CognitOss Granted FDA Breakthrough Device Designation

By Julie A. Vetalice

CognitOss Granted FDA Breakthrough Device Designation

Locate Bio was granted Breakthrough Device designation from FDA for CognitOss, bone graft developed to treat chronic osteomyelitis.

CognitOss presents an alternative to surgical debridement, long-term, high-dose administration of antibiotics, and bone grafting which often requires a second surgical procedure to remove the non-resorbable bone graft. CognitOss is an adjuvant to antibiotics to prevent colonization of the graft material.

CognitOss uses the same bone graft substitute architecture as Locate Bio’s CertOss, a new class of composite collagen product that delivers a leading bone formation response. FDA 510(k) submission for CertOss is planned in 2022.

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, while repairing the bone void. First in human studies of CognitOss are slated for 2022.

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.”

In 3Q20, Locate Bio acquired multiple late-stage complementary orthobiologics assets from Royal College of Surgeons in Ireland University of Medicine and Health Sciences, accelerating its route to market and broadening its orthobiologics pipeline. Locate’s portfolio now includes CertOss semi-synthetic graft substitute; CognitOss, the same graft substrate as CertOss, but designed to elute antibiotics for the treatment of osteomyelitis; LDGraft, a low dose, controlled-release rhBMP-2 spinal fusion product; and Chondro3, a three-layer cartilage repair graft. Locate Bio continues to seek complementary acquisitions or in-licensing opportunities that would further broaden its portfolio.

Product Labels: Bone Graft Materials/DBM

Tags: 510(k) Clearance, Regulatory