Plasma IQ Acquires Health Canada Approval

January 21, 2021 (San Diego, CA) – Suneva® Medical, Inc., a privately held aesthetics company, is pleased to announce the approval of Neauvia North America’s Plasma IQTM by Health Canada, making it the first and only approved hand-held plasma energy device for the aesthetic market.

Plasma IQTM is the latest advancement in aesthetics that delivers focused, controlled plasma energy to safely and effectively create microinjuries on the skin, renewing and restoring it.

“Acquiring Health Canada approval is another important step in ensuring that we can safely and ethically provide innovations to our customers worldwide,” said Sean Wilson, CEO of Neauvia North America.

“Our partnership with Neauvia North America has been mutually beneficial for our customers, their patients and our two companies,” said Pat Altavilla, CEO of Suneva Medical. “We are excited to be able to bring this great technology to Canada and continue our commitment to providing proven and validated innovations for aesthetic providers and their patients.”

About Suneva Medical, Inc.

Suneva Medical, Inc. headquartered in San Diego, CA is a leader in regenerative aesthetics. It is focused on developing, manufacturing and commercializing branded products for providers and their patients. Suneva Medical offers a portfolio of best-in-class products that include Bellafill®, the only FDA approved 5-year filler, Silhouette Instalift®, the first resorbable suture FDA cleared for cosmetic facial procedures, PuregraftTM, a unique fat grafting system, Dermapose RefreshTM, an all-in-one system to harvest, wash and inject sized fat and AmplifineTM, an innovative high density platelet rich plasma (PRP) gel tube and Plasma IQTM, the first FDA approved hand-held plasma energy device. For more information, visit www.sunevamedical.com.

About Neauvia North America

Neauvia North America, headquartered in Raleigh, North Carolina, is the U.S. subsidiary of Neauvia, a global aesthetics brand present in more than 50 countries. Neauvia North America currently offers aesthetic devices, skin care and digital solutions for aesthetic practices. For more information, visit www.neauvia-us.com.

Plasma IQTM is FDA cleared and Health Canada approved to be used in the removal and destruction of skin lesions and the coagulation of tissue. The most common side effects are swelling, tenderness, scabbing, and redness. Plasma IQ is Rx only and should only be used by medically licensed and certified practitioners. For full product and safety information,

visit https://www.sunevamedical.com/ifu/.

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.