SpineGuard: Taming Of The Screw
Much of the innovation in spine over the past decade has aimed at replacing fusion, the standard of care. SpineGuard’s novel sensor technology is betting on fusion’s long-term prospects, helping patients and surgeons by making the procedure safer.
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Spine surgery has gone from the pariah of the orthopedic industry to that sector's fastest growing segment. Large companies have looked to capitalize on spine's rapid growth by acquiring their way into this space, a pattern of consolidation that has left the industry without a major pure play spinal company. SpineVision is looking to fill that void by developing a complete line of spinal products, starting with innovations on core technology, rather than relying on a typical start-up strategy of focusing on a particular device or clinical niche. The company's strategy will bring it immediately into competition with the market leaders' well-established product lines. But SpineVision is counting on experienced management and the current frustration among spine surgeons resulting from recent industry consolidation to attract physicians' attention.
The ECRI report of the top threats to the healthcare industry in 2022 has cybersecurity leading the list. COVID-19-related issues such as supply chain shortages and lack of emergency stockpiles are also on the list.
The company presented 18-month data at a conference that it thinks will support strong uptake. European regulators required the 18-month data for filing; an FDA decision based on 9-month data is expected in April.