SynerFuse has announced that it has completed enrolment 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 completion of enrolment comes after the company successfully performed surgeries on 15 proof-of-concept study patients.
“As we mark the completion of enrolment and the final treatment in our proof-of-concept study, we take another important step towards evaluating our novel SynerFuse e-TLIF procedure,” said the company’s CEO Justin Zenanko.
“Currently, if patients have persistent chronic back and leg pain after a successful fusion, they may eventually become candidates for neuromodulation therapy, but typically only several years after surgery, during which time they may suffer disabling pain and opioid medication use,” said co-investigator Rohan Lall (M Health Fairview University of Minnesota Medical Center, Minneapolis, USA).
“This is an important goal for the study: addressing the need for non-narcotic pain management therapy earlier on to avert the need for opioids. If the SynerFuse e-TLIF procedure proves effective at lowering postoperative pain levels, as early indications have suggested, we may have a new treatment strategy that potentially saves the healthcare system billions of dollars and improves pain management outcomes.”
“The 15th patient implant in our proof-of-concept study represents an important milestone for SynerFuse,” added Greg Molnar, chief science officer of SynerFuse. “We look forward to evaluating the outcome data to inform our pivotal trial.”
SynerFuse currently has 11 issued patents and 70 published patent applications worldwide relating to its novel e-TLIF procedure. In a press release, the company claims that it believes individuals with CLBP/failed back surgery syndrome (FBSS) and their providers deserve an alternative option than spinal fusion alone.
