SynerFuse™ & Velentium Medical Partnering to Scale Integrated Spinal Fusion & Direct Nerve Stimulation Procedure

New Velentium Medical Facility Providing Neuromodulation Device Design & Manufacture

EDEN PRAIRIE, Minn., March 21, 2025 /PRNewswire/ -- To follow up on the completion of its clinical proof-of-concept study, SynerFuse™ and its partner, Velentium Medical, today announced plans to scale the patented SynerFuse™ e-TLIF™ procedure implant device.

"With the completion of our proof-of-concept study, we advanced our mission to improve patient quality of life," 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. And now we move on to the next phase in our quest to bring our therapy to the many patients who could benefit from it."

"The SynerFuse™ e-TLIF™ technique will be a new treatment approach of integrating neuromodulation with spinal decompression and fusion for the 500,000-plus patients who undergo traditional spinal fusion surgery in the United States each year," said Velentium Medical Chairman & Cofounder Dan Purvis. "We are excited about the potential of this therapy and about moving forward with SynerFuse™."

"We are pleased to have been selected by SynerFuse™ as their strategic development and manufacturing partner, showcasing our industry-leading design, development, and manufacturing capabilities for both devices and leads. From our new flagship facility in Houston, Texas, our experienced team will Change Lives for a Better World as we scale production for SynerFuse™," said Velentium Medical Cofounder Tim Carroll.

"Our custom-designed device was conceived by our medical team—that is, by surgeons for surgeons addressing neuropathic and mechanical pain," said Rohan Lall, M.D., SynerFuse™ chief medical officer and former investigator at MHealth Fairview. "With the SynerFuse™ DRG system (implantable pulse generator and custom leads) designed and manufactured by Velentium Medical, the SynerFuse™ e-TLIF™ procedure incorporates insights from our 15-patient proof-of-concept clinical trial that was completed with our collaborators at the University of Minnesota and South Bend Orthopaedics."

"Requiring only a single incision and involving direct visual placement of the neurostimulation device will make the SynerFuse™ e-TLIF™ procedure better in terms of patient safety," said University of Minnesota Associate Professor of Neurosurgery Michael C. Park, M.D., Ph.D.*, SynerFuse™ proof-of-concept study principal investigator. "Our data indicate that we should maintain the therapy we used in the proof-of-concept trial."

"The SynerFuse™ e-TLIF™ therapy represents a novel integration of next-generation stimulation and monitoring with spinal decompression and instrumented fusion. Our initial experience has found this to aid in post-operative treatment of back and leg pain," said Deepak Reddy, M.D., South Bend Orthopaedics and SynerFuse™ proof-of-concept study principal investigator. "The therapy unlocks an additional safe modality to treat surgical, neuropathic and mechanical back and leg pain whilst reducing the patients' exposure to opioids."

More information about SynerFuse™ is available at www.synerfuse.com. More information about Velentium Medical is available at http://www.velentiummedical.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.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 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.³

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. More information about the company is available at 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 Velentium Medical
Velentium Medical is a Richmond, Texas-based professional engineering firm that exists to transform IP into the design and manufacture of safe and secure medical devices that will change lives and create a better world. More information about the company is available at www.velentiummedical.com.

¹ See "Low Back Pain Fact Sheet." National Institute of Neurological Disorders and Stroke, https://www.ninds.nih.gov/sites/default/files/migrate-documents/low_back_pain_20-ns-5161_march_2020_508c.pdf, accessed 3 March 2025.
² Karen L. Saban et al., "Health-Related Quality 3 Marchof 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.

SOURCE SynerFuse