Movano Inc. (NASDAQ:MOVE) Q4 2022 Earnings Call Transcript

Stacy Salvi: Sure. Thanks, J. And I’ll start with the first question. So, just initially, the goals for the product partnership are really just to expand our pool of testers to make sure everything is working as expected and assess as possible. But more fundamentally, there’s really a rich landscape for us when it comes to product partnerships. Of course, partners want to look at what we’re building and conceptualize it how it fits in with their offering. And this reflects not just consumer retail interest, but very importantly, how the Evie Ring can serve as a complement to existing in-market medical solutions. This doesn’t only raise user awareness of their own biometrics, but specifically enhances the efficacy of current treatment.

And really, this is a win-win-win, right? It provides us with a robust partner channel, it provides partners with an innovation and growth story, and of course, most importantly, it provides end users with a better chance at improved health outcomes. And then, I guess I’ll go ahead and jump right into the second question. The second question was about how we’re differentiating from competitors. So, this is probably one of my favorite questions, in fact. But fundamentally, when we think about competitors in the space, we have a lot of the same metrics and all of the same metrics that they have brought to market. But we really differentiate out of the gate by ensuring that the device is medical grade. So, we know that accuracy is something that has been difficult for consumers in the past.

And, yeah, trend data is helpful, but we really want to make sure that we are providing the best in metrics. And then, of course, also really important is that form factor. The form factor being slightly flexible, gets over the finger without discomfort, it accommodates for swelling over the course of a day or over a month. And then, the charging case is a major delighter that goes without saying. So, the experience itself is really aimed at insights and (ph) the user where she is in any given day rather than kind of that standard 10,000 steps a day, which we all know and love, but I think doesn’t appeal to majority of consumers.

J. Cogan: Great. Thanks, Stacy. We have a couple of questions related to the launch of Evie. John, maybe you can start and if anybody else wants to add as well. One has to do with, if we’re going to file — just getting some clarification again, if we’re going to file for the — or if we’ve already filed for FDA clearance for the Evie Ring? Has that actually happened yet? Will it be a Class I or Class II filing? Would we launch Evie in the summer without the FDA approval? How long do you think it will take to get an answer from the FDA? I know, John, you covered some of this already, but just maybe just to reiterate that. And then, also along the same lines, what are the major tasks beyond an FDA filing are still to be completed prior to launch?

John Mastrototaro: All right. There’s a several question in there, but let me start at the beginning. We have not filed yet with the FDA. We’re planning to file this spring. Once we file, it will be a 510(k) Class II device. There were many pulse oximeters on the market that were cleared to provide heart rate and SpO2, and that’s what we’re going after with the first filing. I expect to get some feedback from the agency within 60 days after the filing. And if things go well, I would expect a clearance within three to four months. If for some reason, the FDA has more questions about a product like this, which is new in terms of form factor, and it takes longer, we are prepared to launch the product has a wellness device first.