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Intralink-Spine’s Réjuve Treatment Nears Completion Of Safety Study

By Business Wire | February 6, 2017

Company poised to begin multi-site study of the system.

With positive clinical results at the six-month juncture from its early safety and feasibility study in Malaysia, Intralink-Spine Inc. (ILS) confirms that its Réjuve™ System is now poised to begin its multi-site pivotal study beginning with sites in Southeast Asia.
 
“After a six-month period, patients have had excellent results from the Réjuve treatment,” said Lyle Hawkins, CEO of Intralink-Spine. “Think of it, these patients with chronic low back pain are now enjoying a better quality of life from just one treatment of Réjuve. They’re enjoying activities like hiking, rock climbing, and golf. And, these patients were enjoying their improved quality of life within days after the treatment; so, the positive effects of Réjuve are as expected, both rapid and long-lasting.”
 
Two of the four patients with six-month data reported no pain or disability, and a third patient had only mild pain (67 percent reduction) and zero disability at six months, according to Tom Hedman, Ph.D., Réjuve inventor and adjunct associate professor in the F. Joseph Halcomb III, M.D. Department of Biomedical Engineering at the University of Kentucky. All five o f the patients at three months and 75 percent at six months experienced positive results (both VAS and ODI decreased more than 50 percent from baseline), he added.

"I’d say that is an exceptional start to our clinical studies of this injectable device,” Hawkins said. “We’ve demonstrated the safety of this device, and based on my 30-plus years of experience in this field, the prospects for this microinvasive treatment are unique compared to all other existing and emerging surgical and minimally invasive treatments for degenerative disc disease and chronic low back pain.”
 
“These patients are doing remarkably well following a relatively simple image-guided procedure. Even the one patient with moderate pain claims to be better than prior to the procedure,” agreed Dr. Harwant Singh, an orthopedic surgeon from the Pantai Medical Centre in Kuala Lumpur, Malaysia. ”I’m excited to continue my participation in the multi-site study.”
 
“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, which is why we’re excited about our data thus far and another reason we’re eager to begin our multi-site study,” concluded Hawkins.

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. The Réjuve device is based on the body's own natural response to heal instability and degradation of the spinal disc. Réjuve is an injectible crosslinking product that mechanically strengthens and stabilizes the disc, thereby reducing pain. The micro-invasive procedure can be performed on an outpatient basis and is usually complete with just one injection treatment. 



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