Lyle Hawkins, CEO of Intralink-Spine, Inc reported, “We’re eager to expand our clinical studies into multiple sites and locations. Which is why we have finalized an agreement with Five Corners, a CRO focused on medical device clinical studies in Australia and New Zealand.”
“We’ve restructured for growth and to better position ourselves for a successful CE submission. Now with the involvement of Five Corners, 2018 is shaping up to be a great year for Intralink-Spine,” states Hawkins.
Deborah Bell, Managing Director of Five Corners adds, “We are very excited to be supporting Intralink-Spine in conducting their study to gain CE Mark for the Réjuve™ medical device. There remains an unmet need for micro-invasive solutions for the treatment of DDD and we look forward to assisting Intralink-Spine in their journey through to successful commercialization.”
“Twelve-month data from our early safety and feasibility study demonstrated exceptional results with regard to reducing or eliminating low back pain and disability. And, these benefits began within days of the initial procedure. This was a great start, especially as we begin our larger pivotal clinical studies,” states Dr. Tom Hedman, Ph.D., the inventor and Adjunct Associate Professor in the F. Joseph Halcomb III, M.D. Department of Biomedical Engineering at the University of Kentucky.
According to Hawkins, “We believe the Réjuve™ medical device, which structurally reinforces the native intervertebral disc itself, is going to be a better treatment option for many patients with low back pain. Réjuve has the procedural simplicity of an epidural steroid injection, but with potential long-term positive effects. For example, we continue to see excellent results from our initial patients as they approach the two-year junction. And, we expect these excellent results to continue for years to come.”