Innovating Women's Health: Addressing Pelvic Pain with HYIVY's Floora Device

In this episode, I spoke with Susan Stover, Director of Marketing and Sales at HYIVY, a company focused on improving female pelvic health through innovative solutions. Susan discusses the company's origins, founded by Rachel Bartholomew due to personal struggles with pelvic issues such as Endometriosis and radiation-induced vaginal stenosis. Susan introduces HYIVY's groundbreaking device, Floora, which offers controlled, automatic dilation and heating. We dive into the significance of integrating clinical feedback, leveraging patient data, and the potential future enhancements for Flora. Susan highlights the importance of addressing chronic pelvic pain, a pervasive yet often overlooked issue that affects many women. We also discuss ways for viewers to participate in focus groups and stay updated on the product's development.

For more information, check out: https://hyivy.com/

Timeline:

00:28 Introduction to HYIVY and Susan Stover
01:02 Rachel Bartholomew's Journey and the Birth of HYIVY
02:11 Understanding Pelvic Health Challenges
03:02 The Problem with Traditional Dilators
07:04 Innovative Solutions by HYIVY
11:11 The Floora Device: Features and Benefits
17:38 Future Prospects and Clinical Trials
23:24 How to Get Involved and Final Thoughts

Transcript

Hi there. I'm here today with Susan Stover, who is the director of marketing and  sales for High IV, which is a new company focused on female pelvic health. Like so many companies, it's founded because The founder had an issue that wasn't being served by the medical community. You know, I think their story highlights how antiquated some of the technology that we use in women's health is.

And I want to talk about what they're doing now. And then also kind of their vision for the future, because they have a pretty grand vision about all the things that they want to make better. So welcome Susan. I'm so happy to talk to you today.  

Great to be here.  

Um, so high IV was started by Rachel Bartholomew who had her own pelvic issues, right?

Endometriosis,  bartholin cyst, cervical cancer at a very young age in her 20s, and then that was treated with radiation therapy. And I, I don't think a lot of people  No, what radiation does to tissue, it will treat the cancer, but it dramatically changes those tissues and in many different ways. But one of the things that it'll do to the vagina is it makes it much less elastic and it, it kind of shrinks everything.

And so it can cause  dramatic effects for a young women and can make the vagina, you know, uncomfortable and, and difficult to use. And so do you, do you want to take it from there? I mean, she had these. Pelvic floor issues, vaginal issues,  and then came up with a solution because the solutions we were offering her weren't quite good enough. 

Yeah. I've talked to over 200 women in terms of, uh, their pelvic health. And I always start with the question, tell me more about your pelvic journey. And like Rachel, it's never an a plus B equals C. It's always. Kind of this ping pong journey of, Oh, well, I had this issue and then I had this other issue.

And then, you know, now I'm living this sort of standard of life. Uh, so I, you know, when you mentioned like Rachel's early experiences with Endometriosis, which can cause, you know, extreme pelvic pain, uh, Bartholomew glands issue as well. Like she has. Navigated that medical system, but really when she received the radiation and like you mentioned, uh, experience that radiation induced vaginal stenosis. 

So that is essentially, you know, the narrowing of the vaginal canal, the buildup of scar tissue. She was handed, you know, this 84 year old device that essentially looks like a. Um, a cylindrical device, it's hard and plastic. And to be quite frank, it looks like the outside of a penis and not the inside of a vagina.

So for that pelvic floor, 

can I interrupt you for a second? So when someone has vaginal stenosis, that's, that's what we typically do, right? We give patients dilators. And we give them super skinny dilators and, you know, the smallest one can be about the size of a pencil because things can stenosis down that far.

And then you're supposed to use that and then gradually use bigger and bigger ones to increase the diameter of the vagina. And so that's what you're, you're talking about those dilators and you're right. They've been around forever. 

Yeah. 

Forever. 

I think the thing is about the, the dilators, like you mentioned, the way I like to explain it is like, uh, imagine you have like a sore muscle, like, you want to make sure that you stretched out.

Right? So, I think a lot of people, when they think of pelvic health, uh, and I mean, there's a whole spectrum of different public health issues. I think they think of kegels. I don't know if you've, you've like, heard that whoever did the PR for kegel exercises at some point, like, that seems to be specifically for people with vaginas.

That seems to be what they're talking about. Yeah. 

No, I think that's true. Right. And even when people have painful muscles and their muscles are too tight, that's what everyone kind of defaults to. And they think that strengthening the muscle will always help, which it does not. Um, and I think. I think the female pelvis is just a huge mystery to most people, right?

And there are so many symptoms that can happen. There are so many things that can cause those symptoms, and it causes many women, like you said, to go on this journey of trying to figure out what is causing their symptoms. 

Kind of broadly, uh, the way that, you know, these,  Sort of conditions are categorized, let's say, is we've got hyper tenacity where those muscles are super tight and you have that shortening and narrowing.

And then you have hypotenosity where those muscles are, are, uh, weekend and they're unable to support the, the organs in the, in the pelvic cavity. So kegels can be great for folks who have that hypo tenacity. Right. But we're looking at this entirely different side, which I think is. When I talk to clinicians like you, Sarah, like we, when we had an introductory call to get to know each other, there's this immediate recognition of like, this is a huge issue.

It impacts the quality of life. It is. You know, it can be devastating and, but in the sort of general sort of culture of how, when we talk about pelvic health, it's not as well known because a lot of women are living with that stigma and shame and aren't necessarily being able to go to their clinicians with,  you know, and their clinicians aren't, they're not being able to go to their clinicians with, let's say, objective data about their pelvic floor and their clinicians don't have that, uh, data as well.

Like, what is the standard of how? tense your muscles and your pelvic floor should be like. And when we talk about chronic pelvic pain, so that's when it lasts for six months or more, this can be constant or intermediate. So it can be really difficult. I think if you're not necessarily thinking about your pelvic floor, which I know I wasn't before I joined high Ivy, cause I've been very lucky to not experience these issues.

It's it performs these autonomic. Sort of functions, right? I'm not thinking about, uh, you know, holding up my pelvic organs. I'm not thinking about relaxing my pelvic floor. So I don't experience pain. I've heard, you know, from the patient stories we've heard once it starts to affect it, it's like, Oh, what is this?

This new sensation that I'm feeling and being able to make those correlations between activities and, and when it flares up. And if you have an underlying diagnosis, which, you know, there's over 51 conditions that are related to chronic pelvic pain. 

It really is hard to. Tell right and when you do have tight muscles, sometimes you have pain, sometimes you can have bladder issues, sometimes it can be hard to empty.

Sometimes you can have more leaking, you can have bowel issues pain with bowel movements. I mean, there's just so many different ways that can impact you. And, and I think it's, It can be very difficult for women to get from, oh, this is my symptom to, oh, this is a, this is a tight pelvic floor. 

Yeah, yeah. And I mean, going back to Rachel's story, when she looked into, you know, what is this dilator that I've been handed?

What is this condition? And I know on your podcast, you've talked about, like, there are a lot of, you know, there's pros and cons to social media, but how she found her way into this was, was going on support groups. And. The correlation between her condition and other folks living with chronic pelvic pain and being handed these dilators and being given, let's say, like, very little instruction or not adhering because the actual stretching and the dilation of the pelvic floor has been clinically proven to.

Decrease these symptoms of pain and pelvic pain, but the adherence rate is abysmal because again, going back to that objective data and, you know, having a sense of like how to even track as a patient or clinician, whether or not this is working is, is a, is a huge sort of data gap that we have in the pelvic health industry.

It's hard to keep doing things that are uncomfortable, right? And, and stretching out those muscles. I mean, you know, we started by talking about radiation and we do use pelvic dilators for, um, to stretch the vagina after radiation, but we use it for a lot of other things, right? Tight muscles, um, sometimes after surgery, we'll use it if things are too tight.

Um, but, but it is, I mean, you're absolutely right. We talk about how to use it with patients and then send them home with these dilators. And there are always, you know, questions about how to use them. You know, it's, it's a time where someone really needs a coach and a lot of support that we don't do a great job of providing in physician's offices  and, and it's uncomfortable, right?

And so it's, you know, when something is uncomfortable and you see a benefit, but it takes a while to see the benefit, it's really hard to keep. Keep doing that.  

And I think also, you know, like, we find them in the pelvic floor industry. We see a lot of direct to consumer products, right? That, you know, may or may not have efficacy, but  I don't know if you find this, but, you know, I've spoken to public floor physiotherapists or gynecologists, et cetera, or, you know, have, like,  Closet full of devices that either, like, reps have come in with, or patients come to them and ask them, like, should I use this?

But if you don't have the clinical data to support that, if you don't, if you haven't kept up on the, uh, the latest research, if if this company isn't offering you as a clinician, the kind of, You know, informed clinical study results that you would want to rely on, then how do you advise your patients there?

How do you direct them? Other than, you know, going out of your way to maybe anecdotally collecting, uh, the results or being like, well, it worked for this 1 person, but they don't necessarily have your condition. No, 

I mean, you're right. It's a guess. And when people ask me what they should buy over the counter, if it's for strengthening, I always tell them to buy the cheapest one, right?

Whatever's on sale because there isn't any data. I can't say 1 is better than the other. Um, so, you know, if there's something about it that appeals to you, you should get that. The other thing that I would say is, you know, you're, you're right. There is a lot of direct to consumer. And I think if you have incontinence, it's okay to try a pelvic floor trainer.

But if you have pain, I would say, no, it's not okay. You know, that puts you into, oh, you're complicated and, and you need help navigating this journey  because strengthening, you know, your pelvic floor can make things  much worse. Right. And can really aggravate your symptoms. And then. Yeah, it's, it just, it's hard for women to figure out where to go from there.

So, do you want to talk about the flora and how you change this device, right? Because dilators right now are, are very primitive, right? I mean, they are just rods that you put in the vagina and, you know, you, you put pressure and stretch the tissue. And that's it. 

Yeah. Yeah. I, and I know like this isn't a visual medium.

I know we're both kind of making motions with our hands, like try to explain what it looks like, but I just say, imagine a sort of Russian doll model of like increasing sizes of width and length of these tubes, essentially these long cylindrical tubes. That's what we currently have. So high IV health is currently developing a medical device called Flora that you mentioned that actually uses, um, gentle dilation.

Control dilation without reinsertion that uses air within the pelvic floor. So, as opposed to being a straight cylindrical size, it's actually ergonomically designed to fit into, uh, the vaginal, uh, entry of the vaginal vault. And, uh, that is. I think 1 thing that we  noticed with, you know, like, wanting to, to innovate on the, on the, um, device, but we've gone further than that.

And we've looked at different, um, possible solutions, like heating. So, within our 1st FDA, uh. Application we're going forward with the device that has this auto dilation as well as heat. So actually heating up the device to around body temperature before it's inserted because you can imagine if you have pain or you're reactive.

If you're inserting something that's cold, uh, that Necessary that can put back your, your, your routine. Um, and like I mentioned before, we want to make sure that we're integrating actually the clinicians into the equation. So, this flora vaginal dilator, the patient, it is prescribed for will be prescribed for at home use using their patient app that actually connects to a clinician software so that you're able to actually remotely monitor your patients.

And. This is the first step in what we want to have, like you mentioned are kind of like grand visions, but we're also looking at future applications when it comes to cooling, as well as looking at this, you know, the, that the shaft of this vaginal dilator that we have is kind of a real estate for sensors.

We talked, like I've talked to so many different researchers or clinicians that are just so excited by the prospect of, oh, would we be able to monitor X, you know, we'll be able Look at X, Y, and Z. So we're, we're really excited at that. And also looking at, uh, integrating intervaginal medication. So kind of like a Keurig cup sort of style where you can insert it and deliver that lubrication as well as, you know, a lot of folks with pelvic pain thing, use things like, um, you know, intervaginal estrogen, et cetera.

It really is, you know, pretty, pretty brilliant. Vaginal applications aren't, aren't easy. There's so many things I like about this, right? I think about, you know, when I do hot yoga, how much better I can stretch out my muscles. So I think the heat is brilliant. I think not having to reinsert and having the dilation happen automatically is, is pretty great.

But I have a question about that. If it's dilating and it's painful, there's a stop button, right? 

Oh, my gosh. Yeah. Okay. Yeah. Yeah. It's uh, so this is actually, it's completely user controlled. So it's, uh, the, the patient has control to increase or decrease, uh, at any time. Cut it off at any time. I 

just think that's so important, right?

So that you can increase it and then be like, oh, wait, that's a little too much. Let's go down 1. let's wait a few minutes. Um, and then go on and also the, the hand control, right? Because having, you know, kind of the straight dilators, you have to have really long arms to do that. You know, kind of gracefully.

And so this device has a curve on it. So you can actually hold it and and see the controls. Right. And, um, you know, that just makes things so much easier for so many women and then so you said there was an app with it. And we talked about how a lot of people need coaching as they go through this. I mean, what can women do with that app? 

What's incredible about developing the app and  speaking directly to pelvic pain patients, because that's one of like, you know, as the marketing  lead at high Ivy, that's genuinely my prerogative is to make sure that we're speaking directly to pelvic pain patients and clinicians who treat them to understand that we're not just creating anything based on assumption.

So asking them what they. Uh, saying what do you want isn't necessarily a marketing savvy, uh,  approach to it. You kind of have to understand the granular experience of their life. Like, what don't you like about currently dilating? What, what are, what are these, 

you know, what are your pain points,  

all of these pain points.

So, you know, bringing it to women and showing them, okay, You can actually schedule in what days that you want to dilate. You can connect directly with your, your clinician. You can access education. You can essentially have a, you know, how you're feeling emotionally, how you're feeling physically, and look at that data over time.

So, being able to track their progress. But I will say, Sarah, one of the. Like, kind of amazing things of, like, 1 of the focus groups we did was, you know, we were thinking about all these savvy things that we can put into it. We're looking at all these different kinds of apps. And we had a group of women who were like, I'm just so grateful that we have a calendar.

So, like, I can use this calendar. I can use this app so that I can help myself where it's like. Oh, okay. So that's really where the bar is on, like, 

it's pretty low, 

doesn't, doesn't exist. So we're really excited to offer, uh, you know, those features kind of with version one, but as we move forward with, you know, Flora and seeing that we're, we're definitely going to be dynamically responding to what features that we, we include.

So if I had questions like, Oh, I dilated to, you know, this level and, and I left it for 10 minutes and I don't know if 10 minutes is the right amount. I mean, can you get answers to those types of questions that, you know, just very basic help like that? 

Yeah. And I think for us, like, again, you know, being a pre market device, there's so many, uh, unknown unknowns where.

I think for us, we're going to be, you know, for indications for use, we're going through our first clinical trials with cancer patients, as well as endometriosis patients. So looking at things like 10 minutes of heating and 10 minutes of dilation, right. And seeing like the efficacy there so that we can actually build enough data to say to clinicians being like, we recommend for, you know, your Endometriosis pelvic pain group that they do this.

X amount of heating, X amount of dilation, X amount of days a week. So being able to have that built in where a clinician on their side for the software just clicks a button being like endometriosis program, send that to their app so that you're not having like, again, as a medical professional or provider, it's not your job for us to be able to, to, you know, Advocate for how they use it, but for us to actually bring that evidence based suggestions 

and then I'm assuming once it goes on market that you can collect data from the devices to to to show how it works in the real world. 

Exactly and potentially, I think 1 of the things we're most excited about as well as being able to leverage those sensors to understand the difference between voluntary and involuntary muscle contraction. Right? So, if you have somebody in that dilation mode where, you know, uh, understanding why on Tuesday, I could get up to level 7.

And I was fine, but today level seven kind of hurts and I'm, I'm, I'm not sure why I'm looking at all the factors that kind of relate into that can help both the patient and the clinician. 

Yeah. Well, and it's so important, right? Because this chronic pelvic pain group is a very forgotten group of patients.

And I think they know that it's hard to find clinicians who are good at pelvic pain. Um, and we, You know, we definitely need better tools to treat women  

and isn't it, I just think it's so amazing that it's such a forgotten group, but it's not a niche group. It's not a small group. No, it's 

not a small group.

Yeah. Like I, I know where it's at. Yeah. Like, so when you talk about it to people that don't know, they're like, Oh, it must be, you know, it sounds like it's something where it's like, Oh, we're addressing this kind of small problem, but you know, Endometriosis is just as common as diabetes. And that's And, and, uh, you know, I'm based in, we're based in Canada, uh, but we're looking to launch in the U S as well as Canada when we release our, our product.

But a recent report showed that one of the top five reasons for Canadians to go to the emergency room was pelvic pain. Yeah. Right. So it's, it's such a, it's such a pervasive issue.  

And that's so sad, right? Because if you go to the emergency room, I mean, the emergency room is very good at treating emergencies.

They're not good at treating chronic issues, right? So you're not going to get the right help. You may or may not, but probably not are going to get the right referral, right? Cause they're just making sure that you're stable at that point in sending you home. And I think it also speaks to, you know, how very.

Desperate, these women are and are looking for help, right? I mean, who wants to go to the emergency room? You have to be really uncomfortable to go to the emergency room. 

No, I mean, like in Canada, that's not like a, a first response. That's not how our healthcare system, but if you go to your GP repeatedly and they don't, you know, they might.

Refer you to, you know, a gynecologist, and you kind of have to roll the dice there. If the gynecologist has connections with pelvic floor physiotherapist, which I will say is getting more common. Like, I will say, like, you know, the people reaching out to us, like after finding out about our, what we're doing are these gynecologists who either work in a hospital that's associated with a pelvic floor physio clinic, or they just have their favorite pelvic floor physiotherapist in their area that they refer out to.

And it's, there is a, a symbiotic relationship there. 

Yeah. I, you know, clinicians really like algorithms. I mean, you, you mentioned diabetes. We like knowing, Hey, when a patient comes in with this, this is what we do. And I think what, that's one of the problems with pelvic pain. A lot of clinicians just really aren't sure what to, what to do.

And, you know, the great thing about this device is pelvic floor physical therapists use dilators as well, right? So it will help so many people. It will also help public floor physical therapists to do their job and to help patients. Are you  thinking about, so in the United States, um, physical therapists can do pessaries now.

Would you, I guess they can't prescribe, I was going to ask you a physical therapist could prescribe this device, but they can't prescribe. Can they  

no, no, they can't prescribe the device. So again, this is like, you know, moving into the system. This is why we want to connect all the clinicians and like, really understanding like that, that network.

So like, it's essentially like, uh, you get this prescription, you can bring it to your, your pelvic floor physiotherapist, get it shipped to their office. They're the ones who can, um, yeah. Yeah, do the 

hands on teaching hands 

on stuff, right? So it doesn't add like necessarily that friction of like, you know, you have to like, have it sent to your doctor's office and go there or, uh, et cetera.

So, um, for right now, pelvic floor, physiotherapists can't prescribe it. But again, it's like, it's not quite on the market yet. So, right. 

When will it be on the market?  

So we're looking at, uh, next year for 2025. We're looking at doing our first pilot, uh, somewhere. Uh, we're not sure which state yet. We have a lot of different, uh, folks that we're looking at essentially to prove out these, like the first sort of efficacy of the device.

Um, 

if someone wants to look up the device and get more information, where can they find it? 

Okay, so our company is high IV, which is H. Y. I. V. Y. Uh, and that's high. I. V. dot com. We're also at Instagram at high IV health. Uh, and you can reach out directly to hello at high. I. V. dot com. We are currently recruiting specifically pelvic pain patients and clinicians who treat pelvic pain who might be interested.

In participating in focus groups, online surveys, uh, for clinicians, specifically, uh, potential, you know, clinical trials or pilot sites. Um, so whoever's interested, um, reach out to us through through those platforms. 

I, um, I, you know, I really like this device, but I think more importantly is the, the work that you guys are putting in right to really make it the right.

Device for the most amount of women.  

And I think that's something that's particularly unique. Um, in the fem tech and women's health industry of, you know, you mentioned at the top of this call about, you know, Rachel being a patient solving her own problem. And I think that's the unique approach of this industry is that, you know, it's not coming from a perspective of how can I potentially improve on a current technology, but it's, how can I make something that will help people?

Yeah, I think when you come from that place, uh, even if you're not a clinician, you're like, well, how can I help you help other people? And I think that, you know, as opposed to a top down, it just, it is something that I think is, if you can't,  You know, critique that in the same way, like, you know, like where it's just like, there's, it's, it's so well thought out and then being able to like develop it from the ground up.

And I'm so honored to hear people's stories and, and, you know, be able to bring that back, you know, again, but everyone who's, who participates in these focus groups and, uh, surveys, it's completely anonymous, but just being able to go back to the engineering team and tell someone, you know, like, this is why we're doing this.

Yeah. I mean, the stories are amazing, right? Because pelvic pain is debilitating for many, many women. Yeah. And, and there is a lot of work to be done and I'm so grateful to you guys for, you know, working on this huge issue. 

Well, thank you so much for having me.  

Yeah, I really appreciate your time.