Locate Bio Gets Breakthrough Status for Infection-Treating Bone Graft
Locate Bio has received Breakthrough Device designation from the FDA for its CognitOss bone graft, which is designed to treat bone infections in a single procedure.
The resorbable bone graft releases antibiotics to treat infection of the bone and to prevent reinfections. Currently, the standard treatment for chronic osteomyelitis typically requires a second surgery to remove the nonresorbable bone graft.
CognitOss is intended to be used in addition to oral or intravenous antibiotics, the company said. The product uses the same naturally derived materials as Locate’s CertOss, a composite collagen product that the company expects to submit for 510(k) clearance next year.