News & Press

Suneva Medical Announces Publication of ArteFill® Five-Year Safety and Patient Satisfaction Study Interim Results in Dermatologic Surgery

April 4, 2013

SAN DIEGO, CA – May 5, 2010 – Suneva Medical, a privately-held aesthetic medical device company, today announced the publication of interim results from its long-term study on ArteFill in the May 2010 issue of Dermatologic Surgery, the Journal of the American Society of Dermatologic Surgery. The study highlights the safety profile (adverse events, granuloma …

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Artefill® Featured on The Doctors Television Show

April 4, 2013

®trong>SAN DIEGO, CA – May 7, 2010 – Suneva Medical, a privately-held aesthetic medical device company, today announced that its lead product Artefill, was featured on the nationally syndicated CBS medical talk show, “The Doctors” on May 6th. The “New Body Breakthroughs” segment showcased Artefill as an effective and longer lasting solution for smile line …

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New Study Published in Journal of Drugs in Dermatology Finds Artefill Effective in Treating Atrophic Acne Scars

April 4, 2013

Ninety-Six Percent of Acne Scars Noticeably Improved Over Eight-Month Period SAN DIEGO, CA – October 7, 2010 – Suneva Medical, a privately-held aesthetic medical device company, today announced the publication of an open-label, single center, pilot study on Artefill® for the treatment of atrophic acne scars conducted by James M. Spencer, M.D. M.S. and sponsored …

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Nicholas L. Teti, Jr. Appointed President and CEO of Suneva Medical

April 4, 2013

SAN DIEGO, CA – October 15, 2010 – Suneva Medical, a privately-held aesthetic medical device company, today announced the appointment of industry veteran Nicholas L. Teti, Jr. to President and CEO. Mr. Teti has twenty-five years experience in the pharmaceutical industry and ten years in the aesthetics space, most notably as the President and CEO …

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Suneva Medical Announces Canadian Approval of Bellafill

April 4, 2013

SAN DIEGO, CA – June 29, 2011 – Suneva Medical, a privately-held aesthetic medical device company, today announced the expansion of its core aesthetics injectable business with approval from Health Canada to market BellafillTM, its long lasting dermal filler for nasolabial folds or smile line correction. In addition to offering patients a unique, long-lasting treatment, …

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Even in This Economy, Consumers Invest in Aesthetic Procedures With Long Lasting Results

April 4, 2013

SAN DIEGO, Nov. 1, 2011 /PRNewswire/ –– Physicians say consumers are more willing to invest in longer lasting aesthetic treatments, possibly due to the current economic climate. A recent online survey of 160 U.S. dermatology, plastic surgery and aesthetic practices revealed consumers see the value of a longer term solution and in turn will spend …

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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.