Two Studies Find Artefill® to Be a Long-Term Treatment

Two Studies Find Artefill® to Be a Long-Term Treatment Option for Facial Lipoatrophy

Investigator-Initiated Studies Examine Artefill’s Use with Age-Related
and HIV-Associated Facial Lipoatophy Patients

SAN DIEGO, CA – February 2, 2010 – Suneva Medical, a privately-held aesthetic medical device company, today announced that two clinical studies suggest Artefill may be a safe, effective, long-term treatment option for age-related and HIV lipoatrophy patients. The studies were presented at the Advances in Cosmetic and Medical Dermatology’s “Maui Derm 2010” Meeting in Maui, Hawaii January 23-27th and the American Academy of Cosmetic Dermatology (AACS) Scientific Meeting in Orlando, Florida January 28-31st.

A retrospective review of 11 patients was presented by Joseph A. Eviatar, M.D., FACS, Chelsea Eye and Cosmetic Surgery Associates, New York Medical College, at the AACS Scientific Meeting. The study evaluated the safety and efficacy of pan facial soft tissue augmentation with Artefill for the correction of lipoatrophy in HIV patients. Three patients were previously treated with Sculptra, six with Radiesse. Patients received Artefill injections over a six-month period until full correction was achieved. Changes were evaluated from baseline using a 0 to 4 atrophic grading scale. The results showed that all patients had improvement and no adverse events were reported. In total, 54.5 percent of patients improved at least two grades based on this four point grading scale at their evaluation time point, which ranged from 2 to 25 months.

Dr. Eviatar commented, “Artefill proved to be effective in restoring volume to the face in these HIV lipoatrophy patients and we believe may offer a more long-term, cost effective treatment option for this patient population.”

In a poster session at Maui Derm 2010, Dr. Farhad Niroomand, Attending, Baylor University Medical Center (Dallas) and Associate Clinical Professor of Dermatology, University of Texas, Southwestern Medical Center, presented a retrospective review of 8 patients, 6 with HIV lipoatrophy and 2 with age-related lipoatrophy, from a pool of 100 Artefill-treated patients. The availability of good pre and post-treatment photographs and the diversity of ethnic backgrounds were the main selection criteria. Patients were treated with Artefill in varied intervals ranging from six weeks to one year and changes were evaluated from baseline. Improvement was seen in all HIV lipoatrophy patients ranging between 50-100 percent. Non-HIV patients experienced overall facial contour improvement.

“We believe Artefill is a viable treatment option for lipoatrophy and non-surgical anti-aging enhancement. Our patients found Artefill to be effective, long-lasting and less painful compared to other fillers,” commented Dr. Niroomand.

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

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


# # #


Important Safety Information

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.

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.

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
Toll-free call (U.S. & Canada): 844-Bellafill (844-235-5234).
Local calls: 858-550-9999. International calls: ++ 858-550-9999.