SynerFuse has announced the first implantation in the company’s proof-of-concept study, which will evaluate the safety and tolerability of simultaneously implanting spinal fusion hardware and a dorsal root ganglion (DRG) neurostimulator in patients suffering from chronic lower back pain.
The first patient was implanted by Michael Park and Rohan Lall at M Health Fairview University of Minnesota Medical Center (Minneapolis, USA).
The SynerFuse proof-of-concept study involves combining spinal fusion with the implant of a neurostimulator to provide stimulation of the DRG, a key nerve structure along the spine that can be targeted with neuromodulation to treat chronic neuropathic pain.
The study—which will include up to 20 patients—is designed to evaluate the safety and tolerability of the integrated therapy. Patients undergoing an initial spinal fusion, among other criteria, are eligible.
Justin Zenanko, co-founder and CEO of SynerFuse, said: “The implantation of the first patient in our proof-of-concept study is an important milestone for SynerFuse. We’re one step closer to demonstrating the viability of our non-narcotic solution for spinal fusion patients with chronic lower back pain.”
Greg Molnar, co-founder and CSO of SynerFuse, added: “Bringing this patient-focused therapy from concept to first implant is a true testament to collaboration within our company and with our surgeon and staff partners at the University of Minnesota Medical School and M Health Fairview University of Minnesota Medical Center.”