Suneva Medical Increases Its Leadership in Regenerative Aesthetics with New Partnership

April 15, 2020 (San Diego) — Suneva® Medical, Inc., is proud to announce an exciting new partnership that will further its leadership position in regenerative aesthetics.  The exclusive North American distributorship for Sinclair Pharma’s innovative Silhouette Instalift® sutures will expand Suneva Medical’s aesthetic portfolio that addresses the growing market demand for natural and minimally invasive alternatives in aesthetics. 

“We are excited to welcome Silhouette Instalift® to our already broad regenerative aesthetics portfolio,” says Pat Altavilla, CEO, Suneva Medical. “These unique sutures fit perfectly as they can provide immediate lift to sagging cheeks and, like Bellafill, can activate the patient’s natural collagen production over time.”

“With Suneva Medical, we have a partnership with a company that has strong commercial presence in the U.S. while giving us the ability to expand our footprint in the North American market,” says Chris Spooner, CEO Sinclair Pharma.

To learn more about Suneva Medical and upcoming news from the aesthetics company, please visit www.SunevaMedical.com.

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, Puregraft, a unique fat grafting system and Amplifine™, an innovative high density platelet rich plasma (PRP) get tube. For more information, visit www.sunevamedical.com.

About Sinclair Pharma

Sinclair Pharma is a fully owned subsidiary of Huadong Medicine Limited and headquartered in London, UK. The company operates in the fast growth, global aesthetics market and has built a strong portfolio of differentiated, complementary aesthetics technologies, targeting unmet clinical needs for effective, high quality, longer duration, natural looking and minimally-invasive treatments. The Group has an established sales and marketing presence in the leading EU markets, Brazil, Mexico, UAE and South Korea and a network of international distributors. For more information, visit www.sinclairpharma.com.

Media Contacts:

Sunvea Medical, Inc.

Andy Vutam                                                                                                                     email: media@sunevamedical.com

Sinclair Pharma                                                                                                                Tel: +44 (0) 20 7467 6920

Chris Spooner

Andy Crane

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.