Our History

While there were numerous spinal fusion product companies and several that operated in the neurostimulation market, none had the vision to combine the two therapy modalities of spinal fusion and neuromodulation into a single solution implanted simultaneously at the point of a spinal fusion procedure.

SynerFuse™ was founded in 2018 with this vision. Subsequently, the company identified an enormous whitespace opportunity and built a deep and broad intellectual property portfolio around it, creating the SynerFuse™ solution of integrated spinal fusion and neuromodulation.

In 2022, the first SynerFuse™ e-TLIF™ patented procedure was performed at the University of Minnesota, M Health Fairview.

In 2023, enrollment in the company’s proof-of-concept study--involving 15 e-TLIF™ procedures--was completed.

The Spinal Fusion Market and Pain Management Opportunity

There are more than 570,000 spinal fusion procedures performed annually in the United States alone. And the market is expected to grow steadily based on our aging population and the high obesity rates. As many as 40% of cases result in chronic, residual pain following a spinal fusion surgery costing the US healthcare system $20B annually. A common treatment pathway is a narcotic-based regimen. If that is not successful, neurostimulation is sought in a two-step process: a trial and a final implant, thus subjecting a patient to three surgical procedures. In contrast, the SynerFuse™ approach involves the combined implantation of a spinal fusion device and our SynerFuse™ device concept.

SynerFuse™ Milestones

Company completed enrollment in its proof-of-concept study to evaluate the safety and tolerability of the Electric Transforaminal Lumbar Interbody Fusion (e-TLIF™) procedure integrating spinal fusion with direct nerve stimulation, which is designed to treat neuropathic chronic low back pain (cLBP). The company will prepare for a national clinical trial utilizing a custom-built NeuroFuse e-TLIF™ LE spinal fixation/electronic neuromodulation device. Concurrent with this activity, SynerFuse™ will be continually building out its intellectual property portfolio, and implementing regulatory and reimbursement strategies.