Dermal Filler Appears to be a Safe Treatment for Acne Scars

SANTA BARBARA, Calif. (Jan. 7, 2014)—Suneva Medical Inc., a privately-held aesthetics company, today announced the 12-month follow-up data from its randomized, double-blinded, multi-center, Pivotal acne scar investigational study evaluating the safety and efficacy of ArteFill®, a dermal filler, to treat acne scars. The study treatment was shown to be safe and well-tolerated in study subjects at 12 months. Any treatment-related adverse events were expected, predominantly mild, and resolved in a short period of time.

Cross-over control subjects are currently being monitored for 12 month safety. Once final safety results across the entire study population are available, Suneva plans to submit a premarket approval (PMA) supplement with the goal of receiving FDA approval for the treatment of atrophic facial scars such as acne scars. The study already met its primary efficacy endpoint at six months in which subjects treated with Artefill demonstrated a statistically significant higher response rate in scar correction compared to subjects treated with saline control.

“The effective treatment of acne scars represent a huge unmet clinical need,” said Dr. Pearl Grimes, a Principal Investigator in the study, and Director of the Vitiligo & Pigmentation Institute of Southern California. “The results I was able to achieve in my study patients were remarkable and I look forward to the day when I can offer this treatment to my acne scar patients as an FDA-approved product.”

Nicholas L. Teti Jr., Chairman and Chief Executive Officer of Suneva Medical said, “In reviewing the 12-month follow-up safety results we have even more enthusiasm that ArteFill can offer hope for the millions of patients who suffer from acne scars today.”

About ArteFill
ArteFill is a dermal filler approved by the U.S. Food and Drug Administration in 2006 for the correction of the nasolabial folds commonly known as “smile lines.”

About Suneva Medical, Inc.
Suneva Medical, Inc. is a privately-held aesthetics company focused on developing, manufacturing and commercializing novel, differentiated products for the general dermatology and aesthetic markets. The Company currently markets ArteFill® in the U.S., Korea, Singapore; Refissa® and ReGenica® in the U.S. and Bellafill™ in Canada. ReGenica® is a trademark of Histogen, Inc., exclusively licensed to Suneva Medical, Inc.

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.