You’re looking at somewhere between 60 and 100 people participating in the trial. This is will be Class II, filing 510(k). When we talk about these filings typically on a 510(k), the FDA provides you feedback within 60 days of your filing, and then you work to answer any questions that they may have. If things go well, these can be cleared in three to four months. My last company I was with and this is after the start of COVID, we got two 510(k) cases cleared; one was done in 90 days, one in 108 days. Part of that depends upon how comprehensive your package is when you file it and the amount of questions that the agency may have in evaluating your filing. And I will pause there and see — Michael, do you have anything else you’d like to add?
Michael Leabman: Yeah, I think the only thing to add there is, we typically start in the lab in the control environment, so we can really start optimizing, which we were doing now, our algorithms, our antennas, and really perfect that before we go live with patients. So that’s usually the first step before we go with patients.
J. Cogan: Okay. I think the next question is probably for Tyla. How are you building awareness of Evie ahead of the launch? Are most people discovering you?
Tyla Bucher: Yeah, hi. So, CES was a really excellent ignition point for us. And we’re continuing to build on that amazing organic press and awareness that we received following the announcement of Evie. We’re also continuing to amplify that sort of post-show momentum through a strong paid and organic social campaign that’s currently running across multiple channels, and it’s driving ongoing traffic to our site. And then, these are leads that we’re hoping to convert into emails that we can then retarget once we get ready for launch. In addition, we’re seeing new growth on our social channels every day, not only with likes, but very positive comments and a lot of questions about when the device will be available. In addition to that, we’re driving engagement through our 50,000-person strong newsletter list, and we’re really encouraging our early adopters not only to follow us on social, but to share the news and excitement of the brand with others in their network.
And, yeah, that’s it.
J. Cogan: Thanks, Tyla. That’s awesome. I’m going to turn it over to the operator. I see there is a question on the phone lines. And so, we can do that first, and we’ll come back to the webcast questions.
Operator: Our question is from Bruce Jackson with The Benchmark Company. Please proceed.
Bruce Jackson: Hi, good morning, and thank you for taking my questions. I wanted to focus on the system-on-a-chip study that’s about to start. From the time that you start the study, how long do you think it’s going to take to complete it and get the package ready for the FDA?
John Mastrototaro: Well, thanks for the question, Bruce. Typically, we evaluate somewhere between 50 to 100 folks when we first evaluate in our facility. In our upcoming study, we plan to have numbers in that range. And it takes us about three weeks to collect that data. Now, after we get that data and after we evaluate how well our algorithms are measuring blood pressure, for example, we will then look to partner with a third-party and we have third-parties in mind who would conduct the formal study for us. And that formal study could take two to three months. And then, typically to put our package together for the FDA, because we’re already putting together the package for the heart rate and SpO2, we’ve got the bones of a package set up and naturally we’re looking at some different form factors with this and obviously we’ve got a new clinical trial report.
But overall, you’re talking about a filing that would occur assuming we have the appropriate level of clinical accuracy find that would occur within two, three months of that, and then as we said before, the FDA review process can take another three to four months.
