Intralink-Spine’s Réjuve (GENTIS) Treatment Nears Completion Of Safety Study And Begins Multi-Site Pivotal Study
LEXINGTON, KY, January 31, 2017.
With extremely positive clinical results at the six-month juncture from its early safety and feasibility study in Malaysia, Intralink-Spine, Inc. (ILS) confirms that the Réjuve™ System (GENTIS) 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”, says Lyle Hawkins, CEO of Intralink-Spine, Inc. “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”, says Hawkins. (Message from CEO)
“Two of the four patients with six-month data have no pain or disability. A third patient has only mild pain (67% reduction) and zero disability at 6 months. All five of the patients at three-months and 75% at six-months have excellent results (both VAS and ODI decreased more than 50% from baseline). I’d say that is an exceptional start to our clinical studies of this injectable device”, says Dr. Tom Hedman, Ph.D., the inventor and Adjunct Associate Professor in the F. Joseph Halcomb III, M.D. Department of Biomedical Engineering at the University of Kentucky. “We’ve demonstrated the safety of this device, and based on my 30-plus years of experience in this field, the prospects for this revolutionary 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”, states orthopedic surgeon, Dr. Harwant Singh from the Pantai Medical Centre, 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”, states Hawkins.