Suneva Medical Announces Expansion of Bellafill® into South Korea with New Distribution Partnership

January 29, 2024 (San Diego, CA) – Suneva® Medical, Inc., a privately held aesthetics company, is pleased to announce the reopening of South Korea post-COVID and an expansion for Bellafill within this major global aesthetic market through a new distribution partnership with Renaissance Bio.

With it’s flagship brand, Bellafill, the only biostimulatory filler that is FDA approved to provide safe and effective results for up to 5 years,  Suneva Medical is committed to delivering regenerative aesthetic solutions globally.

“All across the globe, we are seeing a considerable rise in demand for biostimulatory fillers like Bellafill,” said Pat Altavilla, CEO of Suneva Medical.  “We are excited for this new partnership with Renaissance Bio as they are one of the premier Korean distributors with a far reaching network of aesthetic providers who want a unique product that can provide safe and long-lasting results for their patients.”

“Bellafill has established itself as a proven product in the U.S. and globally.  And now Renaissance Bio has the opportunity to represent and support the growth of Bellafill within the South Korean aesthetic market,” said Hosang Yoon, CEO of  Renaissance Bio.  “Our network of plastic surgeons, dermatologists and aesthetic specialists have been eagerly awaiting the availability of Bellafill through our distribution network. South Korea is one of the most enthusiastic and competitive regions when it comes to medical aesthetics. We are delighted to introduce, Bellafill, an innovative filler that offers long-lasting effects, to Korean consumers. Through this, we are confident in meeting their high demand and expectations.”

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 products to address the impact of the aging process to deliver solutions that leverage the body’s own restorative capacity. The product portfolio is composed of several “only” and “first to market” solutions with both FDA PMA approval and 510(k) clearance. For more information, visit www.sunevamedical.com.

About Renaissance Bio, Inc.

Renaissance Bio, Inc. is located in Seoul, South Korea. The term ‘Renaissance’ signifies ‘rebirth’. Staying true to its name, Renaissance Bio infuses new vitality into high-quality products by introducing them to a market that hasn’t been fully explored yet. Collaborating through a global network, we widely introduce cutting-edge medical aesthetic products, including high-end fillers and botulinum toxin, tailored to the demands of the new market, bringing joy to consumers. For more information, please visit www.renasbio.com.

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.