Study Data Show Intralink-Spine Device Significantly Reduces Back Pain

Intralink-Spine Inc. (ILS) is touting early clinical study data showing the benefits of its Réjuve System to treat lower 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 Institutional Review Board and National Medical Research Register clinical safety study had a reduction in Visual Analog Scale (VAS) pain score of 83 percent to 100 percent, two weeks post-procedure compared to pre-procedure levels, with a 93 percent average reduction. Disability, based on the Oswestry Disability Index (ODI), was reduced 57 percent to 100 percent with an 84 percent average reduction. While each of the patients is happy with the treatment effects two weeks post-procedure, ILS Chief Scientific Officer Tom Hedman, Ph.D., is the first to note that it’s very early in the clinical trial phase with more patients and data yet to be acquired.

“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,” Hedman said.

Hedman discusses the Réjuve System in greater detail in the video below:

 

“The patients received fluoroscopic image-guided injections of the Réjuve medical device in the lumbar intervertebral discs, with two posterolateral injections per treated level,” said Singh.

According to Lyle Hawkins, CEO of Intralink-Spine, “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 three days post procedure. And, another subject climbed the Sidney 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 suffers receive numerous epidural steroid injections (ESI) each year in an effort to alleviate 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. And, Réjuve is a much simpler, faster acting, and less expensive treatment than what is being considered with stem cells.”
 
Based in Lexington, Ky., Intralink-Spine was formed to manufacture and exclusively sell the Réjuve injectable medical device to treat degenerative disc disease, low back pain, and related spinal diseases such as scoliosis. Rejuve is not available for sale in the United States, Canada, or European Union. Clinical studies are pending.