Enrollment Completed in SynerFuse™ Proof-of-Concept Study

--Study Is Evaluating Safety and Tolerability of Simultaneous Spinal Fusion and Implant of Neuromodulation Devices in Chronic Lower Back Pain Patients

EDEN PRAIRIE, Minn., Oct. 17, 2023 /PRNewswire/ -- Justin Zenanko, CEO of SynerFuse™, today announced that SynerFuse™ has 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 lower-back pain (cLBP). The enrollment completion comes after the company successfully completed surgeries on 15 proof-of-concept study patients.

"As we mark the completion of enrollment and the final treatment in our proof-of-concept study, we take another important step towards evaluating our novel SynerFuse™ e-TLIF^™ procedure," said 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 Rohan Lall, M.D., co-investigator with M Health Fairview University of Minnesota Medical Center. "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 post-operative 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 15^th patient implant in our proof-of-concept study represents an important milestone for SynerFuse™. We look forward to evaluating the outcome data to inform our pivotal trial," said Greg Molnar, Ph.D., chief science officer of SynerFuse^™.

"The progress we have made demonstrates our commitment to design the SynerFuse™ e-TLIF^™ procedure in a manner aimed at avoiding treatment failure, multiple spinal fusions, and risky opioid therapy," said Zenanko. "With this milestone, we advance our mission to improve patient quality of life and address the opioid crisis head on."

"We want to thank our principal investigators: Michael Park, M.D., associate professor of neurosurgery at the University of Minnesota, and Deepak Reddy, M.D., South Bend Orthopaedics," said Zenanko. "As well as our co-investigators leading the study: Rohan Lall, M.D., a spine surgeon with M Health Fairview University of Minnesota Medical Center; Jonathan Sembrano, M.D., associate professor of orthopedic surgery at the University of Minnesota; and Matthew A. Hunt, M.D., MHA, FRCS, FAANS., M Health Fairview University of Minnesota Medical Center."

With more than 500,000 procedures performed annually, spinal fusion remains a common treatment for spinal instability, albeit with a high incidence of residual neuropathic pain.¹ It has been estimated that up to 40 percent of patients who undergo spinal fusion end up with failed back surgery syndrome (FBSS), a condition resulting in significant, lingering neuropathic pain, costing the U.S. healthcare system $20B per year and significantly affecting the quality of life of patients.²

SynerFuse™ is based in Minnesota—the heart of Medical Alley and the cradle of neuromodulation and medical device innovation. SynerFuse™ currently has 11 issued patents and 70 published patent applications worldwide relating to its novel e-TLIF™ procedure. SynerFuse™ believes that individuals with cLBP/FBSS and their providers deserve an alternative option than spinal fusion alone. More information about SynerFuse™ is available at www.synerfuse.com.

About Chronic Lower Back Pain (cLBP)
cLBP is defined as lower back pain that continues for 12 weeks or longer, even after an initial injury or underlying cause of acute lower back pain has been treated.³ With more than 500,000 procedures performed annually, spinal fusion remains a common treatment for spinal instability, albeit with a high incidence of residual neuropathic pain.⁴ Up to 40% of patients who undergo spinal fusion end up with Failed Back Surgery Syndrome (FBSS), a condition resulting in significant, lingering neuropathic pain, costing the U.S. healthcare system $20B per year and significantly affecting the quality of life of patients.⁵

About SynerFuse™
SynerFuse™ is a Delaware corporation based in Minnesota—the heart of Medical Alley and the cradle of neuromodulation and medical device innovation. SynerFuse™ believes that individuals with cLBP/FBSS and their providers deserve an alternative option than spinal fusion alone. Even when spinal fusion is successful, it can often result in residual chronic neuropathic pain and use of addictive opioids. The company is working to create a non-narcotic pain management for chronic low back pain with a patented therapy that integrates spinal fusion hardware and an active neuromodulation system. For more information on the company, please visit www.synerfuse.com.

This communication contains information about an investigational product. This product is limited by Federal (U.S.) law to investigational use only. SynerFuse™ makes no claims regarding the safety or effectiveness of the unapproved investigational product. The intent of providing this information is to convey research and development initiatives underway at SynerFuse™.

¹ Karen L. Saban et al., "Health-Related Quality of Life of Patients Following Selected Types of Lumbar Spinal Surgery: A Pilot Study," Health and Quality of Life Outcomes 5 (2007), https://doi.org/10.1186/1477-7525-5-71, accessed 17 October 2023.

² Farber SH, Han JL, Elsamadicy AA, Hussaini Q, Yang S, Pagadala P, Parente B, Xie J, Lad SP. Long-term Cost Utility of Spinal Cord Stimulation in Patients with Failed Back Surgery Syndrome. Pain Physician. 2017 Sep;20(6):E797-E805. PMID: 28934786; PMCID: PMC8358894

³ See "Low Back Pain Fact Sheet." National Institute of Neurological Disorders and Stroke, https://www.ninds.nih.gov/low-back-pain-fact-sheet#:~:text=Chronic%20back%20pain%20is%20defined, back%20pain%20has%20been%20treated, accessed 17 October 2023.

⁴ Karen L. Saban et al., "Health-Related Quality of Life of Patients Following Selected Types of Lumbar Spinal Surgery: A Pilot Study," Health and Quality of Life Outcomes 5 (2007), https://doi.org/10.1186/1477-7525-5-71, accessed 17 October 2023.

⁵ Farber SH, Han JL, Elsamadicy AA, Hussaini Q, Yang S, Pagadala P, Parente B, Xie J, Lad SP. Long-term Cost Utility of Spinal Cord Stimulation in Patients with Failed Back Surgery Syndrome. Pain Physician. 2017 Sep;20(6):E797-E805. PMID: 28934786; PMCID: PMC8358894.

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SOURCE SynerFuse