Endometriosis Revealed: Bridging the Gap in Women's Health Diagnosis with Somer Baburek

Parker Condit: 0:00

Hey everyone, welcome to Exploring Health macro to micro. I'm your host, parker Condit. In this show. I interview health and wellness experts around topics like sleep, exercise, nutrition, stress management, mental health and much more. So by the end of each show you'll have concrete, tangible advice that you can start implementing today to start living a healthier life, either for yourself or for your loved ones. And that's the micro side of the show. The macro side of the show is having discussions and conversations around some of these larger systemic issues that contribute to health outcomes. An example of that is talking about endometriosis. So this is a disease that often requires invasive surgery to diagnose, takes an average of 10 years to reach said diagnosis, and this affects roughly 10% of all reproductive age women in the world. Endo is also highly associated with infertility, and this is what we're discussing on today's show, and my guest today is Somer Baburek. Somer is the CEO and co-founder of Hera BioTech, an early stage women's health company focused on commercializing a minimally invasive diagnostic for endometriosis. So in the show we discussed a lot about endometriosis and what exactly Hera Biotech is doing to work towards better solutions in this space. We ended up discussing what exactly endometriosis is and explaining the stages of this disease, how it's currently diagnosed and the approximate cost associated with that, issues that arise from delayed diagnosis and treatment, and why blood based tests are not a viable solution at this time. Somer also has background in the venture capital world, so she offers her insights on funding opportunities for women's health startups and what she sees when she's looking forward for the US healthcare system. This is a great conversation. We cover a lot, and I think if you are at least remotely interested in anything around women's health or endometriosis, this is going to be a great episode for you. So, without further delay, please enjoy my conversation. We'll get started in a minute. So we're going to start with Somer Baburek. Somer, thank you so much for coming on. We're going to end up talking quite a bit about your company, but I think first it's easiest just to get some background information on endometriosis, which is sort of the problem you're trying to solve, and, just for anyone who's not aware of it, I think it's great to just have that background, so everything we talk about later will have much more context around it. So can you just briefly explain what exactly endometriosis is and we'll get started from there.

Somer Baburek: 2:23

Yeah, absolutely, of course. And first, thanks for having me. I really appreciate it. So endometriosis is something that's getting a lot more attention lately, which is great, so very excited that people don't glaze over when I say the word now. There's at least that like oh yeah, I've heard of that before now. So endometriosis is where tissue very, very similar to that which normally lines the inside of the uterus invades outside of the uterus and it forms these tumor-like growths called lesions. And the reason I say tissue very similar to that inside the uterus is because it is not histologically identical to the lining of the uterus. And that's a really important distinction because in terms of therapeutics or in terms of approaching the disease, people tend to treat it like a uterine disease and that's not the case Outside the uterus. That's the problem. So it's very much. Our company took an oncology-based approach to it and if you think about it through that cancer lens, secondary tumors are often not histologically identical to the primary tumor. It doesn't mean that it's a different disease or different type of cancer. It just means that on a cellular level they're a bit different. So I always try to make that distinction. But when we're talking about the disease itself and how it affects women who have this disease. So, first of all, it's the number one cause of female infertility. So huge problem there. And it often is characterized by extremely painful and heavy periods pain with inner force, pain with bowel movements. It has a lot of bowel disruption. So some women struggle with constipation, other women struggle with diarrhea, and it really wreaks havoc on the patient themselves. And when we talk about pain, a lot of people think oh yeah, well, periods are painful and that just kind of sucks. Well, no, they're not. Ask a lot of women and you'll get them to say yeah, I mean it's kind of uncomfortable but it's not that big a deal. Women with endometriosis have painful periods. I mean, we've talked to patients who have blacked out while driving or while taking a bath most of the time, we'd hear. Often they're doubled over heating pads for 10 days at a time during the month and you can just imagine the toll that takes on your education, your work, your personal life. So it's essentially this woman. Despite this tissue not being in her uterus, it's behaving the exact same way. So every month, with her hormones, it's swelling, it's bleeding, it's breaking down and the body doesn't know what to do because it's in a place where it doesn't belong. So the immune system gets kicked up and it's trying to clear this tissue. And it doesn't clear it and so it starts to form scar tissue. It can actually adhere pelvic organs together, which also causes huge amounts of pain. So, in a nutshell, that is what endometriosis is.

Parker Condit: 5:29

I appreciate you sharing that. It sounds like it would be just debilitating and, like you said, so many aspects of life are going to be affected by that negatively. Can you share why this is getting more attention now? I mean, I'm glad it is, but what's been the push towards that?

Somer Baburek: 5:45

Sure. So I think that one of the things that we talk about a lot is, back in the 90s you're old enough to remember that, like I am so the fibromyalgia patients. We didn't know what fibromyalgia was. We just thought these were dramatic patients who were talking about chronic pain. Maybe they were just trying to get opioids, et cetera, et cetera. And then all of a sudden we figured out oh gosh, there's actually a disease here, it's causing a problem and we've been mischaracterizing people. So I think that endometriosis is getting more attention now One it's benefiting from the attention that women's health in general is getting and which has been long needed. Fun fact, women were not required to be included in clinical trials until 1993. So when we talk about a huge gap in research knowledge that we have in women's health conditions, that's what we're talking about. So I think that it's just one of those diseases that's been bothering women. It's extremely prevalent. So it's between 10 and 20% of reproductive-aged women. That's the estimates. So if you think about that, in terms of worldwide population, it's about 180 million women worldwide suffering with this disease. And so I think that, because of its prevalence, because of its connection to the menstrual cycle and because of the recent highlight of women's health. All of those things are kind of converging. Endometriosis is one of those top priority problems that women struggle with.

Parker Condit: 7:19

Okay, is there an age range where this is more prevalent? When should people really start looking out for this? Because we're going to get into the diagnostic issues of how the problems that have sort of precipitated up to this point but is there an age where it's more prevalent amongst that reproductive-aged group?

Somer Baburek: 7:37

So there's an age when it's diagnosed more frequently.

Parker Condit: 7:40

Okay, let's start there.

Somer Baburek: 7:42

Yeah, and that's when women are in their 30s. The probably rational response is when you're in your 30s is when most women nowadays are trying to have children and the infertility issue becomes the problem and they're expending a lot of time and energy to explore the source of the infertility, and oftentimes endometriosis is uncovered at that point. The other side of that coin for women who are not trying to have children is probably that by the time you're in your 30s, you're actually talking about this with your friends, You're recognizing that your pain is abnormal and doctors saying oh well, your aides are painful is just not cutting it anymore and it's really bothering you. So you're willing to advocate for yourself and push for that diagnosis.

Parker Condit: 8:35

Okay, yeah. So I do want to get into the actual diagnostic piece now because, like you alluded to, in the 90s of fibromyalgia, when there's not a clear way to diagnose something, it's very easy for people to kind of come in with these symptoms and it just gets explained away through a variety of vehicles and that's got to be well. One, frustrating, because you're never even getting an answer to the solution. But two, just that dismissive piece of it just must be like just salt on the wound of just not being able to, not just being really unheard in a space where you're just you're trying to go to these people for help and you just leave in probably a worse condition than you would be. So how is currently, how is endometriosis diagnosed?

Somer Baburek: 9:20

So currently the only method of definitive diagnosis recognized by the FDA is a surgical procedure. So at HERA we call it the where's Waldo approach to diagnosis. So for those who aren't aware, with endometriosis those lesions can occur anywhere in the peritoneal cavity, which is a fancy way of saying the abdominal cavity. They've been found at the base of the lungs, they've been found on the diaphragm and they can go all the way down into the lower bow. And of course there's anomalies and outliers. So I'm not covering the whole gamut of where lesions have been found, but that's the general area and they are varied in their appearance. So they can be blue, red, chocolate, brown powder, burn white and they can be very, very small. So the way that it's diagnosed now is through laparoscopic surgery. So the woman's abdomen is pumped full of gas and laparoscopic probes are put in and the surgeon tries to find the result of the disease, which is these lesions growing somewhere. One of the tricky bits of this is the severity of a woman's symptoms does not correspond to the stage of the disease. So you can have a very, very painful patient who's stage one, which means she has small symptoms and there's not very many in them. So the surgeon. Having this entire cavity to search through for something that might be the size of a half P and could be a number of different colors, is really really tough. So the surgery in and of itself doesn't have really good results. About half the time the biopsy is not endometriosis. So or about half the biopsies I should say are not endometriosis. So it's very difficult to diagnose and a lot of OB gens don't do those surgeries. So the OB gens that we've talked to have said look, when I suspect, and though one of two things happens in that surgery I open her up and I don't see anything. Or I open her up and it's such a mess it's beyond the scope of my skill. I need a Urogyne, you know, consult. I need somebody who's very specialized in, you know, separating pelvic organs, you know I, and then I have to close her up and get somebody else in right. So they tend not to do it, and so endometriosis really then becomes a diagnosis of elimination. We're going to run through all these other things because we really don't want to send you for a surgery that may or may not give us the answer that we need. So that's leading to a diagnostic delay on average about eight years in the US, that's very easy. Yeah, it's insane. So I equate it very much to like cervical cancer. When you cervical cancer was bad, the only way we were able to diagnose it was to cut a woman open and look at the cervix and see it and all of those things. Then along comes the pap smear and all of a sudden we have a robust diagnostic. We figure out that actually the cells start to change way before cancer is ever present. We see these mosaic patterns. Then we figure out HPV is a big contributor to most cervical cancer. Now we have a vaccine for it. So it's like everything starts with a really good diagnostic that doesn't require cutting people open.

Parker Condit: 12:45

So, going back to that number, you said 50% of laparoscopic surgeries looking for endometriosis don't find anything. Do you think that's due to the fact that there's actually no endometriosis there or they just couldn't find it?

Somer Baburek: 12:59

So just to clarify, when you look at the clinical literature, in 16% of laparoscopic surgeries they open her up. They see nothing. They close her up and then the accuracy of biopsy endometriosis falls down and you can subcategorize it by the color. So some colors are easier than others to spot, right, but about half the biopsies they take during those surgeries are not endometriosis. So maybe we get it and maybe we don't, but they're taking biopsies to a bunch of different things and there are quite a few instances we've talked to doctors who have said I send it out, it comes back, it's not endo. And I say I know it's endo, I saw it in there, I know it's endo, I'm going to treat for endo. So why would you want to have a surgery if that's the outcome? Right? I mean he or she could have just said I'll just treat for endo and then that's a whole new paniforms, right? Because the treatments for endo none of them are for endo, all of them are for the pain associated with endo. We don't have any treatments out there that are disease modifying today.

Parker Condit: 14:09

So that sounds like a varied US healthcare system type of problem or like a very typical solution where it's like we're just going to treat the symptoms and the underlying cause of it is not really addressed. Is there an underlying cause? Like, do you know of that? I'll just ask that. Is there an underlying cause?

Somer Baburek: 14:26

Yeah, I'm just going to pause there. So yes, I'm sure there is, but we don't know it yet. So it's really highly probable that this is an epigenetic thing. So there's probably a predisposition that's influenced by environmental factors or reproductive choices or therapeutic choices, and so that is likely contributing. With our work at HERA, we're very focused on a gene set that's present in the endometrial lining, which is the cells that get out there and invade and create lesions, and what we're looking at is a gene group called gap junction genes that are. Their whole job in life is to control invasive cell behavior, and when they go awry, invasion goes awry, and so a lot of people you think invasion, cellular invasion, immediately go to cancer. Well, there's a lot of invasive processes that we need in the body. So gap junctions, for example, are critical to the process of fertility, because you have to have implantation of the embryo, you have to have desigilization, vascularization All of those are invasive processes. So the gene set that we're looking at is actually tied to lesion formation. We've shown that on the bench. But it's also tied to the infertility piece, and while we're not saying that gap junctions are the only thing out there that make you have endo, we are saying that they are definitely a contributing factor, and they're contributing to not only the disease formation itself, but also to the infertility aspect of endo.

Parker Condit: 16:06

Yeah, so it sounds like a very good place to start. Can you back up and explain the difference between genetics and epigenetics for anyone who's not familiar with that?

Somer Baburek: 16:15

Oh sure, Sorry.

Parker Condit: 16:17

No, it's great, I love talking about this stuff.

Somer Baburek: 16:19

Okay. So for genetics, it's literally your genes, so your DNA, your RNA. A lot of people have heard the word CRISPR, so this is when things go awry and we can actually pick that through this technology if there's a gap or a chromosome missing. So it's literally your genes, your makeup. When we talk about epigenetics, it's kind of like saying there's something going on on a genetic level, but there are environmental factors that influence that gene and how it behaves. So, very much like the nurture versus nature argument that you can have on a number of different topics, is it definitively caused by nature? Probably not. There are probably a lot of these nurture quote unquote effects that influence the nature.

Parker Condit: 17:14

Okay, so the point I always try to bring up around epigenetics is that you should be somewhat hopeful, in that there are environmental factors, meaning that these are sort of modifiable factors that you can influence Not always, not all of them, but some of them you're going to have some level of control over. Stress seems to be related to everything. Do you think stress is a contributing factor to this?

Somer Baburek: 17:38

I would have to say yes only because I haven't met an endopatient. That isn't stress, but it's kind of one of those chicken or the egg questions, right? Was she stressed before she started having symptoms and then that caused the symptoms? Or is she stressed because everyone thinks she's in her head and she doesn't have a way to treat that, since she can't escape the pain and doesn't really even know what's causing it? So it's again. I think it's probably a contributing factor. Always best to not be stressed, but I don't know whether it's a direct link.

Parker Condit: 18:16

Okay, that's fair enough. Yeah, you have to imagine eight years of dealing with symptoms to the average length of diagnosis. Eight years, probably not feeling great at that point. So can you quantify what the cost of that is? This is obviously an eight-year period from inception of symptom to diagnosis. There has to be a ton of doctor visits involved with that, potentially surgery, probably a bunch of other, maybe therapeutics or pharmacological interventions in the meantime as well. Can you quantify what the cost is for this extremely delayed diagnosis?

Somer Baburek: 18:54

Sure. So we're working on that now, trying to put together the health economics piece of it. What we can tell you is when you talk about direct health care costs and when you talk about lost productivity. This disease costs the US about 80 billion a year, so it's a pretty intense cost. The rough numbers that we have so far. When we look at, women with endo are two and a half times more likely to go to an ER with the pain they're going to be admitted because the source of the pain is unknown. They are about 74% of the time they're misdiagnosed, 68% of the time they get prescribed opioids, which leads us down a whole different thing. So we think that by pulling a diagnosis forward, when you look at payers, right, we could probably save payers somewhere in the neighborhood of $178,000 for that patient, pulling that diagnosis out of eight years, even if we just the rough estimates we have now, because health economic data is limited, especially when your report start up. So you know we have it being diagnosed at five years. So if we could just pull it forward to a year instead of five years, that's the savings that we're able to have for the payer.

Parker Condit: 20:10

Yeah, so that's an enormous amount of savings and then obviously you can't really quantify like quality of life for somebody who can actually get a diagnosis and then hopefully I mean even just a piece of mind of like understanding this is the disease state that you're working on. So how much is a laparoscopic surgery?

Somer Baburek: 20:30

The average cost for that. The average cost in the US is $17,678.

Parker Condit: 20:36

Okay so.

Somer Baburek: 20:37

So not cheap.

Parker Condit: 20:38

Not nothing.

Somer Baburek: 20:40

Yeah, and you know, if you think about it, a huge percentage of US families are on a high deductible plan. So you're going to come out of pocket $5,000 to $10,000 for that procedure because it's going to cost that much. And that's just a procedure itself. And then you've got, you know, the care afterwards and if you have any complications or infection, you know, there's all those. It's like anytime you go to the hospital, right? You're like how many bills am I going to get? How many people are going to send me an invoice for something? I laugh. When we had our child, my husband knew as a CFO was like I'd like to understand everybody. I should expect a bill from you, know, and he's trying to quantify it and no one could tell him who all would be billing him and it was so infuriating for him. I mean, that's just kind of our healthcare system, unfortunately.

Parker Condit: 21:40

Is he a CFO within the healthcare industry?

Somer Baburek: 21:43

So he does CFO work for startups in addition to his regular job.

Parker Condit: 21:50

Okay, yeah, because like, that's not how it works in the healthcare industry.

Somer Baburek: 21:55

Right, I know he's like so into like, okay, you got a bill of materials and I should understand and I'm like you're cute. We don't do that. Well, I'm like they don't know who all is going to bill a because the doctor's office just has rights at the hospital. The hospital then has all these other, like the anesthesiologist is from a different group, and the nurses and the OR staff and all that good stuff.

Parker Condit: 22:20

Yep, somebody walks by and who kind of waves at you. You're going to $300 bill for that.

Somer Baburek: 22:24

Right, they're like I made her feel better about the C-section. No, you didn't.

Parker Condit: 22:29

Right. No, it's nuts. I don't want to delve too deep into that, because that could be an entire hour just on healthcare finance. So can we go a little bit about, like, the stages of endometriosis? I don't really know much about it, but I would assume delayed diagnosis people are getting to later stages of endometriosis, which I'm assuming is contributing to worse long-term outcomes. Is that a fair assessment?

Somer Baburek: 22:57

I think that is a fair assessment. One of the things that's really troubling in some of the literature that you look at is just when you look at it from a demographic point of view. So Asian women are most likely to be diagnosed. They are two times more likely to be diagnosed than Caucasian women, who are four times more likely to be diagnosed than women of color, and women of color are often diagnosed at late stages. And then the question comes in okay, so why Is it? Because the disease progresses more quickly in women of color? I mean, we've seen biological differences based on ethnicity and things like uterine fibroids African-American women are much more likely to get uterine fibroids than Caucasian women. So we actually just received an NIH grant one of our co-founders, dr Bruce Nicholson, to look, because our clinical trial utilizes minority-majority-serving sites and so a lot of our samples are not Caucasian. So he's actually going to be looking mechanistically at the cells to understand if this disease progresses differently in women of color versus not. And if not, then it's a pretty clear-cut case of pain being perceived differently, symptoms being perceived differently and therefore or access issues right, because not everybody can take off and go have a surgery and pay $10,000 out of pocket to maybe get a diagnosis.

Parker Condit: 24:32

Totally yeah. So that just circles back into like social determinants of health. That'll be really interesting to see what the results of that study are.

Somer Baburek: 24:38

Yeah, it will be. I was really, really excited because we've been aware of the access issue. It's not a secret, it's easy to see, and so it is a purposeful choice to go into centers that are minority-majority-serving, because the frequency of the surgeries isn't as high. So you don't recruit your clinical trial as fast. And time is everything and everybody wants you to recruit really quickly and they have all these really fun little rabbit holes that they'll run down like, oh well, they're not recruiting quickly, so women probably aren't wanting to do this diagnostic and I'm like no, no, stop, don't do that.

Parker Condit: 25:16

Don't run down the rabbit hole.

Somer Baburek: 25:19

It's not the man-hatter's tea party. Let's pull it back. We made a purposeful decision so that when we take our data out, it's very easy to extrapolate that to the demographics of the US, not select places where our diagnostic will be very helpful.

Parker Condit: 25:39

Right, yeah, exactly yeah. So you're just kind of exacerbating the access problem, like you're mentioning.

Somer Baburek: 25:47

Exactly.

Parker Condit: 25:48

So all right, so let's go into your company now, herobiotech. Why did you decide this was something you wanted to tackle?

Somer Baburek: 25:58

Sure. So I fell in love with women's health. During my undergrad I invented a medical device around my labor and delivery experience with my first child. And then I got picked up by a venture capital fund. It was a life science venture capital fund. I worked for them for 10 years doing diligence on companies seeking funding. Never once saw a women's health company come across my desk, and we were the largest funds in our metropolitan area, so the old flow wasn't an issue. I didn't understand why there wasn't any women's health products. So I worked into the fund companies. We exited those companies and I decided I wanted to get back into women's health, started in the therapeutic space, because that's where my experience had been Saw. There was no disease modifying drugs really being developed, or if they were being developed, they hit a stone wall after an animal model, right. So then I went down the data rabbit hole on that and it's oh okay, well, we don't understand progression of these diseases. Oh well, we don't really even diagnose them very well. So of course we can't come up with disease modifying treatment. So I decided I wanted to start a diagnostic company, put the horse in front of the cart and then we could chill out the pipeline as it made sense, by understanding the root causes of these diseases. And I had a colleague that reached out to me at UT and no me at. Urosis is very personal to me, it's very personal to my family. I've shared before. My sister had a hysterectomy at 32 to try to alleviate the symptoms of her endo. So when he said I've got an endo diagnostic, I had seen a couple and I was like, is this the test? He said nope, with the tissue based test and I was like I am in, what are we talking about? And the rest is history. I met with the co-inventors of the technology. Their passion for women's health was one of the really big factors for me. I was so appreciative of the amount of bench work that they had put into validating why this tissue type, why this cell, why this gene, you know, and that was really impressive. And so founded the company in February of 2020, because my timing is impeccable. And then there we are today, licensed it and survived COVID and did all the things.

Parker Condit: 28:26

Well, you had a long time to sit at home with no distractions from the outside world.

Somer Baburek: 28:32

Yes, all I had to do was homeschool children and keep bandwidth appropriately prioritized to. Zoom meetings and you know angry husbands and kids who'd never been on laptops. It was all fine.

Parker Condit: 28:47

Easy, light work. It's funny, most of the people that I've interviewed on here have started their company within the past three years, and it's like people either you're the kind of person who's going to like start at the worst time and figure it out no matter what, or you're just going to get crushed, right yeah, so I'm just going to just keep finding the people who have survived through it and not only that, but like the rest I mean it's like they'll fast right?

Somer Baburek: 29:11

No.

Parker Condit: 29:11

They say they'll fast.

Somer Baburek: 29:11

So it's like, okay, we'll start a women's health company which already struggles from funding and attention issues, in the middle of a pandemic which makes everybody care about nothing else. Yeah, I really do.

Parker Condit: 29:25

What is this? It's not COVID.

Somer Baburek: 29:28

Oh, sorry guys. No, we're funding the 58th diagnostic for COVID now. Oh okay, well, that's good. At least it's not erectile dysfunction, because I've seen about 84 of those, so whatever.

Parker Condit: 29:40

God, yeah, okay, so I really do like it seems like a very natural progression to where you were and just kind of reverse engineering be like where do we need to start to get to where it needs to be longterm? So that's a very cool way to see how you got to where you are. I know on a previous podcast you mentioned that didn't you want to go to medical school? Is that right?

Somer Baburek: 30:03

Yeah, I did so it's a really funny conversation. So I went to college on an athletic scholarship for Rodeo that's a thing we have in Texas. Okay, that's like. Some people are like wait what? I'm like, yep, that's a thing. So, anyways, and I went to college and I think it was probably like my second month there. I call home and like dad, oh my gosh, I think I want to be a doctor. He was like what? And I said, yeah, I think I want to go to medical school. I can do, you know, I can minor in biology and major and chemistry or whatever. Right, I can go to medical school. And I was like, yeah, I don't know. You know, doctors have to do a lot of math and you're not very good at math. And I was like, oh, I mean okay, like I hate algebra, but really Okay. So I was like, okay, well, I'll go back to the drawing board. And then I came back and was like, well, now I could be a lawyer. Like I can read, you know, really fast. And he's like, yeah, about, lawyers have to lie a lot and you're not a very good liar. And I'm like what? I was like oh, I get this Hang on a second, I was like what do you think I should do? And he was like oh, I think you should be in college communications. I can see you on the sidelines and you know reporting on I don't know what he said probably football or something. And I was like I don't want to do that, though that sounds horrible to me, not at all, like ever, for sure. And he was like, oh well, then you should probably just get a business degree. And I was like, okay, I have an idea. How about I drop out and I go pro and rodeo professionally for a couple of years, which I did. So, yeah, I did. And then I moved back home, got tired of being on the road, met my husband and Barnes and Nobles I'm not joking and he was like you're too smart not to have a college degree and you really ought to go back. And while medical school wasn't on the table at that point, I did, you know, get my undergrad in entrepreneurship and then master's in data analytics, took multiple accounting classes and multiple statistics classes and did just fine.

Parker Condit: 32:40

Yeah, it sounds like math didn't end up being an issue for you.

Somer Baburek: 32:44

Yeah, I graduated with a 4.0. I'm fine, everything's good yeah.

Parker Condit: 32:49

You had just a very cautionary tale about limiting beliefs.

Somer Baburek: 32:52

Yes, exactly, and you know, in his defense, I'm a first generation college grad, so I'm adopted. I'm 38. Oh no gosh, I just turned 39 on Friday. Sorry, I'm 39. Thank you, but my dad will be 90 in November. So, yeah, he was 51 when I was born and he didn't graduate from college. I was a first generation and so it was like the idea that I was there was great and that's really all, just just check the box, like if you just check the box, it's going to be fine, and it really, I think, was just exceeded his capacity to think about like school beyond school, you know.

Parker Condit: 33:35

So, with the idea or like being drawn to medical school, do you feel like you're sort of scratching that now with what you've been able to do from, I guess, not the physician side, but sort of on the entrepreneurial side?

Somer Baburek: 33:49

I do. I think I still get to do all the cool things like my team, and I joke like I'm a scientist by passion, not by training. So I read just enough to come up with the harebrained idea in the back of the class and it's like, oh, there's random man again back there, or just all at once we just cut that out. People are like, but yeah, I enjoy it and I love talking to the physician, like I just think it's so cool and I was just doing a thing last week about weird facts about women's health and so OBGYNs actually get paid less than any other procedural specialist and there's a correlation between when the field went primarily female and that pay happened. So the article that I was reading said that it's viewed as like women's work now and so like the cool surgeons and the cool doctors don't want to do OBGYN. And I was like man, that is so weird. So when I meet OBGYNs and reproductive endocrinologist I just I have just the utmost respect for them. One of the other crazy facts I learned about them was they are responsible for over 105 indications that can affect their patients. That includes six different types of cancer, but doesn't include any fetal health concerns. So we have this specialty. That isn't really a specialty, it's like a GP, a four year reproductive.

Parker Condit: 35:26

It's huge, it's so crazy. Yep.

Somer Baburek: 35:29

So I have the utmost respect for them. And then it's like, oh, and, by the way, could you also go deliver all these babies at 2 am? Sure, why not?

Parker Condit: 35:40

I was talking to a founder on here of they do menopause specific care, which is like sort of lumped into the OB field but like not specifically enough because they have everything else to do, as you just mentioned. They have so much, so much other. Yeah, there needs to be more sub specialties or fellowships or something around that space.

Somer Baburek: 36:01

I agree, and I think they should be reimbursed better too. Like another fun fact, a surgeon or a physician will get a. Actually, the surgeon will get a 45% higher reimbursement for a biopsy of the penis versus the biopsy of the vagina. Like why I don't understand. So it's just insane to me, like these disparities. Like I have a really good friend, dr Lindsay Harper. She's an OB gen still practices and as a founder of this incredible company called Rosie's and she founded it. It's a sexual health company and she founded it because the only training that she really got to help women who were coming to her with sexual health issues was like to tell them to have a glass of wine or to use some lubrication. And it's like I think that might not be the only answer.

Parker Condit: 36:57

It seems like there could be more done.

Somer Baburek: 37:00

I mean, how many drugs do? Again I'm going to circle back. Or just for funsies to make you so uncomfortable, like, how many drugs do we have approved for erectile dysfunction? We're not telling those guys to go have a stiff drink to help their problem.

Parker Condit: 37:13

Like that would probably not help the problem.

Somer Baburek: 37:16

No, for sure it wouldn't, but like that's the point, right, I'm pretty sure she could drink a bottle of wine and that's not going to help.

Parker Condit: 37:25

No, it's a great point to bring up the very obvious chasm between reimbursements, how well it's studied, like the amount of drugs that are on the market for one thing versus the other. It's a really gross disparity. And you brought this up earlier about women not needing to be included in clinical trials until the 1990s. But they were included in a lot of trials before then. But they would often women's results would get excluded as outliers because with a hormonal fluctuations throughout a month you would get all these weird results and it's too hard to explain those outliers.

Somer Baburek: 38:03

You have to see the matrix to get through that. But what's crazy is that they even take that to the mouse models, right, and they're like we only use a male mice because the hormonal changes in female mice is so crazy and it comes out that actually male mice match more irrationally than female mice and it's like, yeah, of course they do, like we, so we're a girl factor at our house. So I have three daughters and my husband is just this big jacked dude, right, like he's a cross bit athlete, like he's been to regional life and he just rocks the like girl dad stuff, like everything is girl dad. Like even the dogs are girls, like we all joke, like I have a 10 year old and eight year old and a three month old and they all know everything, they know all the words, right, and my 10 year old the other day he was foul about something and she's like, oh, it's dad on a period and I was like, oh, probably. And she was like, at least his nephew or a tampon. I'm like, yeah, that's a positive. But yeah, guys definitely hooked your chicken chin and get grumpy and have bad days, but we just don't call it hormonal.

Parker Condit: 39:15

Yeah, no, it's good she's, she's identifying these things very early.

Somer Baburek: 39:19

Yeah, she cracks me up. The stuff those kids come up with, like it's so true, like out of the mouth of babes, like just the stuff that they say, especially being raised around all of this, they just think it's great. I have a dear friend, naseem Sayani, who runs an incredible female health fund called Emmeline Ventures, and her big thing is they all the words all the time. That's the only way anybody's going to be comfortable saying all the words, like you shouldn't have to say vagina and people be like, oh, like she's done it, she did it, she went there. It's like calm down, yeah, it's okay.

Parker Condit: 39:56

It's a great point. This country, we're very like averse, like talking about anything sexual related organs, using the right antithopical terms. It's. A lot of people are just so uncomfortable around it and I think it's a great idea. Not that we're going to go down the idea of like parenting, but I do not give parenting advice, I'm running a social experiment. I kind of fall into that camp where it's like teach them the words right, it doesn't need to be these silly, fluffy words that are just protecting people, like the idea that you're teaching them that they need to be protected from this words is just feeding into this sort of feedback loop that it's this bad thing that we can't talk about.

Somer Baburek: 40:39

Yeah, I mean we have a very famous story. We started at a school and got called in we are the new family and the principal was letting us know that our daughter said the word vagina in class. And I was like I said like she just said it, just like she has Tourette's. She said it Because my husband asked Tourette's. And so I was like is this the thing and that would happen? And she goes no, no, no, she was saying that her vagina was itchy or something, I don't know. And I was like okay, and she goes well, we just we don't talk like that. And I said you don't talk like what. She explained it. Well, just that word. And such a loud environment with all the children. You know she needs to say that privately. And I was like you know what? You're right, you're totally right. I'm so sorry. I just realized what you were saying. She was supposed to say vulva and I will make sure that she says that next time. And I got. But I walked out of the office and my husband was like so where the back ricks my wife's in women's health? Nice to meet you. There we go.

Parker Condit: 41:50

We'll probably see you around.

Somer Baburek: 41:52

Yeah, we're going to say vulva, like that's what's going to happen, like I might put it on a t-shirt and wear it to school. I don't know.

Parker Condit: 42:00

I can imagine. Yeah, they're probably very comfortable with that whole thing.

Somer Baburek: 42:04

Yeah, it's so funny, though, because when you think about like, I live in Texas and I have pitched like some of our best and biggest investors are ranchers Like and I will never forget, I got introduced with this group of investors and they're all these like South Texas ranchers, which is how I grew up, right, and the woman that introduced me made me sound like a militant feminist and I was just like I've lost them. I have lost every one in this room. They have all crossed their arms and are looking at me like what God awful thing are you going to put up on that screen? And I just stood there and I was like guys, I promise I'm not going to show you anything gory or graphic, that's not needed. And I said, if we can just all agree that the terms I'm using uterus, vagina, these are things that all of your heifers have and they were all like oh, oh, yeah, yeah. And I was like every one of you has been shoulder deep in a cow trying to help her birth a calf Don't tell me you don't care about reproductive organs Like you do. And we were all golden from there. But it was just a funny situation that was like and she couldn't do to us, you know.

Parker Condit: 43:17

Yeah, Now I can definitely see that being a tough room to walk into, but very easy, very good way to win them over. They're like no, I can get it, I can buy that.

Somer Baburek: 43:25

Oh, yeah, yeah, I got that, yep.

Parker Condit: 43:28

So, going back to diagnostic tests, there's probably a lot of investment going into the space right now. You mentioned blood-based biomarkers. Why is that not a viable solution right now?

Somer Baburek: 43:43

Yeah. So it's really important to think about it in a couple of ways. So there's a couple of ways I want to talk this question. So we would all love to be able to just I don't know brick a finger and tell you a host of things. I'm pretty sure there was a company started like that not too long ago out of California. They didn't do so well.

Parker Condit: 44:05

Yeah, weird.

Somer Baburek: 44:06

Maybe you remember her. It's always a good idea right. It's always a good idea. It's just unfortunate that you can't invent science. So anyways, moving on, what most people are looking for when they're looking at a blood-based test and don't get me wrong, we're not in that space Most blood tests are considered to be like screening tests. We're not a screening test. We have a viable path to a screening test, but that's not where we are today. Right now. Our job today is to replace the laparoscopic surgery and to enable the development of disease-modifying drugs, and that's exactly what we plan to do. So it's really important to think about it this way. When we look at blood-based tests, most of them are used for looking at circulating tumor DNA, ct DNA or free circulating DNA, like the Neteras of the world who do the really amazing genetic screening for fetuses. Two things have to happen there. One is, whatever you are looking for in the blood, the source of that has to have access to blood supply, and that requires that it gets to a certain stage of development and vascularization that it can leach something that can be detected later in the blood. We don't know enough about endo and those lesions don't always occur on places that have blood supply. So the idea that we could find something in the blood and definitively tie that back to endometriosis is farcical. It's just not going to happen. The other thing that's really important when you look at blood tests today, most of them are looking at venous blood. Most of them are looking if not all of them are looking at microRNA. Well, microrna is not free circulating DNA, it's not circulating tumor DNA and it is incredibly unstable in the blood. So the clinical literature says it has a half-life of less than 17 hours. What that means is, within 17 hours, whatever you are looking for in that blood has been reduced by half. So you would have to get that vial of blood into the lab and processed before 17 hours, which, from a scale perspective, is just really, really rough. And also a lot of times, when you look at what these companies are looking at in the blood, most of them are in for a long time. So what are the inflammatory markers? Well, yes, we would expect inflammation to be elevated in an inflammatory condition like endometriosis. We would also expect it to be elevated in uterine fibroids, pelvic inflammatory disease, adenomyosis. So, specifically, you can't tie that back to endo. It might tell you that something's going on, but we don't know what that is. It would be the equivalent of taking your temperature at home. Yes, I have a fever, but what is causing the fever? Well, now I have to go into the doctor's office and figure that out, right? So those are my big issues there. And then there's one company that's out there talking about saliva, and they're talking about looking at 109 microRNA markers in the saliva. Well, saliva has far more enzymes than blood, and if the half-life of my RNA in the blood is less than 17 hours, I don't know what it is in the saliva. And you've got to get 109 of these suckers across the line, which just opens you up to a huge amount of variability. So it's the equivalent of reading the dedication in a book and trying to read the final chapter. You're missing an entire encyclopedia of information that you need about this disease to be able to someday diagnose it. Downstream, and if you think about it again from the cancer perspective, what cancer do you diagnose definitively from the blood? Blood cancer, oh well, that makes sense. Do we diagnose cancer? Or look for markers for cancer in the saliva? Sure for head and neck cancer and mouth cancer? Oh, that makes sense, because that's where it is. So endometriosis is a tissue-based disease. It's going to require a tissue-based solution, especially in its infancy. I'm not saying that someday, at some point, once we understand this disease inside and out, that we won't be able to diagnose it from some sort of marker that we have. The literature to support is definitively tied to endo. It's just not today and it's going to take lots of money, lots of research. So this is where the science is today.

Parker Condit: 49:11

Yeah, I really appreciate you sharing all that and it kind of makes sense to the path of where you want it to get, reverse engineering it back to where you think is the best place to start. So it's not to say that this isn't possible in the future. Maybe it is, but it just sounds like not today. It's just not viable from a reliability standpoint at all.

Somer Baburek: 49:31

Yeah, so we just have to I love this, that up here and tell you that it's as easy as doing a swab of the mouth. It's just not there today, but with our technology on the market it's going to give us the ability to track quantitatively what has happened. It's the first opportunity to track progression with this disease and look at different genes and what is their effect on progression. Is there any correlation between certain expression in certain genes and location of the disease? Do certain genes tell us certain things about which of these patients are going to struggle with fertility and which ones aren't? We're right at the end of it, but the opportunity to create so much data which can give us invaluable insights is really, really exciting and hopefully someday we enable that. We enable like oh well, this test has showed repeatedly that this gets leached into the blood, and fantastic. I would love for that to happen.

Parker Condit: 50:35

Yeah, but don't infringe on my patent, Right? It sounds like no. It's really important work that you're doing and hopefully people that are listening to this are excited about the prospect of it, because it does sound like a very important step forward. If somebody is interested in getting this type of testing done, is it accessible? How can they like what would be the nuts and bolts of somebody who suspects they have endometriosis kind of getting this type of testing done?

Somer Baburek: 51:02

Sure. So once we're on the market, it would be very akin to having a pap smear done. So you would call your gynecologist, talk to them about the symptoms that you're having, say you've done some preliminary research, you think it might be endometriosis and you're going to go in. They're going to do what's called a Pypal biopsy, which is an endometrial biopsy. So you transverse the cervix. I equate it to having an IUD placed. No one's signing up to do this for fun, but it's a heck of a lot better than the surgery, let me assure you. So you'll have that done. The physician collects the tissue sample we need and it's really important You're not getting like a hard biopsy of your uterine wall. We're getting the very fluid tissue that is excreted during your menstrual cycle. So it's not something that's like some crazy device going in there. The Pypal is thinner than a pencil and we're collecting that sample. It gets shipped to our lab, we analyze it and we're talking about the same kind of turnaround as a pap smear. So five to seven business days turnaround, ideally at commercial scale, and you'll have a definitive answer yes or no. And we're excited that we'll potentially be able to stage the disease as well, which gives you so much insight into an appropriate care plan for you and hopefully enable the development of disease-modifying parapetting.

Parker Condit: 52:38

Yeah, Now it sounds like you're going about this in a very methodical way, which is important. Is there a path to reimbursement through CMS with us?

Somer Baburek: 52:49

Yes, it will be a long road. Hello, I hope it's not. I really hope it's not. I think that the FDA and the CMS have recognized that women's health is starting from behind the A-ball and we need to get some of these things moved through quickly, and I do believe that they're making every reasonable effort to do that without compromising safety or unnecessary procedures. But, yes, we have planned to go get a reimbursement code for this. We do plan to offer it on a cash pay basis. While we proceeded about getting that reimbursement code and again I'll say it again, I equate it very much to like the NTERA test that you could go to have amniocentesis, which is going to be reimbursed, or you could cash pay over this test, which could tell you the same information. You're probably going to cash pay, especially since we're going to be less than your deductible if you're on a high deductible plan. So again, that's a wormhole that you can go down. But, yes, the short answer is yes, there is a path to reimbursement, but there's nothing out there right now, so we'll have to get a new code.

Parker Condit: 54:05

Yeah, I mean that's just going to be the natural progression of these things. You'd love for new solutions to be reimbursed quickly, but CMS does not necessarily work that way. But, yeah, a lot of these new solutions are just going to be cash pay while the behind the scenes kind of work towards that reimbursement. But it is really important that a lot of these solutions for women's health are kind of getting these new reimbursement codes Because again, like you mentioned, with OBs being kind of the lowest paid specialty practice, it's like anything else economically there needs to be that financial incentive to get these good people kind of working in this particular field. Is there anything else you want to share about? I want to be respectful of your time. Is there anything else you want to share around women's health or endometriosis or sort of the future of where you see things going in the industry? I feel like you have good insights around these things.

Somer Baburek: 54:57

Yeah, I think it's really important. When you think about women's health and we talk about this, there's several things that I get really passionate about because of my background in BC. So we now have this word, fendentech right, which is a cool word coined by Ida Tin, and it gives you vernacular right, it gives you a group, so to speak. When you look at the first group of companies fendentech companies that kind of came to market and came of age when she coined that term a lot of those were direct to consumer products, whether it's a digital app or period tracking, ovulation, whatever I think that that really was spun out of women being left out of the conversation in terms of healthcare, despite the fact that we make 80% of all healthcare decisions for our households. One of the things that I talk about a lot, and I'm very passionate about this, is the second wave of fendentech, if you want to call it. That is going to be hard science companies. It's going to be companies that are going after, in terms of the therapeutic or a diagnostic or a med device, real hard problems. So the investors that rose with the first wave of fendentech have a huge amount of experience in direct to consumer products. They don't have a huge amount of experience in hard science requiring traditional market entry, fda approval, things like that. In my little venture capital mind, that creates a huge blue ocean opportunity for traditional life science. Investors who invest in therapeutics, invest in med device. A lot of those verticals are saturated in whatever indication that you're going after. They are not in women's health, and so I'm very excited by that opportunity and I'm hoping that investors are starting to see it, because the five or four women led funds looking at women's health. They can't fund everything that needs to be funded. They're still infants in terms of funds. They're on their first fund or their second fund. So we need to expand the investment pool by attracting the attention of some of these larger, more mature funds, and so I think traditionally that's been looked at like, oh well, it's kind of a niche, or they've stayed away from fendentech because it's been direct to consumer, that something that they're just not familiar with. I hope that they start to recognize that the companies that you see coming forward now are hard science solutions that give you a really great opportunity to have a blue ocean vertical that hasn't been funded well.

Parker Condit: 58:05

Yeah, there's definitely a huge opportunity there and I appreciate you sharing your insights on that, if you're listening. If they want to get more involved and help push things forward, are there any good resources you can direct them towards?

Somer Baburek: 58:17

Oh yes, so it depends on. First of all, you have to be an accredited investor, otherwise you're going to be relegated to the crowdfunding world, which there's tons and tons of really great companies out there doing funding crowdfunding for life science ventures, and I'm not going to name any because I'm not associated with any of them, so I plug them all, not one in particular. But then, if you are an accredited investor, there's tons of angel groups that you've been getting involved with. Portfolia is a great one for female investors, but there's tons of funds out there that are focused on female founders or women's health. Any of them would love to have you as an LP. I'm sure. If you're on the larger side and you want to be a limited partner and a larger VC fund, there's ways that you can get involved there. If you're looking for ways to connect directly with founders so it's your family office and you just are wanting to expand your portfolio into women's health, there's some really fantastic events coming up towards the end of the year that would obviously be really great places to go get deal 12. The Women's Health Innovation Summit is happening next month in Boston. We're a showcase finalist, so we'll be pitching there. There's also Ignite Healthcare, which is focused on female founders. That's happening in November. You can reach out to me on LinkedIn. I will connect you to any and all of the places, just some of our fabric on LinkedIn. There's lots of ways to get involved.

Parker Condit: 59:55

Okay, great, I'll definitely link to your. I'll have your LinkedIn and the show notes for anyone interested in reaching out to you as well. Somer, what you're doing is I think it's really important work and you're pushing the industry forward in a science-backed direction. That is definitely needed. I really appreciate you coming on and sharing everything that you're doing today. This is a really fun episode for me to learn a lot more about you and what you're doing, and sort of the entire women's health industry as well.

Somer Baburek: 1:00:21

Thank you so much. I really appreciate you being willing to share your platform.

Parker Condit: 1:00:25

Yeah, of course, this is great. Thanks so much. Well, to those of you still here. That's all for today's show. I want to thank you so much for listening. I really hope you enjoyed today's conversation. If you want to learn more about today's guests, please visit our website exploringhealthpodcastcom. There you can find show notes for today's episode, links to the guests and our full episode archives. If you enjoyed today's show and you want to hear more, make sure to subscribe on your favorite podcast platform. I really appreciate each and every one of you listening.

Somer Baburek: 1:00:58

Until next time.