Locate Bio’s CognitOss Granted FDA Breakthrough Device Designation

Locate Bio’s CognitOss Granted FDA Breakthrough Device Designation

CognitOss is designed to treat osteomyelitis, a debilitating inflammatory bone infection

FDA’s Breakthrough Device Program helps accelerate patient access to more effective treatments

Locate Bio, an orthobiologics focused regenerative medicine company, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to CognitOss, currently in development for the treatment of chronic osteomyelitis. The FDA Breakthrough Device Program is intended to help patients receive more timely access to certain technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. 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 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 that delivers a leading bone formation responsei. 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. The need for such a product is currently greater than ever, with the global incidence of osteomyelitis substantially increasing in recent years, in part due to an increase of risk factors such as diabetesii. 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.” Keith Valentine, Non-Executive Chair, said: “This is another important step towards Locate’s ambition of building a world leading, diversified orthobiologics company. We have a clear focus on bringing novel, best-in-class products to the market, in a range of orthopaedic indications, that can provide improved options for surgeons and, in turn, improve the lives of millions of patients.”