Orthobiologics company Locate Bio has received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for CognitOss, a treatment it is developing for chronic osteomyelitis.
Osteomyelitis is a rare but serious and progressive inflammatory infection of the bone that is typically caused by bacteria. Infection can occur either through spread from another part of the body via the bloodstream and into the bone, or an open fracture or surgery that may expose the bone to infection.
It is estimated that up to 50 percent of all amputations not related to trauma are due to osteomyelitis.
Current treatment for the condition includes surgical debridement along with long-term administration of high-dose antibiotics. For larger site infections, bone grafting is the standard treatment. In bone grafting, removal of the non-resorbable bone graft material requires a second surgical procedure.
CognitOss is a graft implant that offers surgeons a single surgical procedure alternative.
There is a growing need for such treatments as the incidence of osteomyelitis has been on the rise globally in recent years, partly due to increases in risk factors, including diabetes.
CognitOss was developed as a resorbable bone graft that does not need to be removed after implantation. The implant also delivers controlled release of antibiotics to the site of infection.
Locate Bio says CognitOss combines “a fully resorbable bone graft with best-in-class bone healing properties and a proprietary dual-phasic release of antibiotics.”
The dual-phasic antibiotics release involves an initial release at the site of the infection and then prevents re-infection through a further controlled release.
The company says CognitOss is intended to be used as an adjuvant to oral or intravenous antibiotics, to prevent colonization of the graft material.
In a news release from the company, 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.”
The FDA Breakthrough Device Program is intended to help patients receive more timely access to technologies that potentially offer more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.
CognitOss uses the same bone graft substitute architecture as Locate CertOss, which is a new class of composite collagen product that delivers a leading bone formation response.
Locate Bio says 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.
Locate Bio has a proprietary, regenerative medicine pipeline, delivering orthobiologics products that have great disruptive potential. It aims to build a “world leading, diversified suite of best-in-class technologies that address the performance limitations of existing products and enable orthopedic surgeons to improve the lives of people suffering from debilitating conditions.”
The company is planning first-in-human studies of CognitOss for 2022.