SynerFuse™ Proof-of-Concept Study Completed

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

EDEN PRAIRIE, Minn., March 3, 2025 /PRNewswire/ -- SynerFuse™ and its collaborators at the University of Minnesota, South Bend Orthopaedics, and RQM+ today announced the completion of the SynerFuse™ proof-of-concept study to evaluate the safety and tolerability of the novel Electric Transforaminal Lumbar Interbody Fusion (e-TLIF™) procedure integrating spinal fusion with direct nerve stimulation, which is designed to treat chronic lower-back pain (cLBP) and neuropathic leg pain. To bring the proof-of-concept study to completion, the team conducted one-year follow-up assessments of the study's 15 surgery patients.

Data from the SynerFuse™ proof-of-concept study will be used to support the publication of peer-reviewed journal articles and to support the company's application for breakthrough status with the FDA.

"I want to thank our principal investigators: Michael C. Park, M.D., Ph.D.*, associate professor of neurosurgery at the University of Minnesota, and Deepak Reddy, M.D., South Bend Orthopaedics," said Justin Zenanko, SynerFuse™ CEO and co-founder. "I'd also like to thank our co-investigators leading the study: Rohan Lall, M.D., our chief medical officer and 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."

"I am also grateful to our regulatory consultants, Sew-Wah Tay, Ph.D., and Ming-Cheng Chew at RQM+, who have been with us since the beginning of our study in 2020, ensuring our compliance and assisting us with our application for breakthrough status with the FDA," 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 Lall. "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 dramatically improves patient quality of life and pain outcomes."

"With this milestone, we advance our mission to improve patient quality of life and address the opioid crisis head on," said Zenanko.

"The SynerFuse™ proof-of-concept study demonstrated the safety and feasibility of integrating direct nerve stimulation with open lumbar or lumbosacral decompression and instrumented fusion," said Park. "The direct placement of the electrode on the nerve also demonstrated no device-related significant adverse events. This technique could be a new treatment approach of integrating neuromodulation with spinal decompression and fusion."

"Our experience with Synerfuse™ e-TLIF™ procedure was very positive," said Reddy. "We saw improvement in acute postoperative pain scores as well as reduced medication usage in the first six weeks. The patient certainly found the therapy an essential part of their postoperative care and was still using it at their one-year follow-up."

"We are pleased to be able to help SynerFuse™ in its regulatory compliance journey with the FDA and other agencies," said Sew-Wah Tay, Ph.D., regulatory, clinical, and QA consultant at RQM+. "We look forward to the next phases of compliance and regulatory approvals with SynerFuse™ and to realizing the team's dream of bringing the company's novel therapy to the market so spinal fusion patients can experience superior outcomes."

More than 93 million Americans (28 percent) report suffering from chronic low back pain.(1) 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.(2) 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,(3) significantly affecting the quality of life of patients, and contributing to the opioid crisis (more than half of opioid users report back pain).(4)

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.(5) 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.(6) 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,(7)

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™.

SynerFuse™ Milestones
July 2018: SynerFuse™ founded
July 2019: FDA approves feasibility study
December 2019: University of Minnesota Institutional Review Board approves feasibility study
March 2020: Clinical trial agreement finalized with University of Minnesota Medical School
January 2022: First patient implanted—Dr. Michael C. Park implanted stimulator and leads, Dr. Rohan Lall implanted fusion
January 2023: South Bend Orthopaedics activated as second clinical site
June 2023: First solo procedure performed by former investigator Dr. Rohan Lall (implanted fusion with stimulator and leads)
August 2023: Second solo procedure performed by principal investigator Dr. Deepak Reddy, showing solo surgeon can learn and implement procedure outside University of Minnesota
October 2023: 15th patient implanted
October 2024: Final 12-month patient follow-up completed
*Dr. Park holds stock options from SynerFuse.

About South Bend Orthopaedics
South Bend Orthopaedics provides specialized care for all musculoskeletal surgery and Orthopaedic rehabilitation patients, as well as those suffering from work-related and sports injuries. Founded on the principle of providing excellence in Orthopaedics, SBO has been serving the needs of northern Indiana and southern Michigan since 1947 and functions as the Orthopaedic Surgeons for The University of Notre Dame Athletics Department since 1949. Dr. Reddy has become a leader in complex spine surgery with specific areas of interest including robotics, minimally invasive spine surgery, 3D printing, and other emerging technologies. Please visit www.deepakreddymd.com.

About RQM+
RQM+ accelerates medical innovation by streamlining the lifecycle of devices, diagnostics, and biotechnology products. Our expertise transforms innovative ideas into market-ready solutions, ensuring life-changing technologies reach patients faster and more efficiently.
The RQM+ portfolio of services enables the delivery of end-to-end solutions across the complete product lifecycle:

• Regulatory and Quality Consulting
• Lab Services and Materials Consulting via Jordi Labs
• Clinical Trials
• Reimbursement

1. Statista. (2024, January 29). Share of U.S. adults with chronic low back pain 2022, by age. https://www.statista.com/statistics/1447559/chronic-low-back-pain-among-adults-by-age-us/.
2. 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.
3. 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.
4. Deyo, R. A., Von Korff, M., & Duhrkoop, D. (2015). Opioids for low back pain. BMJ, 350, g6380. https://doi.org/10.1136/bmj.g6380.
5. 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.
6. 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.
7. 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