Study Results Evaluating the Correction of Atrophic Scars with Artefill

Study Results Evaluating the Correction of Atrophic Scars with Artefill
Presented at 2010 Orlando Dermatology Conference

Study Suggests Artefill® Provides an Effective and Potentially Long-Lasting
Treatment Option for Acne Scar Patients

SAN DIEGO, CA – January 18, 2010 – Suneva Medical, a privately-held aesthetic medical device company, provided a research grant to support an investigator-sponsored research study to evaluate the degree of correction and patient satisfaction after injection of atrophic scars with Artefill. The data was presented by Dr. James Spencer, the grant recipient and study investigator, in a poster session at the 2010 Orlando Dermatology Conference taking place in Orlando, Florida January 15-18th.

“Acne scarring can cause a tremendous loss of self-esteem and remains a difficult burden for affected patients,” said Dr. James M. Spencer. “Based on the data from my study, we are encouraged that Artefill appears to provide an effective and potentially longer-lasting treatment option for patients with atrophic acne scars amenable to filler correction. This study demonstrates that when used appropriately, Artefill is well tolerated and can result in high patient satisfaction.”

The data is a result of a single-center, open label study of 14 healthy male and female patients between the ages of 24 and 69 who met all inclusion and exclusion criteria and had atrophic acne scars amenable to correction with Artefill. The majority of patients (93%) reported that they would do the procedure again and would recommend the procedure to others.

Dr. Spencer continued, “While temporary fillers, such as Juvederm or Restylane, are considered a first line treatment for atrophic acne scars, they necessitate repeated returns to the physician for additional and expensive injections. We believe that correction of atrophic acne scars with a longer-lasting filler could provide a more desirable treatment option for these patients.”

Niv Caviar, President and Chief Executive Officer of Suneva Medical commented, “Based on the data presented at the Orlando Dermatology Conference, Artefill continues to meet our expectations in a number of areas. For patients with atrophic acne scars, we are encouraged that the data suggests Artefill could be a viable treatment option for this patient population. We will continue to support Dr. Spencer as he explores the durability of the corrections seen with Artefill in further studies.”

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


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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.