LEXINGTON, Ky.--(BUSINESS WIRE)--Intralink-Spine, Inc. (ILS) is pleased to announce that early clinical study data has been obtained regarding the use of its Réjuve System for the treatment of low back pain.
Each of the four patients treated in late June by orthopedic surgeon Dr. Harwant Singh at Pantai Medical Center (Kuala Lumpur, Malaysia) under an IRB and NMRR registered clinical safety study had a reduction in Visual Analog Scale (VAS) pain score of 83%-100%, 2-weeks post-procedure compared to pre-procedure levels, with a 93% average reduction. Disability, based on the Oswestry Disability Index (ODI), was reduced 57%-100% with an 84% average reduction. While each of the patients is happy with the treatment effects 2-weeks post-procedure, Dr. Tom Hedman, Chief Scientific Officer for ILS, is the first to note that it’s very early in the clinical trial phase with more patients and data yet to be acquired.
“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 Dr. Singh. And, according to Dr. Hedman, “These initial data support our belief that this device can be safely and effectively delivered to the affected disc using our protocol and standard fluoroscopic techniques.”
According to Lyle Hawkins, CEO of Intralink-Spine, “We are very optimistic about the clinical outcomes thus far, but also excited about the early patient positive feedback. For example, one subject reported that he played golf (18-holes) at 3-days post procedure. And, another subject climbed the Sidney Harbor Bridge within a few days after the procedure! Réjuve is truly going to be a disruptive breakthrough medical device for the treatment of low back pain.”
Hawkins continues, “Millions of back pain suffers receive numerous epidural steroid injections (ESI) each year in an effort to alleviate low back pain. We’re hopeful that two, perhaps even one set of injections of the Réjuve medical device are all a patient will ever need to receive permanent low back pain relief. And, Réjuve is a much simpler, faster acting, and less expensive treatment than what is being considered with stem cells.”
For additional information or to discuss investment opportunities contact Lyle Hawkins 502.419.8099 or LHawkins@IntralinkSpine.com.
