Intralink-Spine announced the expansion of clinical trials in Australia for their patented medical device for the treatment of low back pain. Called the GEMS clinical study for low back pain, the sponsor will test its Réjuve™ with the prominent Dr. Geoffrey Rosenberg, Orthopedic Spine Surgeon.
What is the Réjuve product?
The investigational product is designed to be effective in treating large avascular (no direct blood supply) load-supporting tissues like the spinal disc. A key to the medical device’s effectiveness is its’ ability to promote crosslinking of fibrous proteins including collagen, which rejuvenates the spinal disc area. There are 25 issued patents to date (with more under review) associated with Réjuve.
Low back pain is the most common reason for lost work days in America, with over 80% of the population experiencing an episode of low back pain at some point of 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%, with lifetime recurrence rates of up to 85%. The connection between opioid use and low back pain is well known in the Untied States.
The Réjuve Value Proposition
Réjuve represents a new way to offer alternatives between non-operative treatments and surgery. Dr. Geoffrey Rosenberg from Australia notes, “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.”
Early pilot study data reveals promise, reports Dr. Tom Hedman, PhD, the inventor and Adjunct Associate Professor in the F. Joseph Halcomb III, MD, Department of Biomedical Engineering at the University of Kentucky. He commented, “We’re eager to begin gathering data from our clinical sties in Australia to further validate the unique benefits of the Réjuve device.”
Who is Intralink-Spine Inc.?
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. Intralink-Spine is actively seeking investors. Based in Kentucky, they have raised $1.1 million to date according to CrunchBase.
Lead Research/InvestigatorsSource: Yahoo News