PETER BARTON HUTT APPOINTED TO SUNEVA MEDICAL, INC. BOARD OF DIRECTORS

SAN DIEGO, CA (Oct. 8, 2014)Suneva Medical, Inc., a privately-held aesthetics company, today announced the appointment of Peter Barton Hutt as a member of its Board of Directors. Known in the legal community as the “dean of the food and drug bar,” Mr. Hutt has been a leading food and drug law practitioner and scholar for half a century. Mr. Hutt has specialized in food and drug law at the Washington D.C. firm of Covington and Burling since 1960, pausing only to serve as Chief Counsel of the FDA from 1971 to 1975. A prodigious writer, he is co-author of the Food and Drug Law: Cases and Materials. He has also taught Food and Drug Law at Harvard Law School since 1994.

“Peter is one of the world’s leading attorneys concerning FDA matters, and an expert in U.S. health policy. We are thrilled that he has joined Suneva Medical’s Board of Directors,” said Nicholas L. Teti, Jr., Chairman and CEO of Suneva Medical. “As a director, his regulatory perspective and knowledge of the health care industry will be invaluable as we advance Suneva Medical’s broad product pipeline.”

Mr. Hutt is a member of the Institute of Medicine of the National Academy of Sciences, and serves on a wide variety of academic and scientific advisory boards and on the Board of Directors of several companies. In addition, he has represented the national trade associations for the food, prescription drug, nonprescription drug, dietary supplement, and cosmetic industries.  While at the FDA he drafted the legislation that became the Medical Device Amendments of 1976, and beginning in 1962 he has participated in the drafting of most of the major legislation amending the Federal Food, Drug, and Cosmetic Act.  He has testified before the House and Senate more than 100 times either as a witness or as counsel accompanying a witness.

Mr. Hutt received his B.A., magna cum laude, from Yale University, his LL.B. from Harvard University, and his LL.M. from New York University.
Media interested in speaking with a Suneva Medical representative should contact Melody Demel at 619-234-0345 or suneva@formulapr.com.

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

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.