Suneva Medical to Pursue Expanded Indications for Artefill® with Launch of Phase III Acne Scar Study

Suneva Medical to Pursue Expanded Indications for Artefill® with Launch of Phase III Acne Scar Study

 

SAN DIEGO, CA – January 11, 2012 – Suneva Medical, a privately-held aesthetic medical device company, today announced that it is launching a multi-center study to investigate the efficacy of Artefill for the treatment of acne scars. The 150-patient prospective study is being conducted at 10 centers throughout the U.S. and will enroll its first patient by February.

“Acne can have lasting effects on a patient’s self-esteem, especially when we are limited in our ability to permanently treat the resulting scars,” said study investigator Ava Shamban, M.D. “Artefill is a great solution for my regular filler patients who want to correct facial wrinkles with natural, long-lasting results and we are optimistic about its effectiveness with this new patient population.”

According to the American Dermatology Association, acne is the most common skin disorder in the United States, affecting 40 million to 50 million Americans. By mid-teens, more than 40 percent of adolescents have acne or acne scarring, which requires treatment by a dermatologist. Studies have reported the incidence of acne scarring in the general population to be 1 to 11 percent 1.

“Acne scarring impacts patients both physically and emotionally as it’s a direct reminder of the issues that affected them during their earlier years. However, there is no permanent solution on the market today to address this widespread cosmetic issue. We believe Artefill’s unique composition may provide these patients a real solution for what many thought would be a lifelong problem,” commented Nicholas Teti, Chairman and CEO of Suneva Medical. He continued, “We are pleased to be working with a strong and prominent group of investigators on this trial as we look to expand the indications for Artefill.”

Approved in 2006, Artefill is a long-lasting, dermal filler. It is composed of bovine collagen and unique microspheres and includes lidocaine for improved patient comfort. This distinct formulation offers patients long-lasting wrinkle correction. To date over 30,000 patients have been treated.

Patients interested in additional information about this trial may visit www.clinicaltrials.gov.

—————————

1 Cunliffe WJ, Gould DJ. Prevalence of facial acne vulgaris in late adolescence and in adults. Br Med J. 1979;1(6171): 1109-1110. Goulden V, Stables GI, Cunliffe WJ. Prevalence of facial acne in adults. J Am Acad Dermatol. 1999:41:577-580.

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 long-lasting injectable product is marketed as Artefill® in the U.S. and Bellafill™ in Canada to correct facial wrinkles. For more information visit www.sunevamedical.com/old or Artefill.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.