The cushy crescents of cartilage in the middle of your knee joint—if you’re lucky to still have them—are called the menisci. They go bad for a lot of runners and athletes, as well as plenty of sedentary people as they get older. Now a Bay Area medical device startup has come out with a tool that it bets will help surgeons stitch up tears in that tight little knee compartment, in hopes of helping lots of people avoid arthritis.
Ceterix Orthopaedics, a Menlo Park, CA-based company, has emerged from stealth mode this week by declaring that after less than three years in business, it’s ready to start selling a new surgical device that it says could be useful for more than 600,000 people a year in the U.S. who end up getting part or most of their meniscus surgically removed. The price is about $1,200 per patient, so if Ceterix captures even a fraction of the patients it thinks are candidates for its type of procedure, it will rake it loads of cash.
The company, which has pulled in about $28 million in financing from Versant Ventures, 5AM Ventures, and Novo Ventures, hasn’t proven in clinical trials that its device offers a benefit for patients in terms of pain, swelling, or recovery time. It has only about 30 employees, and is just now hiring the first few people in a direct sales force that will seek to get orthopedic surgeons to try out the new technique. The hope at Ceterix is that doctors and hospitals will be able to show over time that the Ceterix device can help people avoid partial or total removal of the meniscus, which often leads to the grinding bone-on-bone problem that causes so much arthritis.
“Common wisdom with orthopedic surgeons is ‘if you can repair the meniscus, you should. But they can’t repair it very often. We provide them a tool to do what they want to do,” says Ceterix co-founder and CEO John McCutcheon.
The company got going down this road when it raised an $8.1 million financing from Versant and 5AM in October 2010, to commercialize an idea from Justin Saliman, an orthopedic surgeon at Cedars-Sinai Medical Center in Los Angeles. The idea was to create a device that could slide into the tight space of the knee joint and place stitches in the meniscus that can’t be done by hand. The company picked up about $20 million in additional financing in December.
Here’s how it’s supposed to work. The Ceterix tool is a manual device, which the surgeon grips like a caulking gun. The thin business end of the device, which has tiny jaws, slides into the knee joint. Once it’s inside, with help from a tiny camera, the physician can squeeze a trigger to pass sutures from the bottom jaw to the top one and thereby run complex stitching patterns through the tissue. Once a physician has gotten trained, the procedure should take about 20-30 minutes, McCutcheon says. Saliman described the procedure in more detail in a paper published in the peer-reviewed journal Arthroscopy Techniques. The company has also put together a video you can see here.
Ceterix didn’t need to run long and expensive clinical trials to get FDA permission to begin selling, because its suture passing device is considered a “Class 1” device exempt from that kind of regulatory process, McCutcheon says. The company is still registered with the FDA as a regulated medical device maker, and it may need to do some more difficult studies if it wants to 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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