, Oct. 7
/PRNewswire/ -- Suneva Medical
, a privately-held aesthetic medical device company, today announced the publication of an open-label, single center, pilot study on Artefill
® for the treatment of atrophic acne scars conducted by James M. Spencer
, M.D. M.S. and sponsored by Suneva Medical. The article, which appears in the September 2010
issue of Journal of Drugs in Dermatology, shows Artefill to have a significant and lasting effect on patient atrophic acne scars after an eight month period.
The study consisted of fourteen (n=14) healthy male and female patients between the ages of 18 and 60 who met all inclusion and exclusion criteria and had atrophic acne scars amenable to correction with Artefill. Patients were evaluated at six weeks and eight months after the initial injection. The investigators concluded that 96 percent of the treated acne scars noticeably improved and 70 percent improved by two grades. Patients reported being highly satisfied with Artefill with the vast majority or 93 percent willing to have a repeat procedure. No adverse events or side effects were evident over the course of the study.
Dr. Spencer, lead study investigator commented, "Our patients saw an outstanding correction with Artefill and we believe it will provide them long lasting and possibly permanent results. We will continue to follow these patients over a three-year period but the data indicates Artefill is safe and effective for these challenging scars."
Acne is a disorder that effects up to 80 percent of individuals between 11 and 30 years of age and up to 5 percent of older adults. Atrophic acne scars result when there is a loss of tissue and will create a pitted or pockmarked look of the skin. While not all patients will develop acne scars, when they do occur ninety-five percent are on the face, potentially affecting a patient's self-confidence.
Artefill is the first and only FDA-approved microsphere-enhanced dermal filler for the correction of nasolabial folds, better known as smile lines. Since Artefill was approved in 2006, over 25,000 patients have been treated.
The simple, in-office procedure takes approximately fifteen minutes to complete. A patient is injected with microsphere-enhanced collagen similar to other dermal fillers. Artefill comes mixed with local anesthetic, so there is virtually no discomfort during the injection process. The unique microspheres in Artefill are not absorbed by the body and therefore provide the support the skin needs for long lasting natural feeling results. This is different from temporary dermal fillers that are made of different kinds of natural or synthetic materials that are completely absorbed by the body over time and require repeat injections to maintain wrinkle correction. A skin test is required approximately four (4) weeks prior to treatment, to ensure a patient is not allergic to the collagen in Artefill. For more information visit www.artefill.com or join us on Facebook.
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.
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SOURCE Suneva Medical