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Locate Bio awarded FDA designation for osteomyelitis device

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Nottingham-based Locate Bio has been granted FDA Breakthrough Device Designation for its device currently in development for the treatment of 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. The current standard of treatment is surgical debridement, long-term, high-dose administration of antibiotics, and – for larger defects – bone grafting.

Locate Bio’s 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 initially provide a bolus release at the site of the infection and then prevent reinfection 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.

John von Benecke, CEO of Locate Bio, said: “CognitOss is designed to address the enduring unmet clinical need of osteomyelitis, 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, added: “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.”

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