Medical Device News Magazine

Thursday, March 23, 2023

SynerFuse Proof-of-Concept Study-1st Patient Implanted in Integrated Spinal Fusion & DRG Neuromodulation

SynerFuse™ Notes Study to Evaluate Safety and Tolerability of Simultaneous Implant of Spinal Fusion and Neuromodulation Devices in Chronic Lower Back Pain Patients

SynerFuse Proof-of-Concept Study: SynerFuse, Inc., a Minneapolis-based medical device company, announced the first implantation in the company’s proof-of-concept study.

The study 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 (cLBP). The first patient was implanted by Dr. Michael Park, MD, Ph.D., and Dr. Rohan Lall, MD, at M Health Fairview University of Minnesota Medical Center.

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 will evaluate the safety and tolerability of the integrated therapy. Patients undergoing an initial spinal fusion, among other criteria, are eligible for the study. The Proof-of-Concept Study supports the enrollment of up to 20 patients.

“The implantation of the first patient in our proof-of-concept study is an important milestone for SynerFuse,” said co-founder and CEO Justin Zenanko. “We’re one step closer to demonstrating the viability of our non-narcotic solution for spinal fusion patients with chronic lower back pain.”

“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,” said SynerFuse co-founder and CSO Greg Molnar, Ph.D.

About Chronic Lower Back Pain (cLBP)
cLBP is defined as lower back pain that continues for 12 weeks or longer, even after an initial injury or underlying cause of acute lower back pain has been treated. With 500,000 procedures performed annually, spinal fusion remains a common treatment for spinal instability, albeit with a high incidence of residual neuropathic pain. The continuum of increasingly ineffective opioid treatments, additional interventions, and adjacent level spinal fusions leaves up to 40% of patients with Failed Back Surgery Syndrome (FBSS), a condition resulting in significant, lingering neuropathic pain, costing the U.S. healthcare system $20B per year and significantly affecting the quality of life of patients.

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