Intralink-Spine Expanding Clinical Data in Australia
November 16, 2020 09:00 AM Eastern Standard Time
LEXINGTON, Ky.--(BUSINESS WIRE)--Intralink-Spine, Inc. announces that clinical sites in Australia are once again adding data supporting the safety and efficacy of their novel, injectable, nano-tethering device for the treatment of spinal disc degeneration and chronic low back pain (CLBP). The company’s clinical research has resumed after several months of COVID-19 related interruption of patient enrollment. A total of eleven patients have been enrolled in the Australian study to date. Combined with an earlier five participant trial conducted in Malaysia, 100% of participants had clinically relevant improvements in pain and disability 3-months following the procedure, with 75% having “excellent results” (50% or greater reductions of pain and disability). These patient reported outcomes are from treated study participants meeting study inclusion and exclusion criteria. “Our outstanding early data also indicates that 85% of these patients had good or excellent clinical results from the 2-week through 2-year post-treatment time-points,” according to Tom Hedman, Ph.D., Founder and Chief Science Officer of Intralink-Spine, Inc.
Intralink-Spine’s disc stabilization device (brand name: Réjuve® (GENTIS) stands alone as the only injectable treatment that immediately strengthens and stabilizes damaged and deteriorating spinal discs, addressing the core problems contributing to chronic low back pain. “Our injectable device provides immediate and long-term mechanical support to degraded discs by adding upwards of a quadrillion polymer nano-tethers to the dense collagen matrix of the disc,” Hedman explains. “This internal mechanical support resists the progression of this debilitating disorder, and is what distinguishes our injectable approach from those that only temporarily mask the pain signals that stem from inadequate mechanical support of damaged tissues.”
The unique ability of Réjuve (GENTIS) to address the core issues contributing to the wide-spread problem of low back pain and disability is even more important in view of the current opioid addiction crisis. It is now widely recognized that prescription of opioids following back surgery or as part of a treatment regimen for CLBP has played a primary role in the pervasiveness of the opioid epidemic.