August 01, 2017
LEXINGTON, Ky.–(BUSINESS WIRE)–Based on 12-month follow-up clinical data from its safety and feasibility study, Intralink-Spine, Inc. (ILS) indicates that the Réjuve™ System continues to effectively eliminate or reduce low back pain and disability associated with degenerative disc disease.
“We continue to be very pleased with the patient outcomes,” states 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. “Twelve months after the Réjuve procedure, three of the four (3/4) patients eligible for this follow-up assessment have no (zero) low back pain and no (zero) disability. And, the fourth patient has minimal pain and disability. These initial clinical results demonstrate a long-lasting, significant reduction or elimination of pain and disability, not just a slight reduction, and these benefits began within days of the initial procedure. We also have objective imaging data demonstrating the elimination of clinical instability. This is great news, especially as we begin our larger pivotal clinical studies.” (Video – Dr. Hedman discusses recent clinical data.)
“With the reduction or elimination of low back pain coming so quickly after the procedure, skeptics were reluctant to believe that the Réjuve treatment would actually stay the course. And, I understand their skepticism, because alternative treatments with good early results have turned out to only be temporary and with biologic treatments, good results require months or years to take effect, if they come at all,” says Lyle Hawkins, CEO of Intralink-Spine, Inc. “Now, they see data from us that patients improve within days of treatment and continue to enjoy a better quality of life 12 months post procedure. So, yes, they were skeptical. However, we’re beginning to turn skeptics into believers.”
According to Hawkins, “We understand that we need to evaluate this injectable device in a much larger group of patients in a multisite study, but we are very optimistic as we pursue that next milestone. We believe the Réjuve System which structurally reinforces the native intervertebral disc itself is going to be a better treatment option for many patients with low back pain. Réjuve has the procedural simplicity of an epidural steroid injection, but with potential long-term positive effects similar to a successful fusion.”
About Intralink-Spine, Inc. (ILS): Formed to manufacture and exclusively sell the Réjuve™ injectable medical device to treat Degenerative Disc Disease (DDD), low back pain, and related spinal diseases such as scoliosis, ILS is currently conducting a Round C fundraising event for accredited investors.
Lyle Hawkins, 502-419-8099