LEXINGTON, Ky.–(BUSINESS WIRE)–October 27, 2016–
With the continuation of extremely positive clinical results from its early safety and feasibility study in Malaysia, Intralink-Spine, Inc. (ILS) believes the Réjuve System is going to change the landscape for the treatment of low back pain.
“At the 3-month juncture, three of the four (3/4) patients have no (zero) low back pain. And, the fourth patient has virtually no back pain; in fact, she climbed the Sydney Harbor Bridge two-weeks after the treatment and just returned from backpacking and climbing in Europe!” says Lyle Hawkins, CEO of Intralink-Spine, Inc. (Message from CEO)
“We continue to be very pleased with the patient outcomes. Though limited to four patients at this stage, these 3-month data are indicative that the Réjuve device has a more lasting effect on low back pain and disability than the very common epidural steroid injection (ESI),” says Hawkins. “If our VAS and ODI trend lines continue as expected, Réjuve will have a very dramatic impact on how patients are currently treated for low back pain. So, you can understand why we continue to be excited about Réjuve.”
“Within days after the Réjuve treatment, we’re seeing patient pain scores drop from 5-7 to 0 on the VAS pain scale, and disability scores drop from over 50% to 0 on the ODI. These initial clinical results demonstrate a significant reduction or elimination of pain, not just a slight reduction in pain, and these benefits are continuing past the 3-month point. This is great news, especially as we begin our larger pivotal clinical studies in the immediate months ahead,” says Tom Hedman, Ph.D., who is the Chief Scientific Officer for ILS and Adjunct Associate Professor in the F. Joseph Halcomb III, M.D. Department of Biomedical Engineering at the University of Kentucky. “The micro-invasive Réjuve treatment provides immediate local structural support of the disc, versus just using an ESI to treat the pain.”
“The patients received fluoroscopic image-guided injections of the Réjuve medical device in the lumbar intervertebral discs, with two posterolateral injections per treated level”, states orthopedic surgeon, Dr. Harwant Singh at the Pantai Medical Center, Kuala Lumpur, Malaysia. “The patient ODI and VAS scores at the 3-month interval are impressive and encouraging for the Réjuve treatment.”
Lyle Hawkins, 502-419-8099