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Suneva Medical Announces Canadian Approval of Bellafillâ„¢

June 29, 2011 By Bio-Medicine.Org

SAN DIEGO, June 29, 2011 /PRNewswire/ — 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

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SOURCE

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