MIAMI, Sept. 30, 2025 (GLOBE NEWSWIRE) — Vivex Biologics, a leader in developing and delivering innovative allografts, today announced that it has treated the first patient in its Restore U.S. clinical trial evaluating VIA Disc NP™ for patients with lumbar discogenic pain associated with degenerative disc disease (DDD).
“We are proud to advance the clinical evaluation of VIA Disc NP, a disruptive intervention aimed at transforming care for patients suffering from discogenic low back pain,” said Rey Pascual, Co-President of Vivex. “With current treatment options often invasive or limited in efficacy, this landmark study marks a critical milestone in our mission to add to current robust evidence supporting VIA Disc NP’s safety and efficacy. VIA Disc NP offers a new standard of care to address the underlying causes, not just the symptoms of disc degeneration.” The first patient in the study was treated at Napa Valley Orthopaedic Medical Group by Jackie Weisbein, DO.
Dr. Weisbein and Ryan Hill-Falkenthal, PA-C, shared, “As a care team, we see firsthand how debilitating discogenic pain can be for our patients. We are excited to participate in this clinical study, as VIA Disc NP represents a novel approach to supplementing and cushioning the disc and improving the lives of those living with this challenging condition.”
This randomized, double-blind, sham-controlled trial (NCT06778447) will evaluate the safety and efficacy of VIA Disc NP in approximately 400 adults with DDD, across 20 clinical sites in the United States. Patients will be randomized in a 2:1 ratio to receive either a single injection of VIA Disc NP or a sham needle placement procedure. The primary endpoint of the trial is the proportion of participants achieving a minimal clinically important difference (MCID) in back pain visual analogue scale (VAS) score, defined as a 30% reduction in pain from baseline at 12 months post-procedure. The secondary efficacy endpoints include mean change in VAS score and Oswestry Disability Index (ODI) for back pain severity and function assessed at each follow up visit. To rigorously assess patient outcomes, the trial uses a true sham control which maintains blinding and preserves the integrity of placebo control, allowing the study to more precisely measure the clinical benefit attributable to VIA Disc NP.
Tim Deer, MD, the National Principal Investigator for the Restore study added, “I am thrilled to see the U.S. Restore study underway and extend my congratulations to Dr. Weisbein and the entire team. With enrollment now progressing, I’m optimistic that the results will provide level 1, high quality evidence consistent with outcomes observed in the previous prospective studies. I’m honored that The Spine and Nerve Centers of the Virginias is one of the 20 clinical sites participating and I look forward to contributing to this pivotal research that may redefine how we care for patients with chronic back pain.”
Lumbar discogenic pain associated with DDD is a leading cause of disability worldwide and is the result of pathological degeneration of the intervertebral disc. Current interventions include physical therapy, anti-inflammatory medications, opioids, and spinal surgery. To overcome the costs, limitations, and consequences of these approaches, VIA Disc NP was designed as a minimally invasive interventional procedure that supplements and cushions the natural function of the intervertebral disc.
For more information on Vivex and its innovative solutions, visit www.vivex.com. For more information on VIA Disc NP, visit www.viadiscnp.com.
About Vivex Biologics, Inc.
Vivex is a leading medical technology company focused on the science, development and commercialization of advanced therapies for the regeneration, restoration and repair of the body. Its current therapies help patients suffering from chronic lower back pain, musculoskeletal injuries, wounds and burns. By leveraging its robust and proven R&D capabilities and corporate infrastructure, Vivex seeks to continue to channel the body’s inherent healing qualities to provide patients optimal care and medical professionals with innovative treatment options for a broad range of indications.
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