The FDA has granted 510(k) clearance to Anika Therapeutics for a new 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, created during surgery or resulting from traumatic injury. 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.
More than 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. Anika Therapeutics estimates the current market size for treating tibial plateau fractures, stress fractures around joints, and decompression of necrosed bone to be around $300 million.
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. 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 physicians an additional option for treating bone defects or injuries, without the need for expensive and high-risk surgeries, while also reducing 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 provided in a kit with two components—an aqueous solution in a preloaded syringe and a dry powder—that must be mixed intraoperatively using the supplied mixing system to form a cohesive paste prior to administration. It is provided sterile for single use in volumes ranging from 1.5 mL to 4 mL.
Source: Anika Therapeutics; December 27, 2017.