About

SynerFuse® is a Minnesota-based medical device company developing an integrated approach to spinal fusion and chronic pain. The patented SynerFuse® procedure, e-Fusion™ (also known as e-TLIF™, Electric Transforaminal Lumbar Interbody Fusion™), combines fusion with direct nerve stimulation to address chronic low back and leg pain that is unaddressed in traditional spinal fusion surgery, providing Ultra Low Energy™ (ULE™) Technology.

About · Milestones

From the first patent filing to a pivotal trial

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

SynerFuse® was founded in 2018 to work on that gap, and built an intellectual property portfolio around it. That work produced the SynerFuse® e-Fusion™ procedure (also known as e-TLIF™, Electric Transforaminal Lumbar Interbody Fusion™), which delivers Ultra Low Energy™ (ULE™) Technology, integrating it with the spinal fusion.

  1. 2018SynerFuse® is founded and begins building its intellectual property portfolio.
    • SynerFuse, Inc.
    • Minnesota

    SynerFuse® was founded in 2018 to address failed back surgery syndrome, on a patient-first and surgeon-led approach that created the e-Fusion™ procedure.

    SynerFuse Medical has built a global intellectual property portfolio, which now stands at 13 issued patents across the United States, Canada, Australia, Europe and Asia.

    The SynerFuse® e-Fusion™ procedure delivers Ultra Low Energy™ (ULE™) Technology that integrates into the spinal fusion.

    Sources

  2. 2022The first patented e-Fusion™ procedure was performed at the University of Minnesota.
    • University of Minnesota
    • M Health Fairview

    The first patented e-Fusion™ procedure implanted leads under Direct Visual Placement™ in an open transforaminal lumbar interbody fusion (TLIF). The technique is described as Direct Visual Placement in the published study. This enables Ultra Low Energy™ (ULE™) Technology.

    The first five procedures involved two surgeons collaborating: Dr. Michael C. Park placing the ULE™ leads under Direct Visual Placement™, and Dr. Rohan R. Lall performing the fusion.

    Sources

  3. 2023The first solo-surgeon e-Fusion™ procedure was performed at M Health Fairview.
    • M Health Fairview
    • South Bend Orthopaedics

    Dr. Rohan R. Lall completed the first e-Fusion™ procedure without the assistance of Dr. Michael C. Park.

    Dr. Lall then trained Dr. Deepak Reddy, an orthopedic spine surgeon, through the procedure at South Bend Orthopaedics, with the same outcomes. This demonstrates the repeatability and trainability of the technique, and the durability of Ultra Low Energy™ (ULE™) Technology.

    With South Bend Orthopaedics enrolling, the feasibility study ran across two sites in two states.

    Sources

  4. 2025The 15-patient feasibility study is completed.
    • N Am Spine Soc J
    • PubMed Central

    Fifteen patients received the e-Fusion™ procedure, which utilized Ultra Low Energy™ (ULE™) Technology, and had a 12-month follow-up.

    The study reported no serious adverse events from the e-Fusion™ procedure.

    Results including safety and early data were published in the North American Spine Society Journal in 2026.

    Pain scores, disability and opioid use are reported in full on the Clinical Research page.

    Sources

  5. TodayThe NeuroFuse® System is built, and a clinical trial is being prepared with the Big Ten Neurosurgery Consortium.
    • Big Ten Neurosurgery Consortium
    • Med-Ally Medical

    SynerFuse® completed its feasibility study: the e-Fusion™ procedure combined spinal fusion with direct nerve stimulation and Ultra Low Energy™ (ULE™) Technology, designed to treat neuropathic low back pain and radiculopathy.

    The NeuroFuse® System enables Ultra Low Energy™ (ULE™) Technology.

    SynerFuse® plans to submit the NeuroFuse® System under an Investigational Device Exemption (IDE) to be studied by its industry partner, the Big Ten Neurosurgery Consortium, in a 150-patient randomized trial across the United States.

    The next study expands its partnership into the Big Ten Neurosurgery Consortium, utilizing RQM+ for regulatory support and relying upon Med-Ally Medical™ manufacturing to produce the NeuroFuse® System for the e-Fusion™ study.

    SynerFuse® is planning its clinical trial with the Big Ten Consortium. This partnership will enable the commercialization strategy of the NeuroFuse® System for fusion patients.

    The e-Fusion™ procedure and the NeuroFuse® System remain investigational; their safety and effectiveness have not been established.

    Sources

SynerFuse® Indications

SynerFuse® has completed its feasibility study of the e-Fusion™ procedure, which evaluated the safety and tolerability of integrating spinal fusion with direct nerve stimulation and is designed to address neuropathic chronic low back pain (cLBP). The NeuroFuse® System, which provides Ultra Low Energy™ (ULE™) Technology, is finalized. SynerFuse® is preparing its clinical trial with the Big Ten Consortium, and continues to build out its intellectual property portfolio and to implement its regulatory and reimbursement strategies.

Indications and development pipeline. The technology runs through five stages: IP, feasibility, development, clinical trial and PMA. Fusions with ULE™ have reached the clinical stage. Laminectomies with ULE™ and decompressions with ULE™ have reached feasibility. Premarket Approval is a future stage and is not near-term.

Indications

Technology

IP Filings

e-Fusion™ (Fusion + ULE™)

NeuroFuse® System

Big Ten Consortium

PMAFuture

IP

Feasibility

Development

Clinical Trial

PMA

Fusions+ ULE™

Laminectomies+ ULE™

Decompressions+ ULE™

Scroll sideways to see the full path.

SynerFuse® is partnering with the Big Ten Consortium on its clinical trial, a research network of 17 neurosurgery programs across 14 states. The initial OmniPNS™ device is a Class 2 external pulse generator (EPG). The SynerFuse® implantables are Class 3 implantable pulse generators (IPGs), which is why Premarket Approval sits at the end of the path and is not near-term.

A successful fusion isn’t the same as a life without pain.

Up to 28% of patients still live with persistent pain after surgery (Park et al., N Am Spine Soc J, 2026 (opens in a new tab)), and as many as 40% develop Failed Back Surgery Syndrome (Elsamadicy et al., Neuromodulation, 2017 (opens in a new tab)). Millions are left managing their pain with no clear solution or alternative. It’s the problem SynerFuse® was founded to address.

These figures describe the disease state and are provided for context, not a product claim.

Two paths after chronic low back pain. Today’s standard of care reaches a permanent implant more than twelve years after pain begins. The e-Fusion procedure reaches twelve-month outcomes one year after surgery.Today’s Standard of CareDoes not address nerve painat the time of surgery7.3 yearschronic pain before surgeryThe e-Fusion™ Procedurein the feasibility studyFirst fusion5.45yearsAdditional spinal proceduresMore fusionsOpioid medicationSpine injectionsPhysical therapy12+ yearsStim trialPermanent stim≥50%pain reductionFusion + ULE™≥69%pain reduction (12 months)
Two paths after chronic low back pain. Today’s standard of care reaches a permanent implant more than twelve years after pain begins. The e-Fusion procedure reaches twelve-month outcomes one year after surgery.Today’s Standard of CareDoes not address nerve painat the time of surgery7.3 yearschronic pain before surgeryThe e-Fusion™ Procedurein the feasibility studyFusion + ULE™≥69%pain reduction (12 months)First fusion5.45yearsSpine injectionsMore fusionsAdditional spinalproceduresOpioid medicationPhysical therapyStim trialPermanent stim≥50%pain reduction12+ yearsfrom first pain to permanent stim

Outcomes at 12 months

  • Opioid use down 80%: 3 of 15 (15 of 15 in the first 24 hours)
  • No surgical revisions through 12 months
  • Back pain 71% and leg pain 69% better on average
  • Disability 53% better on average

N=15 early feasibility study. Published in the North American Spine Society Journal, 2026. Results are from early feasibility data and may not be indicative of future outcomes.

7.3 years: average duration of chronic low back pain before surgery in the 15 study patients. 5.45 years: Park et al., N Am Spine Soc J, 2026, citing Rizvi and Kumar, Pain Management, 2014. Together more than 12 years. ≥50% pain reduction: the usual bar for a successful stimulator trial before a permanent implant (Medicare LCD L37632, Spinal Cord Stimulators for Chronic Pain). ≥69% pain reduction: back pain improved 71% and leg pain 69% on average at 12 months in the feasibility study (Park et al., N Am Spine Soc J, 2026). The e-Fusion™ path is one year from surgery to 12-month outcomes; the 7.3 years of prior chronic pain is the patient’s history before surgery and is shared by both paths.

At 12 months: opioid use 3 of 15, down 80% from 15 of 15 in the first 24 hours; disability (Oswestry Disability Index) 52.8% better on average. Park et al., N Am Spine Soc J, 2026, Tables 7 and 8.

The approach is being studied as a way to address nerve pain during the surgery the patient is already having. It is investigational, and its safety and effectiveness have not been established.

Led by spine surgeons

The team behind it

SynerFuse® combines experience growing startups with clinical expertise in spine surgery, a focused product development and IP strategy, and regulatory partners who work on the FDA pathway for combination devices. SynerFuse® is a QuantumStim™ company (opens in a new tab).

  • Spine surgeon leadership — the CMO and CTO bring commercial and clinical expertise
  • Product and intellectual property — 13 issued patents covering the procedure, implant and system architecture
  • Clinical and commercialization strategy — partnering as an industry partner with the Big Ten Neurosurgery Consortium to advance e-Fusion™ across the United States
Meet the team

CMO · CTO

Spine surgeon leadership

Commercial and clinical expertise.

13

Issued patents

Covering the e-Fusion™ procedure, implant and system architecture.

Big Ten

Clinical and commercialization strategy

Partnering as an industry partner with the Big Ten Neurosurgery Consortium to advance e-Fusion™ across the United States.