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St. Francis Medical: Staking Ground in Dynamic Stabilization

Executive Summary

Spine, one of the device industry's hottest, most fertile segments, has a history of quick adoption and quick retrenchment (read spinal cages) and standards of care that are anything but gold standards. Perhaps the most interesting example of spine's ambivalent attitude toward technology is artificial discs. Artificial discs caught fire a couple of years ago in the US and promised to be the device industry's next blockbuster technology. But before the first-generation discs had even made it to market, spine surgeons-and the companies that develop new technology-were already onto the next big thing: dynamic stabilization devices, which fall somewhere between the motion-preserving qualities of disc replacement and the stabilization that cages offer. Dynamic stabilization devices are too new for their role in treating spine problems to be fully assessed, but a host of companies are already lining up. One of the first: St. Francis Medical Technologies, which after a difficult struggle with the FDA to get its device approved, is ready to take on the US market and test the potential of at least one category of dynamic stabilization devices: interspinous spacer devices.

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Can Simpirica Simplify Spine Stabilization?

Founded at the height of the spine industry’s surge, Simpirica Spine Inc. has developed a dynamic stabilization device that is reminiscent in its simplicity and novelty of past interspinous spacers. The company will soon embark on a 400-patient pivotal trial in the US testing its LimiFlex against posterolateral fusion in treating degenerative spondylolisthesis. A successful outcome in the trial could help offset some of the setbacks the spine industry has suffered over the past five years.

European Cost Concerns May Impact Devices

Medical device makers may have more difficult time selling in Europe than they'd anticipated as concerns over the economy and costs take hold, according to one analysis.

Vertos Medical's Blue Ocean Opportunity

Given how many start-up companies and their investors have rushed into spine over the past decade or so, one might assume that getting spine surgeons to adopt new technology is relatively easy. - But less than five years after the launch of the first artificial disc was supposed to usher in the era of motion preservation, surgeons are still arguing for the benefits of fusion over disc replacement--underscoring the tension between new devices and traditional therapy options. But one start-up, Vertos Medical Inc., has found a creative way around the adoption issue. Promoting a novel approach to spinal stenosis, Vertos' solution is to focus on the patient, rather than the surgeon, treating stenosis earlier in the continuum of care by reaching out to a new clinical specialty, interventional pain physicians.

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