Intralink-Spine, Excited About Early Patient Feedback Regarding Its Treatment For Low Back Pain.
LEXINGTON, KY, August 8, 2016 Intralink-Spine, Inc. (ILS) is pleased to announce that early clinical study data has been obtained regarding the use of its Réjuve System (GENT) for the treatment of low back pain.
Each of the four patients treated in late June by orthopedic surgeon Dr. Harwant Singh at Pantai Medical Center (Kuala Lumpur, Malaysia) under an IRB and NMRR registered clinical safety study had a reduction in Visual Analog Scale (VAS) pain score of 83%-100%, 2-weeks post-procedure compared to pre-procedure levels, with a 93% average reduction. Disability, based on the Oswestry Disability Index (ODI), was reduced 57%-100% with an 84% average reduction. While each of the patients is happy with the treatment effects 2-weeks post-procedure, Dr. Tom Hedman, Chief Scientific Officer for ILS, is the first to note that it’s very early in the clinical trial phase with more patients and data yet to be acquired.
“The patients received fluoroscopic image-guided injections of the Réjuve (GENT-ISD) medical device in the lumbar intervertebral discs, with two posterolateral injections per treated level”, states Dr. Singh. And, according to Dr. Hedman, “These initial data support our belief that this device can be safely and effectively delivered to the affected disc using our protocol and standard fluoroscopic techniques.”
According to Lyle Hawkins, CEO of Intralink-Spine, “This is another significant milestone for the Réjuve treatment. We are very optimistic about the clinical outcomes thus far, but also excited about the early patient positive feedback. For example, one subject reported that he played golf (18-holes) at 3-days post procedure. And, another subject climbed the Sydney Harbor Bridge within a few days after the procedure! Réjuve is truly going to be a disruptive breakthrough medical device for the treatment of low back pain.”
“Millions of back pain sufferers 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 is a micro-invasive medical device designed to reinforce tissues, provide flexible and durable structural support to stabilize the disc and reduce low back pain. We’re hopeful that two, perhaps even one set of injections of the Réjuve medical device are all a patient will ever need to receive permanent low back pain relief”, says Hawkins. “And, Réjuve is a much simpler, faster acting, 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, job related activities or inactivity, and smoking. Most minimally invasive treatments being used today, such as steroid injections or nerve blocks, are not medical devices, provide only temporary relief, and in the case of ESIs and stem cells are very patient dependent. As a consequence, acute and chronic back pain continues to be a growing part of the US health landscape.
About The Data: These data represent 2-week post-procedure status for a small number of patients. Longer term results are not available at this time. These data are from only one clinical site and one investigator (with considerable experience in micro-invasive treatment of spinal discs). Réjuve is not an approved medical device. The clinical investigator received specialized training in the implementation of the Réjuve clinical protocol.