SI-BONE Company Background

SI-BONE was founded in April, 2008 as a spin out when Wright Medical bought INBONE Technologies. INBONE was founded by Dr. Mark Reiley, the inventor of kyphoplasty, the vertebral fracture treatment, and INBONE, the ENDO-FUSETM Intra-Osseos Fusion System.

SI-BONE provides a less invasive alternative to traditional Sacroiliac (SI) Joint fusion surgery. The iFuse Implant SystemTM uses the same titanium implant technology that has been used in the ENDO-FUSETM System in over 1,000 patient cases. The company is managed by an experienced team of executives from Kyphon, Medtronic, INBONE, Saint Francis and several start up orthopedic and spine companies.

According to the National Institute of Neurological Disorders and Stroke (a division of NIH), "Americans spend at least $50 billion each year on low back pain." Low back pain is the most common cause of job-related disability and a leading contributor to missed work. Several leading orthopedic publications over the last few years have stated that anywhere from 15-25% of all lowback pain is SI-Joint in origin. According to a study by Bernard and Kirkaldy-Willis, over twenty two percent (22%) of individuals who presented with lower back pain actually had Sacroiliac (SI) Joint pain. A wealth of published clinical literature indicates that Sacroiliac (SI) Joint pain freguently mimics discogenic or radicular low back pain, resulting in many patients receiving lumbar fusion instead of Sacroiliac (SI) Joint fusion.

SI-BONE is focused on helping patients in one of the most under-served, under-diagnosed, and under-treated areas in orthopedics, the Sacroiliac (SI) Joint. The iFuse Implant SystemTM is an implant that can be used to fix/fuse the Sacroiliac (SI) Joint using an incision of less than 1.5 inches.

An Advanced Approach to Surgical Management of SI Joint Dysfunction
Up to 25% of all low back pain is SI Joint in origin – but the diagnosis of SI Joint disease is frequently overlooked. (Cohen, et al.)
It is common to link low back pain with protruding disc even when neurological signs are absent. (Weksler, et al.)
It is common for pain from SI Joint dysfunction to mimic discogenic or radicular low back pain. (Weksler, et al.)
Many patients go on to receive lumbar fusion instead of SI Joint fusion – so SI Joint disease should be strongly considered in differential diagnosis of low back pain. (Weksler, et al.)
Now there is an approach to surgical management of SI Joint dysfunction that’s easier and less invasive than traditional open surgery.
The iFuse Implant System consists of porous plasma spray coated implants, surgically inserted across the SI Joint to create fixation leading to fusion—from the inside.
The iFuse creates a biomechanically rigorous fixation/fusion system, designed to support reliable fixation/fusion and acute weight bearing capacity.
With the iFuse Implant System, there is no need for BMP in conjunction with autologous bone graft or additional pedicle screws, rods or hollow modular anchorage screws or cannulated compression screws or threaded cages within the joint or fracture fixation screws.
iFuse benefits:
The iFuse Implant System is designed to be the sacroiliac joint fusion/fixation method of choice for spine surgeons.
iFuse is a minimally invasive surgical solution to replace open surgical SI Joint fusion.
With iFuse there's minimal incision size, minimal soft tissue stripping, minimal tendon irritation and reduced risk of infection.
iFuse is a simplified minimally invasive surgical procedure.
Just drill, broach, insert Implants and close.
iFuse has a simple technique which reduces OR time to less than 1 hour.
iFuse has 3X shear and 7X bending strength compared with screws.
iFuse has improved patient perception of stability post-implant.
The incidence of SI joint degeneration in patients was 75% at 5 years post-fusion, which was significantly higher than in the non-fusion group, 38.2%. (Ha, et al.)
Among patients with one-segment fusion, 91% developed SI joint degeneration. (Ha, et al.)
Regardless of whether the fusion includes the sacrum, the SI joint is influenced by increased mechanical stress arising from lumbar/lumbosacral fusion. (Ha, et al.)
Posterolateral lumbar/lumbosacral fusion can be a cause of SIJ degeneration. (Ha, et al.)