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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.