Kim (00:02.078)
Welcome to this week's episode of Between Two Lips. I am joined today by Tracy McNeil, who is the CEO of Materna Medical. That's correct, that's the correct position, right? Yeah, yeah, I'm really excited to have you and learn a little bit more about this amazing company and product, soon to be products that you have created. So can you start out by telling us a little bit about your background and what led you to...
Tracy MacNeal (00:13.659)
That is correct. Thank you so much. Happy to be here.
Tracy MacNeal (00:22.995)
Yeah.
Kim (00:30.562)
pelvic health, but then also specific to the niche for the one product that we're gonna talk a lot about today, the Millie.
Tracy MacNeal (00:37.883)
Yeah, so, well, I am a chemical engineer by background. I'm just an engineer lost in a healthcare world.
And I've spent 25 years now commercializing healthcare products, medical devices pretty exclusively over the last 15 years, and that's really my specialty. And so I had not been thinking about women's health, I mean I'd been thinking about women's health on and off that whole time, but was working in orthopedics and endoscopy and other areas and then I got a call from Materna Medical. So I'm not the founder of Materna, I'm the commercial CEO. So it's a bit of a relay race.
And I just, every time I talked to a new person in the process, I just got more interested. I had never heard of a lot of the issues that Materno was dealing with. And the more I looked into it, the more interested I got. The people were really nice. The products were really impressive. And I couldn't believe the size of the market and the lack of competition. It's an interesting, and that's really why I took the job. Now when I, you know, four years later, I have to say it's the most rewarding job I've ever had by a lot.
and I love working women's health. I've learned so much. I love working with people like you. It's a gorgeous ecosystem and we're all in it to try to make things better for women.
Kim (01:58.154)
Yeah, amazing. I love that. And so many people that I speak to, some of them are pelvic health professionals who kind of had their own personal story that led them down the path of pelvic health. And then people who may work in the field. I just actually recorded another episode with a fellow named Derek Sham, and he's innovating in the space of pessaries. And he saw his grandmother going through pelvic organ prolapse, and that's kind of what led him there. And then the realization of...
how big the market is, how underserved the market is, and how many different sort of pathways within pelvic health we can influence and tackle and address. So tell me a little bit about, well, I guess maybe start with Materna Medical. What does the company do? And then we'll start to get a little bit more niche down from there.
Tracy MacNeal (02:29.025)
Oh, I'd reserved.
Tracy MacNeal (02:40.187)
Yeah, absolutely.
Tracy MacNeal (02:49.815)
Yeah, so the company is an OB-GYN platform of medical devices and they're called dilators, vaginal dilators. A lot of people have not heard of them, although your followers might know more about them than the average. So our first dilator to hit the market is called Milly and you can look it up at HelloMilly.com, M-I-L-L-I.
And it is the only expanding vaginal dilator on the market. And so the standard of care for vaginal dilation and for vaginismus, which is the high tone pelvic floor disorder, I'd love to spend a little time talking about what vaginismus is, because I think a lot of people really don't know, and it's incredibly common. So part of what gets me up every morning is helping reach the, we think, so ACOG estimates that up to 17% of US women have vaginismus.
Kim (03:32.142)
Please.
Tracy MacNeal (03:42.941)
perfect fit.
So we'll come back to that. But the standard of care essentially is a series of dildos that you insert to try to open the tissue back up when it's locked down. And the primary symptom of vaginismus is that sex hurts or is impossible, and kind of wanted penetration, tampons, fingers, penises. So we thought that it would be better to have, because insertion, penetration is
for these patients having multiple things you have to insert that hurt more each time because it's a bigger size. We felt like it would be better to have a dilator that goes in about the size of your pinky and then expand it has slender arms inside it that expand a millimeter at a time, millimetre.
at the patient's discretion, and so you don't have to take it out in order to go to another size. And it's really gradual. It's just an obviously more comfortable product. Our hope is that patients find it easier to use, less embarrassing, it looks a little more like a sex toy, and it's in a discreet case. It has a USB charger, and it's just trying to level up, you know, those old school dilators are like medieval era technology.
Kim (05:07.246)
I'm going to go ahead and close the video.
Tracy MacNeal (05:08.118)
we can do a lot better for patients now.
Kim (05:10.634)
Yeah, yeah, there's a common thread in the people that I'm speaking with lately about the, the archaic nature of a lot of the therapies and devices and products available with regards to pelvic health and using new technologies to innovate is, is creating, as you just mentioned, opportunities for things to be more accessible, easier to use, more effective even.
Tracy MacNeal (05:34.115)
more elegant, more respectful. I feel like there's more dignity also, like a set of dildos in a bag that you have to use. I mean, it's not sexy. And given that it's such a mind-body issue, like so what we know about, we've got about 4,000 people using Milly now. And what we know is that they tend to blame themselves.
Kim (05:36.332)
Yeah.
Kim (05:44.69)
Mm-hmm.
Tracy MacNeal (06:00.995)
Are they often think they're the only ones, that this is some rare, fringe thing that only they have? And because it's in such an intimate part of their lives, it's really hard for them to not blame themselves. Like something's wrong with me, I'm broken, those kinds of thoughts are pretty common and those are very counterproductive thoughts for relaxing.
And ultimately what you're trying to do is relax and love yourself enough to enjoy sex with your partner and it's difficult. So part of what we're trying to do also is help people feel even more relaxed about all
Kim (06:41.718)
Yeah, yeah, it's such a, it's so common I hear all the time that people are told they may have, they may not even be told the term vaginismus, we're going to explore that a bit more, but it's just too tight pelvic floor, overactive pelvic floor muscles, and they just need to learn to relax and telling somebody to just learn to relax your pelvic floor, which is a part of the body that they've really probably never been given any information or education about is really, really challenging. And so yeah, so what you're talking about, I hear.
all the time that they've done, there's shame associated with it.
Tracy MacNeal (07:13.595)
Yeah, and it's kind of surprising to me that healthcare practitioners say things like that. Like if you had an overly active shoulder that's causing you neck pain, you wouldn't just say to the patient, just relax. Like that's not the standard of care for chronic neck pain or chronic back pain, right?
Kim (07:32.526)
Totally.
Tracy MacNeal (07:35.747)
So that's another reason why I'm so grateful to be on your show and I'm such a fan of your work and really appreciate it because it's not just in this part of healthcare, medical device companies can only do so much. If the curriculum in medical school doesn't really cover these conditions and doctors aren't clear about it or they maybe just don't know and then they do say things like that or they just refer the patient out, we can do better
to get the message out.
Kim (08:07.042)
Right, right. So what is vaginismus as a start? And then another term that can sometimes be in that same realm is vulvodynia. So what, maybe you can describe the two and how they differ.
Tracy MacNeal (08:24.359)
Yeah, so actually it's worse than that. I think there's like a hundred, there's actually a nomenclature. There's like a hundred and eighty different terms used interchangeably and incorrectly in this field and
Kim (08:28.758)
Disparundia is another one. Yeah.
Tracy MacNeal (08:42.347)
the Urogynecology Association is working on a nomenclature project to try to clean this up, for which we are all very grateful. So vaginismus, it's not my favorite term, especially since no one's ever heard of it. It doesn't help people who have it self-identify. Like if you have a migraine, you know what that is, right? Oh, this is a migraine. So vaginismus mostly is a secondary condition.
that happens in response to a primary condition which causes sex to be painful. So that could be, so sex can be painful, sex is painful for three out of four women at some point in their lives. You know, when you have a yeast infection, sex doesn't feel good, you know, that's, that's dyspheronia, is painful sex.
when it goes on for a long time, when it's more of a chronic condition, then sex starts to be painful for long enough that the pelvic floor itself begins to clench up involuntarily when the patient's thinking about, when the person's thinking about having sex. There's also a level of anxiety about it. So the symptoms are both pain and anxiety and pain or impossible penetration. And those muscles are strong, you know?
So that's what vaginismus is. The primary conditions that are most common that cause vaginismus are menopause. So as the tissue's drier and thinner, that's normal, can be treated with estrogen. Not everybody wants to use hormones and not everybody can use hormones. But while that's going on, that can cause vaginismus. So patients will end up with, bless you.
Kim (10:26.658)
Sorry, excuse me. I just had a sneeze.
Tracy MacNeal (10:28.571)
Patients will end up with pain from the dry tissue, but also a size problem. And part of what we're trying to do is get the word out that you might have both. So double check, if it hurts to even, if you find yourself feeling anxious when you think about it, just consider that Millie might be something that can help sort of get you back in the game.
Another group of folks that end up with this issue that also gets confused is cancer patients. So there's about five million people in the world, in the country, at any given time, recovering from cancer.
So radiation is delivered vaginally often for pelvic cancers as well as chemotherapy puts women into a sudden menopause pretty often. So they'll end up with the same kind of thing. And so getting back into your sex life after cancer treatment can be really challenging and Millie can help with that.
Then, you know, I would say there's a big group of folks that I would just call pelvic pain patients that could be endometriosis or fibromyalgia or fibroids or Crohn's disease. You know, there's a lot of things that can cause pain over a long period of time. And I will say, you know, if you've got endometriosis or fibroids and they're not treated.
Millie could help with the vaginismus, but the vaginismus probably isn't gonna resolve if the primary condition doesn't resolve. So finding the right healthcare provider to help with women's health, that's another reason why women's health is such a big ecosystem. There's so much interconnectedness in these underserved, under-researched populations. Lots to talk about, yeah.
Kim (12:10.986)
Yeah. Yeah, exactly. It's confusing because there are all these terms. And if people are Google searching, you know, going to Dr. Google first, they can go down all sorts of different rabbit holes and get even more confused because they're even just, when I think of prolapsers for one type of prolapse, there can be three different names and it just confuses the landscape, right? Yeah. So, and the menopause conversation is interesting. That's where a lot of the people that I work with now, it's primarily that
Tracy MacNeal (12:30.703)
Yes, exactly. Exactly.
Kim (12:39.982)
population and vaginal dryness and atrophy, you know, that whole world, so genitourinary syndrome of menopause is a term that's used now where it used to just be vaginal, vulvavaginal atrophy. And that was a time where they recognized that this is a bigger, it's not just that, there's a whole bunch of other things. So that was a bit of an evolution there, but that conversation is now happening. It hasn't happened for, hardly ever really. And thankfully the conversation of
Tracy MacNeal (12:54.725)
Right.
Kim (13:09.59)
menopause exploding with social media and many celebrities and a lot of fem tech is happening. So that's then indirectly helping our conversation about pelvic health. And so somebody who, let's just take the, if they've not received the diagnosis of vaginismus yet. So the primary is vaginal dryness associated with the estrogen loss around the menopause transition. Could Millie come in?
potentially and play a role in helping it, like prevent it from becoming full-blown vaginismus. Would that be fair to say?
Tracy MacNeal (13:48.547)
I think so, FTA regulates what I can and can't say about this product. So I would not be able to claim that it would prevent vaginismus. However, it would, if for a patient that's experiencing GSM, where the tissue's drier, the tissue's thinner, sex is hurting, they could definitely imagine that if they avoid sex and let...
Kim (13:53.454)
Sure. Yeah, yeah, yeah.
Tracy MacNeal (14:12.871)
the pain and anxiety take over that vaginismus could happen. And Millie looks like a vibrator, and it does vibrate actually. So it's just a small one that can grow inside the anatomy. So I think it would be really helpful, you know, as an adjunct to, what we hear from our patients a lot is that Millie is helpful as preparation for sex. Cause it's...
Kim (14:22.471)
Mm-hmm.
Tracy MacNeal (14:38.095)
It's sexier looking than that's sort of the perception is like, oh, it's like, it's like a lab at a light lavender. It's, it's a silicone wand. It vibrates like it's more relatable, I think, for the partner too. And that's the, that's the other thing that we get a lot from our patients is help with talking to their partners. And as medical device company, you know, we can't really give medical advice, but we certainly can collaborate with people like you who can.
Kim (15:05.538)
Yeah, interesting.
Tracy MacNeal (15:05.927)
you know, give coaching, but for sure I can say it makes sense, right, that you would keep the, use a dilator like Millie to keep the tissue in good shape.
Kim (15:16.63)
Yeah. So how does the, you've given a few kind of highlights of the product itself. How does it actually work? And what does a, if you can call it a treatment session or what does, what does a session look like for the user? And is this something that they would be using on a short-term basis or potentially for the rest of their life?
Tracy MacNeal (15:37.595)
Yeah, great question. Well, it's very, I should have brought Amelia with me. I didn't. Um.
Kim (15:43.882)
I actually, I should have my, I have one, but it's not, it's up in my other, I moved my office down to the basement, so it's not here yet, but, um.
Tracy MacNeal (15:49.799)
You can check it out on HelloMilli. There's a little GIF that expands. But essentially, if you can imagine a really little dildo growing into a bigger dildo inside you, that's basically what it does. And it's nice because it's got a readout at each millimeter. So for folks that, let's just say there's a temporary situation. And that could happen with menopause. So for example.
Kim (16:02.53)
Mm-hmm.
Tracy MacNeal (16:18.731)
One kind of person I can think of is a type of a type of mill user would be someone who gets divorced in her 50s and maybe hasn't been having a lot of sex and you know might have not noticed some of these symptoms as much and then starts dating.
and tries to have sex and it won't go in and it's bleeding, they don't know what's, she doesn't know what's going on. So that would be a really typical kind of situation where I think Millie might be good just on a temporary basis. This is somebody who has a history of a healthy sex life and knows what that feels like, and now it's just really about getting the tissue and the muscles relaxed and stretchy again. Someone like that, and then they end up in a regular intercourse kind of,
situation, you know, they might not need, they might need a dilation anymore. I compare that with someone, like I was just listening to a patient story the other day. She's almost 70 and she's had vaginismus since she was 53.
Right? And so dilation right before sex is part of her life with her husband. And it might always be that way. It just helps her relax. And, you know, so it, and that's personally what I hear the most from our patients is that's the most effective. You get the partner, the more you, the more the partner is supportive and not pushing.
like pressure makes the situation worse for sure. So if you've got a partner that is supportive and willing to do whatever, then it's really down to how good she is at asking for what she needs. And we always encourage everyone to ask for what they need, right? No shame, but everybody's brought up differently, right? So there's a lot of layers there for people. But I think that that's something that we hear works. If you look at the instructions for use that comes with the product, it would recommend,
Kim (18:04.43)
Mm-hmm.
Tracy MacNeal (18:17.777)
and dilating two to five times a week, five to 20 minutes at a time. But we know that we have some doctors that recommend you dilate every day for five minutes, trying to get sort of proximity therapy, like sort of trying to calm those fears by just doing it regularly.
Or you could be like this other patient who she has sex once every week or two and she dilates right beforehand and that's what works for her. So somewhere in there. I think everybody hates physical therapy. Like if I have physical therapy for my neck, like I hate doing my PT, right? I like going to see my PT, but then when I get the homework, like I don't want to do the homework. So I think that's something. Another reason why we think Millie is...
Kim (18:52.108)
Yeah
Wait.
Kim (19:00.406)
Right, yeah.
Tracy MacNeal (19:07.079)
potentially helpful to people in that it's not as embarrassing, it's not as much to clean up, it's more discreet. You know, you can travel with it, that kind of thing.
Kim (19:15.906)
Yep, yep. Yeah, and it's one as opposed to having that, you know, bag of all the different sizes and yeah, I love that. So, like how, you've talked about how long somebody would use it. What, is there a like overall success rate? Like how long does it take somebody to notice a change? And I know that that, I know the answer is gonna be, it depends, because there's so many different.
there's so many different reasons and other factors that are coming into play, but could somebody notice a change within a week, two weeks, a month, or what's the, is there a standard there at all?
Tracy MacNeal (19:54.223)
So we've done some patient surveys and.
while I can't quote anything, because I don't have FDA clearance to do that, I would say just generally, people see progress pretty quickly. Just being able to get it in for some people is a win, and to have the experience of being able to dilate to, you know, maybe, so if it goes in, they can dilate three millimeters that day, for them, that would feel like a huge win. And so people feel progress, you know, in that sense immediately. And then, you know, I think it then,
depend on your partner's size, on your goals, on how well in control your primary condition is. But generally, I would say you should see progress within a couple months. Most of our patients do.
Kim (20:40.462)
Okay. And with the device, how do I, once it's inserted, how do I inflate it and how do I know what my measurement is? Is it connected to something that I look at or is there maybe sound or vocal that tells me where I'm at?
Tracy MacNeal (20:58.491)
Yeah, you know what, I'm going to chat with one of the engineers that's in the office with me and I'm going to see if he can bring me a milly. It would be fun if I could.
Kim (21:08.302)
Yeah, it's always fun to see.
Tracy MacNeal (21:20.847)
All right, let's see if anybody's free to bring me a Milly. It would be fun to be able to show people before we end. So the question is, how does it expand? So Milly has three buttons on the interface. It's just a little, it's a wand with a little handle. It's got three buttons, up, down, and vibrate. Ha ha ha.
Kim (21:39.102)
Yep, easy.
Tracy MacNeal (21:39.587)
So it's pretty hard to get it wrong, you know, as long as you or your partner can reach the button, you know, or the interface. So a lot of people kind of have it tilted a little bit to the side. Millie has four arms inside it that expand, so it doesn't actually inflate. Inflation actually would be a difficult way to do it because we're trying to deal with force. We don't want to force the tissue. It's hard to control force with a balloon.
Milly's should last for, you know, it's kind of, I would say, like a Sonicare toothbrush. If you buy a Sonicare toothbrush, you know, it should last you a couple years. You might want to buy a new one, you know, if you get tired of it or whatever, but get a fresh one. But generally, it lasts for quite a while. So the reason I brought that up is, anyway, you just...
Kim (22:31.26)
I was asking the inflation versus the expansion.
Tracy MacNeal (22:33.323)
Oh yeah, the inflation rate, exactly. So we wanted it to be durable. And so the arms, that technology actually is part of our intellectual property and patents. So I think that that's part of what also makes it able to be gradual and predictable. And then there's a little readout. So if you can see it, everybody's shaped differently. And it has different levels of flexibility. But if you pull it out while it's expanded,
look at your readout and maybe there's an app in the future we'll see yeah
Kim (23:09.334)
Um, it's reminding me of the epino. Are you familiar with the epino? Okay. So the epino is that's really how I got into pelvic health because I used an epino in my pregnancies and, uh, afterwards I thought, you know, how is it that not everybody's using a device or a tool that can help us connect with our pelvic floor and learn how to relax the muscles that helps do some perineal massage and, uh, so this is an especially knowing
Tracy MacNeal (23:13.671)
Yeah, love the happy now.
Kim (23:37.65)
you have listed on your website. So I'm assuming it's okay to say the name of the next product that you have as well, which is talking about birth prep. So of course my mind as you're talking is going to using a similar technology in pregnancy to help with perineal massage, to help introduce those sensations of stretch and pressure. But now it's not a balloon, which is the epineau, which is inflation. And you're talking about expansion. I wanna dive a little deeper into the difference between inflation versus expansion.
Tracy MacNeal (23:41.944)
Yeah.
Tracy MacNeal (23:59.418)
Mm-hmm.
Tracy MacNeal (24:06.511)
Yeah, absolutely. So the epino is...
working on a slightly different problem. So our second product at the moment is called PrEP. It probably will be rebranded when it hits the market in a couple of years. It's in a very large randomized controlled trial right now. So EpiNo is a balloon that goes into the vagina and is used at home by mom to prepare the perineum to stretch. So this is the tissue, like the skin tissue that you can see.
Tracy MacNeal (24:40.925)
Thank you, Connor. I've got a milli. I can show you a milli. I appreciate it. So the That is basically at-home physical therapy I would put it in that category and then Our our product isn't actually not working specifically on lacerations. Our product is trying to prevent pelvic organ prolapse
Kim (25:06.174)
Okay.
Tracy MacNeal (25:06.387)
So we're actually working on the pelvic floor muscles themselves. Specifically, the complex called the levator anus, a group of three muscles. And it's really like that last two centimeters that the baby's head sees. So the baby's head is hanging out kind of up higher in the vagina for most of labor, and then during delivery that last minute.
those muscles stretch really suddenly and up to 30% of the time that muscle separates from the bone, which is called a full avulsion. You can only see it on ultrasound, but it's very visible on ultrasound. And so if you go to our trial study site, it's called...
Ease, trial E-A-S-E, we're trying to ease birth, the ease study dot org is the website. And so you can check out, there's a medical animation that you can see what the muscles are that we're talking about. And the biomechanical thesis of this product is that if you stretch those muscles slowly over an hour in labor and delivery, so this is used in the hospital basically right before the baby comes through.
Kim (26:18.172)
Oh, interesting.
Tracy MacNeal (26:18.539)
And, yep, and we go, again, a millimeter at a time, and it's got force limiters, so it can't over-stretch the pelvic floor. It's like a tenth of the pressure that a baby would put on the pelvic floor, so it's really, really mild. We do require an epidural with this study, because we're also measuring the duration of stage two of labor, that's how long the baby's in the birth canal, or how long mom's pushing, and that does slow down
anesthesia. So we wanted the control group and the device group both to have the same. And since 80% of American women get epidurals anyway. I didn't get epidurals. I don't recommend them. I don't have an opinion about it. But just for the sake of science, that's just where we're at. And so after she's got her epidural, before the cervix is totally dilated, we would be taking this hour while she's resting to pre-stretch. And basically what you're
Kim (27:03.876)
Right.
Tracy MacNeal (27:18.353)
those long red fibers can stretch quite a bit without tearing, whereas the tendons, after 4%, they tend to tear. So that's where they're going to give if they're stretched suddenly, and so that's the biomechanical thesis. And in the pilot study, we reduced that injury rate by 60%. And
Kim (27:37.186)
Wow, that's amazing.
Tracy MacNeal (27:39.863)
and we're seeing really excellent results so far in our Pivotal, which will be the one we need for FDA clearance. So we're aiming to completely transform the standard of care in childbirth. So anybody who's trying to have a vaginal delivery, ultimately we would like to help them have an easier time delivering vaginally without injuring their pelvic floor.
Kim (27:59.806)
Are you able to control for position of birth, like the position that somebody's in while they're birthing? I guess if they have an epidural, most people are in there, most people are on their back. Some people may be sidelined depending on where they're birthing, but that's interesting.
Tracy MacNeal (28:07.493)
Yeah.
Tracy MacNeal (28:10.987)
Yeah, we, you know, the way I think about it, because I was a very natural birth mom. I didn't want any intervention. I didn't.
ended up with an emergency c-section. But I can totally relate to not wanting intervention. But the fact is 80% of people do end up with an epidural. And really what we want to do is help them have an easier time. Absolutely, if people don't, because I think there's a lot of practitioners who feel that if you can let mom get into different positions and walk around, and she shouldn't need all this intervention. And I certainly support that. But if she does end up with an epidural, she's going to be on her back, maybe on her side.
Kim (28:48.814)
Mm-hmm.
Tracy MacNeal (28:49.269)
But beyond that we don't control.
Kim (28:51.138)
Mm hmm. That's super fascinating and amazing, amazing statistics. And I know I have colleagues who are in more the evolution, pelvic floor evolution, levator evolution space and the devastation of that injury is immense and
Tracy MacNeal (29:05.469)
Yeah.
Tracy MacNeal (29:11.975)
Can you talk a little bit about it? Because people might, because it's very embarrassing for people who have it. Um, and so they might not talk about it, but I think it's important to, to help people understand what this even is.
Kim (29:17.377)
Mm-hmm.
Kim (29:24.414)
Yeah, yeah, I did an episode with Stephanie, who's the founder of Brave Mama. And so that's an episode you can go back. I don't remember the number of the episode, but it was fairly early on in me launching my podcast. And she tells her story and she talks about the people she supports in the community where the... So the avulsion, as you had explained, is where the part of the levator,
Kim (29:52.322)
away from the bone and there can be a partial or a complete disruption. And there's different, there's now different conversation about how we name this because is evulsion really the right term? And it can be, you know, one side, both sides and starting to have a bit of hope or innovation in the space with regards to surgical repair, but it would need to be earlier on. And so there's an episode with Dr. Shobari who is helping.
tried to move the space forward with regards to levator avulsion repairs. He's out of Washington. And so levator avulsion, as it is currently termed, is where the muscle either completely or partially comes away from the bone. It increases the risk of incontinence and organ prolapse. And it can really, pessaries are not always effective. It can be difficult for people to even be upright for long periods of time.
in the day, even short periods of time in the day, just for the lack of support. So it's a devastating injury. And if we can find something to help reduce that 30%, that's a big number. If you think of how many people are giving birth vaginally, that's a big number.
Tracy MacNeal (30:49.575)
Yeah.
Tracy MacNeal (30:53.167)
Yeah.
Tracy MacNeal (31:04.154)
60% reduction. Yeah. Oh, 30%, yeah. That ended with that, yeah, with a partial or full, yeah.
Kim (31:04.95)
Windows, sorry, I meant like 30% people of people who have evolution and then, yeah. Yeah.
Tracy MacNeal (31:11.499)
It is, it's really, it's a very sad situation and it's not really talked about. So, yeah, and it's interesting because we are solving a problem, we're trying to solve a problem that urogynecologists would normally see, but it's an intervention in obstetrics. So obstetricians are usually thinking about a healthy baby. They're not necessarily thinking about mom's pelvic floor. Talk to women who've delivered with forceps. I mean.
Kim (31:30.079)
Mm-hmm.
Kim (31:39.818)
Yeah. Yep. Yeah.
Tracy MacNeal (31:42.275)
And it's totally traumatic for them. And it's very clear in the health care system when those kinds of things happen that the baby's more important than mom. And we see that in a lot of places. And so at Materna, part of what we're standing for is that mom's important too.
Kim (32:02.242)
Hallelujah. Yeah. That's amazing. Okay. Like I, I'm, I'm kind of going down this path of the, because that's really where I started my work was, was I use this product. It helped me. And I, I said, how is it that, you know, nobody's talking about anything to do with pelvic health. Nobody's talking about it from a preventive perspective. It's always reactive and it's always reactive many, many years down the road.
of suffering for a long period of time. And so I really wanted to get the word out about what the pelvic floor is, how we can be preparing it for pregnancy, for childbirth, what we should be doing in the postpartum period and not waiting for there to be problems, but also recognizing if the problems happen, here's what you do about it, and here's the team of people that can help you. And so that still remains.
a big passion of mine, although my work has really kind of gone down the perimenopause menopause space now that seems to be the more of the people who are coming to me. But as I said earlier, then we have the menopause, that whole piece adding that in there and a lot of people do have a birth history and they may have been suffering for years and years and years and I'm just so excited. So back to the Milly.
for a moment. I might go back and forth between these two. Oh, you've got the million. Okay, so I wanna ask about the role of vibration. So if you can show us how it works, but also what was the intention behind adding vibration to the product?
Tracy MacNeal (33:26.195)
Okay.
Tracy MacNeal (33:41.711)
So, so Millie is this, it comes in a box. This is its USB case. And this is what.
Kim (33:49.066)
And for those who are listening, if you head over to YouTube, this video will be posted, so you'll be able to see what Tracy is showing.
Tracy MacNeal (33:57.295)
And so the charging actually happens in the case itself, not in the milli. And so you would insert the milli like so. And then this is the plus button. You can see it's at zero. And then it's one millimeter. So you can kind of hear it a little bit, right? And now you can see that it's expanded a little bit.
Kim (34:18.891)
and hear it. Yep.
Tracy MacNeal (34:24.847)
but not very much. So you can do that 25 times, and it ends up about the size of a male penis. And then this button here is vibration. So
Kim (34:28.525)
Okay, that was another question, how big? Okay.
Kim (34:38.766)
Mm-hmm. Got it. Okay.
Tracy MacNeal (34:40.653)
And it has two settings, so low and high.
And we say it's optional. Not everybody wants to use the vibration. The role of vibration in physical therapy has been really well understood. I mean, it brings blood flow to the area. It relaxes the tissue. We don't make any claims in our marketing with FDA about the role of vibration. But just generally, I would say anecdotally, what we hear from our patients is that it helps break through a plateau.
And it certainly would be a lot more fun if you're using it by way of preparation for sex. It's more of a familiar kind of thing for the partner, maybe, than a set of dilators.
Kim (35:17.589)
Totally.
Kim (35:26.134)
Yeah, and I mean, I'm just thinking like multi-purpose. I guess there could be an element of pleasure there too, right, for the person?
Tracy MacNeal (35:31.155)
You might even enjoy yourself, right? Yeah, that is the hope, right? I mean, and it's interesting, right? Because vaginismus is so painful.
Kim (35:40.622)
Mm-hmm.
Tracy MacNeal (35:40.807)
for people. That really ends up being a lot of what we end up talking about. But the goal would certainly be to bring people together and help women understand their worth. And I use women as an inclusive term, people of all genders. But to help people value themselves, feel their worthiness. Like your lack of pain is worth...
Kim (35:55.278)
Mm-hmm. Mm-hmm, mm-hmm.
Tracy MacNeal (36:08.135)
pursuing and then you know pleasure on top of it absolutely like wouldn't it be nice if we could all enjoy ourselves
Kim (36:11.478)
Yep. Yeah, yes, exactly. Pleasure is so often forgotten, especially, well, when we've been dealing with these for a long time, but just the whole nature of there's been shame, there's been, it's never been about pleasure for women. It's been almost about us being able to have insertive sex for the pleasure of somebody else. Right? Yeah. So with the, now jumping back to the prep.
Tracy MacNeal (36:36.495)
Right.
Kim (36:41.034)
Would vibration play a role there as well? Would there be a, like in your trial, was that something that is used in the device or is it a bit different?
Tracy MacNeal (36:41.038)
Mm-hmm.
Tracy MacNeal (36:50.759)
Great question. We don't use vibration in it. It has more capability around force control.
Milly has a passive force limiter, but PrEP has an active force limiter, like we will not ever hurt anybody. That's a major part of our thesis here. So it does have a force sensor and we collect time, force, and diameter on every delivery. So we know actually, what's interesting is we're partnered with the University of Michigan, the Pelvic Floor Research Group, Dr. Delancey's group there has been modeling what happens in the pelvic floor for decades.
Kim (37:08.48)
Mm-hmm, mm-hmm, mm-hmm.
Tracy MacNeal (37:30.421)
with their partnership with Materna, they're actually able to measure it. And it's pretty exciting. So that's basically it, but what we find is that the muscles after they're stretched, because the other difference between PrEP and EpiNode, not just the mechanism and the time that it's used, but also, PrEP gets bigger than the EpiNode. I think the EpiNode gets to about five and a half centimeters or something like that, something that, you know.
Kim (37:36.43)
It's very exciting.
Kim (37:53.396)
Oh really?
Tracy MacNeal (37:59.003)
Like so.
Kim (37:59.969)
It can get to about a 10 centimeter diameter.
Tracy MacNeal (38:03.863)
10 centimeter diameter? Golly gee, did you do that a lot? That's.
Kim (38:05.293)
Yes.
Not that every, I didn't get up to 10 centimeters, no, and close to it actually, but, and the goal is not necessarily that you have to reach a certain number. It has the capacity as trying to mimic the average size of a baby's head, but it's more about the introduction of the sensations of stretch and pressure and you learning how to yield and how to release tension in the presence of something that's contributing to discomfort.
Tracy MacNeal (38:14.525)
Good for you.
Tracy MacNeal (38:35.271)
Okay, that's news. So I don't think EpiNo is available in the United States. I don't think it got FDA clearance. I think it didn't manage to do that. It's a big burden of clinical data that you have to have to get FDA clearance and I don't know. I really don't know that much about their funding or whatever, but I do know that people still talk about it and try to, because it is just a consumer product, I think, in Europe. Yeah. So PrEP gets to eight centimeters.
say like this and the baby's head is going to be like that. So that's basically it. But those muscles we know stay stretchy for a few hours and so the idea is that if those muscles are pre-stretched then as the baby comes through she can push without pushing against her own pelvic floor.
Kim (39:05.954)
Yep, yep, yep.
Kim (39:24.386)
And then so because as you said like Epi knows a consumer product and this would be something used in the hospital space so would it be a Provider discretion or how like once it's sort of out there in the world. How would it be determined who would Who would have access to it?
Tracy MacNeal (39:44.299)
It's a great question. So the way we're thinking about it, it would be sort of like cord blood preservation. If you know anybody who had their stem cells preserved from the baby's cord, placental cord. So that's a medical device kit that lives at the hospital. That's part of the birth plan that the doctor knows how to use, but it's really the patient's decision.
So we would call that a business to business to consumer, B to B to C. Go to market strategy. It's actually similar to Miele, a little different, but with Miele also, we find that about a third of our patients come to us because their doctor recommended it. So.
I think the role of the physician, I'll just say clinician, because it could be a nurse practitioner or a doula or a physical therapist. I mean, those are all very important clinicians in the pelvic health space. And patients take their advice very seriously. So we have a two-pronged go-to-market strategy where we do talk to clinicians, help them understand what their patients need. And we also have, if you go to hellomilly.com, there's a list of providers. And we don't get any money for that.
It's just to try to help our patients get connected. You can put in your zip code, and then you can find clinicians near you that understand your condition. And our hope is that people can get help faster, because what we know from our patient-reported outcomes, some of which were published with North American Menopause Society, that patients often suffer for five years or more, and see three or four, five, six clinicians that dismiss them.
Kim (41:07.309)
Mm-hmm.
Tracy MacNeal (41:21.963)
So helping them find the right clinician the first time, where they don't get it, like you pointed out, the way they don't get told, oh, just have a glass of wine, try to relax. There's nothing wrong with you, you're just small.
Kim (41:30.773)
Right.
Kim (41:34.038)
Yeah. And so you have the list of providers. However, the patient purchases the product directly from you. Correct? Yeah.
Tracy MacNeal (41:42.099)
Correct. And they can also buy, if you go to your clinician and you want to get it from them, your clinician can also sell it to you and we can drop ship it to your house if they're in our network.
Kim (41:51.293)
Oh, interesting.
Tracy MacNeal (41:54.535)
But, and a lot of patients do well with their HSA, FSA reimbursement, they can use those. Yeah, so you can use your FSA, HSA money for that. And some of our patients, depending if they've got a, we have a letter of medical necessity you can download off of our website. If you can have a clinician fill that out, we see a lot of our patients get reimbursed for it from their healthcare, but yeah. Trying to climb the moon.
Kim (41:58.986)
I was just going to ask.
Kim (42:14.67)
Amazing.
That's amazing. Yeah, I know. I guess before we wrap up, I just wanna ask, are there any contraindications for either the Milly or the PrEP, any patient population that may not be able to use the products?
Tracy MacNeal (42:34.715)
So any kind of unresolved infection, you need to go get the infection taken care of because vaginismus can happen from chronic infections.
But you should, like a dilator's not going to help you if you don't take care of the infection. And similarly, there are dermatological disorders like linslerosis and things like that where, you know, again a dilator's not going to help. It won't hurt, but it's not going to really make you feel any better if you don't get the dermatological disorder taken care of first. And they're common, you know, and treatable. But a dilator would typically be a, a mili would be a nice complement to those kinds of therapies.
Actually, all our contraindications are very clearly listed in our instructions for use and on our website. So we want to make sure that nobody's ever being misguided. And actually, I should mention, in March this year, and so in 2023, Millie got over-the-counter clearance. And that's really exciting because it can be hard to find a doctor who can prescribe it. And um...
Kim (43:20.471)
Okay.
Kim (43:26.635)
Okay.
Kim (43:39.362)
Yeah. Is that your milly turning on? Ha ha ha. That's funny.
Tracy MacNeal (43:45.875)
I didn't turn it off and so it turned itself off. It does turn itself off if you forget. So it'll collapse back down to zero. So yeah, so we did the clinical study and the FDA filing to show we gave our website page to patients.
Kim (43:57.069)
Interesting.
Tracy MacNeal (44:08.259)
some with vaginismus, some without vaginismus, over a range of literacy, and asked them after reading our stuff, do you think you have vaginismus, yes or no? And then they went in and saw the doctor, and the doctor didn't know what they said, and then made the diagnosis, yes or no, and we had 96% alignment. And the one that didn't was vulvodynia. Ha ha ha.
Kim (44:25.27)
Wow, amazing.
Tracy MacNeal (44:30.927)
where a dilator would probably be helpful, right? So that's how we proved that if you give patients the right information, you give women the right information, they know what is going on with their body. You can self-diagnose venchiness. Check out our materials. We'd like to help you figure it out.
Kim (44:33.378)
Right, right, right.
Kim (44:39.95)
Mm-hmm.
Kim (44:47.714)
Amazing. Yeah, I'll have, yeah, I'll have all the links to everything to research and FAQs and everything that we've talked about will be in the show notes for this episode. And as I mentioned, the video, we'll put it up on YouTube so people can have a look at the device itself. So simple, so brilliant. I don't mean to simple in a way that it's taking away. I just mean it's.
Tracy MacNeal (45:11.895)
It wasn't my idea, so I agree with you. I think it's so sophisticated, so obvious, right? Yeah, so thank you, thank you.
Kim (45:17.77)
Yeah, yes, simple and sophisticated at the same time. Yeah, it's amazing. Yeah, thank you so much for coming and sharing a little bit about this amazing company and these products and yeah.
Tracy MacNeal (45:27.471)
Thank you so much for the work you do. It's so important the work you're doing. Thank you. We're big fans
Kim (45:31.702)
Thank you very much. Thank you.
