If you regularly follow PCOS Diva, you know I love the OvuSense monitor. I am all for anything that puts knowledge and power in a woman’s own hands. Recently, I invited Rob Milnes, CEO of Fertility Focus which produces OvuSense, to the podcast to discuss exactly how OvuSense works and why women with PCOS should be especially interested (whether we are TTC or not).
Rob has a great way of explaining, in simple terms, the science behind the role of progesterone and the luteal phase in a woman’s cycle as well as exactly how the OvuSense monitor works. He clearly broke down:
- OvuSense monitor system vs. ovulation predictor kits, the Creighton model, basal body temp. charting or other apps
- Why OvuSense can have a 96% accuracy rate when predicting ovulation and not give false positives like other products
- How OvuSense can help diagnose PCOS
- How to use OvuSense to monitor the effects of supplements and pharmaceuticals on your cycle and health
- The new pricing structure
A full transcript follows.
Rob Milnes – CEO
Rob has over 29 years experience in bringing ground-breaking medical technology and software to global markets, with the past 15 years focused on women’s health. He is CEO of Fertility Focus Ltd, the company which developed the OvuSense product, and also of Fertility Focus Inc., the company’s wholly owned US subsidiary. Robert has worked for Roche, Oxford Instruments, and was formerly a member of the Operations Board of Huntleigh Healthcare following the successful sale and integration of the Sonicaid Fetal Monitoring and Medilog Cardiology businesses. He brings additional extensive experience in research and development, sub-contract manufacturing, customer support, regulatory process, sales and marketing.
Amy Medling: Hello, and welcome to the PCOS Diva Podcast. My name is Amy Medling. I’m a certified health coach, and I’m the founder of PCOS Diva, and my mission is to help women with PCOS find the tools and knowledge they need to take control of their PCOS so they can regain their fertility, femininity, health, and happiness. If you haven’t already, make sure you check out pcosdiva dot com. There, I offer tons of great, free information about PCOS and how to develop your PCOS diet and lifestyle plan so you can begin to thrive like a Diva. Look for me on iTunes, Facebook, Instagram, Pinterest, Twitter, and Google Plus as well.
Today, I have the privilege of talking with Rob Milnes. He’s the CEO of Fertility Focus, and we’re actually going to be talking about one of those tools, you know, as I mentioned in the intro, finding the tools and knowledge you need to take control of your PCOS. He is the CEO of a company that develops the Ovusense Fertility Monitor, which I think is one of those really key tools that every woman with PCOS needs to really understand her cycle, and her fertility. Rob, welcome to the PCOS Diva Podcast.
Rob Milnes: Hi, Amy.
Amy Medling: You have over 26 years’ experience in bringing about groundbreaking medical technology and software to market, and you’ve been spending the past 15 years focusing on women’s health, so as the Fertility Focus CEO, you’ve helped bring the Ovusense product to market. That’s why I really want you on, to kind of explain the background and why this product is so unique, and kind of how it works, and how it can really help a woman with PCOS kind of really take control of her fertility, and I think it really helps you advocate for yourself. So glad to have you here.
Rob Milnes: Thank you.
Amy Medling: I was wondering if you could sort of start out by what is the Ovusense Monitor, so that those who have never heard of Ovusense kind of has an understanding about what it is.
Rob Milnes: Sure. It’s essentially an app that goes with a specific sensor of it’s designed for measuring temperature in the vagina, so you place that sensor in overnight, and it takes up to 100 readings overnight. Then, you download the data in the morning to get a fertility status reading each morning, and a chart, much like a basal body temperature chart, but much more accurate than that, and looking at your core temperature, rather than your basal temperature.
Amy Medling: How did you all, I know that’s kind of proprietary, I mean, there’s no one else doing that out on the market, kind of measuring your core temperature. How did you sort of develop that concept?
Rob Milnes: Well, essentially, the idea came from two veterinary scientists in the UK, at a University in the West of England called the University of Bristol. They were looking for ways of measuring rapid temperature rises, but very accurately. Essentially, they looked at that in cattle, and they looked at it in horses as well, but at the same time, they started developing concepts for looking at it in humans, and particularly focused in on the concept of using it for infertility. The use of temperature has been long known, in the clinical literature, for looking at your ovulation, and looking at the movement of progesterone in the body. Essentially, they were just using that idea, but improving on it by looking at the temperature in the vagina. There’s some clinical literature which points to the use of vaginal and rectal temperature as being a very useful way of much more accurately seeing what’s happening with the action progesterone on the ovaries.
Amy Medling: You have the monitor, and the probe that you use, or I don’t know the … What do you call-
Rob Milnes: We call that a sensor. It’s just a vaginal sensor.
Amy Medling: A sensor? Okay. Then, you sleep with that in, and it’s connected to your smartphone, and it takes readings throughout the night? Maybe you could tell us a little bit more in detail how that works.
Rob Milnes: Sure. I mean, we thought it was very important there’s no connection between your phone or your device and the sensor, during the night, so in fact, it’s a completely passive device. It’s just taking readings of temperature. That’s all it’s doing. Then, when you take it out in the morning, you place it next to your phone, or device, and we’d have both an Android and an Apple app. We covered the vast majority of phones out there on the market, and iPads as well. You press connect, and the point at which you press connect then wakes up the sensor for communicating. At that point, it will then communicate with your device, and it will send the data over to your device. As soon as it’s finished doing that, it goes back to being passive again, and all it’s doing is reading temperature.
Amy Medling: It really takes kind of the guesswork out of, like if you were taking your temperature every day, and it’s the traditional sort of way of monitoring your cycle. It’s kind of up to you to notice the temperature and record it, and this, the Ovusensor, does it all for you?
Rob Milnes: That’s right, yeah, and many women that have used it have come back very specifically to say they find that it reduces the amount of stress they have in monitoring their cycles, because BBT is difficult to take, and of course, it’s only one measurement each day, and it’s oral, and you have to do it upon waking, and it becomes quite a grind, whereas this really is something you can forget about. You place it in overnight, and then you take the readings in the morning. Simple as that.
Amy Medling: Can you sort of explain to us why the Ovusense monitor is kind of unique for women with PCOS? Compared to especially for a woman that’s trying to conceive, and you know, she’s really interested in when she’s ovulating, if she’s ovulating, and perhaps using an over-the-counter ovulation predictor kit. How is Ovusense superior to those ovulation predictor kits?
Rob Milnes: Sure. Very happy to take you through that. I suppose there’s two questions there. The first is, “What is the difference between Ovusense and just doing BBT chart and/or using an app, or using,” you know, there are a number of other temperature devices on the market, and the answer to that is we do provide a prediction in cycle with the data that you’re actually acquiring, during that cycle. That’s very important for a woman with PCOS, because obviously, she doesn’t necessarily know she’s going to ovulate at the same time next month, or even if she is ovulating. What Ovusense does is, by giving you that prediction, it’s giving you the ability to see, in every single cycle, when you’re likely to ovulate. It provides a four-day window that we call the ovulation window. That starts on the day before ovulation, and runs up until two days after ovulation.
Second question is really, “What’s the difference between Ovusense and a luteinizing hormone test,” or an OPK, those urine strips that a lot of people know about. The problem with those for women with PCOS is that they don’t work well for you, and they will often produce a positive result at the wrong point in the cycle. That’s because women with PCOS have raised levels of luteinizing hormone at different points in their cycle than we’re looking for to try look for ovulation, particularly early in the cycle, so you’ll tend to get false positives from day five onwards, in most cycles.
What we’re enabling a woman to do is really to see the whole of her cycle, to monitor it from the start of whenever she decides to start monitoring, and obviously, some women with PCOS get no period at all, or they get one very, very infrequently, and this gives them a much better understanding of what’s going on, with the level of progesterone. As I said, that’s the key thing. Progesterone is the hormone that is released as ovulation is happening, and that’s the key thing that we’re looking for, so that raise in progesterone that’s indicative of ovulation is what we’re able to see, and we’re able to see it in advance in the cycle. That’s the key difference.
Amy Medling: It is advanced in the cycle, yeah. What is the accuracy of the monitor?
Rob Milnes: We do two things. We predict ovulation in advance, as I said. The accuracy of that is 89%, and the sensitivity of that is also 89%, and that’s for the days in advance of the ovulation occurring. The accuracy for detecting the exact date of ovulation, which happens afterwards, is 99%. The key difference for predicting is when we tell you we’ve got a result, so in those 89% of cycles where we say, “You’re going to ovulate tomorrow,” the positive predictive value, the accuracy of that result that you’re given, is 96%, so it’s very accurate when it’s telling you it’s predicting in advance. The algorithm-
Amy Medling: Oh, go ahead.
Rob Milnes: Yeah, sorry. The key thing about that is we deliberately designed the algorithm to tell you only when we’re certain, or as certain as we can be, that ovulation is going to happen. Which means you may not get a prediction, but it’s better that you don’t get a false positive, in our view, so we’ve deliberately designed the algorithm, in that way. We could tell you much more often that we think it’s likely to happen, but we don’t want to get it wrong.
Amy Medling: Yeah. You know, it’s just I think that gosh, if I had this device when I was trying to figure out what was going on with my cycles, even before I was diagnosed with PCOS, ’cause it took me almost 12 years to get a diagnosis, it just gives you so much control, and kind of power, so that you could then take the data, right, from, you know, you’re recording a couple cycles, to your clinician, and you can actually show them, so it sort of takes a lot of that guesswork out of, “Gosh, did I ovulate? When did I ovulate?”
Even with, you know, at the time, I was using the Creighton model, which is it’s using observation, and I think it’s really difficult for women with PCOS to use that method, because of kind of the low-level progesterone that we often have, and it kind of causes a lot of, I think, misreading. It is such a powerful tool, to be able to say 90% accuracy, 99% accuracy, that you did or did not ovulate during that cycle.
I’m wondering, with the data that you’ve had, with the Ovusense monitor now being out on market for a couple years, and you have been working with women with PCOS who have been using it. Have you noticed any interesting things around women with PCOS and their cycles? Are they ovulating later in the cycle? Do you have any data on what’s going on with those women with PCOS that are using the monitor?
Rob Milnes: Yes, absolutely, and in a sense, this is the most exciting thing about the product, and the most exciting development that we have. We’re going to carry out an epidemiological study later this year that we’re going to ask users to be involved with which will look at all of the data that we have.
Amy Medling: Oh, cool.
Rob Milnes: We’ve noticed a number of cycle characteristics which we believe would be helpful in assisting clinicians to diagnose PCOS, and for those women who haven’t got a diagnosis yet. Really, that’s all about what happens to progesterone, what happens to their temperature, which is he representation of what’s happening to progesterone, in their cycles. Essentially, the traditional curve for ovulation, as your listeners will know, is your progesterone is relatively low, and then you get a rise over three to five days, a significant rise, usually. That stay relatively high, towards the end of the cycle, and if you have a period, essentially, it drops again. What we see with women with progesterone is at the beginning of some of their cycle, they have a high progesterone, and it comes to a low level.
At the end of some of their cycles, instead of that progesterone being sustained throughout the cycle, throughout the luteal phase, the end of the cycle, what we see is that dropping. We believe these are indications both an ability to diagnose PCOS, but also an indication, potentially, if you’ve got luteal phase insufficiency, or a short luteal phase, where you need some kind of support for your cycle in order to successfully both conceive, and also continue to carry the plastids, and it becomes the embryo that becomes the fetus. We hope to publish on that the beginning of next year, but that’s a very exciting development, and something we can already help our users to understand, as they go through their cycles.
Amy Medling: You know what I’ve found really interesting? In my PCOS Diva community, there’s a lot of women using the Ovusense monitors, and many have been able to get pregnant as a result of being able to better predict ovulation. Now that they’re having their babies, they’re starting to use the Ovusense monitor as kind of a, and I know that you can’t market it as a birth control device, but if you can sort of avoid getting back on hormones, because so many of us really have a problem taking the birth control pill, because it just messes with our moods and our insulin, and it just makes us feel bad. If you can use kind of this non-hormonal way of managing your fertility, whether you’re looking to try to conceive, or avoiding pregnancy, it’s just such a powerful tool. I didn’t know if you are aware that there are women using it in that way.
Rob Milnes: Sure. I think the key thing there is we are not necessarily just about helping you to get pregnant. The product is very much about giving you the information you need to manage your condition, if you have PCOS or if you have some other condition that means that you can’t conceive. Understanding what’s happening to your body is a really key thing to getting back in control, as we were saying earlier, and in addition to that, if you then get put on any kind of medication, Ovusense helps you track that medication as well, and we have I would guess it’s something like 40% of the users are, at some point, are on some kind of medication, so obviously, the women who have PCOS will be likely to be on Metformin, and if they’re being stimulated with Letrozole or Clomid, then they’ll be able to see the effect of that as well. A lot of women also have, as you know, thyroid problems, so they take Thyroxin, and again, the control over the cycle and the understanding of what the Thyroxin is doing is very important, in that regard.
Amy Medling: Yeah, and also, lifestyle change and supplements, like Ovasitol, which is a combination myo-inositol, D-chiro-inositol supplement that I’ve talked a lot about, and you can actually see your cycle improve often on the Ovusense monitor after taking some of these supplements like Ovasitol, and N-Acetyl Cysteine and other supplements that I’m talking about on PCOS Diva. Then, you kind of see that the proof is in the pudding, so to speak. You can see how these supplements and pharmaceuticals are impacting your cycle and your health.
For those of you that are listening that may have purchased sort of your first prototype kind of Ovusense monitor, things have changed, and you alluded to it in the beginning of the podcast that now you have an app, and it’s kind of this smart app, and the sensor, but how has the pricing structure and all of that changed from the first phase of the product?
Rob Milnes: Sure. The first product cost a lot to manufacture, and therefore cost a lot to buy as well, for a user. Obviously, we have to pass on the costs, and also make money in order to manufacture it. It was relatively high, so it started out at around $500 and came down to about $399 dollars. The new product, essentially the starter pack, is the thing that you need to get going, and you get 30 days free subscription with that and a sensor and a reader device, if you need it. That costs $99, and then each month of subscription costs you $35, but you can get a significant discount by ordering an annual subscription, so the total price for you, if you’re going to use it for a long period of time, comes down significantly compared with the previous product.
Amy Medling: Then, now, what if somebody gets pregnant, and discontinues the subscription? Is it something you can start up again?
Rob Milnes: Yes. We have two options for the subscription. The first one is just monthly. A lot of users use that. As I said, that’s $35, so you can start and stop at any time, and quite interesting, we’re seeing quite a lots of people who will use it, say, for one, two months, then they’ll have a month’s rest, or then they go off and do IVF for a month, and they then stop using Ovusense, but then they’ll come back again. That’s quite a common usage, and about 65 to 70 percent of our users use it on a monthly basis. Then, if you want an annual subscription, that costs you $210, so it’s about half-price, if you were going to use it for a full 12 months.
Amy Medling: I was just thinking. I was wondering if you could share any success stories with us with women, specifically, with PCOS. Do you have any that sort of come to mind?
Rob Milnes: Well, we have a lot, as you told already. I think the key thing is that each month that we continue, we find around 20% of women are getting pregnant, and as you know, a significant number of our users do have PCOS. We have a lady called Kirsten. There’s a very nice video of her, who had other diagnoses as well as PCOS, and she got pregnant within two months of using Ovusense, and said it was very much about her understanding that she was ovulating like in her cycle.
We have other users who have used your supplements, and your, one of your programs, and that particular lady had, it was very interesting. She had a completely flat cycle, essentially showing that she was anovulatory before she started your program. She then took the supplements, and went through your program. Was able to see, obviously, her cycle recovering, really, in terms of ovulation, and she then got pregnant as a result of using the two things combined, so as we said earlier, it’s a pretty useful thing for doing that.
Amy Medling: Yeah, and I think it’s really great to be able to show your doctor, because they speak sort of in test studies and statistics. When you kind of think, “Gosh, I’m thinking about trying this supplement,” but and they might roll their eyes, but when you come back with the actual data on your Ovusense app, you really can’t refute that. I just think that it’s just really cool.
Rob Milnes: Yeah, and I’d say as well in Ovasitol, inositol, and the various forms of that are gaining significant traction in the clinical community as well, I’d say. I was recently at the European Society of Human Reproductive Endocrinology, and there were papers there on inositol and its use for fertility management, so I absolutely believe it’s going to become more common.
Amy Medling: That’s great to hear, because I was out, I’m trying to think what year it was, 2015, 14, 15, at the American Association of Reproductive Medicine. I actually went up to, I won’t name names, but one of the prominent PCOS researchers, and kind of brought a bunch of, you know, I’m a Diva, so I had all of my print-outs of studies, and brought it up to him and said, “You know, how come nobody’s talking about inositols on this stage?” He sort of poo-pooed me and said, “You know, there’s nothing that’s going to help as much as the pharmaceuticals,” and just wasn’t even willing to speak to it.
It’s good to hear that it’s gaining some traction, because I’m a big supporter of natural ways of managing your fertility and PCOS, and Ovusense, that’s why I’m a big champion of Ovusense, because I think it really is aligned with what I’m trying to share with women with PCOS, and I’m seeing, hearing and seeing, the success stories as well through my community. I’m just so glad that you came on the podcast, Rob, and gave us some more information.
Rob Milnes: Yeah, my pleasure.
Amy Medling: If somebody is interested in trying the monitor, how can they order it, and where can they find the app?
Rob Milnes: Sure. Very important to us is first of all, we educate you about what Ovusense does, so we have a lot of detail, but relatively easy to read information on our website. That’s W-W-W dot Ovusense dot com, O-V-U-S-E-N-S-E. The website is available in all English-speaking countries around the world, basically, so in the US, it will automatically redirect you to our US site, but it’s all the same information on all the sites. Then, we have a store on there, so in the top menu, there’s a store, and when you click on that store, if you want to buy Ovusense this month, there is a special code, which allows you 25% discount. You put that in, during the cart process. That code is diva, D-I-V-A-2-0-1-9, so DIVA2019.
Amy Medling: Can you get that throughout all countries?
Rob Milnes: Sure. That code is applicable on all our sites.
Amy Medling: Okay, and you ship all over the world?
Rob Milnes: We do. Basically, all English-speaking countries around the world, at the moment. Sorry, primary English-speaking countries, so US, Canada, New Zealand, Australia, UK, Ireland, and then you can purchase it in other countries, as well.
Amy Medling: Okay. Well, great. Well, thank you so much, Rob. I really appreciate you taking the time to share this really valuable tool.
Rob Milnes: Thank you, Amy. The pleasure’s mine.
Amy Medling: All right, so yeah, that wraps up our podcast today. Thank you so much for listening and joining us. I hope you enjoyed it. If you liked this episode, please subscribe to PCOS Diva on iTunes, or wherever else you may be listening to the show, and if you have a minute, please leave me a quick review on iTunes. I love to hear from you. If you have somebody that might benefit from this free podcast, please take a minute to share it with your family or friends so that she can benefit from it too. Don’t forget to sign up for my free newsletter. It goes out once a week with lots of new, cutting edge information about PCOS, so just enter your email on PCOSDiva.com to make sure that you never miss a future issue. This is Amy Medling wishing you good health. I look forward to being with you again soon. Bye-bye.