MIAMI, July 29, 2025 (GLOBE NEWSWIRE) — Vivex Biologics, Inc., a leader in developing and delivering innovative allografts, today announced that it has completed subject enrollment in its ASCEND clinical trial evaluating VIA Disc NP for symptomatic degenerative disc disease (DDD), a condition strongly associated with chronic lower back pain.
This randomized, double-blind, sham-controlled trial (NCT06615505) enrolled 110 participants across five sites in Australia to assess the safety and efficacy of VIA Disc NP versus a sham procedure in subjects suffering lumbar discogenic pain associated with moderate to severe DDD. 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 from baseline at six months post-procedure. Data from the trial are expected in the first quarter of 2026.
“We are pleased to announce the completion of enrollment in our ASCEND trial ahead of schedule, a key milestone in the continued development of VIA Disc NP,” said Barry Salzman, Co-President and Chief Operating Officer of Vivex. “This achievement reflects the dedication of our clinical teams and strong engagement from the spine care community, underscoring the need for innovative, minimally invasive treatment options for DDD. We are deeply grateful to our lead investigator, Dr. Paul Verrills, the co-investigators, site staff, and, most importantly, the patients for their participation. We look forward to sharing data from ASCEND in early 2026 and continuing to build on the real-world momentum behind VIA Disc NP.”
In addition, Vivex is currently enrolling participants 22-85 years of age in an additional Level 1, randomized, sham-controlled trial known as RESTORE (NCT06778447) in the United States. This is an expanded clinical investigation of VIA Disc NP, conducted at up to 20 clinical sites, that will pave the way for further insights to strengthen the growing body of evidence supporting VIA Disc NP.
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 supports the cushioning function of the intervertebral disc to compensate for tissue loss.
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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