First-ever published 12-month results from Level 1 intradiscal study for treating patients with one or two level symptomatic degenerative disc disease
Early evidence suggests greater than 70% reduction from baseline in pain in Visual Analog Scale (VAS) and functional improvement measured in Oswestry Disability Index (ODI) that is sustained at 12 months in allogeneic disc tissue treatment groups
ATLANTA and MIAMI, April 30, 2020 /GlobeNewswire/ –
VIVEX Biologics, Inc., a leading regenerative medicine company specializing in the development of naturally sourced treatment options, today announced that the initial clinical trial results of VIVEX’s VAST Trial evaluating VIA® Disc were published in the peer-reviewed journal The International Journal of Spine Surgery. The paper was the first-ever published 12-month results from Level 1 intradiscal study for treating patients with one or two level symptomatic degenerative disc disease (DDD). VIA Disc is a non-surgical, injectable treatment option for patients suffering from chronic lower back pain resulting from DDD.
The paper, titled, VAST Clinical Trial: Safely Supplementing Tissue Lost to Degenerative Disc Disease, by Beall, et. al., reported initial results from the 24-patient safety cohort of VIVEX’s VAST Trial evaluating the safety and performance of VIA Disc. Data demonstrate that VIA Disc improved pain and function in patients with DDD by greater than 70%, as measured by visual analog scale (VAS) and Oswestry Disability Index (ODI), and that these improvements were durable one-year after the procedure.
“I am highly encouraged by the initial results and safety data from the VAST study. Implantation of disc tissue allograft can be done safely, and early evidence suggests greater than 70% improvements in VAS and ODI sustained at 12 months in the allograft groups,” said Douglas Beall, MD, chief of radiology services at the Clinical Radiology of Oklahoma and principal investigator of the VAST study. “Interventions like VIA Disc have the potential for treating mild-to-moderate degenerative discs that greatly advance an alternative to surgical intervention.”
Lower back pain is the most expensive occupational disorder in the U.S. and is the leading cause of disability globally. DDD is a major factor contributing to this disability and is the most common etiology of chronic lower back pain in adults. Low back and neck pain in the U.S. were the third-largest condition of spending in 2013, with estimated health care spending of $87.6 billion. Today, there are limited treatment options, including progression to opioids and surgery for patients who fail non-surgical management.
To address this gap in the continuum of care, VIVEX developed VIA Disc to offer patients a novel, non-surgical intervention for treating one to two levels of symptomatic DDD.
Peter Wehrly, chief executive officer of VIVEX, stated, “These results provide further validation of the therapeutic potential VIA Disc may offer patients in critical need of innovative solutions for degenerative disc disease. Leveraging our expertise around naturally sourced treatment options, our team developed VIA Disc to maximize the regenerative powers of the body to provide patients with a minimally invasive option that provides lasting relief. The early evidence from the VAST study suggests VIA Disc is able to deliver meaningful and durable pain relief, restore function and improve quality of life. We look forward to continuing to build this important clinical body of evidence.”
The VAST Trial is a prospective, randomized, parallel-arm, multicenter study approved to enroll up to 220 subjects at up to 15 clinical sites. Outcomes of the trial were based on assessment of primary and secondary endpoints of six and 12 months after transplant of supplementary allograft compared with placebo or sustained conservative care in subjects who had discogenic pain attributable to disc degeneration as judged by magnetic resonance imaging scoring, physical examination and subject-reported pain.
About VIVEX Biologics, Inc.
VIVEX Biologics is a pioneer in regenerative medicine, specializing in the development of naturally sourced treatment options and solutions that improve clinical, surgical and therapeutic patient care through innovation. With tissue damage resulting from a variety of diseases, direct injury or trauma, there is a significant need for advanced solutions. By leveraging the resources of the nation’s oldest civilian tissue bank, VIVEX is channeling the body’s inherent healing qualities to bring patients optimal care and to provide medical professionals and patients with innovative treatment options for a broad range of indications.