SUNEVA MEDICAL CELEBRATES 10 YEARS OF STEADY GROWTH WITH FLAGSHIP BRAND, BELLAFILL

June 1, 2017 (San Diego, CA) – Suneva® Medical, Inc., renowned privately held aesthetics company, announces their 10-year anniversary of flagship brand, Bellafill®. Over the last 10 years, Bellafill’s growth within the industry has been exponential, and one that Suneva Medical is honored to stand behind.

Bellafill is the only dermal filler clinically proven and established safe and effective for the correction of nasolabial folds and the correction of moderate to severe, atrophic, distensible facial acne scars on the cheeks in patients over the age of 21 years old. It has five-year safety and efficacy data from the largest and longest prospective dermal filler study ever conducted through the FDA, where 1,008 patients enrolled and 87% stayed on for all five years. 83% of patients were also reported to be satisfied or very satisfied at the end of the 5 year span.

The extensive clinical testing and 5 and 10 year post market surveillance revealed results that were astounding. A total of 1,542 patients have been treated with Bellafill® across four U.S. clinical studies, more pivotal clinical trial subjects than any available dermal filler on the market. When taking a closer look at the results, the observed granuloma rate across all Bellafill studies was 1.2%. In the 5 Year Post Approval Study, granulomas occurred infrequently (1.7%), with the majority being mild to moderate in serverity and the ongoing granuloma rate at the end of the study was <1%. When taking a closer look at the 10 years post market surveillance, from 2007 to December 2016, approximately 600,000 syringes have been sold with a remarkable 0.11% of Total Adverse Events reported.

 

Suneva’s subsequent advancement of their ground-breaking product can be attributed to the brand’s dedication to diligently working to provide physicians with the education and tools they need to meet the results-driven, high-demand of patients, while filling a need in the marketplace. In fact, a recent study revealed that 53% of patients begin to experience ‘treatment fatigue’ after receiving routine filler treatments for 3 years or more, and 82% of patients expressed interest in an FDA-approved filler that would last up to 5 years. Driving the demand of a more long-lasting solution, 71% of patients also said they would be extremely or very likely to switch providers if their current did not provide a 5 year filler and another provider did.

 

“We are focused on developing, manufacturing and commercializing novel, differentiated products for the aesthetic markets,” says Suneva Medical CEO Preston Romm. “The 10th year anniversary of Bellafill along with its clinical evidence of safety and efficacy is a very proud milestone for the company. Bellafill’s time is now, and our goal is to become a leader in the market.”

With an emphasis on training, Suneva works hard to help medical professionals obtain the best patient outcomes. The company has pledged to offer comprehensive, professional training and online didactic training for Bellafill®. It is this commitment, in combination with impressive post market surveillance results and proven efficacy, as well as the high patient demand for  long lasting filler that has driven an optimistic future for Bellafill.

 

Bellafill® is only available through licensed medical professionals. The list of providing physicians and additional information can be found at www.bellafill.com.

About Suneva Medical, Inc.

Suneva Medical is a privately‐held aesthetics company focused on developing, manufacturing and commercializing novel, differentiated products for the aesthetic markets. The innovative aesthetics leader markets Bellafill®, the only dermal filler on the market that is approved by the U.S. Food and Drug Administration 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. The company markets Bellafill® in the U.S., Canada, Hong Kong, Korea and Mexico; Regenica® skin care in the U.S., Canada, Hong Kong, Korea and Mexico. For more information, visit sunevamedical.com/old

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

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.