News & Press

BELLAFILL® RECEIVES FDA APPROVAL FOR TREATMENT OF ACNE SCARS

Bellafill® is the only filler on the market approved in the U.S. for the correction of acne scars Proven safe and effective in a well-controlled clinical study, Bellafill® addresses an unmet need for millions who suffer from acne scarring Bellafill® is a simple in-office treatment that offers immediate correction and lasting results San Diego, CA …

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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 …

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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 …

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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 …

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‘THE REAL HOUSEWIVES OF NEW JERSEY’ ORIGINAL CAST MEMBER JACQUELINE LAURITA REVEALS ARTEFILL® AS HER BEAUTY SECRET

Lasting Dermal Filler for Wrinkle Correction Gives Laurita a Refreshed Look SAN DIEGO, Calif., Feb. 12, 2014  Jacqueline Laurita, original cast member of The Real Housewives of New Jersey, revealed that she relies on ArteFill® Injectable Wrinkle Filler as one of her beauty secrets. “Having tried a few different temporary fillers in the past, I’m very happy to have found …

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SUNEVA MEDICAL RAISES 35 MILLION DOLLARS IN FUNDING

SUNEVA MEDICAL RAISES $35 MILLION IN FUNDING Polaris Partners and HealthCare Royalty Partners Lead the Capital Raise in Support of Company’s Growth Initiatives SAN DIEGO, Calif. (Jan. 9, 2014)—Suneva Medical, Inc., a privately-held aesthetics company, announced that it has recently raised $35 million in debt and equity capital. The new capital was structured to be …

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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.