Suneva Medical Announces Canadian Approval of Bellafill

SAN DIEGO, CA – June 29, 2011 – Suneva Medical, a privately-held aesthetic medical device company, today announced the expansion of its core aesthetics injectable business with approval from Health Canada to market BellafillTM, its long lasting dermal filler for nasolabial folds or smile line correction. In addition to offering patients a unique, long-lasting treatment, Bellafill provides physicians the opportunity to provide a differentiated, premium product and enhance their practice economics.

“Temporary hyaluronic acid based fillers are quickly becoming recognized for what they were designed to be, a short term fix to a lifelong aesthetic issue. Additionally, patient fatigue with temporary fillers and a desire by physicians to differentiate their practices by offering unique and premium products, creates a significant opportunity and benefit for the patient, the physician and the Company ,” commented Nicholas Teti, Chairman and CEO of Suneva Medical, Inc. “Canadian approval of Bellafill allows Suneva to meet this growing demand in the market. The approval of Bellafill is also an important milestone in our overall international expansion strategy. We are currently evaluating our options for a Canadian launch; in addition, we have established international partnership agreements in several countries around the world and expect a number of international product launches later this year.”

Bellafill is composed of bovine collagen and unique, third generation, engineered microspheres and includes lidocaine for improved patient comfort. This distinct formulation offers patients long-lasting wrinkle correction. In addition, the proprietary microsphere production process provides tightly controlled microsphere size and an enhanced safety profile versus products previously sold in Canada. Bellafill meets the rigorous standards of quality and safety of Health Canada. A pre-treatment allergy test is optional. In clinical trials, Bellafill demonstrated a significant duration of correction and a positive safety profile with no significant device-related adverse events.

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 long-lasting injectable product is marketed as Artefill® in the U.S. and BellafillTM in Canada to correct facial wrinkles. For more information visit 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

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.