Leading Plastic Surgeons Report Positive Data on Artefill® at Key Society Meetings

Leading Plastic Surgeons Report Positive Data on Artefill® at Key Society Meetings

SAN DIEGO, CA – May 4, 2010 – Suneva Medical, a privately-held aesthetic medical device company, today announced that Steven R. Cohen, M.D., F.A.C.S, Clinical Professor, University of California, San Diego and John H. Joseph, M.D., F.A.C.S, Assistant Clinical Professor, UCLA, presented interim results from the prospective, open-label, five-year safety study on Artefill for nasolabial fold (NLF) correction. The oral presentations took place at the American Society of Aesthetic Plastic Surgery’s Aesthetic Meeting 2010 in Washington, D.C. and the American Academy of Facial Plastic & Reconstructive Surgery’s International Symposium in Hollywood, FL, respectively.

Dr. Cohen commented, “Artefill has consistently proven to be an effective, more permanent treatment option for smile lines. Our initial findings from this five-year study are consistent with the pivotal trial and show Artefill has a safety profile that appears to be similar to other dermal fillers on the market today.”

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 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.

Dr. Joseph added, “Patient satisfaction is critical to our success as surgeons. Our patients have been extremely pleased with the long-term benefits of Artefill and the interim trial results further support this, showing consistent and lasting high patient satisfaction ratings with the product.”

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 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.