Suneva Medical Announces Publication of ArteFill® Five-Year Safety and Patient Satisfaction Study Interim Results in Dermatologic Surgery

SAN DIEGO, CA – May 5, 2010 – Suneva Medical, a privately-held aesthetic medical device company, today announced the publication of interim results from its long-term study on ArteFill in the May 2010 issue of Dermatologic Surgery, the Journal of the American Society of Dermatologic Surgery. The study highlights the safety profile (adverse events, granuloma incidence) and level of patient satisfaction with ArteFill for nasolabial fold (NLF) correction 18-months into the 5-year follow-up period.

Steven R. Cohen, M.D., F.A.C.S, Clinical Professor, University of California, San Diego, CA and co-author commented, “Our findings further substantiate the safety of this PMMA microsphere dermal filler and we hope will alleviate some of the misperceptions in the market about its long-term safety profile.”

Study Design

This open-label, prospective, post-approval study is being conducted at 23 centers in the United States. Subjects seeking treatment with the injectable filler for the correction of nasolabial folds were recruited and 1,008 patients with no recent history of nasolabial fold correction were enrolled. Patients received an initial treatment with Artefill, and up to two touch-ups after 30 and 60 days, until full correction was achieved. Potential adverse events and satisfaction data are reported by all patients 6, 12, 18, 24, 36, 48 and 60 months by questionnaire to assess the presence of or absence of adverse events, patient satisfaction, and any changes in health. Potential subject-reported AEs were followed up on and changes thought to be granulomas were biopsied and confirmed or ruled out by histology. All study patients will complete a final in-office visit at 60-months.

Study Results

These initial results show the incidence of adverse events with Artefill compare favorably to the current label and are similar to the safety profile seen in temporary fillers. Overall, 6% percent (49/1008) of subjects experienced device related adverse events, however, the majority were mild and none were unanticipated. There were no device related serious adverse events reported. One granuloma was reported, which resolved completely with medical treatment. Patient satisfaction with Artefill remained high (~80% very satisfied/satisfied) throughout the entire follow-up period.

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 20,000 patients have been treated. 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 dermal filler for the correction of nasolabial folds, or smile lines. For more information visit www.sunevamedical.com/old.

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.