News & Press

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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SUNEVA MEDICAL ANNOUNCES 12-MONTH SAFETY RESULTS FROM PIVOTAL ARTEFILL® ACNE SCAR INVESTIGATIONAL CLINICAL STUDY

SUNEVA MEDICAL ANNOUNCES 12-MONTH SAFETY RESULTS FROM PIVOTAL ARTEFILL® ACNE SCAR INVESTIGATIONAL CLINICAL STUDY Dermal Filler Appears to be a Safe Treatment for Acne Scars SANTA BARBARA, Calif. (Jan. 7, 2014)—Suneva Medical Inc., a privately-held aesthetics company, today announced the 12-month follow-up data from its randomized, double-blinded, multi-center, Pivotal acne scar investigational study evaluating the …

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Suneva Medical Signs Multi-Million dollar Line of Credit Agreement

Suneva Medical Signs Multi-Million dollar Line of Credit Agreement with Western Technology Investment Additional Financing Used to Fund Suneva’s Growth SAN DIEGO, CA – December 17, 2009 – Suneva Medical, a privately-held aesthetic medical device company, today announced that it has signed a multi-million dollar line of credit facility with Western Technology Investment (WTI). The …

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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

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.