Study to Evaluate Safety and Tolerability of Simultaneous Implant of Spinal Fusion and Neuromodulation Devices in Chronic Lower Back Pain Patients
MINNEAPOLIS, July 26, 2022 /PRNewswire/ — Justin Zenanko, CEO of SynerFuse, Inc., a Minneapolis-based medical device company, is pleased to announce completion last week of the company’s groundbreaking procedure in a fifth patient in the company’s proof-of-concept study. The patients have been implanted by Michael C. Park, MD, PhD, and Rohan Lall, MD, at M Health Fairview University of Minnesota Medical Center.
“The implantation of the fifth patient in our proof-of-concept study is an important milestone for SynerFuse,” said Zenanko. “Now that we have implanted five patients, the Data Safety Monitoring Board will be assembled to review the safety of the SynerFuse therapy concept. We’re one step closer to demonstrating the viability of our non-narcotic solution for spinal fusion patients with chronic lower back pain.”
The SynerFuse proof-of-concept study involves combining spinal fusion with the implant of a neurostimulator to provide stimulation of the dorsal root ganglion (DRG), a key nerve structure along the spine that can be targeted with neuromodulation to treat chronic neuropathic pain, to provide relief to patients suffering from chronic lower back pain (cLBP). 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.
“Bringing this patient-focused therapy from concept to the fifth implant milestone 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 Molnar.
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.
SynerFuse is a Delaware corporation based in Minnesota—the heart of Medical Alley and the cradle of neuromodulation and medical device innovation. SynerFuse believes that individuals with cLBP/FBSS and their providers deserve a better option than spinal fusion alone. Even when spinal fusion is successful, it can often result in residual chronic neuropathic pain and use of addictive opioids. The company is working to create a new future of non-narcotic pain management for chronic low back pain with a patented therapy that integrates spinal fusion hardware and an active neuromodulation system. For more information on the company, please visit www.synerfuse.com.