MIAMI, Oct. 28, 2026 (GLOBE NEWSWIRE) -- Vivex Biologics, Inc., a leader in developing and delivering advanced allograft solutions, today announced that results from its pivotal ASCEND study of VIA Disc® NP have been published in Journal of Clinical Medicine. The trial met its primary endpoint: 60% of participants treated with VIA Disc NP achieved clinically meaningful back pain relief at six months, compared with 1.6% of sham-treated participants (p < 0.001). At three months, the last visit before sham participants who had not responded were permitted to cross over to treatment, 53% of VIA Disc® NP participants and 5% of sham participants achieved clinically meaningful relief under fully blinded conditions (p < 0.001). The publication, titled, “Intradiscal Nucleus Pulposus Allograft versus Sham Procedure in Patients with Lumbar Discogenic Pain: A Randomized Clinical Trial,” makes VIA Disc® NP the first intradiscal allograft to demonstrate success in a gold-standard, sham-controlled clinical trial for chronic lumbar discogenic pain.
Vivex Biologics' VIA Disc® NP Meets Primary Endpoint in Pivotal, Sham-Controlled ASCEND Trial Published in Journal of Clinical Medicine
Low back pain is the leading cause of disability worldwide and is projected to affect more than 800 million people globally by 2050, with disc degeneration accounting for at least 40% of chronic cases. Until today, patients have faced a stark choice between conservative care that often fails, long-term opioid use, or invasive surgery. VIA Disc® NP offers a new path: a minimally invasive procedure performed under light sedation in an outpatient setting, preserving spinal anatomy.
“These results redefine what’s possible for patients living with chronic back pain,” said John McCallum, Executive Chairman of Vivex. “Degenerative disc disease drives the number one cause of disability worldwide, and for decades, healthcare providers have lacked an intradiscal, evidence-backed, minimally invasive option. ASCEND closes that gap with the kind of rigorous, blinded evidence physicians and payers expect, showing that VIA Disc® NP can meaningfully reduce pain and improve function.”
Rey Pascual, Vivex’s Co-President, added, “The strength of a rigorous sham-controlled trial marks a defining moment for Vivex, for spine care, and most importantly, for the millions of patients searching for relief. ASCEND builds on a growing body of evidence for VIA Disc® NP, and we look forward to publishing 12-month results from this cohort in the near term.”
“In my 25 years treating back pain, I’ve rarely seen a controlled trial produce a therapeutic effect of this magnitude,” said Paul Verrills, MD, Principal Investigator of the ASCEND study. “A 53% responder rate against 5% for sham at three months under blinded conditions, maintained at the six-month primary endpoint, paired with meaningful improvements in function and infrequent related adverse events, are the kind of data physicians and patients have been waiting for. VIA Disc® NP offers a genuinely new option for a condition where innovation has been scarce and success has been elusive.”
Key Findings from the ASCEND Trial
60% of VIA Disc® NP participants achieved clinically meaningful back pain relief (≥30% reduction) at 6 months vs. 1.6% of sham participants (p < 0.001). As prespecified, the 3-month values of the 55 sham participants who crossed over to treatment were carried forward to 6 months.
At 3 months, before crossover, 53% of VIA Disc® NP participants vs. 5% of sham participants achieved clinically meaningful back pain relief (p < 0.001), corresponding to a number needed to treat of about 2.
53% of VIA Disc® NP participants vs. 32% of sham participants achieved clinically meaningful improvement in back function (Oswestry Disability Index) at 3 months (p = 0.03), and 60% vs. 31% at 6 months (p = 0.001).
Nearly half (48%) of VIA Disc® NP participants reached a patient acceptable symptom state for back pain at 6 months.
Treatment effect was consistent in crossover participants. Sham participants who crossed over to open-label VIA Disc® NP treatment at 3 months showed a comparable trajectory of improvement, with 56% achieving clinically meaningful back pain relief 3 months after treatment vs. 53% of the original blinded VIA Disc® NP arm.
ASCEND (NCT06615505) is a randomized, double-blind, sham-controlled trial that enrolled 121 participants across five Australian sites to evaluate the safety and efficacy of VIA Disc® NP in participants with chronic lumbar discogenic pain. The primary endpoint was the proportion of participants achieving a minimal clinically important difference (MCID) in back pain visual analogue scale (VAS) score, defined as at least a 30% reduction from baseline at six months post-procedure. By protocol, sham participants who had not achieved at least a 30% reduction in back pain at three months could cross over to VIA Disc® NP treatment. Participants will be followed through 24 months.
ASCEND builds on a growing body of published evidence for VIA Disc® NP. In a prospective, single-arm pilot study at six U.S. sites, 64% of participants assessed at two years had at least a 50% reduction in back pain after a single procedure (Journal of Pain Research, 2025). In a second prospective study of 21 Medicare-age participants, 82% achieved clinically meaningful back pain relief at six months (Clinical Interventions in Aging, 2025). A pooled safety analysis of patients found a product-attributable serious adverse event rate of 0.26%, with no infections, neurological complications, or escalations to surgery among patients (International Journal of Spine Surgery, 2025). Most recently, in a retrospective analysis of the 100% Medicare database, 1,804 patients treated with VIA Disc® NP used physical therapy and epidural steroid injections significantly less often over the following year than matched patients managed conservatively (40% vs. 76% and 31% vs. 55%, respectively) (Journal of Pain Research, 2026).
VIA Disc® NP is a sterilized nucleus pulposus allograft derived from human donor nucleus pulposus disc tissue, delivered minimally invasively in an outpatient procedure under light sedation. It is commercially available in the U.S. Learn more at www.viadiscnp.com.
About Vivex Biologics, Inc.
Vivex Biologics is a leading medical technology company advancing the science, development, and commercialization of next-generation allografts. Its therapies serve patients suffering from chronic lower back pain, musculoskeletal injuries, wounds, and burns. By harnessing the body’s inherent healing capacity, Vivex aims to give patients better outcomes and give clinicians better tools. Learn more at www.vivex.com.
Media Contact
Kathryn Larson, VP of Marketing, Vivex Biologics
klarson@vivex.com
Author
The De Angelis Group | Orthopedics This Week | MSK Innovations
Why This Matters
Two Perspectives
MBA Lens: Economic and industry impact
Vivex Biologics' VIA Disc® NP, an intradiscal allograft, met its primary endpoint in the sham-controlled ASCEND trial for chronic lumbar discogenic pain. This minimally invasive, outpatient procedure offers a new market solution, addressing the global leading cause of disability. Its strong evidence base is crucial for driving physician and payer adoption, positioning it as a significant alternative to current conservative care failures, opioid use, or invasive surgery.
- The trial's rigorous, blinded evidence is expected to facilitate market penetration and reimbursement for this novel therapy.
- VIA Disc® NP targets a large, underserved market segment lacking an evidence-backed, minimally invasive treatment option.
PhD Lens: Clinical and outcomes impact
The ASCEND trial demonstrated VIA Disc® NP, a sterilized nucleus pulposus allograft, significantly reduced chronic lumbar discogenic pain. At six months, 60% of treated participants achieved clinically meaningful relief versus 1.6% of sham (p < 0.001), with functional improvements also noted. This randomized, double-blind, sham-controlled study provides robust evidence for this minimally invasive allograft solution.
- The allograft is derived from human donor nucleus pulposus disc tissue, delivered via an outpatient procedure.
- Safety data from a pooled analysis indicated a low product-attributable serious adverse event rate of 0.26%.
Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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