SUNEVA MEDICAL ANNOUNCES LANDMARK CLINICAL STUDY CONFIRMING LONG-TERM SAFETY AND EFFECTIVENESS OF BELLAFILL® THROUGH FIVE YEARS (FDA)

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  • World’s largest and longest prospective dermal filler post-approval study conducted assessed the five year safety and effectiveness of Bellafill®with unprecedented results
  • Bellafill® is the first and only FDA approved dermal filler indicated for the correction of nasolabial folds that has been established as safe and effective through five years with high patient satisfaction
  • Completing the only study of its kind, Suneva Medical sets a new benchmark for establishing the long-term safety of dermal filler treatments

San Diego, CA (Sept. 10, 2015)—Suneva Medical, Inc., a privately-held aesthetics company, today announced that Bellafill® is now the only FDA approved dermal filler with demonstrated safety and effectiveness through five years, following the completion of its five year post-approval study for nasolabial folds. The study marks the largest and longest prospective dermal filler study ever conducted, with unprecedented retention, high patient satisfaction and strong evidence to support the long-term safety and effectiveness of Bellafill®. Patients who have experienced dermal filler fatigue or are frustrated with the recurring costs associated with filler treatments and time spent at appointments may consider Bellafill® for natural-looking and long-lasting correction.

“No other aesthetics company has completed a clinical study of this magnitude for dermal fillers. In a world where the demand for injectables is rapidly increasing, this is a tremendous achievement by Suneva Medical that further substantiates the long-term safety and effectiveness of Bellafill® treatment,” said Dr. Steven Cohen, F.A.C.S. and clinical professor at the University of California, San Diego who has studied Bellafill® for more than 15 years. “The strong supporting evidence of Bellafill®’s safety profile supplies data that allow physicians to use the filler with confidence, dispelling misconceptions about the product’s long-term safety profile including the very low rate of granulomas, which can occur with any dermal filler.”

“Injection-based cosmetic treatments and the expansion of the dermal filler market have established a strong need for data that demonstrate the long-term outcomes of these products,” said Nicholas L. Teti, Jr., Chairman and Chief Executive Officer at Suneva Medical. “The Bellafill® post approval study is a landmark event for Suneva and the second significant development for Bellafill® this year, following its acne scar treatment approval announced in January. These studies validate our commitment to helping physicians and patients achieve long-term treatment goals with innovative products backed by rigorous scientific data.”

The five year post-approval study on the use of Bellafill® in the nasolabial folds was primarily designed to determine its long-term safety, whereas, effectiveness was a secondary objective. There were 1,008 patients enrolled across 23 U.S. prestigious study centers. At five years, an impressive 87% retention rate was observed with the majority of patients (83%) rating a “satisfied” to “very satisfied” outcome with their Bellafill® treatment at the conclusion of the five year study.1 No treatment-related serious adverse events (SAEs) or unanticipated adverse events were noted. The incidence of treatment-related adverse events (TRAEs) in patients was 11.7%. The majority of these events were mild in severity and resolved by the conclusion of the study. The most commonly reported TRAEs were lumpiness at the injection site (~4.5%) and redness (1.8%). The incidence of granulomas was infrequent (1.7%).

Bellafill® is the only dermal filler on the market that is approved by the FDA 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. A total of 1,542 patients have been treated with Bellafill® across four U.S. clinical studies.1 Three of the four studies were conducted on 1,399 patients treated with Bellafill® in support of the indication for the correction of nasolabial folds. One of the four studies was conducted on 143 patients treated with Bellafill® in support of the indication for the correction of moderate to severe, atrophic, distensible facial acne scars on the cheek. Suneva Medical’s recent announcement that it has raised $35.4 million in financing for ongoing product commercialization efforts and expansion of business development activities provides a strong basis for the continued growth of Bellafill®.

To learn more about Bellafill® and find a licensed provider in your area, please visit www.bellafill.com. For more information on Suneva Medical, visit www.sunevamedical.com/old.

About Suneva Medical, Inc.
Suneva Medical is a privately-held aesthetics company focused on developing, manufacturing and commercializing novel, differentiated products for the general dermatology and aesthetic markets. The innovative aesthetics leader markets Bellafill®, the only dermal filler on the market that is approved by the U.S. Food and Drug Administration 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. In markets outside the U.S., Bellafill® is only approved for the correction of nasolabial folds. The company markets Bellafill® in the U.S. and Canada; ArteFill® in South Korea and Singapore; Regenica® skin care in the U.S. and Canada; and ReFissa® tretinoin cream in the U.S. ArteFill® was rebranded to Bellafill® in the U.S. to reflect the transformational outcomes this unique product can provide to patients seeking correction of their acne scars and nasolabial folds. For more information, visit www.sunevamedical.com/old.

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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.