Vivex Biologics Initiates Pivotal Trial for VIA Disc NP in Degenerative Disc Disease
核心洞察
Vivex Biologics (搜索) has treated the first patient in its Restore clinical trial evaluating VIA Disc NP for lumbar discogenic pain (搜索) associated with degenerative disc disease (搜索).
The randomized, double-blind, sham-controlled trial will enroll approximately 400 adults across 20 U.S. clinical sites with a 2:1 randomization ratio.
The primary endpoint measures the proportion of participants achieving a 30% reduction in back pain at 12 months post-procedure.
Vivex Biologics (搜索) has treated the first patient in its Restore U.S. clinical trial evaluating VIA Disc NP™ for patients with lumbar discogenic pain (搜索) associated with degenerative disc disease (搜索) (DDD). The milestone marks the initiation of a pivotal study that could transform treatment approaches for a leading cause of disability worldwide.
The first patient was treated at Napa Valley Orthopaedic Medical Group (搜索) by Jackie Weisbein, DO, launching enrollment in the randomized, double-blind, sham-controlled trial (NCT06778447). "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.
Trial Design and Endpoints
The Restore trial 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 focuses on 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. 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.
The trial employs a true sham control to maintain blinding and preserve the integrity of placebo control, allowing researchers to more precisely measure the clinical benefit attributable to VIA Disc NP.
Clinical Significance and Unmet Need
Lumbar discogenic pain (搜索) associated with DDD represents a significant medical challenge as a leading cause of disability worldwide, resulting from pathological degeneration of the intervertebral disc (搜索). Current interventions include physical therapy, anti-inflammatory medications, opioids, and spinal surgery, which often present limitations in efficacy or invasiveness.
"As a care team, we see firsthand how debilitating discogenic pain can be for our patients," shared Dr. Weisbein and Ryan Hill-Falkenthal, PA-C. "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."
Therapeutic Approach
VIA Disc NP was designed as a minimally invasive interventional procedure that supplements and cushions the natural function of the intervertebral disc (搜索). According to Pascual, the treatment "offers a new standard of care to address the underlying causes, not just the symptoms of disc degeneration," distinguishing it from current symptomatic approaches.
Tim Deer, MD, the National Principal Investigator for the Restore study, expressed optimism about the trial's potential impact. "I'm optimistic that the results will provide level 1, high quality evidence consistent with outcomes observed in the previous prospective studies," he said. "I look forward to contributing to this pivotal research that may redefine how we care for patients with chronic back pain (搜索)."
The study builds on previous prospective studies that have evaluated VIA Disc NP's safety and efficacy profile, positioning this trial to provide definitive evidence for the treatment's clinical utility in addressing degenerative disc disease (搜索).