Largest, Longest Post-market Clinical Evaluation of Dermal Filler

Billed as the largest and longest post-market clinical evaluation of a dermal filler, a new study reported by Suneva Medical shows high levels of patient satisfaction and favorable safety outcomes with Bellafill five-years post-treatment. With an 87 percent retention rate, the study showed that a majority of patients (83 percent) were “satisfied” or “very satisfied” with outcomes five years after treatment.

The size and duration of the study reflect Suneva’s commitment to building an aesthetic brand around a strong scientific platform, says Chief Executive Officer Nicholas L. Teti, Jr. On the heels of the company’s study and subsequent indication for Bellafill for the treatment of acne scars, Suneva has now reported two “landmark studies,” Mr. Teti says, “That are completely novel.”

The new five-year satisfaction study enrolled 1,008 patients 23 US study centers. At five years. Patients were treated to optimal correction (allowing for touch-up injections, if needed) then followed for five years after the last injection. In all, 83 percent of subjects were “satisfied” to “very satisfied” with outcomes with their Bellafill treatment at the conclusion of the five year study. No treatment-related serious adverse events (SAEs) or unanticipated adverse events were noted. The incidence of treatment-related adverse events (TRAEs) in patients was 11.7 percent. The majority of these events were mild in severity and resolved by the conclusion of the study. The most commonly reported TRAEs were lumpiness at the injection site (~4.5 percent) and redness (1.8 percent). The incidence of granulomas was infrequent at 1.7 percent.

The research focus fits Suneva’s strategic initiative, Mr. Teti says, which includes expanding the company’s sales force, a focus on physician education and practice management support, capital investment (recently acquired), and bringing new products into the aesthetic marketplace.