Osteomyelitis treatment awarded FDA Breakthrough Device designation

Locate Bio, an orthobiologics focused regenerative medicine company has been granted Breakthrough Device Designation by the Food and Drug Administration (FDA) for CognitOss, currently in development for the treatment of chronic 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 best-in-class bone healing properties and a proprietary dual-phasic release of antibiotics, to initially provide a bolus release at the site of the infection and then prevent re-infection through a further controlled release. CognitOss is intended to be used as an adjuvant to oral or intravenous antibiotics, to prevent colonisation of the graft material. 

CognitOss uses the same bone graft substitute architecture as Locate Bio’s CertOss, a new class of composite collagen product that delivers a leading bone formation response. 510(k) submission for CertOss is planned in 2022.

CognitOss is designed to extend the capabilities of this bone graft with a dual-phasic and uniquely responsive antibiotic release mechanism that releases higher levels of antibiotic in the presence of infection, all whilst repairing the bone void. First in human studies of CognitOss are planned in 2022.

John von Benecke, CEO of Locate Bio, said: “We are delighted that CognitOss has been granted Breakthrough Device designation by the FDA. 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.”