EXECUTIVE SUMMARY
Filling the Gaps in Orthopedics
OrthoBolt is an expandable pedicle screw with cutting-edge rotating strut technology resulting from a synthesis of orthopedic and co-opted cardiovascular sciences optimized for safe and secure pedicle screw anchoring in spinal fusion procedures.
01
The Problem
The World Health Organization reports nearly 500 million people suffer from osteoporosis: a common disease in the elderly, characterized by a decrease in bone mass and an increased risk of fragility fractures [1]. Vertebral fractures are the most common osteoporotic fractures with an incidence of 1.5 million per year in the US alone [2]. Many of these fractures warrant spinal fusion surgery involving the use of internal fixation devices, including pedicle screw placement in the vertebral bodies of the spine.
02
Complications
A common complication of pedicle screw fixation is screw loosening, which has been reported to occur in up to 60% of patients with osteoporosis [3]. When screws loosen, patients can suffer several of the issues they encountered before surgery, some of which include back pain, muscle weakness, paresthesias (e.g., tingling, numbness), incontinence, shortness of breath (via changes in posture), and immobility [4]. Despite these challenges, pedicle screw design has seen little innovation since its introduction, leaving insufficient fixation strength as a persistent issue, particularly in osteoporotic bone.
03
The Solution: OrthoBolt
OrthoBolt fills the gaps of the increasing challenges in spinal procedures, particularly in patients with osteoporosis and low bone density, through the design of an expandable pedicle screw optimized with cutting-edge rotating strut technology. These screws offer optimal anchoring in both healthy and compromised bone, reducing the risk of complications associated with traditional screw fixation methods. OrthoBolt is also designed to be removed without significant compromise to precious bone quantity, an issue not addressed by other expandable screws or unforgiving augmentation techniques (e.g., cement augmentation).
Sources:
1. Kanis, J.A., et al., A reference standard for the description of osteoporosis. Bone 2008. 42: p. 467-75
2. Alexandru D, So W. Evaluation and management of vertebral compression fractures. Perm J. 2012 Fall;16(4):46-
51.
3.Yuan L, Zhang X, Zeng Y, Chen Z, Li W. Incidence, Risk, and Outcome of Pedicle Screw Loosening in
Degenerative Lumbar Scoliosis Patients Undergoing Long-Segment Fusion. Global Spine Journal.
2023;13(4):1064-1071.
4. https://my.clevelandclinic.org/health/diseases/17498-spinal-fractures
WHY ORTHOBOLT?
We are innovating to meet patient needs
The OrthoBolt is engineered with a focus on compatibility with osteoporotic bone structures, ensuring secure fixation and adaptability to patient-specific conditions.
01
Patient-Centric Focus
Compared to tradition fixation methods, OrthoBolt’s innovative rotating strut technology ensures better anchoring, in both healthy and compromised bone. This improves patient outcomes by reducing the risk of screw loosening, and subsequent complications including back pain, muscle weakness, and immobility. This patient-focused design leads to better postoperative outcomes and an improved quality of life.
02
Advantage Over Competitors
Unlike competitors' traditional screw systems or other expandable screws that lack versatility or bone-sparing features, OrthoBolt's solution stands out with its unique expansion mechanism and customization options. Our technology not only enhances fixation strength but also allows for easier deployment and removal without compromising precious bone quantity.
03
Setting New Standards of Excellence
OrthoBolt is committed to pushing the boundaries of orthopedic innovation, ensuring that patients receive the best possible care and outcomes in spinal fusion procedures. With our expandable pedicle screw technology, we are raising the standard of care and establishing new benchmarks for excellence in the orthopedic industry.
