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win clearance for a more advanced “Class 2″ form of its device, like one that’s pre-loaded with stitches, McCutcheon says. The current device needs to be manually loaded with stitches.
About 1 million meniscus surgeries are done in the U.S. each year, and today only about one-tenth of them can be addressed with minimally invasive repair tools. Smith and Nephew, Johnson & Johnson, and Arthrex offer such surgical tools, but they tend to only be useful in meniscus tears that are straight up and down. The other 90 percent of procedures end up partially or totally removing the damaged meniscus. Ceterix is focusing all of its energy on those patients who currently can’t have their meniscus fixed, and it expects it will be able to help a majority of them, McCutcheon says.
Ceterix has considered using a distributor to sell the product, called NovoStitch. But it is now looking to lean on its own direct sales force, because it believes that approach will work better for a product with potential to “change the clinical paradigm,” McCutcheon says. Although the company is rolling out the welcome mat for new customers today, it doesn’t expect to be deluged with orders. The plan is to grow sales gradually, starting in 2014. “This will take years to build up,” McCutcheon says.
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