Revolutionizing Sexual Health With Innovative Devices

Introduction and MysteryVibe's Mission 0:00

Welcome to The Parkinson's Solutions Summit 2.0. I'm your host, Dr. Kenneth Sharlin here in Ozark, Missouri. And I have the great pleasure of interviewing Dr. Soum Rakshit. And I believe Soum is on the other side of the Atlantic Ocean in London, England. So they've just been through their own election, and, we're going through ours. But it's a real honor to visit with Soum today. he is, a, biomedical engineer and, hits some of his very early work is in creating a startup, company that worked on technology for Iraq cognition, and that ultimately was acquired by the United States Department of Defense.

and I'm very interested in learning all about this, but essentially, in a nutshell, his journey ultimately led him to see a huge need for, creating, a real value in the area of sexual health and doing this in a very science oriented research oriented way. And his company is called MysteryVibe. So without further ado, Soum Rakshit, thank you so much for being part of The Parkinson Solutions Summit. Thank you so much for having me. So it's such an interesting journey. Soum. Could you I mean, take take me back to the beginning.

We were just folks, you know, this is going to that's a great narrative. And, ultimately, you know, one of the really important messages, of course, is that sexual health is important for all of us as human beings. It's certainly part of a holistic health plan, and it is a particularly large problem in Parkinson's, where libido may be affected, as well as, autonomic dysfunction occurring. So both men and women, have trouble on the physicality of intimacy. So we'll get into that. But let's take a journey together from the very beginning.

So the like you said, it's 20 years ago, that I did my PhD in biomedical. Back then, I was focusing on eye recognition. but in reality, it's not that different. We, as engineers, worked with opthamologist eye doctors, to create devices. back then, it was cameras which understood the eye and recognize people. And now I work with urologists, ob gyns, pelvic floor therapists. But again, the same engineering building devices and us being told by the medical community what to build. So in a way, the work hasn't changed.

You know, from what I did 20 years ago to what I do now, we're very much driven by, the clinicians and the experts telling us this is how the body works. This is what needs to be done. And then we figure out what to do from an engineering perspective. So, the the main reason why we started, MysteryVibe is from our work before we knew that engineering can help a lot in the medical community and especially, having worked on, with doctors before and ten years ago. So 2014, when we started, there was hardly any discussions about, say things like prostate health or prostate cancer, menopause, pain of the childbirth, pelvic floor issues, erect erection issues.

So all of these things, obviously very common, but hardly now there's a lot more. But ten years ago, hardly anyone talked about it. So the we knew that we wanted to do something with our biomedical engineering expertise, and we wanted to focus on an area which is common, a common issue, but often overlooked. So that's how we, picked on sexual health. So Uruguay overall and, and it is, complex area because everybody's different. the anatomy is different. penises are different. Vaginas are different.

You know, so you have to, figure out how you can make devices which the user can tailor to their needs, because that was the biggest issue is, let's say something as simple as that would be pain. you wouldn't know as a, user where the pain is that you reach and press the pain points.

Biomedical Engineering Roots and Sexual Health Focus 4:54

which is when you would go to a party and the party would do that. But the problem is, it cost a lot of time and money. and often, there just isn't enough, clinicians available. you know, given how many patients there are. same applies to, say, prostate been prostate help. you know, you need a urologist for the fingers. So the issue that we realized is, the problems are common. You know, a lot of people have prostate issues. A lot of people have erection issues. Other people have been issues to other people.

Every woman at some point will have menopause. So very common things. But the solutions beyond going to a clinician, which was a big barrier for a lot of people, when it wasn't really there. So the the work we did over the last ten years on the engineering side is create devices which are completely malleable. So that was the technology we invented. where whether it's, erection device that stretches and fits the penis, whether it's a pelvic pain device that mimics the fingers and bends to reach the point, across the device, which again mimics a finger and adapts to the rectum.

menopause device for dryness of the vulva. So all of these devices were created for one purpose, which is to deliver the vibration exactly when needed. And that's what makes them effective. So the concept of delivering vibration is very old. You know, there is research for over 100 years of using vibration for various, you're going issues or even pain generally like back pain, for example, right now, the so that was established clinical research, which was great. So we use the existing clinical research.

And then our work was delivering that vibration exactly where needed. And that's where the ten years of engineering came in of making malleable, electronic, malleable circuits, malleable plastics, malleable silicone, everything, very, very malleable, which then is incredibly robust. And, you know, no matter how many times you stretch it, bend it, it will never break. and being able to deliver the vibrations exactly what you need. That is fascinating. I was just curious if this sort of, you know, came about your happened to have some relationships with physicians or one in particular sitting down over, you know, applying to veil.

I'm just making things up because it's England, of course. and say, you know, I've got this patient, I've got this real problem. and, you know, I wonder if you have any ideas on how you can help me solve it, or were you just kind of looking at the marketplace overall saying, hey, here's a really, a niche that needs to be filled? so it's the latter first, as in, that's how we decided to focus on. even before we started, we thought, okay, this is an area that is really what solving. because it seemed like the biggest area where people have issues with the least amount of discussions.

You know, like, you see. even ten years ago, most of the discussion was around cancer, which is obviously, you know, very important. But hardly anyone talked about menopause, for example. So, so we decided to focus on Uruguay. And then with the help of NHS, which is the National Health Service here in England, we, identified the doctor who was a clinician scientist, physicians who worked in engineering alone and pioneered things like robotics, prostate surgery. And then we, got together with him and, got him on board as our chief medical officer, who, is the professor of surgery at King's College.

and because he had 30 years of research experience, in areas including vibration, he could bring the knowledge both from the medical perspective but also the interaction with engineering. And and that's what helped us a lot, which is much more than, a clinician telling us, you know, these are the medical issues and this is how the body works, which is important, but also having research which said, I've worked with vibration of certain frequencies, and this is how this helped. So, for example, one of the papers he wrote 30 years ago was helping, patient pass urine who couldn't pass urine using vibration by pushing vibration on his bladder.

he was able to pass urine. So, so. And this is long before we even thought about working in this space. So having a his knowledge of both, engineering and medicine and our knowledge of building stuff helped a lot. but again, it's a very small piece of the big puzzle of various topics like andrology and ob gyn and pelvic tilt therapy and menopause. So then getting all the experts and reaching out to them and working closely with them, so that it's not just, one part of medicine that we are looking at, but the entire gamut of sexual health.

Well, you know, this interesting because this is the Parkinson's Solution segment. There's actually a classic, I think a 19th century, I could be wrong, connection to vibration, where one of the sort of the pioneers, the patriarchs, if you will, of neurology, of modern neurology. Charcot, observed that people who had Parkinson's, when they got off a train, I think this is the story. And they were the normal vibrations of the train that at least temporarily, there are parkinsonism or their tremor seemed to be better.

And I think fast forward to the present. There's been some development of these vibrating gloves. I don't think they're in wide commercial use at this point in time. but it's still very interesting that vibration has played a huge role, even directly in Parkinson's disease. Yeah, you're absolutely right. There is just so much work in vibration. Like when you, you know, products like Theragun, they're widely used by osteopaths, chiropractors, with very good results on back pain and just general body pain.

And that's all, proven clinical literature on why vibration is effective. And it's very simple in the sense that when when you vibrate a certain body part, it helps with getting oxygenated blood to that area. And that helps with pain relief or arousal in the case of erection. But generally, pain relief is the main reason most people use vibration in very simple fundamental. but the key there are two key points. One is the frequency has to be the right frequency. And what we have learned from existing research is 100Hz is the most effective frequency for, sexual health.

And that's research which already exists. And then the work that we have done is how do you make it really easy for the patient to adapt the device to their body? Because otherwise it becomes a huge challenge. If either they have to there's a wide array of devices and they have to pick the right one for you, which is very difficult to decide. Or you have to go to an expert who then custom make it, then it would be very expensive. So to the biggest challenge we have to overcome is how do we make something which is super easy for, let's say, 80 year old to use, not nothing complex tech, and incredibly robust, does not break and fit 90% of body shapes and sizes.

So that was the that was the biggest challenge. So so it was five years of research before we could even launch anything.

Vibration Research and the First Pelvic Pain Device 13:12

So did you do that? Was there an initial prototype so to speak, and what specific device or problem did you did you start with. Because I know you have a kind of a portfolio of different devices now. So we started with, a device called crescendo, which was the pelvic pain device, because that was the one which we originally looked at. The first problem to solve is post childbirth pain. Yeah. And the, the, the, we devised, they told us the standard of care even now is fingers. So, Yeah, a person suffering for pelvic pain would go to a PT, they would insert two fingers and reach, on the vaginal wall and press the pain points and massage them.

And that's really the that's it. So it's quite simple. It's quite effective. it's no different from having back pain going to a chiropractor and they rest your pain points, right. It's exactly the same thing. So however, it's really hard to get because one, it's expensive because it's not one session, it's three sessions a week for 12 weeks. So that's 36 sessions. So imagine if it costs $100, $200. We're talking about thousands of dollars. Well, and then the time you easily spend 2 or 3 hours going treatment coming back, which is really hard, especially if you have a new kid. Right.

So so what we saw is most, in this case the new mum pelvic pain. Of course, pelvic pain can happen in other scenarios, but in this case, hardly anyone availed of the therapy. And the data shows that 50% of mums after two years still have pain because they don't do anything about it. It's not that they don't want to just they have time, they might not have the resources or they just not might be anyone to go to. But just curious, what's the what's the general thought, prevalence overall how how common is this problem?

Oh, it's, 9 in 10. So nine, 90% of mums will have some sort of pelvic health issue. And it's very, natural. It's not anything uncommon. It's because the pelvic floor carries, let's say, 20 kilos of weight, which it's not used to weight. So there's, you have a lot of, stretchmarks and a lot of stress on. It's just a muscle. So, you know, then you have scar tissue, so you have pain, and it's very natural. There's nothing special about it. It's what is an issue is not doing something. And then the pain becomes chronic.

Right. So then I imagine there's sort of a domino effect in all of the different ways it interferes with quality of life. Correct. Exactly, exactly. So, so one of the things that we're trying to do now is we have just presented a couple of months ago to CMS to create a code to have the pelvic pain device reimbursed. So with the goal of then including it in the new mum box. So when you have a kid in any hospital, you would just get the device. And this already happens in France. so you get the device and an instruction.

It's really simple. It's just like a few pictures. So it's made to be super easy for someone to use without even needing any medical medical help. And then you have the device, you have the instructions straight out of the hospital in the box, covered by insurance. And it's only a few hundred dollars. It's really very small cost. And then you just use it whenever, you know, like ten minutes a day. So we have, clinical research. We show that you have to use it only ten minutes for three times a week, and within three months you have no pain.

So it's a very little time cost and, very negligible financial cost from insurer perspective, especially in the cost of childbirth. And then, you would not have any pelvic pain, chronic pelvic pain, at least for this cohort, which is the new mums, which is a very big one within three months. So so that's something we've been working on for a few years now. It's a very long process, trying to get a code created. And the goal is others with devices instead of it. So therapy would be able to use that code because the code wouldn't be for us.

It would be a code for anyone. So so the goal is just to have more things available that people can use, either straight out of hospital or on a prescription. Well, I would imagine too, there's, you know, probably sort of a silent cohort of people who women who suffer, even if so, there's there's to your point, there's you have to access a pelvic floor specialist. You then have to maybe have insurance typically you have to, you know, women are, you know, fortunately accustomed to having pelvic exams.

But obviously these are deeply personal, types of, you know, you know, encounters, and so there may be even a subset of women who just don't want to talk about it, you know, they don't want to bring it, you know, to the attention of their physician. Yeah. Sexual health is normal at every age. it to an extent, it, you know, to some people, it's, they make choices about the frequency or what have you of, of their intimate relations. But nevertheless, when you're a younger person to be faced with pelvic pain, I imagine that could have all kinds of even sort of societal impacts like divorce rates and things like that.

Massively, massively. And and then so just going back to the device, so we spent the initial years focusing on how do we, perfect the device and the way we do it, and we do this for all our devices is we make, a certain number of products entirely by ourselves. So just in a lab, end to end, the whole thing, we don't, manufacture, in bulk. We don't send it to anywhere. So we do the whole thing in-house. So we set up our lab that way here in UK. and that gives us the ability to make changes very quickly.

So we have, we get to a final product, which is safe for someone to test. We do 30, 40, 5000 maximum, get enough feedback, then we know, okay, we need to change these 20 things. We change a lot of things. And this is not quick. Sadly, with hardware, the button is much quicker than manufacturing. Getting it and then getting feedback and changing. That's really long. You know, that's a very, expensive way to do it, because the biggest issue with hardware is unlike software. So let's say, you know, you build an app, you can put it out there, you get feedback and you fix it and you, you know, send a new one.

If I send hardware out that people have paid for it and it's not good, then that's the credibility gone. you can't say, oh, you know, tell us what is not good will make a new one. And even if you say, I'll give it to you for free, you're waiting at least one year and it just doesn't work in hardware. Right. and I think a really good example was Google Glass, because Google is a software company. And I think it was the first time they did hardware and they launched it and it wasn't cheap. I think it was like, $2,000.

That was not an insignificant amount. from what I remember, the battery lasted 30 minutes, something like that. It was just not, commercial product. So either they could have given it for free for people to test, or they could have waited till the product is ready. But because they released it as a product, which is not really and charged a lot of money for it, it died right. You know, I don't think people are willing to pay that much money for a product which is just for testing. So, as, as hardware people, you know, that's not how we would ever do things.

And also in medtech, you just cannot launch things which are not complete. no doctor would ever recommend it. So, so with medtech, the biggest thing is you need to have spend enough time, iterate before you even ask a doctor to try it. Right. So, so it was five years before the first product was ready. So between 2014 and 2019, we were basically R&D in iteration keep kept building, changing, building changing, building changing. And then we got to a point five years maybe like, okay, this is a good product that we can, go for, FDA, we can, it get all our, certifications like electronics and then start medical trials, and then eventually get HSA and then reimbursement.

So, so we started that with the first product in 2019. And then the second product was for erectile dysfunction because that was and still is the number one issue in male sexual health, with 40% of men have some form of ed. So, so that was the second product.

Clinical Validation, Reimbursement, and Product Expansion 23:00

and then from there we started creating more products based on what, both doctors and patients said were big topics like prostate pain, menopause, vulvar pain. So that's how we decided what to do. and the next two products coming out, one is on period pain and one is on Brisbane. and you have taken a very sort of science, evidence based approach to product development. So you have several published papers at this point. Yes. and that was more I would say, a result of the work we did because, a lot of the studies we do is, one is often inbound as people want to research on areas that we haven't even designed the product for.

So, for example, the Tenuta device, which is for Ed, was being used by menopause specialist to help with, lubrication because dryness is very common. and they were using the front part of the new tool on the labia. I mean, it kind of works, but it's not designed for that. So they said this is helpful for a patient. Can you make something specifically for menopause and for labia? So we then made the got to it. So often what happens is, doctors would reach out to us saying, I want, you know, some devices, I want to do this study.

And then, sometimes they become papers, sometimes they don't. so till now we have eight published papers. ranging from erectile dysfunction and prostate pain, post prostate cancer, the, arousal disorder, anosmia, pelvic pain. So various topics which have been published. And then there's loads of studies ongoing and there are lots of other studies that, people have done just to understand, you know, how it works, which are not published. So the publications often are, you know, it just happens as a result of activity going on.

what we cared the most is the feedback that we get. And a really good example is one of the doctors wanted to test crescendo for period pain, and we haven't designed it for that. So they use crescendo. They emptied the placed it on the lower abdomen. and it helped with period pain. But there were two issues. One is period pain loss. Many hours and the battery life of crescendo. It's not designed for that. It's designed for pelvic pain, which you only need to play ten 20 minutes, maybe maximum an hour.

So the battery life, I think if you run it full on it is to us. But period pain my last three hours for us. So that was one issue. And the second issue was you need to keep it on the, lower abdomen. You need to keep it, touching the body. So with crescendo, because it's not designed to hold, in that position, you kind of to hold it with your hand. and as you can imagine, holding something vibrating for 2 or 3 hours is very, uncomfortable. So that gave us all the feedback which said, this is this is very effective as a vibration for period pain.

But it's not very user friendly. Can you go and make something which takes all these requirements? So that gave us all the data we need to now make the next product. So so often what happens is studies that happen may not lead to papers but lead to incredible feedback, which then helps us either improve the product or make new products. So erectile dysfunction, just as an example, is a very common problem for men with Parkinson's disease. And then being men, they may also have other issues prostate cancer, prostatectomy, benign prostatic hypertrophy that creates other problems for them.

I'm just kind of play, you know, devil's advocate. But there's a point here. You know, we all know about the blue pill, right? Viagra. So they're often ill, and all the other related similar products. So my point is that it seems like they're not necessarily mutually exclusive. but perhaps what you have developed is ideal for people looking for non-pharmacological pharmacological solutions. But also, it seems to me that the device approach does more than simply helping a man achieve an erection in the first place.

You're absolutely right. So we are definitely not. We don't ever see an alternative to pills. We always say we're complementary to you might and obviously, you know, there will be people who can't, who won't pass the questionnaire, for Pde5 inhibitors and, you know, heart disease or whatever. for them, obviously devices is the main solution. But let's say you can take the pill and it works for you. often what we see happens is you can't take it too often, you know, you can't take it more than once a day.

it might give you headaches. There are generally some side effects, so you might decide. I will take it once a week or a couple of times a week, and then I'll. You know, I can use the device as many times as I want. and the second thing is, sometimes down to cost. Cost, devices, you know, one time cost, you will have a three year warranty. You don't really have to worry about it. and pills, obviously there is a cost per pill. So those are the two main reasons why often people, even if they have pills, they'll have the device.

And then the 30% who typically don't pass the questionnaire will buy a device like us vacuum pumps, etc.. So the device, all the devices I would say are complementary to the pills rather than a replacement. Excellent. Okay. So now, you've got a whole, portfolio of devices, you've created avenues for people to either for women of childbearing age who've had a baby to take them home, in kind of a care pack after, their, brief hospitalization, if they, if they choose to, use a hospital for, for delivery.

Is that in the UK or is that. No, this is in the US, but it's still a work in progress we've presented to CMS. we are awaiting decision. And then if we do get the code, we know in October, then from next year we can start to roll it out. Very good. And a code doesn't exist. So it's the first time it's ever been, if it does get created, will be the first time ever. And do you have to, this may get a little technical for the people watching this, but I know, I'm somewhat familiar with FDA guidelines since.

So medical devices have to have a specific clearance. you know, in the United States, I'm sure there's equivalent in other countries around the world. Do you then seek, I think what is it, 510 K clearance for your devices? Yes. So, it depends on the devices. So we fall under the category of, therapeutic vibrator for, genital use. and that category is FDA class two, a 510 exempt. and that's simply because of predicate devices which have existed for a while. and the risk is very low of using them.

That's the reason that is five didn't exempt. So we did our FDA registration a while back for all the devices. The next step after that was having enough users to then get FSA, HSA eligibility to. That happened a couple of years ago when once we had enough data that, you have this 90% rule that you have to prove 90% of a users are using it for one of the categories that FSA, HSA allow. Then, after that, the final step was, applying to CMS to create codes. because sadly, codes don't exist for most of sexual health areas.

So this is this is the hardest challenge. And it's the longest piece of work is creating cause, which in effect will help the entire, ecosystem, because what we hope it will lead to is beyond helping existing companies who already have devices with very few, if will encourage especially bigger corporates who have the resources to create more products in Europe. Going for consumer help, right. So whether it's prostate related, Ed related, menopause related, childbirth. So there is just not enough, devices for these areas.

and most of the work that has to be done is generally surgical, which is typically the lasting last resort. So, you know, how can we do things. So for example, the Malta device that we have for prostate health, the idea is that if you use it when you have prostate, it's pain and you relieve your pain and your healthy, it might, you know, reduce the chances of prostate cancer, which is much better than doing nothing. And then eventually, 20 years later, you have to remove your prostate because that is the only option.

The other element of this, I imagine, again, in my familiarity with how drugs come to market because of our research company, is that, for example, in the United States, Eli Lilly is Donanemab was just recently approved by the FDA. It's the second approved disease modifying therapy for, early stage Alzheimer's disease or mild cognitive impairment due to the underlying pathology of Alzheimer's disease. And what then happens is the that then gets passed over to CMS folks that centers for Medicare Medicaid Services, and they have to do something called a national coverage determination.

And so we're sort of in limbo right now with Donanemab because there's no payer, even though Medicare is probably, I'm sure, what well, into the process of working on that. There's no payer policy as of yet. But the point then is that once that national coverage determination happens, then the private insurance companies BlueCross, you know, Aetna, Cigna, UnitedHealthCare, and, you know, the United States, then they take that national coverage determination and they use that as their their bar, so to speak.

Okay. Here's the baseline measure. Are we going to just go along with Medicare and do the same thing. Or are we going to have our own policy. But it's basically you know, Medicare has to sort of step in first. So I guess I'm asking, are you seeing the same thing with your. Is exactly the same process. So we want to get that created, at the CMS level and Medicare Medicaid, and then reach out to the, let's say the top four who cover 80%, and then get them to get on board with those. So, but I think the second step is much easier once the first step is done.

Now, your devices have very, very specific features. the crescendo device that is pliable, bendable, as you said, to read certain pain points, etc. but I'm even wondering beyond that, when we classify your devices as being medical devices for sexual health in comparison, I'm not sure that you necessarily view other manufacturers as direct competitors. We're not necessarily marketing their device as medical devices, but we do know that there are sexual health devices out there that I can go to my local adult store and purchase or purchase online.

So I'm wondering if you can kind of help the the viewers here see the difference between what you've created and what they could not like. you know, just go on the internet and buy something, you know? Yeah. It's a question we get often from, a customer. That is really good question. And I would say the it really depends on the purpose. So for example, let's say if somebody wants to improve arousal. Yeah. And it's quite generic. and then not that it's not something specific that they need help on.

Then we would recommend they look at the market, look at what's most suitable for them. because a non-medical device, just from a manufacturing perspective is much cheaper to make. So as a result, it's cost a lot less. And that might be the right answer for them. And now, if they have specific pain points that they want to solve, let's say it. Then they need something which will be tailored to their penis, which will give them the right vibration frequencies, which will then create directions or directions to then they're buying it.

And the mindset would be, would I invest, say, $300 on a device, which will help me and adapt to my penis and work for me? or I'm buying pills, you know, like they're then comparing to, medical solutions, rather than, if they buy, let's say, a ring, which is, of course, a good, pleasure product. But the ring wouldn't help them get erect, so then they would still have to figure out how they're getting erect. Maybe they have to buy a pump, and maybe the pump isn't, suitable for them. So it's a it's quite, nuanced decision making process because they first need to figure out, what pain point they want to solve, then do a bit of research on whether or, a toy would be enough.

And it might be, because it would be much cheaper to buy a toy, in order to address the issue, maybe they can get erect easily, but they can't maintain direction, in which case a simple ring which is very cost effective would be the solution. But maybe their issue is they can't get, strong enough or a total erection,

Medical Devices vs Consumer Products 38:00

in which case it's either a pill if it's suitable for them or, any specific device. So. So I think with these things, it needs to be very needs based. because what we don't want people to feel is they buy an expensive med device compared to a toy, and they don't actually need it. You know, like if a 20 year old who has no health issues, emails are saying, you know, which device should I buy? And, I would say, you know, look up Adam and Eve. If all you want is a toy, you'll find a huge range of toys and maybe one of them is good enough for you.

There's probably no need for you to spend $300. Absolutely. Well, and then I'm wondering, because these are medical devices, and again, I just the crescendo is just the easiest one for me to think about and talk about because it it is kind of technical in a way. but it's, it's obviously designed to be user friendly, but, do you if, if I were a customer or a potential customer, do you do your does your company actually provide some sort of online, you know, like consultation whereby, hey, if I call a customer service line or I use, a chat, you know, an online chat, and they say, here's the problem I'm trying to solve.

Is this right for me? I want to make sure I'm using it properly because it seems to me with this device and similar devices you have created, that there is an element of proper use, not necessarily. If you're using a properly, you're going to have some danger. I, I'm very unfamiliar with the devices. You know, there's absolutely no element of danger whatsoever. But I want to get a certain result. Right. So, what kind of guidance is Mystery Vibe offering to customers. To, there's quite a few elements to it.

a lot of the users get the device, either post consultation with some doctor and they'll say, you know, go buy it or, you know, here's you can buy it straight from the clinic. in which case they've got the training. And the training is really easy, like the way we've designed it. all our instruction is one page, you know, like, literally and a few diagrams. It's designed for somebody who has no technology, has the patience of 10s. You know, it's like, turn it on, bend it and apply it at it, because we know that the more complicated we make it, the more the less people will use it, right.

So so that's one of the biggest things about our product design is every time we have, our customer ticket review, which is once a month, we try to figure out any issues that keep coming up, which we can address through the next design change. So, so over ten years, we've tried to make it easier and easier with buttons charging. You know, every little element. So, so so that's part one, which is if the if you see a specialist, whether it's your guy or whoever, then they will give you a certain amount of instructions, they'll give you a leaflet and you'll know what to do, if you're buying it on your own.

so our each product page has a lot of animations because we find us the easiest way to explain, with animations, you know, showing how, you would put it on the penis and the vagina. It's just animations, not, real images. And that gives people a good idea before they decide whether it's right for them. Because what we don't want is people, buying it and then realizing, you know, this doesn't work for them, because then that's a very poor experience. Then we obviously, have a money back. 30 day money back warranty, because one of the biggest issues in Europe game is because it's an intimate product.

You can't. And especially in our area of medtech, we can't reuse anything. So, you know, we we rely 100% on trusting the customer. So we do not take it back because it is simply, you know, it's simply wasted. Like we would not be able to do anything with it. So right. Until we just refund the person if it if they don't, if it doesn't work for them. And we know that like, even when we look at dimensions, penis guts, vaginal dimensions, etc., we know that it will only work for 90%. It won't work for 10% because it's just the way the design is done.

Because if we try to do 100%, it would be too big. and it just wouldn't work for the majority. So the and we know from our hundreds of thousands of customer data, we have less than 3% who, who it doesn't work for. So it's a very small percentage. And we have we don't ask any questions. We totally understand. You know, it's not it doesn't fit your body. It's totally fine. You know, money back. So that's something, which we felt is really significant, especially when it's online. And you have to make a decision without touching and feeding the product.

And it's really hard. and it's something that you can't really, like, we can't do anything about when it comes to, sexual health. You can't. I can't reuse anything. You know? So, you know, we can't just take it back. We have to refund them. So. So that's the second piece. The third piece is, yes, we have a phone number. we have email. And, some people do call and some people do email about questions, but anything medical. So let's say, you know, somebody email saying, you know, I have a pacemaker.

Can I use it. We wouldn't advise. We would say, you know, you need to talk to your doctor and they need to tell you whether you can, because that gets really complicated. You know, we would not we will tell you, you know, this is how you use it. This is, all the benefits. These are all the, use cases of, health issues that you can apply it. But when people email us for medical questions and we don't have that set up where you know, we can pass it on to, like a telehealth service, but and it's something we should look at.

if there is enough people contacting us about medical questions, then we would say, okay, here is, telehealth provider who you can ask these questions to, but we as a company do not, we say it's a. Session per se, and that, you know, I will say I obviously am a physician. I'm a neurologist. And, well, there's always going to be a certain percentage of people with pacemakers because heart disease is, you know, so very common in the Parkinson's population. You'll have people with deep brain stimulation.

And I will say, as a neurologist, I'm unaware of any contraindication to using, a device around the pelvis that really just provides vibration and it doesn't provide any sort of electrical charge or electrical current, and it's covered in silicone and so forth, that there would be any danger. From my perspective as a physician, you know, we can say certainly talk to your doctor, on, you know, to get your personal guidance on this, but I would doubt, that any physician would say otherwise. now, as we wrap up, you have a website.

We're going to mention that, but I was just curious. oh. Are you doing any distribution through, say, durable medical equipment companies, other, you know, are they being stocked in, you know, in hospitals that keep things like, you know, walkers, canes, various other devices that they can then provide to patients, whereas it's strictly the website at this point in time. So, it's used we used to do B2B distribution prior to Covid. Then we had a severe shortage

Distribution, Support, and Closing Remarks 46:30

of stock for a while, and we had to give up all our B2B work for a couple of years. And we just because we didn't have enough stock. and now we have caught up on all of that and we have managed to build surplus inventory. So now we are exactly at that point where we are looking at distribution again. So definitely to me, that's the real way to reach patients, you know, where they go to a doctor and they know the solution right away. So that's where I want to be in the next year and beyond. the reason we did DTC, originally was to get customer feedback directly because the biggest challenge would be to be is we do get feedback from the doctors, but it is, rare to get that feedback.

So it would be at a average level, you know, there's a general feedback. And of course doctors are busy. And, you know, we might get to talk to them once a month or less. Right. and mostly I get to meet them at various conferences rather than, you know, have a call with them. So the biggest benefit we had of getting so now we have 150,000 direct customers, who we can email and who email us or call us, you know, and we get such incredible feedback, not just about what they have and using, but about a new product we are thinking of.

I think, you know, would would this be useful and would you, or the way we have thought of it, do you want us to do anything differently? And so that's the bit that we felt was really important early on. because we were creating devices which, didn't have any, any, you know, any, any reference point. So like, legato is a really good example. it's a labia vibrator and there's no such thing. It just doesn't exist. Labia vibrators have never been made before. and we only made it because, the menopause specialist were using computer and said it's useful.

Can you make one? we hadn't even thought of it. So, you know, it's that rare. So we like to get feedback because then we can make devices which we haven't thought of, which might have significant value. So. So the DTC element, which is the website sales, which has various channels like Walmart, Amazon, etc., so it's all online. And then some of the element is the permission. And then they recommended, I think they stock it or they tell people to buy it. but the next step, which ideally is in the coming months, is to find the right distributor to get it into a lots of bottle clinics nationwide.

That's what we want to do. Yeah. So as we wrap up again, Dr. Soum Rakshit, this has been an excellent, very informative, very important conversation to have. You know, I spoke with another sexual health expert as part of this summit, and he said, you know, too often physicians do not include questions about sexual health in their general screening with their patients. And maybe there are many patients who are also very embarrassed or not comfortable with bringing it up spontaneously. So we do need to have these conversations.

He is the co-founder and CEO of MysteryVibe, so that is the website MysteryVibe. yes, that is our company site. And they can also go to mv.health which has all the health information and the product. So mv.health is our main health care site. And then MysteryVibe.com. Yeah. Is our company site. So so mv.health is the health care site MysteryVibe.com is the company site. Well, Dr. Soum Rakshit thank you for doing this very important work and helping so many people. I just want to say that we really we really have kind of a silent epidemic.

insofar as many people are many, probably many people are suffering, who don't know that they can ask, should ask, should seek help, are uncomfortable seeking help. There are doctors uncomfortable bringing this up. And and so we really want to open up the conversation and and really reassure people that, you know, what I say is this is human health. You know, we are all humans, doctors, nurses, biomedical engineers. We are all human beings. And we encounter the same challenges and our own personal lives as everyone else.

And so by having this product or this line of products available, you have definitely helped many, many people. Thank you so much. Thank you.