News & Press

Suneva Medical Inc. Announces Multiple Regulatory Approvals in the U.S. and Canada

May 3, 2022

Canadian Regulators have approved Dermapose® All-In-One fat sizing syringe U.S. FDA 510(k) clearance for a larger volume Amplifine PRP Gel Tube SAN DIEGO, CA (May 3, 2022) — Suneva Medical, Inc. (“Suneva” or the “Company”), an innovative medical technology company using regenerative medicine to change the standard of care in aesthetic treatments, and partner Bimini Health Tech (“Bimini”), today announced …

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Suneva Medical Inc.’s Silhouette InstaLift Wins Best Thread Lift Treatment in NewBeauty’s 2022 Beauty Awards

April 13, 2022

 SAN DIEGO, April 13, 2022 /PRNewswire/ — Suneva Medical, Inc. (“Suneva” or the “Company”), an innovative medical technology company using regenerative medicine to change the standard of care in aesthetic treatments, announced that its Silhouette InstaLift®, a non-surgical thread lift, has won the Best Thread Lift Treatment title in NewBeauty’s 2022 Beauty Awards. Silhouette InstaLift …

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Viveon Health Acquisition Corp. Announces Board and Stockholder Approval to Extend Period to Consummate Business Combination

March 21, 2022

NORCROSS, Ga., March 21, 2022 /PRNewswire/ — Viveon Health Acquisition Corp. (NYSE American: VHAQ) (“Viveon Health” or “VHAQ”), a special purpose acquisition company, announced the approval of its board of directors (the “Board”) to extend the date by which Viveon Health has to complete a business combination for an additional three months, to June 28, …

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Viveon Health Acquisition Corp. Announces Clarified Contribution Terms in Connection with the Extension Related to Merger Agreement with Suneva Medical

March 2, 2022

NORCROSS, Ga., Feb. 11, 2022 /PRNewswire/ — Viveon Health Acquisition Corp. (NYSE American: VHAQ) (“Viveon Health” or “VHAQ”), a special purpose acquisition company, today announced that it is clarifying certain terms regarding the Annual Meeting of stockholders to be held on March 18, 2022.  Viveon Health previously announced that on January 12, 2022 it entered …

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Bellafill 1 Million Syringe Milestone

Suneva Surpasses 1 Million Syringes of Bellafill® Distributed Since the Biostimulator’s Inception

February 8, 2022

San Diego, CA (February 8, 2022) – Suneva Medical, Inc. (“Suneva” or the “Company”), an innovative medical technology company using regenerative medicine to change the standard of care in aesthetic treatments, today announced that it reached a milestone of distributing more than 1 million syringes of  Bellafill® at the close of 2021. Bellafill, which has been available for regenerative …

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FDA Accepts Label Update for Plasma IQ™, the First FDA-Cleared Handheld Plasma Energy Device

January 28, 2022

San Diego, CA (January 28, 2022) – Suneva Medical, Inc. (“Suneva” or the “Company”), an innovative medical technology company using regenerative medicine to change the standard of care in aesthetic treatments, today announced that the U.S. Food and Drug Administration (FDA) accepted updates to the Plasma IQ™ label, including the removal of the product’s eye contraindication. The removal of …

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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.