New Study Published in Journal of Drugs in Dermatology

New Study Published in Journal of Drugs in Dermatology Finds
Artefill Effective in Treating Atrophic Acne Scars

Ninety-Six Percent of Acne Scars Noticeably Improved Over Eight-Month Period

SAN DIEGO, CA – October 7, 2010 – 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.

About Artefill
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/old.

 

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Important Safety Information

Bellafill®
Bellafill® is indicated for the correction of nasolabial folds and moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over the age of 21 years. Patients who have had a positive reaction to the Bellafill® Skin Test, have a history of severe allergies, have known bovine collagen allergies, are allergic to lidocaine, have bleeding disorders or are prone to thick scar formation and/or excessive scarring should not receive Bellafill®. The safety of Bellafill® for use during pregnancy, breastfeeding, or in patients under 21 has not been established. You may experience temporary swelling, redness, pain, bruising, lumps/bumps, itching, and discoloration at the treatment site. These side effects are usually transient and typically resolve within 1–7 days. You may experience lumps/bumps/papules that may occur more than one month after injection and that may persist. Less common side effects include rash and itching more than 48 hours after treatment, persistent swelling or redness, lumps/bumps, acne, and increased sensitivity at treatment sites. Infrequently, granulomas may occur and may be treated by your licensed physician provider. Be sure to call your licensed provider immediately if you notice any unusual skin reactions around the treatment area. Based on the 5-year Post-Approval Study on nasolabial folds with 1,008 patients, long-term safety of Bellafill® for up to 5 years has been established.

PUREGRAFT
This product is certified as a medical device in the European Union under the Medical Device Directive 93/42/EEC by SGS CE0120, exclusively for the indication of autologous fat transfer. Other non-medical uses ascribed to this device such as aesthetic body contouring are not within the scope of CE certification, and users should be aware product performance and/or safety has not been evaluated by SGS for those purposes.

Suneva Medical HD PRP
REGULATORY STATUS: FDA-cleared 510(k) Class II medical device. Healeon HD PRP is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of peripheral blood at the patient point of care. The PRP is mixed with autograft and/orallograft bone prior to application to a bony defect for improving handling characteristics. 510(k) number: BK170136

Silhouette Instalift
Silhouette lnstaLift® is indicated for use in mid-face suspension surgery to temporarily fixate the cheek sub-dermis in an elevated position.

IMPORTANT SAFETY CONSIDERATIONS
The Silhouette InstaLift device should not be used in patients with any known allergy or foreign body sensitivities to plastic/ biomaterial or in situations where internal fixation is otherwise contraindicated, (e.g. infection.) The device should also not be used in patients appearing to have very thin soft tissue of the face in which the implant may be visible or palpable.

Like all procedures of this type there is a possibility of adverse events, although not everybody experiences them. These adverse events include but are not limited to infection, minimal acute inflammatory tissue reaction, pain (which may be temporary or persistent in nature), swelling and edema, transient hematoma or bruising and transient rippling or dimple formation. For further safety or product information, please consult your physician.

For more safety information, please consult with your physician and the patient labeling that can be found by visiting our website www.bellafill.com.
Toll-free call (U.S. & Canada): 844-Bellafill (844-235-5234).
Local calls: 858-550-9999. International calls: ++ 858-550-9999.