LEXINGTON, Ky.–(BUSINESS WIRE)–August 30, 2016–
With the continuation of extremely positive clinical results at the 1-month juncture, Intralink-Spine, Inc. (ILS) explains why the early reduction of low back pain in each of its four safety study patients was expected, given the almost immediate device formation associated with the Réjuve System.
Initially conceived by Tom Hedman, Ph.D. while an Associate Professor at the University of Southern California, the Réjuve device provides almost immediate mechanical support and stabilization to the spinal joint by the addition of numerous molecular bonds, which act as cross-ties in the tissue matrix. This immediate effect, according to ILS, is now being demonstrated in the clinical trial stage of its development.
According to Hedman, who is now the Chief Scientific Officer for ILS and Adjunct Associate Professor in the F. Joseph Halcomb III, M.D. Department of Biomedical Engineering, “Four chronic low back pain patients were treated by orthopedic surgeon Dr. Harwant Singh at Pantai Medical Center (Kuala Lumpur, Malaysia) in an NMRR registered clinical safety study. Each of the four patients are pleased with their treatment and continue to have positive results at the 1-month juncture.”
“Patients experienced an average Visual Analog Scale (VAS) pain score reduction of 92% and an average Oswestry Disability Index (ODI) disability reduction of 88% at the 1-month interval. These positive one-month data are great news, especially as we move forward to our larger pivotal clinical studies,” says Hedman.
“All four patients are already enjoying a better quality of life than prior to the Réjuve treatment. And, they didn’t have to wait weeks or months, because the effects of Réjuve are almost immediate,” says Lyle Hawkins, CEO of ILS.
“The patients received fluoroscopic image-guided injections of the Réjuve medical device in the lumbar intervertebral discs, with two posterolateral injections per treated level,” states Dr. Singh. According to Hedman, “It’s unrealistic to think that all of our patients will achieve these same results, but these early data make us very optimistic that a single set of injections of the Réjuve medical device are all that some patients will ever need to receive permanent low back pain relief.”
According to Hawkins, “The Réjuve treatment is going to be very disruptive to how patients are currently treated for low back pain. Réjuve has the procedural simplicity of an epidural steroid injection, but with potential long-term positive effects. And, Réjuve is not patient dependent, complex, and expensive like most stem cell procedures currently in development.”
Lyle Hawkins, 502-419-8099