BELLAFILL® TO REPLACE ARTEFILL® AS NEW BRAND

  • ArteFill® dermal filler changes name to Bellafill® in the U.S.
  • Bellafill® is FDA-approved for the correction of facial wrinkles known as nasolabial folds, or smile lines

San Diego, CA (Dec. 1, 2014)—Suneva Medical, Inc., a privately-held aesthetics company, today announced that ArteFill®, a dermal filler, has been rebranded as Bellafill® in the U.S. “We feel that the brand Bellafill® better embodies the transformational outcomes this unique product can provide to our customers and their patients,” said Suneva Medical’s Chairman and Chief Executive Officer, Nicholas L. Teti, Jr. “In addition, Suneva will build and invest in Bellafill® to increase awareness for the new brand.” Bellafill® is approved by the U.S. Food and Drug Administration for the correction of facial wrinkles known as nasolabial folds, or smile lines. Proven safe and effective, the dermal filler is comprised of 80 percent purified bovine collagen with 20 percent polymethylmethacrylate (PMMA) microspheres, and lidocaine. In addition to immediately adding volume to smooth away smile lines, Bellafill® helps skin re-create its own firmer structure for beautiful, younger looking skin and lasting results.1,2 To learn more about Bellafill® visit www.bellafill.com or follow on Facebook: facebook.com/bellafillglobal and Twitter: @bellafill.

Media interested in speaking with a Suneva Medical representative should contact Melody Demel at 619-234-0345 or suneva@formulapr.com. For more information on Suneva Medical, visit www.sunevamedical.com/old.

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 Bellafill® in the U.S. and Canada; ArteFill® in Korea and Singapore; Regenica® in the U.S. and Canada; and ReFissa® in the U.S. For more information, visit www.sunevamedical.com/old.

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1Gottfried Lemperle, et. al., ArteFill® Permanent Injectable for Soft Tissue Augmentation: I. Mechanism of Action and Injection Techniques., Aesthetic Plast Surg. 2010 Jun;34(3):264–72.
2Data on file, Suneva Medical Inc.

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.