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Intralink expands clinical trials
LEXINGTON, Ky.—Intralink Spine, Inc. has announced the expansion of clinical trials in Australia for their patented medical device for the treatment of low back pain, called Réjuve.
According to Intralink’s website, “Réjuve is an injectable crosslinking device that mechanically strengthens and rapidly stabilizes the disc; thereby, reducing the pain of the patient. This micro-invasive procedure can be performed on an outpatient basis and should be complete with just one injection treatment.”
“The Réjuve medical device is designed to be effective in treating large avascular (no direct blood supply) load-supporting tissues like the spinal disc. A key to Réjuve's effectiveness is the device’s ability to promote crosslinking of fibrous proteins, including collagen, which rejuvenates the spinal disk area,” the website continues. “Réjuve medical device reduces pain by strengthening annulus against tearing and delamination, increasing joint stability and reducing disc bulge.”
“We’re pleased that Dr. Rosenberg and his staff are participating in the GEMS clinical study for low back pain,” said Lyle Hawkins, CEO of Intralink Spine. “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 shown to have rapid results like an epidural steroid injection, but with potential long-term positive effects similar to a successful fusion.”
Low back pain is the most common reason for lost work days in the US, with over 80 percent of the population experiencing an episode of low back pain at some point in their lifetime. Those afflicted with recurring low back pain, or back pain that extends beyond 3 months, are considered to have chronic low back pain. Recurrences of low back pain are common, with subsequent episodes within 1 year (for employed persons) ranging from 20–44 percent, with lifetime recurrence rates of up to 85 percent.
“The Réjuve treatment has the potential to fill the gap between non-operative treatments and surgery, which is why I’m excited to be involved in this study,” added Dr. Geoffrey Rosenberg, orthopedic spine surgeon.
“The data from our early pilot study demonstrated exceptional results with regard to reducing or eliminating low back pain and disability. These benefits began within days of the initial procedure, demonstrating the immediate mechanical support provided by this device,” stated 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. “We’re eager to begin gathering data from our clinical sites in Australia to further validate the unique benefits of the Réjuve device.”
Intralink originally began initiation of clinical trials in Australia back in March.
“There remains a great need for a simple, effective and cost-effective treatment for discogenic back pain. Spinal fusion is indicated for the few, but not the many. At Genesis Research, we are very excited to be involved in this clinical trial, which holds much hope for low back pain sufferers,” noted Dr. Marc Russo, medical director of the Hunter Pain Clinic, in an earlier press release. “I have seen many attempts at providing pain relief solutions for this large group of patients but strengthening the disc AND providing pain relief is a very attractive combination of attributes.”
“We continue to see excellent results from our initial patients beyond the two-year mark. And I expect similar results from our studies underway in Australia,” Hawkins explained.