Suneva Medical Completes Enrollment and Initial Treatment of Patients in Phase III Acne Scar Study

Suneva Medical Completes Enrollment and Initial Treatment of Patients in Phase III Acne Scar Study

SAN DIEGO, CA – September 18, 2012 – Suneva Medical, Inc., a privately-held aesthetics company, today announced that it has completed the enrollment and initial treatment of patients in its Phase III acne scar study. Touch-up treatments are expected to be completed by the end of September. This multi-center, prospective study is being conducted at 10 prestigious aesthetic medical practices in the U.S. and is investigating the efficacy of Artefill® for the treatment of moderate to severe atrophic acne scars.

“We have reached yet another milestone in our pursuit of expanded indications for Artefill. If the study is successful and the FDA grants an approval for this indication, Artefill would be the only dermal filler approved and on the market for the treatment of acne scars. This represents a significant market opportunity for our growing aesthetics company and could expand the patient and physician audience for Artefill,” commented Nick Teti, Chairman and CEO of Suneva Medical. He continued, “Acne scars have a profoundly negative impact on the millions of people that have been living with this condition. If approved, Artefill could truly help these affected people.”

According to the American Academy of Dermatology, acne is the most common skin condition in the United States, affecting 40 to 50 million Americans at any one time. By mid-teens, more than 40 percent of adolescents have acne or acne scarring requiring treatment by a dermatologist.

“Patients have been eager to enroll in the study as they are seeking a new and long-lasting option to treat their acne scars. We are excited about the prospects for this dermal filler with this growing patient population,” commented study investigator Ava Shamban, M.D.

Artefill is a long-lasting, dermal filler approved by the FDA in 2006 for the correction of the nasolabial folds commonly known as “smile lines.” To date, approximately 50,000 patients have been treated with the product.

This announcement follows several significant corporate developments for Suneva Medical in recent months. As previously announced, the company acquired Refissa® and its generic equivalent, the only tretinoin cream currently available with a .05% strength, emollient base and broad indication for fine facial lines, hyperpigmentation and tactile roughness. Suneva Medical also previously announced the official roll-out of ReGenica™ Skincare, a next generation, growth factor skincare line clinically proven to reduce the signs of aging.

About Suneva Medical

Suneva Medical, Inc. is a privately-held aesthetics company focused on developing, manufacturing and commercializing novel, differentiated products for the dermatology and the plastic and cosmetic surgery markets. The Company currently markets Artefill®, Refissa® and ReGenica™ Skincare in the U.S. and Bellafill™ in Canada. For more information visit www.sunevamedical.com/old.

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Contact:
Kate Gilbert
Vice President, Marketing
Suneva Medical
(858) 550-9999 x7844
or
Kellie Walsh
(914) 315-6072
kwalsh@kwmcommunications.com

 

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.