SUNEVA MEDICAL WELCOMES DEEPAK CHADHA AS VICE PRESIDENT OF REGULATORY AFFAIRS

Seasoned Veteran in the Aesthetics Industry Joins the Suneva Medical Team

SAN DIEGO, CA (March 10, 2014)—Suneva Medical, Inc., a privately-held aesthetics company, announced today that it has appointed Deepak Chadha to Vice President, Regulatory Affairs. With nearly two decades of regulatory experience, Chadha will be responsible for leading the development and implementation of Suneva Medical’s regulatory strategies. Chadha comes to Suneva Medical after holding regulatory affairs positions at companies that include KYTHERA Biopharmaceuticals and Allergan Medical.

“Deepak has been responsible for several global regulatory strategies that have led to the successful submission and approval of aesthetic and therapeutic products in the U.S. and overseas,” said Nicholas L. Teti, Jr., Chairman and Chief Executive Officer of Suneva Medical. “This track record is highly regarded by Suneva Medical and we welcome Deepak to the team, as he will help us meet our vision to become a standout in the aesthetics market.”

Chadha brings to Suneva Medical a wealth of experience in regulatory submissions and projects for drugs, biologics, medical devices and combination products. Prior to Suneva Medical, he held the role of Vice President, Regulatory Affairs at KYTHERA. During his time at KYTHERA, Chadha successfully led their lead compound ATX-101 from an early clinical phase to an NDA stage, and also supported the ex-US regulatory activities.  Chadha has also served as Vice President of Global Regulatory Affairs at Allergan Medical, helping build the organization’s Global Regulatory Affairs department. In addition, his career has included positions of increasing responsibility at Biomeasure Inc. (Ipsen) and Stryker Biotech.

“I am pleased to join Suneva Medical’s experienced management team and am optimistic that my role will help drive the company’s growth strategy,” said Chadha.

For more information on Suneva Medical, visit www.sunevamedical.com/old.
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®   Skincare in the U.S. and Bellafill® in Canada. 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.