SynerFuse™ Successfully Completes Groundbreaking Study for Chronic Back Pain Treatment

SynerFuse™ Study Paves the Way for Improved Chronic Back Pain Treatment

On March 3, 2025, SynerFuse™ and its partners, including the University of Minnesota and South Bend Orthopaedics, announced the successful completion of their proof-of-concept study. This pioneering research focuses on the Electric Transforaminal Lumbar Interbody Fusion (e-TLIF™) procedure, which innovatively combines spinal fusion with direct nerve stimulation, aiming to address issues like chronic lower back pain (cLBP) and neuropathic leg pain.

The study included 15 surgery patients, for whom extensive one-year follow-up assessments were conducted. Results highlighted not just the effectiveness but also the safety profile of integrating spinal fusion with neuromodulation techniques.

Throughout the study, registrants noted significant improvements in pain management post-surgery, emphasizing a potential shift in treatment approaches for those grappling with chronic pain. The co-founders of SynerFuse™, along with the principal investigators, expressed gratitude to everyone involved in the study’s execution, including regulatory consultants from RQM+, who provided vital support.

Addressing the Opioid Crisis

With chronic low back pain affecting around 93 million Americans, the need for innovative treatments is paramount. The current traditional spinal fusion surgeries often leave patients in opioid dependency due to residual neuropathic pain. This groundbreaking study addresses this pressing issue by exploring the potential of combining surgical treatment with direct nerve stimulation, paving the way for reduced reliance on opioids and improved quality of life for patients.

SynerFuse™ CEO Justin Zenanko emphasized the team’s commitment to improving patient quality of life and tackling the escalating opioid crisis caused largely by chronic pain management failures. As the e-TLIF™ procedure shows promise in lowering postoperative pain levels, it could represent a transformative option in the future landscape of chronic pain treatments.

Future Application and Research

The data gathered from this proof-of-concept study will serve a dual purpose: it will lay the groundwork for future peer-reviewed journal publications and will support the company’s application for breakthrough status with the FDA. This progression could usher in enhanced regulatory support for the e-TLIF™ procedure, ensuring faster access for patients in need of relief from chronic pain.

Given that spinal fusion remains a widely performed procedure for spinal instability, the minor—yet significant—improvements noted in the study could represent a crucial evolution in orthopedic and neurosurgical practices. These developments could also aid in reducing failed back surgery syndrome (FBSS), a condition where up to 40% of spinal fusion patients experience ongoing neuropathic pain, costing healthcare systems billions each year.

Conclusion

As SynerFuse™ prepares for the next steps in regulatory compliance, its foundational belief remains steadfast: patients suffering from chronic lower back pain deserve more than one-dimensional treatment options. The integration of neuromodulation with surgical procedures signals a hopeful future where effective, non-narcotic pain solutions can be made widely available.

For further information about the SynerFuse™ and its pioneering efforts, please visit their website at www.synerfuse.com.