But in the world we live in now with generic implants, the lead-times are very significant. They can be in excess of eight months, they can even be up to a year. If you imagine for a small company, you have to have the working capital to fund all of that implant inventory, you need to have robot inventory. And it’s — and then you have to obviously fund the operations, while the clinical trial is running. So, it becomes not an astronomical cost, but a significant cost in a market that is an oligopoly, where there’s a general let’s call it, adversity to new market entrants and where funding can be expensive. So, that’s a long way of saying we don’t want to do a clinical trial if we don’t have to. And so as we started to get a feeling that we may need to do a clinical trial without certainty, it’s still a gray area, we could still submit a 510(k) and say we think we have good arguments, but we don’t think that’s prudent.
We have been working on making some technical differences to our system that we think could significantly enhance the safety profile and equivalents to systems that are on the market already. So, we have kind of — we’re putting a package around what our, let’s call it, our active system is. We’re going to know exactly what the FDA wants to see. And then in parallel, we’re going to have another version of the product that we are working on and very likely going to be the one we submit for approval, that we think is — really does not meet the threshold of a clinical trial, and they will say that, that’s our opinion. Maybe the FDA would see it another way, but we’ve had enough meetings with them where we think we understand where their concerns lie and which I’ll get into what their concerns are largely and they — I don’t want to characterize everything they’ve said, maybe there’s other concerns that we haven’t identified, but these are the ones that we think are relevant.
And so I’m going to jump into that next. So, where do we think the main problem lies with the FDA’s, sort of, concerns about our product and the technical equivalent to the current state-of-the-art. You think it mostly relates to what they characterize as active versus semi-active. So, on the left there, you can see two semi-active systems, Mako, which is owned by Stryker and Velys, which is owned by J&J. And what you’ll notice is that the surgeon is holding the saw that is mounted to the robot arm. And the surgeon is responsible for moving the saw during cutting. With the Monogram system, the movement of the saw doesn’t depend on force applied by the user directly to the cutting tool. So, that’s more of an active embodiment. This is really what the FDA has concerns with.
Now, I will say — I’m going to jump into this now, we had very good reasons for designing the system this way. We actually think that our embodiment potentially enhances the safety profile of our device. So, for example, with both hands-free, the surgeon who is the most experienced and trained user of the device and the most trained person in the operating room now has two free hands to hold retractors and protect soft tissue. So, we think that’s a pretty significant enhancement. You don’t have any surgeon fatigue because the surgeon isn’t holding a trigger and trying to wrestle a robot. They’re focusing entirely on where the blade is cutting. And there’s a lot of other things we can get into. But be it as it may, that’s kind of the perspective that we are working with.
The reason we designed an active system really was some of those things I already said, we believe that it would minimize the learning curve, we believe that eliminates a lot of the surgeons skill required with cutting, surgeon fatigue. Our goal is really to enable complex bone preparation, so milling for patient-specific implants, minimize the disruption to the workflow. We also don’t think that it’s a perfect safety feature for devices that have virtual boundaries for the user to be pushing into a virtual boundary. A lot of times, those virtual boundaries are protecting soft tissues, and we don’t think it’s kind of a perfect system to be pushing into a boundary that is protecting soft tissue. And really, our goal generally is to have a robotic system that is multi-application and we believe that a more active paradigm is more scalable for that.
So, that’s some of the design motivation. With that said, there’s limitations to an active design that we’ll get into. But I’m not going to get into the weeds on that. This is highly proprietary, and we’re just not going to talk about how we’re changing our system. But we basically believe that we can modify our robot to basically be closer to the predicates that we’re claiming substantial equivalents too. So, we think the devices in the market that were more similar to are Mako and Velys. Velys did not have to do a clinical trial, and they claim substantial equivalents to Omni, which is another system on the market. We think we have pretty strong equivalents arguments. So, for example, if you just look at the Velys 510(k), they describe their system as a motorized instrument controlled by the system automatically positioning the reception plane within the planned plane.
For the bone resection, maintains alignment through dynamic compensation. So, to make a long story short, we believe that we have some very, very strong equivalent arguments with that system. It is foot-pedal-operated for movement of the arm between reception planes, and we can — we’ll leave it at that. So, there’s — the company has decided that the technical differences of concern relating to active versus system-active can be addressed with some technical tweaks and that’s what we’re going to be doing. And we believe that these changes will mitigate the risk of the clinical data request. So, we think that’s really positive news. We announced that in the 10-K, and I’m going to get into a little more detail on that. But before I do, I just want to talk about potentially some benefits because there is certainly ways that these technical improvements potentially improve the system.