Intralink-Spine touts early safety data for Réjuve cross-linking device

Spinal device developer Intralink-Spine today released 1-month clinical results from a trial of its Réjuve system, touting early reduction of lower back pain in its 4 safety study patients.

Rejuve is an injectable crosslinking device designed to mechanically strengthen and stabilize spinal discs and joints to reduce pain, according to the company’s site.

“Patients experienced an average Visual Analog Scale pain score reduction of 92% and an average Oswestry Disability Index disability reduction of 88% at the 1-month interval. These positive one-month data are great news, especially as we move forward to our larger pivotal clinical studies. Four chronic low back pain patients were treated by orthopedic surgeon Dr. Harwant Singh at Pantai Medical Center in an NMRR registered clinical safety study. Each of the 4 patients are pleased with their treatment and continue to have positive results at the 1-month juncture. It’s unrealistic to think that all of our patients will achieve these same results, but these early data make us very optimistic that a single set of injections of the Réjuve medical device are all that some patients will ever need to receive permanent low back pain relief,” chief scientific officer Tom Hedman said in a press release.

Each patient in the trial received fluoroscopic image-guided injections of Réjuve in their lumbar intervertebral disks, as well as 2 posterolateral injections for each treated level, the company said.

“All 4 patients are already enjoying a better quality of life than prior to the Réjuve treatment. And, they didn’t have to wait weeks or months, because the effects of Réjuve are almost immediate. The Réjuve treatment is going to be very disruptive to how patients are currently treated for low back pain. Réjuve has the procedural simplicity of an epidural steroid injection, but with potential long-term positive effects. And, Réjuve is not patient dependent, complex, and expensive like most stem cell procedures currently in development,” CEO Lyle Hawkins said in a prepared statement.

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