SynerFuse Announces Solo Spine Surgeon Implants 8th Patient in Integrated Spinal Fusion and DRG Neuromodulation Proof-of-Concept Study

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

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Summation

  • 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).

Justin Zenanko, CEO of SynerFuse, Inc., a Minnesota-based medical device company, is pleased to announce that for the first time in the world, a solo spine surgeon performed the groundbreaking SynerFuse procedure. Rohan Lall, MD, at once both performed a spinal fixation procedure and implanted a neurostimulator with leads on the eighth patient in the company’s proof-of-concept study.

“So far in the study, the SynerFuse procedure has been efficient and straightforward to perform,” said Lall. “The industry has seen the efficacy of DRG stimulation for patients with chronic pain, and it is very exciting to be able to study incorporating it earlier in the treatment process for these patients in an attempt to reduce their pain levels and needs for opioids. I believe this will become widely adopted in spine surgery.”

See photo taken after the eighth surgery, left to right: Zenanko, Lall, and SynerFuse Co-Founder and Chief Scientific Officer Greg Molnar, Ph.D.

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 SynerFuse proof-of-concept study supports the enrollment of up to 20 patients.

“This is an important step toward demonstrating that our combined procedure can be performed without needing two surgeons,” said Zenanko. “Spinal fixation procedures today are performed by one spine surgeon. This study aims to conclude that one spine surgeon can also perform the integrated SynerFuse procedure. This is an important step toward adoption of the procedure.”

“The implantation of the eighth patient in our proof-of-concept study is an important milestone for SynerFuse,” said Zenanko. “With each new patient, we’re one step closer to demonstrating the viability of our non-narcotic concept for spinal fusion patients with chronic lower back pain.”

“Bringing this patient-focused therapy from concept to the eighth 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 Molnar.

Seven patients previously had a neurostimulator with leads implanted by Michael C. Park, MD, PhD, and spinal fixation by Rohan Lall, MD, and Jonathon Sembrano, MD, at M Health Fairview University of M Health Fairview University of Minnesota Medical Center.

More information about SynerFuse is available at www.synerfuse.com.

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.[1] With more than 500,000 procedures performed annually, spinal fusion remains a common treatment for spinal instability, albeit with a high incidence of residual neuropathic pain[2]. Up to 40% of patients who undergo spinal fusion end up 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[3].