SynerFuse™ and Velentium Medical to Scale Innovative e-TLIF™ Implant Procedure After Successful Proof-of-Concept

SynerFuse™ and its partner, Velentium Medical,  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."