John Mastrototaro: Sure. First off, we are still engaged with the first four beta partners that we had worked with previously, who were basically at this point, just waiting for us to get to the juncture where we have rings available, and some of them are looking for the 510(k) clearance. So – but we are in communication with them over time. Now, there is two new large groups, as I mentioned on the call, an insurer payer, and as well as the remote patient monitoring company that we have started an additional beta program with. We now – now that we have got our final solution, we have other interested parties who have expressed interest in testing our solution. And with the recent blood pressure clinical results that we just obtained, it has initiated some additional dialoguing with companies who have an interest in blood pressure, specifically.
So, these conversations with potential strategics are gearing up right now, both because of the fact that the ring is imminently going to market next week. The FDA, we are working closely with and hopefully we will have a clearance in Q1, and then the results of the blood pressure study. So, I think you are going to see this area, in terms of B2B partnerships, expanding more and more in the coming months.
Jay Cogan: Okay. And then there is another one. John, I think that you can probably answer here as sort of relates to the blood, excuse me, blood pressure clinical studies. There is a couple of them. So, one of the questions is, what is your trial results? What does it really mean? How long will it be before blood pressure finds its way into a commercial device for the company? And kind of a question alongside, do you expect blood pressure measurements to be made from the ring or from a wrist based device?
John Mastrototaro: Thanks Jay. First off, as it relates to where the measurements will be made, as I mentioned in the call, we do have the ability because the chip that we have developed is so small, that we can put it in both ring or wrist worn form factors. For the purposes of our clinical trials to-date, we have done everything on the wrist. And it may be ultimately that we want to use a bracelet type device to do this, but we do have a bit of flexibility, but we have not initiated any blood pressure trials on the finger yet. We focused on the wrist. And primarily that’s just because of, it’s easier to do it on the wrist, where we have an adjustable band. And we can use a prototype on multiple people versus a ring where we need individual sizes for folks.
So, we felt that that was the best way to get out there and conduct trials relatively rapidly. In terms of how long it will take to bring this to the market, our prototype device is a prototype, and we use it in the clinical lab. It’s not to biggest risk warrants. But we do want to convert that into something that’s a bit closer to what the commercial product would look like. And so – and we need to get to that point, ultimately to run our pivotal trials for the FDA. So, we are going to go through the steps of reconfiguring the hardware, putting it into a updated form factor. And then we have got some clinical trial work that we want to conduct. We will continue to use our current prototype to look at some of the longitudinal studies, bringing in people, some are employees, week-after-week-after-week monitoring their blood pressure, looking at the accuracy, determining whether there is any drift or adjustments that we need to make with the algorithms over time.
We will run those studies in parallel to bringing up new hardware. And once we get to the point with our internal studies, where we think that we are good to go, we will need to embark on a pivotal trial, which would involve somewhere between probably 80 and 120 individuals monitoring their blood pressure. The FDA has standards for how you conduct these tests, and we know the accuracy requirements that need to be met. And we will do things similar in fashion to what we did for heart rate and oxygen, monitoring before. And the last thing I will mention is that what we have done is scale down the hardware from multiple chips into this really small chip. And it’s unique to us, it’s something that’s patented that has this capability for glucose and blood pressure and potentially other analytes.
It’s fully functional, that just getting to that point has been a real stunning achievement. And I credit Michael Leabman and the team with all the work that’s been done, to get to that point with the product right now. The fact that we were able to achieve the accuracy results using it in the clinical study, which were well within the FDA guidance mean absolute errors, the guidance is at 7 millimeters, and we are at 5.9 millimeters of mercury error is just tremendously exciting. And we have seen that from some of the B2B partners we are talking to right now and what this could mean to the healthcare industry at large. I was at a meeting last night and someone was saying that’s like the Holy Grail of how to be able to do this seamlessly and automatically for people to track blood pressure longitudinally over time.
