OvuSense Pro – a new tool for clinicians and their patients for advanced remote cycle monitoring

Ovusense Pro is a device that is going to be used by clinicians but it can also be accessed by the user. It’s a browser-based view of the data produced by the OvuSense app and it will allow you to see additional analysis on the OvuSense data. It’s specifically for women that are already consulting with a clinician, be it with their GP or, in fact, with a fertility specialist so that both parties can understand more about what’s happening with their cycle patterns. It identifies simple things like whether or not you’ve got a short luteal phase but it will also identify these typical patterns that I discussed earlier on in the introduction.

This was really based on our clinical research and identification of specific problems. As I said earlier, we had a very clear set of customers that were using OvuSense who had the variable temperature in their patterns and that variability started to take on consistency between particular women that had particular ovulatory issues, so the most obvious one, as I mentioned earlier, is a polycystic ovarian syndrome. It became very clear that a disturbed temperature pattern is very commonly associated with the polycystic ovarian syndrome. It makes sense because what you’re looking at with OvuSense is the level of core body temperature and the level of core body temperature basically matches the level of progesterone in the cycle. Therefore, what we’re looking at when we look at a normal cycle, we’re looking at a low level of temperature to begin with, a rise associated with ovulation and then what we hope to see is that the temperature stays high. What we were noticing with women particularly those with the polycystic ovarian syndrome is that that pattern wasn’t as common and that there was a great deal of variability in the temperature throughout the pattern itself. That’s why we characterize those specific cycle patterns and that’s why we’ve developed Pro to give that information in a standardized fashion to the clinician so that that can help those patients out, particularly those that have not yet received the formal diagnosis of any of these particular issues.

I was talking about that in the final slide that I showed. We have already published two papers. We’ve just submitted a third to an SRM 20/20 which will hopefully be published in October of this year. It’s only online. The first of them which was presented last year identifies the patterns that I was talking about. The second of them then relates those patterns to specific diagnoses that those patients had already had so that’s the important point about that research. It doesn’t mean that pattern means you’ve got a particular issue but by relating those two things together what we can do is to start to indicate to a clinician that they might want to test further for particular issues that we find.

The Ovusense Pro will be available to buy from the middle of June to the end of July onwards. We’re currently running a beta trial of that device and we are very happy to offer that to existing users as of OvuSense for free so they will get a 12-month subscription for OvuSense Pro. The existing users have some form of connection currently to a clinician that they’re talking to at least about the fertility even if they’re not in the treatment of diagnosis yet because we need to be able to connect the doctor to this process in order to test it properly with them as well. So if you have a doctor that you’re currently consulting with basically we can send you to a page where you can type this information into and then you can even come to us, basically, and we’ll give you free access for a year to OvuSense Pro as long as you have a clinician that’s connected to it as well.

It is safe to use but we don’t recommend using it while you’re pregnant. There are no indications for use so I should have mentioned. It’s a class 2 medical device and that means we are heavily regulated in terms of use and we have not tested it for use in pregnancy. Whilst there might be some value in understanding what’s happening to your progesterone level in pregnancy, our indication for use doesn’t essentially cover pregnancy at the moment. So we don’t recommend the use during pregnancy.

The first thing is I’ve just given you the link to a page which should allow you to enter your e-mail address and, hopefully, if you can identify your doctor’s e-mail address at the same time that would be good. If not, then what we’ll need is your permission to contact your doctor in some form of connecting connection to them and then you can get the beta trial for OvuSense. In terms of the pricing, at the moment, it’s free to existing users so the people that are online at the moment, that’s fine, it’ll be free for you for a year. Then when it launches, it will cost GBP100 extra for an annual subscription. You will be able to buy OvuSense Pro plus the current OvuSense devices in a bundle if you want in the future but that won’t go live until we’ve gone through the beta testing.

No, you have to have Pro in order to be able to see the data and the reason for that is again from a regulatory perspective. The data that we’re displaying is essentially useful for the clinician and if you’re not consulting with the clinician, then, in fact, it’s not correct in terms of our duty of care to our users to provide that data. Because there’s not a lot you can do with it unless you’re consulting with the clinician. So you have to have Pro in order to see the data. There’s a second reason which is just a technical one: we have not put this analysis into the app because we didn’t want to burden the app with more calculation. So this is a completely separate product that is accessed via a web browser and so you need to see this from that point of view as well.

Very good question. We already have prior to the launch of OvuSense we already had that issue of course because we are operating within an app environment currently. When you download your data from your sensor, nobody but you can download that data to any other version of the. That’s the first step in the chain. Those two things are connected and they are connected to a single patient ID – there’s no way that anybody else can get that data. Once it’s in the app, the next time you connect to the internet it will connect using an encrypted connection to a specific database which we operate on a separate server using a commercial program to log those data. The only pieces of information we retain about each customer is their e-mail address and, if they provide it, the date of birth and how long they’ve been trying to conceive. We don’t, actually, retain the name of the customer. We’ve just added in the fact that we need to know where you’re located when you’re using this ever since this is because there are certain data restrictions in various countries. In Germany and the UAE, the data that you provide to a company like ourselves has to be stored under specific circumstances for those countries. We use an encrypted methodology and then the Pro basically uses the same database for access but again that is encrypted and password-protected entry into the database. The last piece of the chain which is very important is the user that decides whether or not the clinician can connect to their data and they do that through the app. They have complete control over whether or not the clinician can see their data and how long for and when, whether they want to stop doing that, that’s the under the complete control of the user.

Correct, not through OvuSense Pro but through the version in the app so and this has always been a feature of the OvuSense product. Partners and sisters in some cases quite often do this so they share data through the app so each of the users has to have the app downloaded from the store. The app itself is free of charge so in fact it’s only the active user that is paying for OvuSense and everybody else can access the data shared through the app by the user by basically typing in the e-mail addresses they want to share with.

Yes, we use a standard coin cell battery for the sensor. It’s not recharged. It’s basically constantly in place and each sensor, from a regulatory requirement, has a lifetime of one year from the point at which you start using it. The exact time is 330 days plus 56 days to enable women with longer cycles to have a final cycle with the sensor and then you just replace the sensor after each year of use. We sell replacement sensors at cost value so you are essentially paying a very small amount of money to get the second sensor once you’ve started with OvuSense.

Yes, we suggest that it should be worn for at least six hours a night. If you sleep for less time during the night, for instance, if you get up to go the toilet, we recommend taking it out and then putting it back in again so it doesn’t have to be a good set of six-hour period. If you sleep for less time, it will sometimes be able to use that data depending on how stable it is. But, essentially, 6 hours when you’re not menstruating is the advised period of time to use it.

It’s a similar question and a very good question. The answer is the sensor is always recording but it cannot use the data if it is less than six hours. As I said six hours is the recommended period and generally users if they have less than four hours, it can’t use that data because it can’t establish an overnight temperature for those users. It’s an area that we’re looking to potentially improve on. We’re going through an algorithm revision probably at the end of this year. Now we’ve got a large number of cycles that we can test back over and we can probably see that most women will have a stable temperature at some point during the night that we can use. The issue is that the way that the technology works at the moment is it requires a large amount of data in order to determine an accurate temperature for that particular woman.

I think there are two separate parts to that question. The first thing is you can have a gap so it doesn’t have to be consecutive four or six hours which is one thing I said earlier. If you take the sensor out, OvuSense works on a very small temperature band so it’s ignoring all temperatures that are over 42 degrees Celsius which is obviously way above where you’d expect it to be anyway and it’s ignoring all temperatures below 36 degrees Celsius so it just throws them away. Because it’s throwing them away, it doesn’t matter at all if you take out the sensor, wash it if you wash it under cold water it’ll probably go back down to 15 degrees in that amount of time, no problem because it’s ignoring all that data. If you wash it in the hot water, it might go up to 45-50 degrees even but that’s going to also ignore in terms of data. It’s always had this intelligent filtering system to enable it to check whether or not the temperature looks like it’s real, it’s physiological and it represents something that’s going on within the body so it throws away that data.

It’s available directly on OvuSensec.com. It’s geolocated so wherever you’re located it will work out, so if you’re located in the USA, it will go to the US website, if you’re located in the UK, to the UK website and so on. You will also notice if you google it, it’s available at the moment in the United States on Amazon, we will shortly start selling on Amazon and in the UK as well. But, in fact, there’s no benefit to buying it off Amazon, you get more choice in buying it from us and there are no discount offers on Amazon but we simply do that because some people want it delivered the next day and we don’t currently deliver next day certainly not nowadays.

These are two very different things. The first question, yes, no problem. No problem inserting after intercourse. Again, we obviously recommend washing the sensor in between taking it out and putting it back in again. There’s no issue with inserting it after intercourse in terms of luteal phase temperature tracking. If you’ve inserted a pessary, if it’s a progesterone pessary which is what I presume the question comes from, if you are inserting it around the time at which you expected to ovulate, then there is a chance that you will get a false positive caused by the rise in temperature that’s caused by the artificial progesterone that is being put into the body. In most regimes for progesterone supplementation using pessaries you generally have the progesterone provided after you ovulate in which case that’s not a problem at all because you’ve already gone through the process of understanding ovulation. If you think about it if you’re taking progesterone pessary for supplementation after you’ve ovulated, then you want that progesterone to stay high and if that’s an artificial process. Then that’s fine because you want them that you want progesterone to stay high.

It is again an excellent question. No, it doesn’t interfere with implantation because the process of implantation is taking place fairly obviously in the uterus. The device itself is placed in the vagina but it’s only being placed overnight so there’s no physical contact, there’s no issue there which is not being implied by the question at all I’m sure. But also you’re not changing the physiology of the hormonal process during implantation either so there’s no issue in terms of implantation.