LEXINGTON, Ky.--(BUSINESS WIRE)--Intralink-Spine, Inc. (ILS) announces the expansion of clinical trials in Australia for their patented medical device for the treatment of low back pain, called Réjuve™. “We’re pleased that Dr. Rosenberg and his staff are participating in the GEMS clinical study for low back pain,” says Lyle Hawkins, CEO, of Intralink-Spine, Inc.
“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,” says Dr. Geoffrey Rosenberg, Orthopaedic Spine Surgeon.
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 shown to have rapid results like an epidural steroid injection, but with potential long-term positive effects similar to a successful fusion.”
“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,” 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. “We’re eager to begin gathering data from our clinical sites in Australia to further validate the unique benefits of the Réjuve device.”
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 for more details.
1. Rubin DI. Epidemiology and risk factors for spine pain. Neural.Clin. 2007;25:353-71.
2. van Tulder M, Koes B, Bombardier C. Low back pain. Bes.Pract.Res.Clin.Rheumatol. 2002;16:761-75