SAN DIEGO, June 1, 2017 /PRNewswire/ -- 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 www.sunevamedical.com.
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SOURCE Suneva Medical, Inc.