Investigator-Initiated Studies Examine Artefill’s Use with Age-Related and HIV-Associated Facial Lipoatophy Patients
SAN DIEGO, CA – February 2, 2010 – Suneva Medical, a privately-held aesthetic medical device company, today announced that two clinical studies suggest Artefill may be a safe, effective, long-term treatment option for age-related and HIV lipoatrophy patients. The studies were presented at the Advances in Cosmetic and Medical Dermatology’s “Maui Derm 2010” Meeting in Maui, Hawaii January 23-27th and the American Academy of Cosmetic Dermatology (AACS) Scientific Meeting in Orlando, Florida January 28-31st.
A retrospective review of 11 patients was presented by Joseph A. Eviatar, M.D., FACS, Chelsea Eye and Cosmetic Surgery Associates, New York Medical College, at the AACS Scientific Meeting. The study evaluated the safety and efficacy of pan facial soft tissue augmentation with Artefill for the correction of lipoatrophy in HIV patients. Three patients were previously treated with Sculptra, six with Radiesse. Patients received Artefill injections over a six-month period until full correction was achieved. Changes were evaluated from baseline using a 0 to 4 atrophic grading scale. The results showed that all patients had improvement and no adverse events were reported. In total, 54.5 percent of patients improved at least two grades based on this four point grading scale at their evaluation time point, which ranged from 2 to 25 months.
Dr. Eviatar commented, “Artefill proved to be effective in restoring volume to the face in these HIV lipoatrophy patients and we believe may offer a more long-term, cost effective treatment option for this patient population.”
In a poster session at Maui Derm 2010, Dr. Farhad Niroomand, Attending, Baylor University Medical Center (Dallas) and Associate Clinical Professor of Dermatology, University of Texas, Southwestern Medical Center, presented a retrospective review of 8 patients, 6 with HIV lipoatrophy and 2 with age-related lipoatrophy, from a pool of 100 Artefill-treated patients. The availability of good pre and post-treatment photographs and the diversity of ethnic backgrounds were the main selection criteria. Patients were treated with Artefill in varied intervals ranging from six weeks to one year and changes were evaluated from baseline. Improvement was seen in all HIV lipoatrophy patients ranging between 50-100 percent. Non-HIV patients experienced overall facial contour improvement.
“We believe Artefill is a viable treatment option for lipoatrophy and non-surgical anti-aging enhancement. Our patients found Artefill to be effective, long-lasting and less painful compared to other fillers,” commented Dr. Niroomand.
Artefill is the first and only FDA-approved microsphere-enhanced collagen filler for the correction of nasolabial folds, better known as smile lines. Since Artefill was approved in 2006, over 20,000 patients have been treated successfully with very high satisfaction rates. For more information visit www.artefill.com.
About Suneva Medical
Suneva Medical, Inc. is a medical technology company focused on developing, manufacturing and commercializing novel, differentiated aesthetic products for the dermatology, plastic and cosmetic surgery markets. The Company’s lead product is Artefill®, the first and only microsphere-enhanced collagen filler for the correction of nasolabial folds, or smile lines. For more information visit www.sunevamedical.com/old.