Long-Term Large Animal Testing For Réjuve Shows Positive Results Related To Lower Back Pain
LEXINGTON, KY, June 23, 2015 Intralink Spine, Inc. (ILS) is pleased to announce the completion of the phase 1 long-term large-animal in vivo testing for the Réjuve treatment for lower back pain.
“The purpose of this study was to verify and validate the final design and safety of the Réjuve device in a six month large-animal (sheep) model. The sheep received fluoroscopic image-guided injections of Réjuve in two lumbar intervertebral discs, with two posterolateral injections per treated level”, states Dr. Tom Hedman. “No infections, inflammatory disorders, or behavioral or neuromuscular effects were seen in the animals over the course of the six month study. This study showed that the procedure to inject Réjuve is safe and can be effectively administered using only standard fluoroscopic techniques.”
According to Lyle Hawkins, CEO of Intralink-Spine, “This is another significant milestone for the Réjuve treatment. This study clearly shows the safety and simplicity of the Réjuve treatment. We’re excited about these results and even more excited about what this treatment means to those suffering from lower back pain; Réjuve is truly going to be a disruptive breakthrough for the treatment of lower back pain.”
According to Dr. Hedman, CSO of Intralink-Spine and a leading researcher in soft-tissue biomechanics, “Réjuve works in the same manner as the body’s natural response to heal instability and degradation of the spinal disc. The Réjuve device immediately strengthens and stabilizes the disc upon injection to reduce the pain of the patient and eliminate future episodes of debilitating back pain. This micro-invasive procedure can be performed on an outpatient basis and completed with just one injection treatment.”
“Millions of back pain suffers receive numerous epidural steroid injections (ESI) each year in an effort to alleviate lower back pain. However, ESI’s are temporary, so patients are relegated to receiving numerous injections during the life of their treatment. Réjuve creates permanent molecular bonds, so we’re hopeful that two, perhaps even one set of injections are all a patient will ever need to receive permanent lower back pain relief”, says Hawkins. “And, Réjuve is a much simpler and less expensive treatment than what is being considered with stem cells.”
About 80 percent of the adults in the U.S. experience significant back pain at some point in their life and most back pain sufferers find no relief. In fact, low back pain (LBP) is a challenging condition to treat and one of the most common health problems in the United States for a host of reasons including widespread obesity, an aging population, job related activities or inactivity, and smoking. And, unlike Réjuve, most minimally invasive treatments being used today, such as steroid injections or nerve blocks, are temporary and palliative. As a consequence, acute and chronic back pain continues to be a growing part of the US health landscape.
ILS is located on the University of Kentucky’s Coldstream Research Campus in the heart of the Kentucky Bluegrass Region. Coldstream provides ILS with a connection to students, researchers, and resources at the University of Kentucky.