Locate Bio, an advanced orthobiologics firm, has secured the US Food and Drug Administration (FDA) Breakthrough Device designation for its bone graft product CognitOss.

CognitOss is currently under development for the treatment of chronic osteomyelitis, a progressive, inflammatory infection of the bone caused by bacteria.

The current standard treatment for chronic osteomyelitis is surgical debridement, long-term, high-dose administration of antibiotics, and bone grafting for severe defects, which requires a second surgical procedure to remove the non-resorbable bone graft.

The company said that its CognitOss offers a single surgical procedure alternative for surgeons, and is intended to be used as an adjuvant to oral or intravenous antibiotics.

Locate Bio CEO John von Benecke 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.”

CognitOss uses bone graft substitute similar to CertOss

CognitOss combines a fully resorbable bone graft, with enhanced bone healing properties and a dual-phasic antibiotics release mechanism.

The product initially facilitates a bolus release at the site of the infection, and prevents the re-infection through a further controlled release.

CognitOss uses the bone graft substitute similar to CertOss, a new class of composite collagen product designed to deliver bone formation response.

Locate Bio said that the CognitOss is designed to extend the capabilities of the bone graft with a dual-phasic antibiotic release mechanism that releases enhanced levels of antibiotics at the site of infection, while repairing the bone void.

Locate Bio non-executive chair Keith Valentine 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.”

In September 2020, the company has acquired multiple late stage orthobiologics assets from RCSI University of Medicine and Health Sciences for an undisclosed sum.