Kuros Biosciences, a leader in next generation bone graft technologies, today announced that the first patient has been treated in the STRUCTURE trial, investigating Fibrin-PTH (KUR-113) for transforaminal lumbar interbody fusion (TLIF) procedures in patients with degenerative disc disease.
The first patient was treated by Dr Richard Todd Allen, principal investigator at University California San Diego. The STRUCTURE trial is conducted under an open Investigational New Drug (IND) for spinal fusion, which was recently filed with the U.S. Food and Drug Administration (FDA).
Editor's Note: This article originally appeared on Kuros Biosciences' website
Kuros’s STRUCTURE trial is a prospective, randomized, controlled, single-blind, dose-finding, multi-center study with the primary endpoint of radiographic interbody fusion, using CT-scans, at 12 months as determined by an independent radiology expert panel. This Phase 2 trial, conducted in the U.S., intends to demonstrate safety and efficacy of Fibrin-PTH in patients undergoing a single-level TLIF procedure.
In this first-of-its-kind investigational trial, a flowable drug-biologic bone graft will be delivered through a narrow-gauge delivery system to achieve interbody spine fusion. Not only is this the first time a drug-biologic bone graft is being tested for the treatment of Degenerative Disk Disease (DDD) in patients within a clinical trial, but it is also the first time such a technology is being evaluated for both open and minimally invasive surgical technique under clinical trial conditions.