In this episode, we’re joined by Emilė Radytė, Co-Founder and CEO of Samphire Neuroscience – a London-based women’s health company focused on bringing evidence-based solutions to neglected areas of women’s health (can we get a whoop whoop?). Here we dive into the science behind The Samphire Headband device, a neurotechnology-based headband that addresses menstrual symptoms, and the mind-blowing data showing success from trials so far.
They were right: it IS all in your head.
PMS and PMDD actually starts with the brain, so why aren't we focusing on it more?
Well, someone named Emilė Radytė is.
There are over 130 different symptoms that are recognized with premenstrual syndrome (PMS). Some experience cognitive and physical symptoms that can cause a real interference with daily life. These should not be dismissed.
In this episode, we dive into this revolutionary science with our brilliant guest Emilė Radytė. Em is the co-founder and CEO of Samphire Neuroscience, the innovative company behind this upcoming, wearable device. She has an undergrad in neuroscience and social anthropology from Harvard, as well as a Master degree in neuroscience from Oxford.
It's called the Samphire Headband and it's the first medical device designated for treating PMS. The fascinating technology behind it has shown to seamlessly reduce pain, PMS, and PMDD symptoms by wearing it for 20 minutes at a time.
We discuss:
Lastly, we end on a high note in the making! This is the perfect app for your next hot girl walk.
Thanks for listening, learning, and being you. And join us back here every Tuesday for all things uterus, in service to you, uterinekind.
__________
Shownotes:
Learn more about the Samphire Headband and join the waitlist to get early access and $200 off the standard price: www.samphireneuro.com
Massachusetts Participants for Study on Endo: www.umass.edu/news/article/volunteers-needed-new-study-endometriosis
Carol:
PMS, something we've all been expected to suck up forever. But what if you could wear a headband for 20 minutes and painful periods are reduced to just normal, regular garden variety periods? I'm Carol Johnson and this is Hello Uterus. Thanks for watching! Today's guest, M. Radite, the co-founder of Samphire Neuroscience, is coming for your PMS and our guest is you're ready to hand it over to her. But first, uterus in the news. An endometriosis study alert for those in Massachusetts. Researchers at UMass School of Public Health and Health Sciences are looking for participants for their study to learn about barriers experienced by women of color related to endometriosis diagnosis. Eligible participants will be 18 years old and older, self-identify as a person of color, have been diagnosed with endometriosis in Massachusetts and are willing to have their interview audio recorded. Participants will engage in a 60-minute interview, which can be conducted via Zoom or over the phone to discuss their experience receiving an endometriosis diagnosis, and participants will be compensated. So for more information about this study, please contact the study staff directly at endostudy at umass.edu. Endostudy at umass, U-M-A-S-S dot E-D-U. It's so important that we support these studies. So I know this is like a slightly targeted uterus in the news segment, but if you know somebody in Massachusetts who's a person of color who's been diagnosed with endometriosis, please call them and ask them to email this study team because without the participation, without participants, we don't have study data and we need that. We really need that. A new study shows that estrogen as both catalyst and cause of cancer. A new study shows that estrogen is a more powerful breast cancer culprit than originally thought. I pulled those three words directly from the article because those three words scare the, scare the whatever's out of me than originally thought, like whoops. You know, but we kind of. Don't we kind of know this? We talk about this a lot on heliuteris about the effects of endocrine disrupting chemicals on the body and the fact that we know so little about the female system as it is that to think that, you know, we know the effect, the cumulative effect of exposure to endocrine disrupting chemicals, we don't. And also we don't even know like how the system itself works. So we just have a lot of work to do. And that's why This is so fantastic because better late than never, right? This study was conducted by researchers at Harvard Medical School, and they found that estrogen can directly cause tumor-driving genomic rearrangements in breast cells. This means that estrogen is not just a fuel for cancer growth, but can also directly cause cancer cells to develop by this alteration in the cell itself. The findings suggest that estrogen-suppressing drugs, such as tamoxifen, may be more effective at preventing breast cancer recurrence than previously expected, and that's another great thing that comes from research. This research is so powerful and you know where our heads go here at UterineKind because it may also lead to understanding the effects of endocrine disrupting chemicals that mimic estrogen. So now that we know that estrogen can both fuel cancer growth and cause cancer, what impact is caused by the cumulative exposure to endocrine disrupting chemicals in the products that we use and in our environment? And when we can show if it exists a direct causal link that the endocrine disrupting chemicals are contributing directly to the cause of disease, which is a very tragic thing to discover in research, we then have a foundation from which to force the industry to stop using these chemicals. It's been a slow, painful, two steps forward, 600 steps backwards to get the EPA to regulate the petrochemical industry. And so any research that we have on the foundational understanding of the female body, and then we can build upon that and show these direct causal links, it's very important. Very important. One of our missions at UterineKind is to keep you informed on research and innovation, because it's research and innovation that will keep us healthy. Healthy means pain-free, but for millions living with painful periods or dysmenorrhea, that pain-free state often involves a complicated regimen of pain meds, heating pads, tub soaks, fetal position. some emotional outbursts, missing out on school, career, fun times, right? Just from painful periods. M. Radite, the co-founder of Samfire Neuroscience joins us after this quick break to give us a sneak peek at their technology which may enable some people to leave pain meds and hormonal treatments for PMS behind. And the coolest part, It's well, probably not the coolest part. The coolest part is the pain reduction, but I mean, I still can't help but get excited about, about this other fun aspect. It's got do it yourself fashion accessory opportunity written all over it. You'll know what I mean. And team Sapphire wants to see your design shops. They want your ideas. You could be an inaugural custom Sam fire designer. So don't go anywhere. We'll be right back.
Joining us today is Emily Redite, co-founder and CEO of Samfire Neuroscience. M has an undergrad in neuroscience and social anthropology from Harvard, as well as a master's in neuroscience from Oxford. She's currently pursuing a PhD in neuroscience at Oxford, while also because... you know, multitasking while also building Sanfire Neuroscience, the company launching the Sanfire Headband, a wearable device designed to treat symptoms of, I'm gonna loosely say, PMS, but we're gonna talk about this, and PMDD and others, I would imagine, other conditions. And by wearable, we mean hormone and drug-free, and the crowd goes wild for that. Thank you, Em, for being with us today on Hello, Uterus. I'm so excited to talk to you about this relative, it's not really new, we're gonna get into that too. This is a technology that's been around for a while, but it's new in terms of female health and just the attention that we're finally getting on female health is new and exciting. So welcome to Hello, Uterus and thank you for being here today.
Em:
Thanks for having me. Really excited to share more about our work.
Carol:
So why neuroscience? Take us back to that moment where you decided to pursue neuroscience, and then how did you find that super tiny small side door down some long academia hallway that says in tiny type women's health, and you decided to open that door and venture into the unknown. Can you take us back to that point in time?
Em:
Absolutely. And I like your framing because women's health still is a very small door. And a lot of our work and your work is in making those doors bigger and more visible and more exciting and enticing to future generations as well. But my path towards that door was not straightforward. I was born and raised in Lithuania. And in Lithuania, when I was growing up, neuroscience wasn't even a field. It wasn't something spoken about, didn't even think about it much. And then when I went to the States to Harvard for my undergraduate, I was actually very fascinated with biology. I was a biologist by training and actually worked as an emergency medic for over three years and eventually led Harvard's Emergency Medical Service. So it was very much more on the medical side of things. And then accidentally being dragged by a friend, ended up going to a couple of psychology classes. And I think that's the thing that really hit me. It was the interaction between biology and psychology and trying to understand how the hormones, how all the molecules in our body, how all the organs in our body at different hierarchical structures impact our experience and behavior as humans. Because I guess one of the things that I understood is that biology is a study of different systems at different levels and our behavior represents those cognitive constructs behind them. And I got really, really fascinated with the human brain. And so that led me to neuroscience and kind of as you explained in the introduction, I have been and spent most of my time working as a neuroscientist. And then just working in mental health and psychiatry, realized that there's aspects of brain that we don't really understand that well. And that happens to be especially true for women because they're especially difficult to study according to a lot of researchers because you must study them according to their cycles, whether that's the menstrual cycle, the menopausal cycle, the gestational cycle. And I just saw that there was this huge gap in literature where if we understood the brain. It usually meant we understood the male brain, a brain that is static, a brain that isn't responsive to too much hormonal change. And I got really excited about filling that gap. And our work is one of those steps in doing it, but I think there's so much more work to do for us to understand how women's health throughout their lifetimes affects their brain and affects their behavior as they go through those stages as well.
Carol:
So that's fascinating. I imagined, as you were describing that, I imagined male researchers running from the female brain and female researchers running toward it, which thank goodness, because obviously we can't assume... We're not small men. That's probably the fastest way to say it. We can't assume that what they experience is what the female body experiences as well. So... So you started down this path of bringing biology and then bringing neuroscience into the picture. Then what was the light bulb moment for you when you first keyed in on a wearable for PMS and we'll talk about the various flavors of PMS?
Em:
Yeah, that's a great question. Um, so I actually was studying noninvasive brain stimulation methods for the treatment of depression. Because increasingly as I was going down the whole of studying neuropsychiatry, I realized that I just couldn't get myself to believe that in 10 years time, we would treat depression just with drugs and therapy and try to find the right drug over time without taking any blood tests or any brain tests as we do now. And so I kind of just couldn't believe that psychiatry would just be that in the future. And I started really subscribing to the idea that in the future we will have much more personalized psychiatric treatments, but also ones that have multiple options available. So drugs and medications will definitely be part of it. Therapy will probably be part of it, but so will non-invasive brain stimulation technologies, as well as invasive brain stimulation technologies as they're increasingly used. And so I got into depression and the light bulb moment to me went... As I was living as a woman and talking to the women around me, I realized that oftentimes when we talk about depression, the narrative around depression has fundamentally changed. Historically, we would say someone is suppressed and it's kind of their fault and they should do something about it. But over the last 20 years, we've gone leaps and bounds in mental health and explaining how people can actually struggle with depression, how they can get better, and sometimes they cannot, and how we can help them along those journeys. However, that hasn't happened to most of women's health. If you look at the way we speak about PMS, we still say, you know, you're being dramatic, everyone goes through it, whatever. Same with actually menopausal depression, same with postpartum depression, as well as peripartum depression as well. So I guess that was the light bulb moment to me when I spoke to my friends and they would tell me their symptoms, which were often low mood, anxiety, mood swings, irritability, anger. And those were also symptoms that I often heard from my depression patients. However, the way that I responded and the way society responded to women with premenstrual depression, PMDD, or PMS was very different to the way we've learned to respond to depression. And I guess being a scientist, that's when the light bulb went off. And I'm like, if the symptoms are the same and the current treatments for these conditions don't work as well for women, when we try to treat, for example, postpartum with the same antidepressants, they work less well. then there must be some other mechanism. And if we put in dedicated research and dedicated products to make it happen, maybe we could understand and treat it better. And so I think that was the key insight of the overlapping symptoms and the fact that even though there's overlapping symptoms, the solution needs to be tailor-made because if we make something generic, it will end up being made for men because that's just easier oftentimes. And so... Fast forward to why it became a headband. We did a lot of R&D, kind of trying to figure out how the technologies could best be applied for women. And in that process, we actually started with PMS and PMDD treatment, but ended up also adding the treatment modality for menstrual pain. So we also actually stimulate a brain region that reduces sensitivity to pain, and kind of developed a custom-made solution for women with a design that women have voted for and thought that it would fit into their lives seamlessly as well. So that's kind of the roundabout way that we ended up with a product we've been working on for a couple of years now.
Carol:
I was going to say you made that sound like it happened over the course of a weekend and a couple of brunches, but like this is, that was a long journey, right?
Em:
Absolutely.
Carol:
So when you first started putting the pieces of the puzzle together, were you pursuing your PhD or were you still pursuing your masters?
Em:
No, so this was right at the end of my masters. And actually I connected with another student in my year, but in another group. So Alex, my co-founder was, I came from a background in law and finance and had worked previously in product development. And I think him, as well as our other group of friends, we're just talking a lot about this new found discovery of it, of it not making sense, essentially, that women have the same symptoms and don't have solutions, but because I was a scientist and I came from a much more. I guess scientific background, I just didn't understand how to build products or the fact that you could even build a product. I think a lot of people in academia, and I'm sure that those listening from academia will relate to this, were often taught that there's kind of a linear path. You do research for a very long time, then you maybe get a grant, you do more research, and over time, maybe you can think of products, and then you know, you kind of start working with industry. And I guess meeting someone like Alex, who eventually became my co-founder, I realized that actually, if we have an insight, we can work with industry earlier enough and develop it into a technology. that can both be a vehicle for conducting more research because if someone has a device that they can take home, it's much easier to generate data than it is in the lab and the data as well is more organic and more relevant to real life. But it's also a way to actually provide treatment while gathering data. Like oftentimes the amount of time we will need to get to the level of evidence we need for women's health is very long. We need to collect so much data. And the quicker we can collect data as well as deliver value for women, I think the better it is. So yeah, so I think having that insight and sort of to work with Alex, I think the part where we clicked is the fact that we had a really unique insight and an idea for a product, but also the reality check that it will be a medical device that will need to go through regulation for which a lawyer is great. And it is a product that we need to develop from literally scratch. And I think that blend has been the key aspect in bringing Sam Fire to life.
Carol:
I hope that you write a story about this, either in depth, The New Yorker, wherever it needs to be, because it's both a blueprint for people in the future, but also really exciting to see how it can come together. I think sometimes there's just this manufactured blockade when we start looking at women's health and how can we bring a product to market. It just seems like such a long, complicated road. And I love, I'm sure you're simplifying it for our conversation, but it feels like that's a healthy way to perceive this experience is to reduce it to its simple parts and be able to drive relief earlier for someone, deliver relief
Em:
Well,
Carol:
earlier
Em:
I think,
Carol:
for someone.
Em:
absolutely. And I think you're really hitting the nail on the head there in that I am simplifying a little bit, but I think the core is that with women, we actually have been so cautious over time. And I think the reason that we've perceived women as such complicated organisms has actually delayed a lot of critical research. Because if we actually understand what's happening in women's bodies, and there's a lot of things happening, whether that's just the menstrual cycle, which is a heavily orchestrated piece of events that have to happen in a woman's body. whether that's pregnancy or menopause, a lot of these things happen. And I think because they're so complicated, it has actually discouraged a lot of researchers from betting their careers on it. Because if you're wrong, and there's so many ways to be wrong, but there's only probably one way to be right. And so because of that, I think it's actually a really key for anyone working in women's health, not to try to oversimplify it, but to show it as a component of parts. And if we start tackling one part, we will figure out what the next step is and then be able to contribute again. So I guess what I'm saying is that we really shouldn't be scared of tackling a complex issue because if you understand a complex issue, it can usually be broken down into more simple parts if we understand it really well. So I really hope this is kind of an encouraging conversation for anyone listening, doing research or building products.
Carol:
Absolutely, and I love how you stated that it is so easy for people to forget that, or maybe it's not easy to forget, it's just simply that they don't realize that when someone chooses to pursue a career in women's health research specifically, that that brings complications that don't exist in research that is either not gender specific or is designed for the male body. that just, I've said it a thousand times, 1% of worldwide health research funding goes towards conditions that are non-cancerous that primarily impact the female body. So when a person is leaving an academic career where they've probably racked up a tremendous amount of debt and they look at, well, I can go down the path where funding is fairly easy to get, or I can go down the ridiculously difficult like nail lined broken glass path that is female health research where I'm going to have to beg for money. And where would you go? Right. I mean, so I think it's so important to point that out because you could have picked any area of research that you wanted to. And you picked this and thank goodness because.
Em:
And I didn't.
Carol:
God
Em:
No, I just, I was about to say I'd even push it further because I think in the beginning you were mentioning, you know, there's female researchers and there's male researchers. And actually there's a lot of risk associated with women going into researching women's health because then it's also seen as exclusive. So for example, if you try to look at papers studying the neuroscience of pregnancy, so or the changes in the first two years following a pregnant, following birth and how essentially a woman becomes a mother in those first two years, which we know are critical. you will see that a lot of first authors, there are women, but you will also see that over time, those women, while they were pregnant, they were running research on pregnancy, but then once they're no longer pregnant and it's less relevant to them, they just realized that, whether that's the study of the eye, the study of depression or something else becomes, as you say, in some ways, maybe easier to get the grants, but also less risky reputationally to bet your career on, because no one wants to be perceived as a female scientist who... When she's young, studies menstruation, then when she is pregnant, studies pregnancy, and then when she's getting older, she studies menopause because that just feels extremely stereotypical and women really want to be respected in academia and neuroscience is increasingly female, but still like any scientific field, still has to fight for legitimacy for women as high-end researchers.
Carol:
Just sit with that for a second. Still have to fight for legitimacy. I mean, that's a bit of a gut punch. And
Em:
Yeah, sadly.
Carol:
then to think that you might really love the rhythm of following research that mirrors where you're at in life, but then you have to be concerned about how that's perceived. So many complications. And so now I want to segue into what I think is also really, really complicated. Can you describe the connection between the brain and the reproductive organs?
Em:
Absolutely. So one thing that every woman listening to this will recognize is that women know best their bodies and you know that you think differently at different stages of your cycle. And that's the case if you have a natural cycle, but also women on hormonal contraception sometimes notice that they still have a little bit of underlying fluctuations. They're usually not your original cycle, but you still have some cyclicity. It might become a 60 day or 75 day cyclicity. in the way you think, in the things that you prioritize, and in the way that you are sensitive to the world around you, both emotionally and physically. And the reason that's important is because I know that you go into other podcasts in much more detail, but we know that hormones change throughout the menstrual cycle in general, and I will focus on the menstrual cycle, though we know that's the case with pregnancy, menopause, and kind of all other stages of a woman's life as well. But the importance of the menstrual cycle is that there's a lot of changes happening, the main ones that we associate with progesterone and estrogen peaking at different times and essentially controlling that very tight balance. And it is very important for that process to work well, that our brain responds to it appropriately as well. So the brain also has lots of estrogen and progesterone sensitive receptors, and they are distributed in particular regions of the brain. So if we look and zoom into the brain, and this is research really from 2019, this is very relatively new research. We know that the frontal cortex of the brain, as well as the limbic system of the brain, are especially sensitive to the effects and the peaks of estrogen. And so those parts of the brain are specifically focused, the limbic system is focused on emotional control, and the frontal cortex is responsible for cognitive control. And when I say those things, the reason that's relevant is the main things that most women will recognize around their cycle changing is really how sensitive they become, whether that's anger control, whether that's low mood, whether that's anxiety. or it's the ability or rather the inability to make decisions at particular points in their time. So the frontal cortex and the limbic cortex, these are really the signatures of it and their response to primarily estrogens, but also some other molecules as well. And we know that those rotate over time and they have evolutionary purposes as well. And so the reason that's important is that we can think of the cycle as falling into four different category, four different phases. based on how those hormones interact. So that's the menstrual phase when you're bleeding or when you kick off your menstrual cycle with bleeding. Then you have the follicular phase where essentially you're most thriving per se. Then you have the ovulation and then it's followed by the luteal phase, which is usually a conservation phase. And that luteal phase is actually the most sensitive one for the brain. That's when the brain is the most vulnerable and that's when you see the symptoms of premenstrual syndrome or PMS occurring. that's when you see the symptoms of premenstrual dysphoric disorder. So those are the seven to 10 days pretty much before your period happens. What's also interesting is that in the last couple of years, there's been this term identified called premenstrual exacerbation called PME. So if you are a woman living with mental health issues, whether that be depression, anxiety disorders, or any other conditions, those will tend to get worse during that luteal phase. And in fact, oftentimes, even if you're in a recovery, that premenstrual phase can be a trigger for a condition restarting. So really consciously and looking at the way that our hormones interact with our brains and the brains affect our behavior and our mood, we should be really sensitive in that particular luteal phase. So to kind of bring it all together, there's always processes happening where the hormones in our body are changing and interacting with the receptors in the brain and those receptors affect how well and strong our systems are working at that time. But if you were to remember one thing from all of this, I'd say remember that the seven to 10 days before your period, are called the luteal phase. And those are the most, that's the most sensitive time for your brain and essentially the way it interacts with your hormones. And sometimes it can go awry. And so far we don't yet have enough research to say why exactly that's the case. Because if we were to only look at hormones between you and me, for example, we might have the same hormone levels of estrogens and progesterone, et cetera, but our brains might be reacting to it differently. I might be experiencing PMDD because my brain is extremely sensitive to that change, whereas you might just treat it as normal. And the reason that's important and the reason we ended up first building a product for premenstrual and menstrual pain conditions was specifically because we know that premenstrual depression, and this is actually a meta review that was published just in April this year in 2023. We now know that if a woman experiences PMDD, she's much more likely to suffer from depression in general, which means she's at a higher risk, as well as postpartum, as well as menopausal depression. So it's an early indicator of women to essentially take care of their health and prioritize their health and just be aware of things that can happen.
Carol:
That brilliant. I don't think I ever have to interview anybody else about this because you just described it so perfectly.
Em:
Hopefully though, there'll be too many people to interview as the research here increases.
Carol:
Exactly, and we want to shine a light on everyone doing it, but that was amazing. So a few things that just kind of came to mind. One, I think what you just described underscores the importance of understanding your cycle, not just from a fertility perspective, right, to either conceive or not conceive, but because it is sort of a topographical map of how your... your overall mental and physical wellness is responding to these cyclical changes that are happening. And so we have data that shows that when you understand your body and you understand the – oh, what is the word? Cycles, the cycles that it's going through. that you're just that knowledge in and of itself, even if you don't take any other actions, improves your ability to self-manage throughout that time period. So that's really, really important to understand. And then the other thing that I wanted to dig in a little bit is, you know, PMS has been kind of obliterated as a term, you know, it's sort of... It's been weaponized. It's been used as like in a dismissive way, like, oh, you just have PMS. Can we talk about, you know, what is normal from a symptoms perspective? And then at what point in time should somebody seek out help because the symptoms are beyond that normal faint?
Em:
That's a great question. That's a great question. And as you say, this is still a very rapidly developing topic. I was recently at a conference, the European Women's Health Innovation Summit, and someone put it very well in that when we don't know what's happening in a particular condition, we call it a syndrome because it means it has lots of symptoms and we don't really know what's going on. And then as we figure out what's going on, we figure out specific diagnoses. The problem is that most of the things that we know about women's health at the moment the level of syndromes. So when we speak of PMS, it's maybe the best known premenstrual syndrome, but that's actually also the case with postpartum syndromes, all of those, you know, emotional as well as physical symptoms that women experience, as well as menopause. So I think it's worth first stepping back and seeing the word syndrome and all of the symptoms that come with it as essentially an early stage of our understanding rather than necessarily a diagnosis in and of itself. So if we take that perspective, I myself have gone through quite a bit of a journey about whether we wanna associate with the word PMS or not, because officially there are over 130 symptoms that are recognized with the premenstrual syndrome. And the reason we decided to go with it is exactly because of the question you ask, because a lot of women know the words PMS and they know them as things that they feel, but they feel have been disparaged and not recognized. So we thought that by creating the first medical device that's specifically designated for treating what we chose to call PMS and the cognitive and physical symptoms of it, we're actually validating the way that they feel about their health. And so for me, you know, and as a company, We cannot tell when it's bad enough or what's normal or not because the medical community hasn't decided it yet. But what I do know is that 84% of women in the UK feel that when they tell their doctor about their pain or their cognitive symptoms, it's usually dismissed. And when I saw that statistic, trying to imagine that four out of five women feel that when they complain about something, it's said that that doesn't matter. I think that tells us that we should hear women more than not and acknowledge it more than otherwise. So I think for everyone listening, the way that I would think about it is if you recognize those changes in your luteal phase associated with mood, anxiety, and any changes in those as well as pain, those are legitimate enough. And then the next question you have to ask yourself is how much do they affect your functionality? And for most women that we see approaching samphire is that they notice that it affects their productivity, it affects their sense of control because they feel outside of their control, they know their cycles. and they know that they're gonna feel like crap on Thursday, but they cannot do anything about it. And that's where we have tried to provide support. So I think to me, it's less about the severity of the symptom that matters, but how it affects the way you feel. Because I think that it puts the power into the hand of the woman to determine what's not normal for her. Because for too long, women have been told by external figures of what's not normal. And actually not in women's health, but also not in psychiatry, have we really realized where that boundary is. We usually know the extremes. but for many women, actually the line is extremely blurry and it's likely to change throughout your life as well with the earlier life being dominated around menstruation with menstrual pain symptoms being very severe. But over time, we know that women over 30 and after pregnancies tend to have especially severe cognitive symptoms of menstruation. So kind of being attuned to your body and recognizing that functionality to me is the highest level of trusting women with their health.
Carol:
Again, brilliant. I'm so glad that you didn't jettison PMS because of exactly what you just described and thinking about adolescents and what a disservice we do when we don't intervene or we don't have a method for intervening early because these symptoms show up in their teen years. And they can, especially with premenstrual dysphoric disorder. And again, I'm not exactly sure where the line is on what is, you know, PMS, PMDD, like, so we all know what we're talking about here. That,
Em:
Yeah.
Carol:
you know, we just are taught to deny it, or, you know, another thing that I love is the irony in, oh, it's, you know, it's just, it's all in your head, you're stressed. Well, it is all in our head. It's in our head.
Em:
Absolutely.
Carol:
That's exactly why I'm here. That's the point, you know? And being able to get everyone together to understand this, you know, everyone from therapists and primary care physicians and pediatricians and, you know, like, and it's unfortunate because we have to undo a lot of conditioning around how this is treated. And that's exactly why I think it's so important. for companies like yours to speak directly to the patients, obviously in a compliant fashion, but to, you know, and that's why I wanted to have you on HelloUterus, because I want the patients to understand that this is recognized, this meaning your experience is recognized by the scientific community. It may not be recognized by the particular physician that you're going to see, which is why we can't have the physician as the sole gatekeeper. of information and knowledge around this space. So that is, I'm so glad that you stuck with PMS because it's the one we all understand. So.
Em:
Yeah. And I'll actually just emphasize here that I think that actually one of the statements that we thought as a company is that if you are building a solution, then you're actually legitimizing the problem because to date, again, we will be the first medical device that officially has as its claims, menstrual pain. We have the word menstrual in there and premenstrual mood and anxiety symptoms. And the reason to us that is so, so, so critical is because once you point it out and once it's recognized as an indication for treatment, then suddenly the problem has to be real because otherwise your indication is fake. And I think that's super, super important for people building products because if you have something that cannot be treated, which is actually the case for most conditions, whether that be endo, PCOS, fibroids or whatever, where treatments are really, really limited and oftentimes not eligible for all women, the moment you start creating targeted solutions that actually legitimizes the problem, and I think that's especially needed in women's health as well. And also we want to be a tool for women to facilitate diagnosis. So if they come to a solution that they think can help us, we actually do want to provide them all the tools so they would have the standards of care and the ways to essentially at least complete the questionnaire that should be recognized by their physician and bring it to them on essentially a silver platter, being like, this is what you need to see. And I know that's what you guys are working a lot on. And I think that's absolutely key to empower women to make those decisions for themselves and be informed.
Carol:
Absolutely. So let's take a dive into how the headband works and the technology behind it. And I'm gonna
Em:
Yeah,
Carol:
try to
Em:
absolutely.
Carol:
keep up.
Em:
Yeah, no, no, it's, it's again, we're gonna go the simplification route, but we can always delve deeper. But essentially, so we're using what's called transcranial direct current stimulation, which is a form of putting in low frequency and very weak electrical currents into very specific parts of the brain has been used in psychiatry for over 20 years and is primarily established for the treatment of depression and chronic pain. which makes the relevance on why we're now using it in women's depression as well as women's pain in particular. And essentially you put on the headband and I can show you what it looks like. This is exactly what it is. And it stimulates two different parts of the brain. For our case, we stimulate the prefrontal cortex, which I mentioned before, that's the part responsible for decision-making, but it's also the part that's responsible for top-down controlling the limbic system responsible for emotions. So what I'm saying by that is that usually in that luteal phase, One of the reasons why we have this mood dysregulation or low mood or low anxiety or increased anxiety is because what we see is there's a asymmetricity in the two frontal hemispheres. So essentially one of your hemispheres in the brain starts acting more actively than the other. And we use electricity to equate them back to their balance because when they're out of balance, your brain doesn't know if it's happy or sad, or if it's happy, it's extremely happy. If it's sad, it's extremely sad. It's not able to modulate that effect. And so we are able to essentially give the brain back the tools to do that by putting electricity to essentially change that electrical symmetry and bring it back. So that's on the mood side. The other part of the brain that we stimulate is the motor cortex, which indirectly is able to stimulate also deeper parts of the brain, including the insula, which is a part of the brain responsible for pain perception. And now this is where I think the really, really neat thing about our device and about women's health comes in. is that historically and the way that you use it for treating depression and chronic pain, this technology is that you essentially wear it for multiple times per day for about six weeks until you start seeing effects. And it's still very effective and drug-free. But for us, the key insight was that menstruation is so, so unique because to our mind, it's the only predictable mental and physical health condition. Like if you think about any other disorder. you can never tell that I will feel depressed in five days or I will be in pain in three days, unless it's post-operative
Carol:
Right.
Em:
or whatever. But women's health is really, really unique in that cyclical feature. And what that means is that we can use a very weak intervention five days before your period in order to anticipate those effects and essentially never let that symptom come up in the first place. So for example, for pain, what we do is not actually painkillers that take a pain of let's say nine out of 10 or 10 out of 10 or. To be honest, for most women, a 12 out of 10, and then take it down to zero, but instead, as your pain sensitivity increases throughout the luteal phase, so the five days before your period, we just mush it down. So we never need to take a nine out of 10 to a zero, but we always do a two out of 10 or a one out of 10, and we just never let it come up. So it's not a painkiller, it's a pain prevention kind of mechanism in some ways, or at least in your perception level. And that I think is why neurotechnology has to be successful in women's health. and why maybe it hasn't yet taken off in the mainstream for the general population, because women are unique. And honestly, we should be proud and exploit that fact in our technology.
Carol:
Oh, absolutely. I have goosebumps because it just, you know, when you hear a solution that that resonates, like it makes practical sense rather than a solution that seems like a leap or stretch or, you know, like an okay, I'll do it if
Em:
Out
Carol:
I
Em:
there.
Carol:
have to kind of solution, you know? So so then I'm Assuming that this could also be beneficial for people who have endometriosis or adenomyosis.
Em:
Absolutely, and those are actually a lot of the people we see. So our primary populations that we already see are, of course, women who just have symptoms of menstrual pain or PMS, but the primary groups are PMDD and endometriosis and adenomyosis as well. And the reason for that is obviously that they experience extremely severe menstrual pain that is one of the first signals of those conditions as well. And actually for a long time, we were kind of extrapolating and doing our own research on the topic. But a couple of months ago, a great randomized control trial came out that exactly demonstrated the efficacy of this technology for specifically endometriosis-related pelvic pain, as well as some of its chronic aspects as well. So yes, we're very excited. I think endometriosis is a huge population for us, and we see a lot of interest there. The one caveat that I will put for everything is that obviously we only manage symptoms. So we treat the symptoms of pain, but we do not treat those underlying conditions. So one thing that we always kind of flash very brightly on our... when we interact with our users is, you know, even though you're not actually in pain, make sure that you consult your doctor for long-term treatments as well, that you can use in combination. It means that you can live a high quality of life without pain while undergoing treatment or seeking options is a huge value for us, but we want to make sure that we never mask symptoms as well. So I think I'll just add that as a caveat because we know that at the moment, a lot of women don't have treatments for the underlying conditions and live in pain, and we at least want to remove one part of that equation.
Carol:
Absolutely, and that by reducing the pain, it opens up the opportunity for that person to uptake other lifestyle choices that maybe they couldn't have really considered before. And they can just make improvement overall. I mean, first, just being able to get out of bed is really kind of a good thing, right, if you want to improve your life. And in a lot of cases, they
Em:
Yeah.
Carol:
can't. And then with adenomyosis, there's no... There's really no... treatment beyond a hysterectomy and a lot of people are, you know, not anti-hysterectomy, but like you pointed out at the top of our conversation today, we lack research. So the uterus is perceived as a disposable organ. I'm pretty sure that that's not the case.
Em:
Yeah, and you know
Carol:
It just doesn't line up, right? We don't have a lot of disposable, unnecessary stuff in our bodies. I mean, we're finding out that even tonsillectomy is not a great idea if you can avoid it. And so we don't wanna just be taking out the uterus because it's a problem, right? So if people, as they become aware of that research, if they have a solution for the pain aspect of it, I would imagine that has an impact across the entire physical form.
Em:
Absolutely. And actually to delve deeper into this. So there's a couple of really interesting things that you mentioned. One is that, you know, coming into it as a scientist, I thought that what women will really care is the point change on the scale of pain or on the scale of mood on how much they're improving. So, you know, if you're coming and you're like, I usually have low mood. If I tell you that the device will increase your mood by five points, I will make you happy, or that it will decrease your pain by five points, I will make you happy. But actually, so we had a bunch of people testing our device and essentially recording videos of how it made them feel. And the thing that was surprising to me is that none of them spoke about their pain on a scale because actually women are really bad at scaling their pain because they've been told for so long that their pain doesn't matter. So even though they're experiencing a 12 out of 10 type of pain, they might call it a three or a seven depending on the context they were in. But instead what we saw them talking about is, look, this is the first time I've been able to go to the gym while on my period, never been able to do that. Or this is the first time that I'm not crying for multiple hours every day before my period. crazy, or, you know, this is the first time I haven't canceled all of my social appointments and gotten into a fight with my partner. And I think the reason that was so powerful is because when someone tells you that they're in a pain of seven out of 10, you have no real idea of understanding what that means for them. But when you try to imagine yourself crying for three hours every day, every month before your period, then, and you're trying to imagine what it would take you to get you there, that really hits very differently. And I, so I think what we understood is exactly what you said is those. functional abilities of like what can we enable women to do that they've been prevented from doing before and what can we give them control over rather than some Objective quote-unquote, but really not very helpful Clinical and medical measures that aren't very intuitive for a lot of women out there as well
Carol:
That's a fabulous point to bring out because it makes me think of the disconnect that happens when a female is experiencing symptoms of PMS or PMDD. There's this disconnect. There's this me versus it, right? That the uterus is the problem. And there's... I've interviewed women who, like, when they talk about their period symptoms, they... perceive their pelvic region as like a black hole. Like they don't see it as a healthy grouping of organs. They see it as like you would perceive an enemy, you know, sort of at the end of a dark alley or something. And that can't be healthy, right? Because this whole thing is connected. I don't understand it like Em does, obviously. But I just, from a common sense perspective, I have to assume that the entire thing thing that I'm living in that my consciousness is in is completely connected. Like there isn't one aspect of it that's sitting
Em:
Yeah.
Carol:
out on its own, you know, at the lunch table at like the not cool kids lunch table, like everything is connected. Make that
Em:
For
Carol:
clear.
Em:
sure, absolutely.
Carol:
Yeah. So then I would also imagine that, that this is kind of like a snowball effect, right? So if I'm wearing the headband and now I can go to the gym, I don't feel like I'm in this. alien body, I feel more in control of my whole life. And then that snowball grows because now I don't feel like I'm walking on eggshells, you know, like this impending doom. And I think it's important maybe to pause here for a second and really specifically talk about PMDD. Because
Em:
Yeah.
Carol:
that is... Like it does feel, I did not have it, but I've interviewed people who have PMDD and it sort of reminds me of like the water's going out before a tsunami. Like, you know, in the ocean that like, you sort of get this feeling like, oh gosh, here it comes. And then this tsunami comes. And as you indicated, this happens during the luteal phase. So it's, you know when... Maybe the patient doesn't know when it's going to happen, but from a cycle perspective, we know when it's likely to happen. And it doesn't necessarily happen every single month or in the exact same way, but there is this representation on some scale of this doom. And I get very concerned about adolescents who are experiencing this. And as you indicated earlier, these are like... These are early onset symptoms that can indicate a lifelong problem
Em:
Yeah.
Carol:
that this person is going to need to manage or that it's not going to need to manage. It's more like we have the opportunity to intervene earlier in their life to give them tools to start living a high quality of life today. And that
Em:
Cheers.
Carol:
this PMDD... This is not you being broken or you being emotional or or you not able to manage, you know your life this is literally a physiological response to To a very complex system that we know very very complex Communication system speaking about the hormones that we know very little about and probably knows more about it And there might be like what, 200 of you on the planet that like really understand this. This is not a widely understood area of health research.
Em:
Yeah, I mean, as you say, PMDD is extremely complex as are all mental health illnesses and all women's health illnesses, and this happens to overlap in between the two. But I know that you have spoken about this in previous podcasts, but obviously it affects about three to eight percent of all women of reproductive age. And as you say, it manifests with extremely severe kind of dread symptoms, anxiety symptoms, low mood symptoms. as well as about 70%. I was reading in one study of those women experience suicidality as well. So it's extremely severe. And I think it's important to kind of mention that because oftentimes I find that when I speak to even scientists, even psychiatrists, they actually think that it's a quote unquote mild form of depression that happens to be cyclical. And so I think that always emphasizing the severity is extremely important. And because so many, in fact, only the last ICD-11, I believe, had recognized PMDD as a condition altogether. I think it was only recognized in 2015. And so because of that, a lot of actually psychiatrists that are practicing at the moment were not really trained in diagnosing it. And the reason that's important is, of course, and it is in the DSM, which is great, but I think that the reason that's important is a lot of psychiatrists are still on the path of getting educated and... My experience is that when they learn more about the severity, they're really excited about it. But it also means that actually the onus has been for a while now on women to educate their treatment providers. And I guess where I want to lead into that is that through, you know, our work with Samfire, I have now spoken to quite a few people living with PMDD. And what has always fascinated me is that those women are so, so high performing. They're such high achievers, such high performers on average of the ones that, you know, have reached out to us. So I'm sure that that could be a bio sample. But one thing that we realized is those are women who know that they're dysfunctional for a week every single month. So these are people who always live on 75% of time and 120% productivity during all of that time, because they know they need to account for that time that they're not active. And I've now met managers who know that they will not be available for a week. So they, you know, pre-assign tasks for all of the people on their team. or I have met programmers who essentially pre-program files to be submitted on that week of the Lutile phase because they know they will not be able to get out of bed. I have met women with such crazy coping mechanisms that are extremely advanced, but that they're just craving for a solution for, and they usually tend to be extremely educated about their conditions and try to push it further and get it recognized. For a lot of them, these were symptoms actually that, as you suggest, appeared when they were teenagers, when they were really young. they kept being told that these are not real and had to figure it out all by themselves. And that's why they've developed such extreme situations. And this is, I think, a perfect moment to also outline the fact that a lot of those women were first trying to get a diagnosis of depression because they knew this was a mood disorder. But the official diagnosis for depression requires symptoms to be present for 14 days. That's actually a diagnostic criterion. And the reason that's funny is because obviously women never have 14 days in a cycle, or if they do, that's usually temporary. So... even the way that diagnoses are written, oftentimes may doctors dismiss them because they're like, if you were only sat for seven days, then I guess that doesn't count, even if that's seven days every single month. And of course the situation is changing, but I think that's kind of a very important angle to keep in mind whenever we talk about those health aspects. And so obviously when we were developing the product, PMDD is a very complex condition. And so we addressed some of the symptoms associated with it, specifically the low mood and the anxiety aspect. but there's others that we cannot fully target. What we think is the first step, because we know that a lot of standard antidepressants don't work too well in these conditions. And we also know that now there was a study, I think in 2021 that came out, that when it looked at the brains of women with PMDD during the luteal phase and people with depression, they actually, the ML algorithm couldn't differentiate the difference between the two. They actually couldn't tell which one was depressed, which one had PMDD, because women with PMDD tend to have a... significantly different brain functionality in that luteal phase compared to all other essentially weeks of the month. And I think that's really important from seeing the mechanism working from the neuroscience up to the behavior up to the mood experience and validate it. I think that I'm kind of returning to the point, whatever you feel is legitimate, I'm just using brain images to essentially tell you it's real.
Carol:
Yeah, which is great because that idea again of, you know, it's all in your head. Yeah, it legitimately is. And you can, you know, if you're ever in an appointment and someone, you know, tries to suggest that, then you can come back and say, yes, you're right. And you can reference M's research and talk eloquently about how that is the case. So we have, we talked about how the samphire headband is effective on both mood and pain, right? So that's, I wanna make sure that people understand that it is, that's massive. It's really massive. And
Em:
And
Carol:
also...
Em:
what I'll emphasize is that it's effective on pain, but the cognitive aspect of pain is pain perception, right? So even though it affects, so essentially you don't feel pain and most people don't need to take painkillers, I think oftentimes the mental health aspect associated with pain is often neglected. So I'm gonna make
Carol:
Yeah,
Em:
sure the emphasis is there as well.
Carol:
I was gonna try to probably not as elegantly sort of touch upon that because when we're exposed to pain on a chronic basis, our brain changes how it works with that pain, right? So does it,
Em:
Absolutely.
Carol:
and it's not that it becomes desensitized. Like you would think, like if your job was to pick up. you know, spiders every day, eventually you would stop freaking out about that job and you would be like, Yay, I'm just going to pick up spiders all day.
Em:
So it's actually the opposite, right?
Carol:
It's the opposite.
Em:
It becomes hypersensitized. Yeah, so I have spent a lot of time trying to think through that logically and kind of trying to anthropomorphize the brain and understand why we do this quote unquote maladaptive thing where you experience pain regularly and you become hypersensitive rather than undersensitive to it. And so I've delved quite a bit into the research on especially chronic pain disorders. So things like fibromyalgia, other chronic pain conditions, as well as menstrual pain, which is very weird because now... I am very much part of that movement and increasingly researchers working in the pain area are as well. That menstrual pain and the medical term for that is dysmenorrhea is actually a chronic pain disorder as well because if you look at the brain, essentially the brain is always freaked out about that time of the month where it's going to go into extreme pain. So it gets hypersensitive so it can know when it's coming. So essentially it's maybe it's not the right way to call it. It's definitely counterintuitive, but maybe it's still evolutionarily adaptive. It essentially puts you on standby because it always knows that something is about to come. And that's why there's a hypersensitive rather than the hyposensitivity, because whenever all of the functions in the brain that become hyposensitive, so less sensitive to specific features are essentially examples of a safe environment. So for example, If something is initially scary, like public speaking, the more you do it, the more comfortable you get it because your brain starts believing that when you speak publicly, no one's about to eat you and you're
Carol:
Yeah.
Em:
safe. But the problem with menstrual pain is that the brain just doesn't understand why this keeps happening and disappearing. So it maintains that like active threat level and therefore it's always on standby. And I agree with you, that was really, really boggling my mind. But I think that the two key outputs of that is understanding the hyposensitivity and understanding that it's actually ever present in women with severe menstrual pain rather than just something that happens once per month.
Carol:
So great for people to understand and I hope that that that the types of things that we've talked about today I hope it inspires curiosity and interest because The more that we understand even just a very basic levels It's not like you have to take deep dives into intense research, but just understanding it on a basic level there's this like calming kind of self-talk that you can do and and it it like that process of talking to yourself is over time going to build a relationship between you and this incredibly exquisite, delicate, phenomenal system that you inhabit. And I don't think there's anything more beautiful than that, actually. I think that having that relationship with yourself, where you're like a partner
Em:
Thank you.
Carol:
with the physical body and operating it from a position of knowledge, I think every aspect of one's life would improve if we were able to accomplish that, and it's not hard.
Em:
Absolutely.
Carol:
Well,
Em:
And
Carol:
I
Em:
I
Carol:
mean...
Em:
think if we mentioned the word brain more often, when we talk about the women's physiology and women's body, we would do ourselves a very big service as well.
Carol:
Again, right there, so simple, right? Just recognizing, like just saying to yourself things like, okay, they don't know a lot about my body. They don't know a lot about my brain. They were afraid of the complexities of it and that it would make their jobs more difficult. And by they, I'm talking about like, you know, research over the past several decades. But it's really cool. Like everything that this female body does is like ludicrously cool. And so if you
Em:
Absolutely.
Carol:
just settle into that, I really do feel like there's a way to. Well, obviously it's like meditation. You're just, you're going to settle the things down and build, build a stronger relationship. So the, the headband, how often does a person need to wear it?
Em:
So you only need to wear it for 20 minutes and you actually officially tested that you can do downward facing dog with it if you wanna do yoga while wearing it. And you wear it for the five days before your period to achieve that specific building up effect. So forJust some 20minutes a day?
Em:
menstrual pain, 20 minutes a day. Whenever convenient, a lot of women wear it around their skincare routine or in the morning on your way to work. It's lightweight, it's Bluetooth controlled. No one on the train would be able to tell that it's not, it's a medical device. It just looks like a fancy headband. And actually a lot of our thought was put into making sure that design is sleek, that it's able to fit into mother's life, working women's life. Um, and yeah, it's only 20 minutes per day.
Carol:
It's fantastic. I know you can't see it on this podcast, but we're going to be we're going to be flashing pictures of this all over the place. And I can just I can see it like she's got on. It's completely
Em:
Thank
Carol:
adorable. But
Em:
you.
Carol:
I mean, first of all, OK, you look like Emily in Paris right now. Like that looks like
Em:
Hahaha
Carol:
a Parisian headband that somebody would wear but here's what I'm really excited for. I'm excited for what people do to it. Can you decorate that headband?
Em:
Extremely serious question and we have investigated it a lot. So the first version will be kind of a unisex one for all, but we will, we're very excited to launch covers for it. So specifically that you could fit it to your lifestyle and add essentially like iPhone covers on top of it. And we're currently actually talking to a bunch of artists working on it as well. So if you are an artist listening to the podcast and would like to contribute to some cool designs, we're really excited to hear from you. So just email us at Sampara Neuroscience.com.
Carol:
Oh my gosh, okay, we're gonna make sure that that happens
Em:
Hehehe
Carol:
too because you, like, you know, part of it, I was originally thinking decorating it like, you know, just the typical decorations, right? But what about the messages? What about, like, literally saying, this thing that I'm wearing is improving my experience with my period, you know, like just.
Em:
Well, even pushing it further, like, you know, we made it to look like a headband where no one could tell that it's something that works on your menstrual pain or your PMS. And it's actually your own choice of whether you want to be screaming out loud about it, wearing it in public and doing whatever makes you feel confident. That's absolutely something you can choose to do. But we also wanted to free women from doing that as well. And honestly, it's just a black headband that, and we have tested this, men can't even tell that it's a medical device, which is great, as most other women will know. And it's something that you can also hide in the public if you're not someone who wants to scream and shout out loud about your body and what's happening with it as well. So we really think it's, for us, it's all about giving women control and giving women options and giving women drug-free options, which we know is critical.
Carol:
I'm trying not to laugh because when you said, now I'm failing, I'm failing at it. When you said men can't tell it's a medical device, I was like, well, yeah, that makes sense, that lines up. Just, okay like a once a quarter dig, at our male counterparts who we love and adore, and we're so glad you're here,
Em:
and I'm very grateful for it. Absolutely, and I'm very grateful to my co-founder and honestly throughout we've been advised by so many amazing men who usually call up their wives and they're like, hey, I figured out this is a problem, let's solve it together. And I'm like, whatever makes you convinced, that's the right approach. And yeah, I also think that women's health is a huge area for men researchers, for men builders to join. And I think it's the more we work together, the more we will leave the times where it needs to go.
Carol:
Absolutely. And again, they are affected by the same experiences that we're affected by, which is when you don't have any knowledge about something, then you just aren't thinking about it. You're thinking about the other things that are flashing lights drawing your attention. So can you speak, just a couple of questions to wrap up here. Can you speak about the results so far in your research? Is there... a way to characterize the level of improvement that people are experiencing.
Em:
Yeah, so there's a couple of smaller case studies, but what we're aiming to do is really getting large scale data. We think that's the most valid data to get from the real world rather than clinical experiments. But what we've seen so far is essentially in randomized sham controlled studies. So where people take the same headband and without the researcher knowing, without the user knowing, without the data analyst knowing, so it's triple blinded, we essentially test whether there's a real effect of the headband. And what we saw is that specifically for the pain effects, we see an 88% improvement. So 88% of the people in those trials got better. And so those are people who self-identified on clinical pain scores that they're getting better. And then for mood symptoms, so specifically for low mood and anxiety, we're actually seeing some very good early evidence on insomnia as well, but that's where long-term and kind of large-scale studies will come in. So that's where we see an 84% improvement. So it's actually, it's really high up there, especially when you compare it to drugs. And it kind of makes sense because we're circumventing the entire digestive system, the entire hormonal system and going straight to the brain. So it does make sense that we're more targeted. But yeah, these are early stage results and I'm expecting that at scale that will probably decrease to 80%. But, you know, four out of five women can benefit from something like this. And we will always have extremely generous return policies to make sure this is something that works for you. That's at the core of why we're building. I think honestly, it's a unique solution on the market.
Carol:
Absolutely. And just collectively I'm hearing livers cheering. They're like, thank you!
Em:
That's actually a big reason why we're seeing people coming over. They're like, you know, I like my painkillers, they're helping me. But after you take two pills every couple hours during your period, you just have to second guess of whether it's really right for you.
Carol:
Absolutely. So, what is the timeline for availability? And also, in tandem with that, can people participate in clinical trials? And how are you... Is that available in the US?
Em:
Yes, absolutely. So it will be available as a medical device in both the EU and in the US. It's going to be available in the EU in Q1 2024. So sometime between February and March this coming year, and then the US, um, likely the next quarter. So sometime between April until June, uh, next year. However, we will have a very limited first party and that's specifically for kind of those research purposes and launch. So I really recommend people to go and sign up for early waitlist and also get a huge discount. So the best time to do that would be now. and that's actually the best place to get enrolled in our clinical trials as well, because we will contact people on the wait list to get them an opportunity to test the device, get it early, and make sure that you secure the part of the first batch as well.
Carol:
Excellent. And so will it require a prescription or is this going to be an over the counter?
Em:
So it will be an over the counter. We will always recommend people to consult with their healthcare provider around the use and kind of make sure that they always pursue treatment to underlying conditions and don't just mask their symptoms. But you can buy this device without any prescription because we know that women's pain and mood is oftentimes ignored. So we wanted to make sure that's not a barrier for accessing care.
Carol:
Do you think that there might be a way to get reimbursement for it if they're able? Yeah.
Em:
Yeah, so that's absolutely our long-term aim. So in fact, Estonia is one of the first EU countries that's already started reimbursing this technology for the treatment of depression. So we suspect that we will first obviously start getting reimbursement in the EU where it will most likely require a prescription or at least the doctor validating the need. But we are planning to bring it and are currently in conversation with pairs as well in the US, so. Again, if there's listeners who have worked with pairs in the area and have experienced specifically with women's health, we always welcome any advice. Um, because we know it's a complicated system. I mean, the first medical device in this area, there's a lot of ways in which we feel like we are pioneers in making this legitimized and reimbursable as well. But it's definitely our plan. We want this to be the most boring device that's every woman can access when she needs it and. You know, however she needs it.
Carol:
I'm like five, seven years into menopause and I wanna try it. I don't even have, I don't even have PMS symptoms
Em:
You
Carol:
and
Em:
want
Carol:
I want,
Em:
to rewind the period here.
Carol:
exactly. And I mean, I do think about, you know, I'm just so grateful that these technologies are coming to help now because it really has just been a desert. So your website is where to go for everything, right? So for, because you're... There
Em:
Absolutely.
Carol:
is a wait list that you can sign up for there. And then also, please remember, for all those designers out there, anyone with creativity, like send your designs. And then in general,
Em:
Please do.
Carol:
I just, I wanna reiterate the, how cool it is. Like there's, we burn so much time every day on a wide variety of stuff. I want to encourage you to take just 10% of all of that time, whether it's social media or it's just like, you know, staring off into space. and follow people like M because when you support what they're doing, like that just to me makes it the coolest thing ever. Like we're joined, right? You know, nobody, nobody at Apple making the new iPhone is really, you know, like who cares? Like we've been, this stuff is really important. And so like you have the opportunity to be sitting courtside and watching these technologies unfold. And ultimately you may decide or you might help inspire in your children the opportunity to follow female health research and then pursue that as a career one day. And I can't think of anything more exciting because it's the wild west.
Em:
and we are all building better together. Like this is still such an early field where there's so much to be done, but honestly, every FemTech founder or anyone working on women's health, it only makes everyone's lives easier the more people we have working here. So also very, and we care about every user early on as well. So really excited
Carol:
Absolutely.
Em:
to hear from you as well.
Carol:
Yeah, it's a very super supportive and exciting community. So, Sampfire Neuroscience is the company that Emma has co-founded and is the CEO of. And are you guys on social?
Em:
Yes. So we are at Sampire Neuro on Instagram and we are on LinkedIn Sampire Neuroscience and we're Facebook Sampire Neuroscience and you can just type in our name and you will see us pop up.
Carol:
So definitely go check out their site. There's some research that's there. And then you can also sign up for the wait list as well. And I just want to thank you so much for taking time out of your weekend on a holiday weekend. And we're cheering you and your team on. So please let them know. And we appreciate so much that you are focusing specifically on the deep and powerful connection in the female body between the physical and mental health and well-being and how our cycles impact that. And it's taking it just from, oh, that's just your period. It's like obliterating that statement. And it's saying, no, no,
Em:
Absolutely.
Carol:
no, no, no. It's way cooler than just your period. So thank you so much for being with us today.
Em:
Thank you so much for having me.
Carol: We'll be right back with ending on a high note. This is a high note in the making, if you will. Hiker, spelled H-double-I-K-E-R, one of the most popular hiking apps, has made 27,000 trail maps available for download for free in a bid to increase hiker safety, which is just the coolest thing, right? They love hiking, they have a great app for hiking, but why gate that information? Like, I mean, I get why make money off of it, but it's like gating safety. Right. Why, why gate that you need to know before you go, you need to be prepared. You need a map that you can access, especially offline. You know, I mean, people get lost even when there's trails and signs. I've gotten lost on trails before. It is no fun. And we don't want that to happen to you. So to make sure your hikes end on a high note, download Hiker. You can go to hiker, h-i-i-k-e-r dot app. Free stuff from apps is cool. And that's what you get with Uter and Kind. Free to use and we don't sell or share your data. But you can help us continue to bring the latest research innovations and tips for better female health by downloading UterineKind and leaving a review in the App Store. You can also subscribe to the HelloUterus podcast wherever you get your podcasts and leave a review there as well. Word of mouth is our preferred marketing methodology because that means that we don't have to use data to like track you down and shove an ad in your face. And we just prefer not to roll that way. Thank you, Angel, for your production prowess and to the team at UterineKind for your passion. Improving uterine care for everyone is our mission. Make doctor appointments suck less, is another way of saying that. And that's no dig at doctors. It's no blame on anybody. Together, we're just gonna make it better. Thanks for listening. We'll be back next week with another episode of Hello Uterus. Till then, be well, be cool, be kind. I have to go get a kid. I'll see you soon.