Suneva Medical Announces Results of Its Pivotal ArteFill® Acne Scar Study
ArteFill study meets its primary efficacy endpoint in the treatment of acne scars
Clinically and statistically significant results
Company intends to file PMA supplement by the end of 2013
SAN DIEGO, May 14, 2013 /PRNewswire/ -- Suneva Medical, Inc., a privately-held aesthetics company, today released the initial treatment results from its Pivotal acne scar study evaluating the safety and efficacy of ArteFill®, a dermal filler, to treat acne scars. The treatment of acne scars represents an important unmet clinical need, as sixty to ninety-five percent of people with acne may go on to develop scarring with limited treatment options.
"Acne scars are not only a physical disfigurement, but studies have shown the emotional toll is significant—from feelings of low self-esteem and negative self-image to hopelessness and even depression," said Nick Teti, chairman and CEO of Suneva Medical. "The outcomes from this study are quite important, demonstrating that ArteFill has a statistically significant improvement in treating moderate to severe atrophic acne scars. The next phase of the study will be to follow the patients for an additional six months, primarily to continue evaluating the safety of the product. We plan on filing a premarket approval (PMA) supplement by the end of the year with the goal of the FDA approving ArteFill for this new indication."
The study's lead physician, Stacy Smith, M.D., added, "According to the American Academy of Dermatology, about 20 million Americans have acne severe enough to cause scarring; to date, however, no single treatment has proven to be as effective a solution for improving this condition. I've conducted numerous clinical trials and the initial findings from the ArteFill acne scar study are strikingly impressive. Even more impressive is the enthusiasm by the study investigators for this easy-to-administer therapy to assist patients with limited options."
The randomized, double-blinded, multi-center, controlled study evaluated subjects to determine the safety and efficacy of ArteFill for the treatment of moderate to severe atrophic acne scars.
In order for subjects to be counted as responders, they had to exhibit a two-point improvement on a four- point Acne Scar Response Scale (ASRS) for at least half of the scars treated. This fifty percent improvement rate represents one of the highest efficacy hurdles for a dermal filler study. Additional qualitative improvement endpoints were rated by physicians and subjects.
Clinically and Statistically Significant Results
The study met its primary efficacy endpoint. Subjects treated with ArteFill demonstrated a statistically significant greater response rate relative to the control at six months, and as early as six weeks after treatment.
Secondary endpoints at six months included Physician Global Aesthetic Improvement Score (PGAIS) and the Subject Global Aesthetic Improvement Score (SGAIS) in which physicians and subjects saw statistically significant improvements in appearance in subjects treated with ArteFill relative to the control subjects at six months. Subjects were also asked to rate their satisfaction using a Subject Assessment of Scar Correction (SASC) scale and subjects treated with ArteFill demonstrated a statistically significant higher degree of satisfaction at six months relative to the controls.
Interim Safety Profile
During the study, physician-recorded, treatment-related adverse events were rare, mild and all resolved. There were no statistically significant differences in Adverse Event rates between ArteFill and the control at six months. Furthermore, no Unanticipated Adverse Device Effects (UADE) or treatment-related Serious Adverse Events (SAE) occurred. Subjects will continue to be followed up to 12 months after the last treatment and full safety results will be available after that time.
Unlike other clinical studies of dermal fillers, this study enrolled a substantial number of male subjects (40 percent). Additionally, 26 percent of subjects treated had Fitzpatrick skin type of V or VI, which is one of the largest percentages of darker skin types enrolled in any FDA filler study.
"As dermatologists, we all struggle with treating patients with acne scars. Currently there is no adequate solution or combination of solutions that provide predictable long-lasting improvements," commented study investigator Ava Shamban, M.D. "As part of this initial ArteFill study, I've witnessed firsthand a remarkable option that can provide acne scar sufferers with a real option that can result in a significant impact on patients' quality of life."
Commenting on the significance of the results, investigator William Werschler, M.D., concluded, "After years of practicing and working with other treatment options, I have not been able to achieve scar correction to the degree I recently experienced as part of the ArteFill study."
ArteFill is a lasting 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." To date, approximately 100,000 patients have been treated with the product since it came on the market in 2007.
Media interested in speaking with a Suneva representative to learn more about ArteFill should contact Melody Demel at 619-234-0345 or email@example.com.
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®, Refissa® and ReGenica™ Skincare in the U.S. and Bellafill™ in Canada. For more information, visit www.sunevamedical.com.
SOURCE Suneva Medical, Inc.
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