The US Food and Drug Administration (FDA) has granted Breakthrough Device designation to orthobiologics company Locate Bio’s CognitOss, which is currently being developed for treating chronic osteomyelitis.
Through the Breakthrough Device Program, FDA aims to help accelerate patients’ timely access to certain technologies that can potentially offer more efficient treatment or identification of diseases that are life-threatening or irreversibly debilitating.
A progressive, inflammatory bone infection, osteomyelitis is generally caused by bacteria.
Estimates show that it accounts for up to 50% of all amputations associated with non-trauma.
Currently, surgical debridement, long-term, high-dose antibiotics administration, and bone grafting for larger defects are the standard treatment for the condition.
In addition, bone grafting needs a second surgical operation for non-resorbable bone graft removal.
Locate Bio noted that CognitOss can potentially offer surgeons a single surgical procedure alternative, which merges a fully resorbable bone graft with bone healing qualities and a proprietary dual-phasic antibiotic release.
It can initially provide a bolus release at the infection site, and later, through a further controlled release, can avert re-infection.
CognitOss is meant to be used as an adjuvant to oral or intravenous antibiotics for preventing graft material colonisation.
Locate Bio CEO John von Benecke said: “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.”
Locate Bio expects to conduct first-in-human studies of CognitOss next year.
CognitOss puts into use the bone graft substitute architecture of the company’s novel class of composite collagen product, CertOss, that offers a leading bone formation response.