Two Studies Find Artefill® to Be a Long-Term Treatment Option for
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
"We believe Artefill is a viable treatment option for lipoatrophy and non-surgical antiaging
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.
Sr. Director Marketing
(858) 550-9999 x7844
Reproduced with permission - "Suneva Medical"