Suneva Medical Announces Positive Interim Data

Suneva Medical Announces Positive Interim Data from Five-Year Safety
and Patient Satisfaction Study on Artefill®

– Study Suggests Artefill Is As Safe as Other Dermal Fillers for Nasolabial Fold Correction –
– Data Presented at Maui Derm 2010 Meeting –

MAUI, HAWAII — January 25, 2010 – Suneva Medical, a privately-held aesthetic medical device company, today announced 18-month interim results from its prospective, open-label, five-year safety and patient satisfaction study on Artefill for nasolabial fold (NLF) correction. The study assessed adverse events with Artefill starting at 6-months post treatment. Initial results show the incidence of adverse events with Artefill compare favorably to the current label, and that the majority of patients (88%) reported a high satisfaction rating. Upon completion, this will be the largest and longest duration prospective U.S. clinical study of any dermal filler.

The data is being presented by study investigator W. Philip Werschler, M.D., FAAD, FAACS, Assistant Clinical Professor in Medicine/Dermatology at University of Washington, at the Advances in Cosmetic and Medical Dermatology’s “Maui Derm 2010” Meeting taking place in Maui, Hawaii January 23-27th.

Dr. Werschler commented, “Our initial analysis is very encouraging as it further validates Artefill’s strong safety profile and high level of patient satisfaction for long-term wrinkle correction. A granuloma incidence rate of less than 0.1% is also indicative of this and suggests Artefill is as safe as other dermal fillers, such as Juvederm and Restylane.”

The 23-center, prospective, open-label study consists of 1,008 patients who had no recent history of nasolabial fold correction. 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 at 2, 6, 12, 18, 24, 36, 48 and 60 months to assess the presence of or absence of adverse events, patient satisfaction, and any changes in health. Potential subject-reported AEs were followed up by phone (non-device related) and/or office visit and possible granulomas were analyzed by biopsy. All study patients will complete a final in-office visit at 60-months.

Niv Caviar, President and Chief Executive Officer of Suneva Medical commented, “These results are consistent with what we observed during the pivotal trial and further validate Artefill’s role as a long-lasting filler in the aesthetic market. We look forward to reporting additional interim results later this year as more patients reach the two-year point.”

About Artefill
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/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.