Clinical and strategic partner
150 patient clinical trial
SynerFuse® has moved from the e-Fusion™ procedure to partnering with the Big Ten Neurosurgery Consortium to conduct its upcoming pivotal trial, serving patients across the United States.
An academic alliance of neurosurgery departments running multi-center studies across the United States. SynerFuse® is an industry partner.
17
neurosurgery programs
14
states
1/3
of the nation’s population
- Big Ten Neurosurgery Consortium14 states
- Additional sites4 states
Additional sites
Florida and Colorado: site names to come.
Consortium program, state and population figures: Big Ten Neurosurgery Consortium public data. SynerFuse® partnered with RQM+ (opens in a new tab) for clinical monitoring and regulatory services.
Completed feasibility study
SynerFuse® and its collaborators at the University of Minnesota and South Bend Orthopaedics completed a 15-patient feasibility study of the e-Fusion™ (also known as e-TLIF™) procedure, across two sites in two states. The study integrated spinal fusion with direct nerve stimulation utilizing the e-Fusion™ Ultra Low Energy™ (ULE™) Technology, to evaluate its effects on chronic low back and leg pain.
As reported by
“Combining DRG stimulation with lumbar fusion cuts pain 70%”
Read the article at Becker’s Spine Review (opens in a new tab)
Integrating dorsal root ganglion stimulation with transforaminal lumbar interbody fusion: proof of concept study (opens in a new tab)
Patients
15
Sites
2
Minnesota and Indiana
Follow-up
12
months
Serious adverse events
0
Years of chronic pain
7+
before the procedure, on average
Who was studied
- Patients indicated for a fusion. This is not an alternative to fusion. It is an addition to a fusion the patient is already having.
- Patients who experienced greater than six months of chronic low back and leg pain.
- Lumbar or lumbosacral fusion: decompression and instrumented fusion of the lumbar or lumbosacral spine.
ULE™ Technology
- under 1 mA
- amplitude
Read the published study (opens in a new tab)See the ClinicalTrials.gov record (opens in a new tab)
Stimulation parameters as reported in the published feasibility study (Park et al., 2026). Up to 28% of patients who have surgery for chronic low back pain or radiculopathy still have that pain after a technically successful operation, likely from neuropathic pain (Park et al., 2026 (opens in a new tab)). Described for context, not a product claim.
Published results
These figures describe the disease state and are provided for context, not a product claim.
Back and leg pain
Average improvement in pain scores from before surgery to 12 months, all 15 patients.
Outer ring: back pain. Inner ring: leg pain. Pain was scored on a visual analog scale (VAS).
N=15 early feasibility study. Published in North American Spine Society Journal, 2026. Results from early feasibility data and may not be indicative of future outcomes.
View as a table
| Measure | Average improvement at 12 months |
|---|---|
| Back pain | 71% |
| Leg pain | 69% |
Disability before surgery and 12 months after
Oswestry Disability Index (ODI), all 15 patients.
- Minimal disability ODI 0–20%
- Moderate disability ODI 20–40%
- Severe disability ODI 40–60%
- Crippled ODI 60–80%
Average ODI score: 52.6% before surgery, 23.1% at 12 months.
N=15 early feasibility study. Published in North American Spine Society Journal, 2026. Results from early feasibility data and may not be indicative of future outcomes.
View as a table
| Timepoint | Disability band | Share of patients |
|---|---|---|
| Before surgery | Minimal disability | 6.7% |
| Before surgery | Moderate disability | 6.7% |
| Before surgery | Severe disability | 53.3% |
| Before surgery | Crippled | 33.3% |
| 12 months post surgery | Minimal disability | 46.7% |
| 12 months post surgery | Moderate disability | 40% |
| 12 months post surgery | Severe disability | 13.3% |
Opioid pain medication after surgery
As expected after spinal fusion surgery, all 15 patients were prescribed opioids in the first 24 hours. At 12 months, 3 of 15 were taking them.
Within 24 hours of surgery15 of 15 patients
100%
80%reduction
in opioid use
At 12 months3 of 15 patients
20%
Red capsules: within 24 hours of spinal fusion surgery, all 15 patients were prescribed opioid pain medication. Blue capsules: at 12 months after the e-Fusion™ procedure, 3 of 15. Ghosted outlines: the 12 patients no longer taking opioids.
N=15 early feasibility study. Published in North American Spine Society Journal, 2026. Results from early feasibility data and may not be indicative of future outcomes.
View as a table
| Timepoint | Patients taking opioids | Share |
|---|---|---|
| Within 24 hours of surgery | 15 of 15 | 100% |
| At 12 months | 3 of 15 | 20% |
Sleep quality before surgery and 12 months after
Self-reported sleep quality, same N=15 patients. Higher categories are better.
Before surgery
42.9% reported Bad or Very Bad sleep
12 months after surgery
11 of 15 reported Good or Very Good sleep (73.3%)
- Very Bad
- Bad
- Fair
- Good
- Very Good
SynerFuse clinical data, same N=15 patient population. Sleep quality data is not included in the published paper.
N=15 early feasibility study. Published in North American Spine Society Journal, 2026. Results from early feasibility data and may not be indicative of future outcomes.
View as a table
| Timepoint | Sleep quality |
|---|---|
| Before surgery | Very Bad 14.3%, Bad 28.6%, Fair 42.9%, Good 14.3% |
| 12 months after surgery | Bad 6.7%, Fair 20%, Good 26.7%, Very Good 46.7% |
Source for pain, disability and opioid figures: Park MC, Lall RR, Reddy D, Sembrano JN, Falowski SM, Haider NR. Integrating dorsal root ganglion stimulation with transforaminal lumbar interbody fusion: proof of concept study. N Am Spine Soc J (opens in a new tab), 2026. Read the published study (opens in a new tab). Sleep quality data: SynerFuse® clinical data, same N=15 patient population; not included in the published paper. Based on a 15-patient proof-of-concept feasibility study (Park et al., NASSJ 2026). Investigational device (IDE G190045); not FDA-approved; safety and effectiveness not established.
Research partners
Two sites, two states.
- 2022First e-Fusion™ procedure
- 2023Second study site joins
- 2025Study completed
- 2026Results published
University of Minnesota and M Health Fairview
Minneapolis, Minnesota
Investigators
- Michael C. Park, MD, PhD
- Rohan R. Lall, MD
- Jonathan N. Sembrano, MD
Department of Neurosurgery (opens in a new tab)M Health Fairview (opens in a new tab)
South Bend Orthopaedics
South Bend, Indiana
Investigator
- Deepak Reddy, MD