News & Press

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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Study Results Evaluating the Correction of Atrophic Scars with Artefill

Study Results Evaluating the Correction of Atrophic Scars with Artefill Presented at 2010 Orlando Dermatology Conference Study Suggests Artefill® Provides an Effective and Potentially Long-Lasting Treatment Option for Acne Scar Patients SAN DIEGO, CA – January 18, 2010 – Suneva Medical, a privately-held aesthetic medical device company, provided a research grant to support an investigator-sponsored …

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Suneva Medical Announces Positive Interim Data

Suneva Medical Announces Positive Interim Data from Five-Year Safety and Patient Satisfaction Study on Artefill® – Study Suggests Artefill Is As Safe as Other Dermal Fillers for Nasolabial Fold Correction – – Data Presented at Maui Derm 2010 Meeting – MAUI, HAWAII — January 25, 2010 – Suneva Medical, a privately-held aesthetic medical device company, …

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Two Studies Find Artefill® to Be a Long-Term Treatment

Two Studies Find Artefill® to Be a Long-Term Treatment Option for Facial Lipoatrophy Investigator-Initiated Studies Examine Artefill’s Use with Age-Related and HIV-Associated Facial Lipoatophy Patients SAN DIEGO, CA – February 2, 2010 – Suneva Medical, a privately-held aesthetic medical device company, today announced that two clinical studies suggest Artefill may be a safe, effective, long-term …

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Leading U.S. Dermatologist Reports Positive Data on Artefill®

Leading U.S. Dermatologist Reports Positive Data on Artefill® Dr. Christopher Zachary Discusses Interim Data from Artefill Five-Year Safety and Patient Satisfaction Study at the Hawaii Dermatology Seminar SAN DIEGO, CA – February 16, 2010 – Suneva Medical, a privately-held aesthetic medical device company, today announced that Christopher B. Zachary, MBBS, FRCP, Professor and Chair, Department …

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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.