Cycle Breakers: How Belle Health's Smart Ring is Transforming Women's Health

Victoria: I would say it's probably really the marriage between those two backgrounds and bringing all, the different opportunities together of what can we do.

We really started with the problem in the end of and they're focused in on one health condition that we decided to start on working with, which is premenstrual symptoms or pre-menstrual dysphoric disorder, which is a very severe version of. Symptoms that only occur before the period. but that can lead to our extreme suicidality and like many symptoms.

And then. During follicular phase. So, like after the period, the symptoms just disappear. And we realized, and that was something that came over from my side, that there's literally no treatment. Nobody's talking about it, but around 90% of women are affected by some sort of pre-menstrual symptoms.

20 to 30% by symptoms that are so severe that they should be treated medically speaking. And with that, I came to Rapid where think, okay, what can we do? Where can we bring data in? How can we develop like therapies? For that and develop like first a psychological approach. We were like, okay, but now to get like more specific data of where is somebody in their cycle, how is the cycle varying?

We need more of this physiological data that we get via hardware and where we need the electronics part. And that's where you ref came, into the whole conversation of saying, what solutions can we develop for this?

Rafael: Probably at the beginning, like Victoria was like really trying to.

Even convince and, showing the pain because as a man, like you not necessarily know about all those conditions and all the, implications that the hormonal filtration occur on the female body. Because we do have variations on testosterone, but not I. As much on oestrogen and progesterone. So, even understanding that it is a problem.

It is something that have a lot of pain related to it and symptoms. And then of course like, okay, let's build something that it's. Medically scientifically relevant, especially on female health, that there is a lot of pseudoscience. So yeah, it was based on science that Viki convinced me to join.

Ruth: Something that pops up on YouTube ever once so often is, like a pain simulator.

I don't know if you know about this. There's like a device that simulates the pain. Some women go through every month, and it was tested on, I think, I don't know, some policemen from Texas as a video. I know. At a convention that like a booth and every guy that came along could see and how high on the scale he got was from one to 10.

And then the woman would say, for me an eight is normal. And he would already start crying at level four. So that was an interesting concept to, make, yeah. Men understand what some women go through. Yeah.

Victoria: That one was interesting because I think we just came across it maybe two weeks ago.

And realized that it's a very old trend that we completely missed. Yeah. And then I showed it to you, Rafa, as well, like on. Understand. It's very interesting because I think that's already a visualizing One of the aspects of like physical pain that especially, for example, women with endometriosis experience very strongly, and which I think was already a little bit earlier, also recognized that are like different companies that are working on solutions like for those areas.

And then I think now the, next, I would say fem tech, start with fertility. Then it got into menopause, like some solutions for endometriosis, which is the severe period pain in like from, one of the symptoms. And I think now there's Going to be like also a next wave where a lot of it is about understanding female health as hormonal health.

And how do health conditions in general change, like not only those typical gynaecological conditions, but how do health conditions vary in biological women to biological men because of those differences in hormones. And that can be even diseases that we would normally talk about.

Like diabetes. Like diabetes type one. Glucose fluctuations change across the menstrual cycle. Insulin resistance changes, so actually how medications should be applied across the menstrual cycle.

Should also change for a lot of conditions so that we don't think about female health necessarily as this one category, but it's more that it applies to every single area of the body.

So, every single area of medicine is impacted with that and for every single area, we will also need then that type of data. And that's the same for the devices that we use, that we need to include that type of data collection that is specifically for women then and bring this perspective of female first into the products that we do so that we can deliver like a better value for women as well.

Ruth: Most of all the hardware and even the pharmaceuticals, the treatments are usually, as I understand it, and you must correct me if I'm wrong, are only tested on men. And that doesn't cater forth to the fact that women's bodies are just not physically but also like from their components and from the way they take in treatment.

Completely different.

Rafael: So, from 1993 onwards, it was all the clinical trials. It was like a rule that it needed to have, like every new drug development would need to have a female cohort. But before that, all medication that we have available. It was not necessary to have a female cohort.

Victoria: It still doesn't consider like the variations of the cycle, right? And not, there's still a lot of limitations. So, for example, for pregnant woman and then yes, you do have like dangerous effects, but then if you use those things like down pregnancy as well, then you also need to test it. Like as simple as that.

So it's like there's still like a lot of limitations and I think there are in certain areas like maybe some steps back, but there's also like a lot of, especially in Europe, I think like a lot of willingness and in Germany when we see a lot of interest from our political side, from like health insurance side, from systematic partner side, to actually start to conversations about those topics to see like how can we even get the data.

That is lacking right now.

Ruth: 1993. This is not long ago. It is scary. And that's something that I, used to never think about it for some naive reason. I always thought that it would've been tested on women as well. I was really shocked to learn that it's not like What? Thank you. Yeah. yeah. Yeah, it is quite shocking and not well known.

And then with, PMS and PMDD, I think it's also. Maybe you can elaborate a little bit on that. What the real problem is, it's not only in quotation marks pain, but as you said, it's also fatal consequences because some symptoms are, I think, severe depressions that can lead to suicide and not understanding the hormonal consequences can lead to severe medical conditions.

So just to give our listeners a little bit of context, maybe you can. Summarize that from your standpoint as well.

Victoria: For example, if you're PMDD, which is like this most severe version, it stands for pre-menstrual dysphoric disorder. And it affects around five to 8% of women in reproductive age.

So, if, one of our listeners knows around 20 women, one of them is very likely going to have this condition. And what it means is a very severe depression that only is apart for one to two weeks before the period. Then it completely disappears again and then it returns as soon as ovulation occurred.

That every single month again and again, and many of them are just misdiagnosed with a depression or bipolar disease or anger management or like many, other things that are not recognizing the impact that those hormonal changes in the cycle have. So, they can also not be treated properly and not get the care.

Just to put up like one number here, there like studies that show that. Around 76% of women with PMDD have suicidal ideation and 35% have attempted suicide. Like not thinking about suicide, not having a suicidal plan, but have attempted suicide during their lifetime. So that's like really the group that has.

Really at risk in the end, and we're not recognizing how much this is tight to the cycle. It's also in the end like the population of women who are in prison. We have like higher numbers of them who are impacted by that because it leads to a lot of consequences on society. And the more research we'll do on that will also understand even the impact that it has on relationships and like work and how that impacts not only the women who are affected, but as a society.

Ruth: It really is quite astonishing. Once you make the effort to really understand this, what is the solution you are now working on? What does your product try to solve? Can you walk us through what you have developed?

Victoria: Our product right now consists really of two parts.

We have the app which provides, first, like symptom tracking correlations to the menstrual cycle because the first step is if we need to recognize that those symptoms are tied to our certain pattern. With that, we include a lot of different psychological therapy approaches inside the app.

That's like where the evidence base comes in from what is evidence based for giving recommendations of what lifestyle changes can be done, what like therapy concepts and psychology can be applied to improve. Conditions of that, but then also What are potential treatment options?

Because it really varies based on the person, on whether a medication route is better or whether like a therapy would be like the better route to go. And that's all included in our app. And for that, we've also already finished our first clinical trial to proof effectiveness for this first health condition.

And then the second part that goes into this concept is the Belle Smart Ring. Which will track like a variety of physiological variables. And again, look at this like how do those changes of the menstrual cycle that we can, and determine way more specifically by knowing did a woman ovulate?

Did she not ovulate the changes, the hormonal patterns from that. Like how did, like the heart rate variable to change, like a lot of those patterns that like we know that change across the menstrual cycle and where we have like more like from that veer, like our own custom smart ring. That integrates into that, and with that gives more specific and better recommendations as well as showing how much like the exercises at one moment can even help.

It really works together to bring like this system that's digital with psychological. Like inputs together with a physiological system, that we're developing and with the goal to really start with a first version of that and then build on top of that to bring the most accurate data analysis to that female body.

And we really see that as starting with PMDD and PMS, but then like also right now, for example, already around 40% of our users. Of our app have ADHD as well, which is one of those conditions where we know that it changes significantly across the menstrual cycle, which is also one of the reasons why it wasn't really recognized properly in the past in women.

And making those changes visible. And with that, using that data that we are collecting to really give better recommendations and predictions and potentially in future use cases, also enhance the diagnostic process.

Rafael: Also like the difference between currently our society historically are addressing like in a temporal way of 24 hours, seven days, like weekly or monthly.

Or than yearly. But when we investigate the. The female biology, it makes so much more sense to have a menstrual cycle length that you analyse your patterns and your data based on that flexibility of sometimes 28, 32, and so on, so forth. So, to analyse those data points based on a menstrual cycle.

Timeframe and not necessarily on a daily timeframe. And then that is, we see as a big root cause of mis diagnostic for ADHD or female ADHD. Because basically you don't take into consideration that, where that individual is on her menstrual cycle. And the symptoms that like vary depending on if she's on luteal or follicular face.

Ruth: Interesting. And so, you're using the hardware angle to collect the data to then prove or to make it visible, basically the data you're collecting. So, there are, I suppose there are lots of sensors in your ring. What data are you collecting or which sensors are on board?

Rafael: Initially we want to map with state-of-the-art technology because today's so well known, wearable devices, apple Watch, garbing, like all of those with state-of-the-art sensors such as heart rate, temperature, activity, monitoring, and those are very standard and used on validated into, the market.

Right now, as a first iteration. We use those sensors to map the difference between what we know about general population slash default male, to really see, okay, what is the difference within those metrics at the female body? And of course, ideally what we aim for is to have a constant measurement of progesterone and oestrogen and be able to plot that graph and correlate how high your oestrogen or how high your pro progesterone.

Are, and then the effect of that with your symptoms. But that technology, it's not ready yet. Those ics, those integrated circuits for measuring those are not, there is like studies, for example, at Cambridge with meter infrared, laser for a skin, sweat, like localized sweat. But that it's only validated within labs and not available to the public.

Ruth: How are you measuring those levels?

Rafael: Right now, we don't, we create that platform which basically uses the state-of-the-art technology that today every wearable uses, or the better ones use to really differentiate to a female solution.

Victoria: And a lot of the magic comes at the stage from the data interpretation and the data algorithms.

And there is so much potential of things that are not done at all yet where we have. Enough indications from small research trials, but then what is a research trial when you have 100 people and not like on a bigger scale, really using that even for like applications for that. So just to give one example, heart rate variability varies across the menstrual cycle.

That's not used like for that purpose at all anywhere right now. Okay. Right now, temperature. Sensors are used to do like a prediction of the period length at like this state, but for some heart rate variability is like just ignored. And then there are even more studies that show, for example, for one specific use case as PMDD heart rate variability might vary between women who have it and who don't have it.

Again, it's segment use and that's really something that for accuracy it is like going condition by condition and segmenting like different women because just because it's female health doesn't mean it's the same exact same use case for everybody because body still vary a lot, but really honing in on like those different ones and then providing specific value from that data that we are collecting.

Rafael: I think society for long. Face female health as reproductive health and being like, okay, the female body is something just to reproduce, which, and then we want, and that's very bad. We want to really like, okay, how can we face the female body as. Ethe body that needs to live better and with better quality of life.

And then for that, addressing endometriosis, PMS, and end perimenopause with all those symptoms. And then mapping like the type of variability on those measurements for those individuals.

Ruth: And once this sensing data hits the cloud, how do you translate this into actionable feedback?

Rafael: One example, it's very like, that is a tangible example is like, Let's say you have PMDD, so you have a severe depression before your period, and we are measuring your heart rate frequency, your stress movements, and we identify that you are on your face, on your critical face, and you are with an elevated heart rate, elevated stress. We can ping you a notification to, okay, calm down, let's.

Maybe do one of your favourite CBT exercises. Let's say progressive muscle relaxation or art meditation. Something that I, really is like just going through an art and then pushing your mind out of whatever you are doing. And we can have the biofeedback of before that activity and after that activity.

It's acute to that moment that you need the most. Or for example, you are feeling suicidal. Which is something that unfortunately we see more and more on our social media, people mentioning that they feel suicidal before their period. So, at those moments you would measure very high stress levels, very, high heart rate frequency.

It's something that we could. At that point be at their side and recommend something as well. As of course, we do have a SOS feature within the app to, if you are feeling that, that way, please just call your emergency local emergency, and then you have a professional to take care of.

Ruth: I can imagine that at one point along the roadmap, it would be really cool if you bring everyone together, if you can, then from app users that can then get professionals psychological or psychiatric help, or that you can be referred to your doctor or that you can share the data and help your medical professional with a diagnosis.

And so that's basically the goal you have, right? Yeah, that's exactly the goal.

Rafael: The average diagnostic delay is 12 years for PMDD Wow. Version of PMS. Okay. Why that happened? Because it needs to be so severe and the person, it's so, low on that difference between post period and after period that the person really Tried maybe suicidal a few times, and then the family members or herself in a different moment, okay, I need to take care of it. And then convince a general practitioner to take a look. And many of the doctors they don't even know about, or it's not very well known, PMDD, by measuring those biomarkers, by having that as a digital health.

Constantly with that user, you can probably reduce those 12 years, and our goal is to not have 12 years, like maybe a few months, only to identify if that person has like that degree of difference between symptoms in one phase and the other, and then not allow that patient to have those very severe symptoms to then have help.

Ruth: You're based in Germany, but your solution targets the European market. How do you tackle all the different regulations and is there like a European-wide health standard, or does every country have its own regulations?

Victoria: Actually, Europe is fine because it's literally one standard. It's like the medical device IES framework.

I think it's like way more I think for us, we are also looking into the American market as well, because even in like in, in the American market, which is usually a little bit earlier on the innovation side, there's literally nothing. And many of our users are also coming from the US currently already.

That's like those two frameworks that we are focusing on first. And where we see also that there's yeah, like a maybe enough awareness because the prevalence is like clear. Then it depends a little bit on where people are, based on whether they even know like about it and whether they will recognize things early enough or at what stage.

We really enter in like their, journey because for some we'll be able, as VE just said, like to. Really reduce like the time of like diagnostics to two, three months instead of like years and years of waiting. But many of them waited or really for a long time. But then for others it will also be this.

What is like the right treatment for me? Because currently even for like many, other use cases beyond MDD, it would be like, okay, try this Hormone, hormonal contraceptive. those like side effects are not that great. Then go for like the next one. And then it's like this really, like this trial-and-error phase.

And wait, it's like ours. Really like a lack of a data-based approach to understand what is working better, like what is the impact. Because often in like this area, whether it's antidepressants, whether it's like hormonal contraceptives, whether it's like psychological therapy piece, whether it's like supplements that are like, probably like the least evidence-based, but it's like it's not this one perfect solution that works.

Just for everybody in the same way. So, a lot of this approach. Will need to be also data based and like in a trend error. But the more you can reduce like this time to really know, okay, this is like working better, this is working worse. And even bringing this data together and aggregating that from a lot of users will do like a big difference in the future for being able to figure out like what makes really sense like for those areas and like for the conditions people are really experiencing.

Rafael: In Europe there is the medical device regulation, the call MDR, within Europe. And that really eases deployment of medical devices within the Euro zone. But also, one of the things that I, really would like to mention here is that it's within the core of what we build is that digital component.

The fact of being digital and having that digital companion to with you, you can target populations on. Remote places or countries where they don't necessarily have access to health. And that is something that it's very, like for us, it's very important. For example, let's say you only have a phone in the middle of Africa.

If you have access to internet, you download our app and, then you can use it to literally follow you along with your menstrual cycle. So of course, once you have that data. They are within; we have medical reports That you can export from your phone to then Okay. Bring to your doctor and say, Hey, that's my patterns here.

It's saying that I have something like PMDD maybe probably for the person will not even know what it is, and then the doctor can then actually give the appropriate guidance.

Ruth: That is cool. Also, in areas where there's probably not, a medical professional around for, in rural areas, I imagine it'll be like a radius of 200 kilometres at least.

If you're lucky, Interesting.

Rafael: And with that, even for example, in rural areas, normally the professions, the medical professions on those areas. For example, Victoria can have like her testimony here, not that long ago, Victoria was like studying at Cambridge and there the knowledge around female health conditions or female variations are not necessarily the most relevant or the most.

Taught on university. So sometimes you have like maybe a rural area with a very old professional that doesn't necessarily know those terms or those conditions or not, or it's very far from the cotedian. Okay. So even giving that to the doctor of Hey, here you have something on your patient that it might not be something that you are used to diagnosed, but here we have a likelihood score that patient.

Probably has that PMDD or endometrial or PCOS.

Victoria: Actually, very often the knowledge is also lacking. And the data, like the data in medicine. And then also coming from a medical background, I not even judge it sometimes too harshly because there's a lot of different stuff that you will need to know, and it's very complicated and we like to simplify it also.

And then you'll forget like a lot that you're learn like at some point. But right now, I think the status quo in medicine is that. We lack a lot of data, and we lack a lot of knowledge of how the female body varies. And it's something that you said at the beginning that a lot of like pharmaceuticals were for a very long time, not studied at all on the female body and their justification, the reasoning for that was, like the female body changes across the menstrual cycle, that's too complex, so the data will vary too much.

Data will not be that good, so we will not use it. And then, okay, let's go back a little bit in time. Like fair enough, it was more difficult to do data analysis and interpretation back in the days, but right now we live in like an age where we have really personalized treatments for a lot of areas and we believe that's also the time to have that for the whole area of like medicine that impacts women and the impacts moment and what Rafa said about that being even more the case in rural areas For sure.

But not only it's like across the board that we are like lacking that and like this knowledge and understanding of recognizing diseases in the right way. And we start with for us, like in one focus area so that we can really make the biggest impact there. But then in the end, heart diseases are also not recognized properly in women.

If a woman has a heart attack and goes. To the hospital. She's way more likely going to be sent away and told that she's just making up the pain that she's experiencing. Also, symptoms show up a little bit differently, so we don't learn about those because we learn like the typical symptoms of a pain, like your shoulder and your jaw and like then.

It's symptoms that men experience. And yes, men are more typically affected by heart attacks. But then women are not recognized to be treated properly. And that's something where there we see like a little bit of change in like certain areas and like certain conditions where we get more data.

And we need that in just way more. And I personally really believe, or like at least hope that we are going to look back in, let's say 10 max, like 20 years, we're going to say “Crazy”. Like back in the days, those days, it was like in the stone age. Like they were like not doing any of this.

Can you imagine living in this time when they would just not know about this and not consider that your biomarkers change and that we would need to consider that time variable. To make more accurate predictions or when we say what the medication will get, that we didn't have any of that personalization that must have led to way worse outcomes back then.

It's like my hope that at some point we'll look back like this and that we'll even laugh about like how we used to do it.

Ruth: That's, a great vision. So, in five years’ time, or maybe 10 years, what would success look like for you for Belle Health and how can listeners or even potential partners get involved Right now?

Rafael: I think our society right now, it's developing AI. It's on everybody's mind and machine learning algorithms, the capability of digitally compare one data point to millions of data sets. It's not even the future; it's the reality right now. So, in five years’ time, having the possibility of.

Translating a physiological body, which is like then our like vision of that single individual and being able to compare to those data sets to really screen automatize screen of who's this person, what she's experienced, how can we improve her quality of life? That I think it's the future and we are working for that.

Victoria: Maybe to add to that, I also feel like our goal in five years is to reach the maximum amount of women to make the biggest difference also like in the end, in, in their lives. And for the information that we can like provide and the same time collect in some way, like a very comprehensive data sets that for users that opt in enough course, that we can use that long term, unlike the research side, so that we have a better understanding and.

In many ways, that also would mean that we start to set a new standard so that from a company perspective, that we're the first to strongly go into that. But then in maybe five years, a lot of other companies will also have joined us like on this journey of saying I. To give me like a very random example of we've been developing our notifications feature for our app and our users of for feedback for like our, initial design drafts.

And then some user said, and I felt so embarrassed at that moment of Hey, I need to take my medications cycle based, so I only need to take it in certain cycle days and not on others. And. We, I would need to have a feature that is like adaptable for that. And I was like there, and I was like, why did I just develop like a feature that's just based on the week and then like on the days on, so Monday, Tuesday, Wednesday, that you can choose which days.

And not thinking about like those changes. And I think that's like an, like a very concrete example where that applies to this one individual feature. I think the goal in five years is that every single part of the process and what we are developing, we are thinking through. Newly of what would it mean if this would be developed for the first time for the users that are only female?

What difference does that make at this point and set a new standard deadline like this area so that like when people go like into like application, there are like more changes because we can do that and use like this data to give more personalized experiences. So that those for women also become more accurate for them.

Ruth: And I do have to ask you what drew you to, participate in the Advanced Electronics Challenge? It is a very technical engineer focused, hardware-based competition. were there any takeaways? What did you learn? What did you like about the challenge? Why did you do it?

Rafael: The first why is that I come from engineering and my class of engineering was 200 guys, like male individuals.

And with that it's the amount of technology that is the developed all AI and everything that it's advanced historically was built from mail to mail. And why not take the. Technical approach to something that it's not necessarily the status quo to really bring. And as I mentioned at the beginning, unfortunately a lot of the female health companies and efforts that we see, they lack on scientific evidence and being really a reliable, scientifically fought through.

Advanced electronics let's say.

Basically, like by using that and having, access to experts with Renesas Silica to really boost and bring the best on the market right now to that population. So that's mainly the why we work on it.

Victoria: I think what we are trying to do involves a lot of expertise and knowledge and it's difficult and there's, we in the end, like the change that we want to create from like in individual product development to like really the big change of the company we want to be build and the change we want to make in the world.

We cannot do that alone. We do need supporters and we, need people who are like equally excited or not excited yet, but are thinking about us like, hey, yeah, like this wasn't like done like this yet. Like that’s like something that has a lot of potential of impact on people and this an interesting challenge.

We need all those different types of collaborations and partnerships and supporters to. Create this to have a village to create like something that was not there yet, like for women. And I think that's really like what the Advanced Electronics Challenge was also for us. Like the support to really go ahead, like on this journey that we're working on, creating something that is also technically challenging, but to really make their, like the biggest difference that we can do alone.

Ruth: Absolutely terrific. Victoria, Rafael, it has been an absolute pleasure having you on the show. It was super interesting to learn about the differences in medicine and physiology and the product you have built around it and the effort you're putting into. Getting the message out. I hope this podcast will help on this journey, and we will put all the information about Belle Health in the show notes so that if maybe potential partners, supporters, researchers, whatever you need, can reach out to you.

I wish you all the best, and I hope to have you again on the podcast and talk more about the journey you had. In the future.

Victoria: Thanks so much for having us.

Rafael: Thank you very much.