FDA approves Injectable Hyaluronic-Acid–Based Bone Repair Treatment

The minimally invasive technology is a synthetic, resorbable bone- graft substitute. The FDA has approved 510(k) clearance to Anika Therapeutics for another hyaluronic- acid (HA)– based injection indicated for filling bone voids or defects of the skeletal system (i.e., extremities and pelvis), which are not intrinsic to the stability of the bone, made during surgery or resulting from traumatic injury.

The bone-void filler, which is made out of a synthetic, biocompatible bone- graft substitute material, is injected into a void, solidifies at body temperature, and is then resorbed and replaced by the growth of new bone during the healing process.

More than one million musculoskeletal procedures performed in the U.S. involve bone-void filling, otherwise called bone grafting, and such methods are most normally required for spinal fusion, injury, and revision total joint replacement procedures.

The present market size for treating tibial plateau fractures evaluates by the Anika Therapeutics, stress fractures around joints, and decompression of necrosed bone issue around $300 million.

While the utilization of autologous bone or autograft has been the highest quality level of treatment for bone grafting, the increased risk of procedural complications has prompted a shift towards alternative therapies, for example, synthetic, resorbable bone- graft substitute materials.

In a press release, John Tierney, DO, an orthopedic surgeon affiliated with New England Baptist Hospital who has worked with the new treatment, described it as minimally invasive, and said the product “offers doctors an additional option for treating bone deformities or wounds, without the requirement for costly and high- risk surgeries, while additionally decreasing the operating room time spent on each case.”

The new bone-repair treatment is an injectable, HA-based, settable osteoconductive calcium phosphate bone graft substitute material.

It is given in a unit two components —a fluid solution in a preloaded syringe and a dry powder that must be mixed intraoperatively utilizing the supplied mixing system to form a cohesive paste before administration. It is given sterile to single-use in volumes running from 1.5 mL to 4 mL.

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