Regenerative medicine company Locate Bio announced today that the FDA has granted breakthrough device designation to a bone graft/antibiotic combination designed to combat chronic bone infection, also known as osteomyelitis.
Osteomyelitis is a progressive, inflammatory infection of the bone, usually caused by bacteria and is estimated to account for up to 50% of all non-trauma related amputations. Currently, the standard treatment for chronic osteomyelitis is surgical debridement, long-term, high-dose administration of antibiotics, and — for larger defects — bone grafting, which often requires a second surgical procedure to remove the non-resorbable bone graft.
CognitOss is intended to offer surgeons a single surgical procedure alternative, combining a fully resorbable bone graft with bone healing properties and a proprietary, dual-phasic release of antibiotics to treat the infection and prevent a recurrence, according to UK-based Locate Bio. CognitOss is intended to be used as an adjuvant to oral or intravenous antibiotics, to prevent colonization of the graft material.
CognitOss uses the same bone graft substitute architecture as Locate Bio’s CertOss, a new class of composite collagen product formulated to encourage bone formation for which Locate Bio intends to submit a 510(k) application in 2022.
“We are delighted that CognitOss has been granted breakthrough device designation by the FDA,” said Locate Bio CEO John von Benecke in a news release. “CognitOss is designed to address the enduring unmet clinical need of osteomyelitis patients, through a novel, single-stage therapy that combines the local delivery of therapeutically appropriate levels of antibiotics with an effective, biodegradable, state-of-the-art material that promotes the regeneration of bone. We look forward to progressing CognitOss through its regulatory pathway and into clinical trials.”