Suneva Medical, a privately-held aesthetic medical device company, today announced the expansion of its core aesthetics injectable business with approval from Health Canada to market Bellafill™, its long lasting dermal filler for nasolabial folds or smile line correction. In addition to offering patients a unique, long-lasting treatment, Bellafill provides physicians the opportunity to provide a differentiated, premium product and enhance their practice economics.
"Temporary hyaluronic acid based fillers are quickly becoming recognized for what they were designed to be, a short term fix to a lifelong aesthetic issue. Additionally, patient fatigue with temporary fillers and a desire by physicians to differentiate their practices by offering unique and premium products, creates a significant opportunity and benefit for the patient, the physician and the Company," commented Nicholas Teti, Chairman and CEO of Suneva Medical, Inc. "Canadian approval of Bellafill allows Suneva to meet this growing demand in the market. The approval of Bellafill is also an important milestone in our overall international expansion strategy. We are currently evaluating our options for a Canadian launch; in addition, we have established international partnership agreements in several countries around the world and expect a number of international product launches later this year."
Bellafill is composed of bovine collagen and unique, third generation, engineered microspheres and includes lidocaine for improved patient comfort. This distinct formulation offers patients long-lasting wrinkle correction. In addition, the proprietary microsphere production process provides tightly controlled microsphere size and an enhanced safety profile versus products previously sold in Canada. Bellafill meets the rigorous standards of quality and safety of Health Canada. A pre-treatment allergy test is optional. In clinical trials, Bellafill demonstrated a significant duration of correction and a positive safety profile with no significant device-related adverse events.
SOURCE Suneva Medical, Inc.