News & Press

SUNEVA MEDICAL ANNOUNCES LANDMARK CLINICAL STUDY CONFIRMING LONG-TERM SAFETY OF BELLAFILL® THROUGH FIVE YEARS (Health Canada)

September 10, 2015

World’s largest and longest prospective dermal filler post-approval study conducted assessed the five year safety of Bellafill® with unprecedented results Bellafill® is the first and only Health Canada approved dermal filler indicated for the correction of nasolabial folds that has been proven safe through five years with high patient satisfaction Completing the only study of …

SUNEVA MEDICAL ANNOUNCES LANDMARK CLINICAL STUDY CONFIRMING LONG-TERM SAFETY OF BELLAFILL® THROUGH FIVE YEARS (Health Canada) Read More »

SUNEVA MEDICAL RAISES $35.4 MILLION IN CAPITAL FOR ONGOING PRODUCT COMMERCIALIZATION EFFORTS AND EXPANSION OF BUSINESS DEVELOPMENT ACTIVITIES

July 28, 2015

Financing includes $15 million in a Series C equity investment from Almirall, Inc., an affiliate of Almirall, S.A and a $20.4 million growth-capital term loan from an account managed by HealthCare Royalty Partners Capital to support continuing commercialization of company’s aesthetic product portfolio Company will expand its business development and licensing activities to enhance its …

SUNEVA MEDICAL RAISES $35.4 MILLION IN CAPITAL FOR ONGOING PRODUCT COMMERCIALIZATION EFFORTS AND EXPANSION OF BUSINESS DEVELOPMENT ACTIVITIES Read More »

SUNEVA MEDICAL JOINS TOGETHER WITH LEADING SKIN CARE AND DATING EXPERTS FOR JUNE’S ACNE AWARENESS MONTH

March 23, 2015

Leading aesthetics company teams up with Zoosk, the #1 dating app, and renowned dermatologist Dr. Ava Shamban to help online daters fight their battles with acne and acne scarring Acne is the most common skin disorder in the U.S., affecting 40 – 50 million people1 and up to 95% of people with acne may go …

SUNEVA MEDICAL JOINS TOGETHER WITH LEADING SKIN CARE AND DATING EXPERTS FOR JUNE’S ACNE AWARENESS MONTH Read More »

BELLAFILL® RECEIVES FDA APPROVAL FOR TREATMENT OF ACNE SCARS

November 26, 2014

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 …

BELLAFILL® RECEIVES FDA APPROVAL FOR TREATMENT OF ACNE SCARS Read More »

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

November 5, 2014

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 …

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

BELLAFILL® TO REPLACE ARTEFILL® AS NEW BRAND

September 12, 2014

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 …

BELLAFILL® TO REPLACE ARTEFILL® AS NEW BRAND Read More »

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.