With positive clinical results at the six-month juncture from its early safety and feasibility study in Malaysia, Intralink-Spine, has confirmed that the Réjuve system is now poised to begin its multi-site pivotal study beginning with sites in Southeast Asia.
“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 six months. All five of the patients at three-months and 75% at six-months have excellent results (both visual analogue scale and Oswestry disability index) decreased more than 50% from baseline). I would say that is an exceptional start to our clinical studies of this injectable device,” says Tom Hedman, the inventor of the Réjuve systen and adjunct associate professor in the F Joseph Halcomb III, Department of Biomedical Engineering at the University of Kentucky. “We have 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 orthopaedic surgeon, Harwant Singh from the Pantai Medical Centre, Kuala Lumpur, Malaysia. ”I am excited to continue my participation in the multi-site study.”