Message from the CEO, Lyle Hawkins
Opportunity: Réjuve™ improves upon what is already being done (ESI’s), while providing a non-surgical (micro-invasive) alternative to fusions.
Back pain is a global problem affecting ½ billion people worldwide. In the United States, low back pain leads to 2.6 million emergency room visits each year. (A recent study reported that opioids were prescribed in about 60 percent of such cases.)
Back pain is:
A leading cause of disability in Americans under the age of 45;
2nd most common reason to visit a general physician;
Most common reason to visit an orthopedic surgeon;
2nd most common cause of job-related disability;
Causes nearly 80% of injured workers to miss at least 8 weeks of work.
Back pain has a $50 to $100 Billion impact on the US economy via medical costs and lost wages each year in the US.
Currently, chronic low back pain sufferers first resort to over-the-counter medications, patches, exercise, and other non-invasive treatments. However, these options don’t treat the underlying condition, so for many the pain continues.
After weeks or months of pain, these millions of low back pain sufferers will often resort to an epidural steroid injection. In fact, the CDC states that over 9 million injections are given each year. However, ESI’s as they’re commonly called, only mask the pain for a short period of time. So, the back-pain sufferer is left with the poor treatment choice of either continuing with pain masking injections or undergoing a more complicated surgical procedure, which may or may not resolve the problem.
The Réjuve Disc Crosslinking Device has the potential to fill the treatment gap for millions of people worldwide suffering from chronic low back pain by providing an alternative to palliative treatments like steroid injections, nerve deadening neuromodulation devices, and complicated surgeries like fusions, which dramatically increase the patient’s risk and recovery time.
Réjuve is designed to provide immediate local mechanical support to degenerated intervertebral discs by increasing the number of crosslinks in the collagen matrix via covalent bonding to mechanically strengthen the disc tissue and stabilize joint motion; thus, reducing low back pain. Think of it as rejuvenating your spine.
Réjuve is a single 20-min procedure consisting of two injections- one per side of the disc. This single, micro-invasive treatment improves joint stability and motion (over a fusion), while providing long-term pain relief (unlike an ESI).
This makes Réjuve an excellent opportunity for chronic low back pain sufferers to avoid opioids and surgery.
We continue to see excellent results from our initial patients beyond the three-year mark. And, now that the Data Safety and Monitoring Board has unanimously approved the continuation of the GEM-SE study, I expect similar results in Australia, as we increase the number of clinical sites and study participants.
When you consider Réjuve’s potential to fill the treatment gap for millions of chronic low back pain sufferers and a few of our milestone achievements such as:
Three-plus years of patient safety data,
Additional patient data coming from Australia,
Two long-term large animal studies,
ISO-13485 certification, and
Successful completion of ISO 10993 biocompatibility testing.
..You’ll understand why we’re excited about the months ahead as we pursue our commercialization objectives.
In anticipation of forthcoming commercialization under the CE mark, ILS is conducting an active fundraising round for accredited investors. Watch the videos and read the releases found on the ILS website. If you feel there’s a fit, then please give me a call.
Thank you for your time.
CEO, Intralink-Spine, Inc.
Director, Intralink-Spine Australia Pty Ltd