Anika Therapeutics receives FDA 510(k) clearance for HA-based bone void filler
Anika Therapeutics (ANIK) announced that its HA-based bone void filler received 510(k) clearance from the U.S. Food and Drug Administration and is indicated for filling bone voids or defects of the skeletal system, which are not intrinsic to the stability of the bone, created during surgery or resulting from traumatic injury.
HA-based bone stands for therapeutics based on its proprietary hyaluronic acid (“HA”) technology. The bone void filler, which is composed of a synthetic, biocompatible bone graft substitute material, is injected into a void, hardens at body temperature, and is then resorbed and replaced by the growth of new bone during the healing process.
Over one million musculoskeletal procedures performed in the U.S. involve bone void filling, also known as bone grafting,, and such procedures are most commonly required for spinal fusion, trauma, and revision total joint replacement procedures.
While the use of autologous bone or autograft has been the gold standard of treatment for bone grafting, the increased risk of procedural complications has prompted a shift towards alternate treatments, such as synthetic, resorbable bone graft substitute materials.
The company estimates that the current market size for treating tibial plateau fractures, stress fractures around joints, and decompression of necrosed bone to be around $300M.
ANIK closed at $52.44.
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