LEXINGTON, Ky.--(BUSINESS WIRE)--Today, Intralink-Spine, Inc. announces the initiation of clinical trials in Australia for their patented medical device for the treatment of low back pain, called Réjuve™. “We’re excited that patient enrollment has begun in Australia. The physicians and staffs involved in the Réjuve clinical safety study (GEM-SE) are top-notch,” says Lyle Hawkins, CEO, of Intralink-Spine, Inc.
“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,” states Dr. Marc Russo, Medical Director. “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.”
“The data from our early safety and feasibility 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,” 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 similar to a successful fusion. For example, 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.”
About Low Back Pain
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 LBP at some point of their lifetime.1 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.2
About Intralink-Spine, Inc. (ILS)
ILS was formed to manufacture and exclusively sell the Réjuve™ medical device to treat Degenerative Disc Disease (DDD), low back pain, and related spinal diseases such as scoliosis. In anticipation of forthcoming commercialization under the CE mark, ILS is conducting an active fundraising round for accredited investors; contact LHawkins@IntralinkSpine.com for more details.
1. Rubin DI. Epidemiology and risk factors for spine pain. Neural.Clin.
2. van TM, Koes B, Bombardier C. Low back pain. Bes.Pract.Res.Clin.Rheumatol. 2002;16:761-75