The indication covers filling bone voids or defects that aren’t intrinsic to the stability of the bone, created during surgery or the result of traumatic injury. Made of a synthetic, biocompatible bone graft substitute material, the filler is injected into a void and hardens at body temperature. It’s then resorbed and replaced by new bone growth.
“We’re proud to announce the U.S. regulatory clearance of our innovative injectable HA-based bone void filler, which represents the U.S. commercial debut of our robust regenerative medicine portfolio,” CEO Charles Sherwood said in prepared remarks. “The rapid 510(k) clearance is a testament to Anika’s operational and strategic expertise. In addition, this new treatment represents a promising revenue growth opportunity, and advances our mission to provide innovative treatments to patients that address the full continuum of orthopedic care.”
“Anika’s 510(k) clearance allows for the marketing of one of only a handful of bone graft substitutes that can be administered in a minimally invasive manner. It 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,” added Dr. John Tierney of Boston’s New England Baptist Hospital.