Chronic low back pain is the second most common cause of disability in U.S. adults, a large percentage of which – 15% to 30% or more – can be attributed to sacroiliac joint (SIJ) pain. Historically, due to the highly-invasive nature of surgical treatment options, SIJ pain therapies have been limited to nonoperative treatments including epidural injections, physical therapy, radiofrequency ablation, and (often opioid) pain medications. While some patients benefit from such treatment, many sufferers experience no relief, or temporary relief at best.
In 2008, the first minimally-invasive SIJ fusion device was approved by the FDA and since that time minimally-invasive SIJ fusion surgery has become the standard of care for surgical treatment of SIJ pain. In 2019, in the U.S. alone, tens of thousands of patients will benefit from the procedure and – with demand growing at upwards of 15% to 20%+ per year – experts estimate that 200,000+ patients, annually, could benefit from minimally-invasive SIJ fusion surgery.
Along with the procedure’s exponential growth there has been a corresponding increase in the number and type of SIJ fusion products available to surgeons and patients. Despite the proliferation of such products, surgeons indicate that current solutions still do not allow for an optimal combination of (1) fast, thorough decortication of the joint space, (2) powerful, controllable compression, and (3) procedural efficiency throughout.
The minimally-invasive, SIJ Fusion System – manufactured in 3D-printed titanium alloy – is designed to address this clinical and market need. In addition to other features, the system is designed to differentially promote bony fusion of the SI joint by allowing for easy, thorough decortication of the joint – requiring far fewer steps than existing, decortication-enabled SIJ fusion technology – and by also allowing for powerful, controllable compression.
Available for exclusive licensing or acquisition
Initial cadaver lab study with first-generation, 3D-printed prototypes, completed in August 2019
Anticipate 510(k) regulatory pathway in U.S.
Intellectual Property: full U.S. Provisional Application filed