Since it spun out of parent company Zimmer Biomet last year, ZimVie has been looking to differentiate itself from its competitors in spine with a focus on mobility. The Westminster, Colo.-based orthopedics firm makes cervical disc implants and tethering systems to treat pediatric scoliosis, both of which grew in sales last year as the company’s core spine business declined due to competitive pressure.
The company also received FDA approval last month for a shorter version of its Mobi-C cervical implant, which allows for an optimally sized product for more patients.
Rebecca Whitney, ZimVie’s global spine president, talked about the company’s latest FDA approval and how it is differentiating itself from the competition.
This interview has been edited for length and clarity.
MEDTECH DIVE: What’s the significance of the new FDA approval for Mobi-C?
WHITNEY: We are the market leader in the cervical disc replacement market, which is something we’re very passionate about. And this smaller version, that we are in the process of launching, it’s shorter. We’ve been selling this version in the European market for quite some time. We saw a need to bring that sort of version into the United States market, which is the largest portion of the global market for cervical disc and spine. The reason we did this is because about 15% to 20% of patients are smaller stature or have smaller anatomy, where that smaller height is going to be the most optimal device size for their treatment.
What is the market for cervical disc replacement in the U.S.?
It’s not as developed as it should be still, even after having solutions out there for a while. The way we think about the market is, if you think about everyone who has a cervical spine issue, there are really two ways to treat it:
There’s the historical gold standard, which is ACDF [anterior cervical discectomy and fusion], and then there’s cervical disc replacement. And we know that about one in three times a patient will actually receive a cervical disc, when two out of three times, even if they’re perfectly indicated, they’re still being fused. And the fusion will solve the clinical problems most of the time, but it comes with some trade-offs in terms of range of motion and flexibility.
Our number one priority is to continue to develop that market by educating more surgeons and more patients that there’s another option out there and it’s not just fusion. We think the market right now is about $350 million globally, but we think it could be a billion.We’re only about a third of the way there in terms of developing that market and making sure that every patient that’s properly indicated has the choice to receive a cervical disc replacement.
What factors go into the decision between a cervical disc replacement or spinal fusion?
What we’ve found is, the perfect scenario for us is when the patient is informed and knows they have choices, [and] the surgeon is informed and trained up on both procedures. When that happens — and the patient is indicated — they’ll usually end up with a disc replacement. If we have a patient who doesn’t know to ask, and we have a surgeon who has never been trained, [or] maybe has been trained but prefers fusion … that case is likely going to get fused. And so it’s a combination of surgeon preference, comfort with the procedure, and frankly patients advocating for what they want.
How much does Mobi-C contribute to your revenue?
It’s a great product for us. It’s our single biggest brand for ZimVie Spine, as well as all of ZimVie. We’re a full-line spine player … but where we really set ourselves apart is in these motion-preserving solutions: Mobi-C and then we have the Tether, which is a non-fusion solution for pediatric scoliosis.
Those two products are our motion preservation segment. Collectively, that’s about 25% to 30% of our revenue. That’s where we’re a little different from other spine players, in that we have such a heavy percentage of our business that’s not in the fusion bucket.
How is coverage in other countries?
It varies by country. France is a good example. It is one of the biggest healthcare markets in Europe. They’ve really taken off with Tether, which is great. Just three months ago, we won the French reimbursement status for Mobi-C, which were the only cervical discs that have this now, which means that any patient in France who wants or needs a cervical disc can get it paid for. Just last month, we got a similar approval in Belgium. So we’re definitely starting to see this global kind of clinical history is helping us to win over [coverage].
In Asia, we’re having really strong success in our most important countries like Taiwan, Japan and Korea.
What does the competition look like in cervical fusion and scoliosis treatments?
We are the market leader in both of those spaces still, and we’re very proud of that. We’ve had new entrants and new competitors come into the cervical disc space over the last few years. And that’s been a good thing, because our philosophy is we still need to develop that huge market. And so we welcome having others that share our passion to say, hey, collectively, let’s go inform patients and surgeons that there’s a better way out there. Inside of that, though, we’ve got to be sure that our devices and our programs are as competitive as anybody is to keep our market-leading position.
With Tether, it’s a similar story, but we’ve been the only product on the market in the U.S. until about two months ago, when Globus introduced [their Reflect system]. They’ve had their tether available outside of the U.S., but they’ve now brought that to the U.S. We see it as a really good thing for the category, because hopefully, it’s going to give more kids access to this.
Screws and rods and cervical plates, those are never going anywhere. So our whole philosophy is if we lead with differentiation, and then we pull through the rest of our business, that’s the way we go to market.