The Fremont, California-based company’s main product is a minimally invasive, one-size-fits-all adjustable implant cage system, designed to expand to fit the gaps between vertebrae. SpineEX submitted its Sagittae Expandable Cage to the FDA for 510(k) clearance in June and expects a decision before the end of the year.
If cleared for marketing, the company also plans to offer a lateral access system for surgeons, as well as disposable accessories used during the fusion procedure, and sterilization and storage containers, in a bid to provide a total solution for the surgery process.
Traditional spinal implants come in a variety of sizes and shapes, and can require more than 120 implants and tools for a single procedure, the company said in its prospectus, which cited a Markets and Markets report forecasting the global spine fusion devices market to top $17 billion by 2021.
The Sagittae implant’s design allows surgeons to adjust its size, height and angle during the procedure, in order to fit individual lumbar segments, cutting down on the number of devices and the amount of time needed for sizing implants.
SpineEX plans to design implants for additional procedures used to correct deformities or adjust the angle or curvature of the spine in different directions. Over the past two years, the company raised a total of $3.33 million in venture capital through series A and B rounds, since beginning operations in March 2017.