Assessing the Risk of Premature Birth by Measuring Stiffness of the Cervix: Dr. Sabrina Badir, Pregnolia

Dr. Sabrina Badir, Pregnolia: 0:00

Measuring cervical stiffness could actually give us earlier information about a risk of preterm birth than measuring cervical length.

Alex, X-Health.show: 0:12

Hi, I'm Alex and welcome to the X-Health. s how, where I talk to visionaries behind the latest innovations in healthcare. For the eXtra health of the future. We're in Zurich, Switzerland, in an area that offers both cafes, quick access to the city, and the peacefulness of thick greenery. This is where my guest, dr Sabrina Badir, a seasoned startup CEO of Pregnolia, recharges. She is a biomechanics engineer that developed and researched a method for assisting more accurate diagnosis of preterm birth. She founded Pregnolia as a spin-off of ETH Zurich, Swiss Federal Institute of Technology. Pregnolia's system measures the stiffness of the cervical tissue of a pregnant woman and its changes during pregnancy. In a moment you'll hear about how the cervix works during pregnancy, how to assess risk pregnancies fast and accurate, cervix finger palpation examination results versus Pregnolia device reading, the unexpected benefits of startup speed-dating, the art of pitching, and more. Sabrina, every 15th child is born prematurely in Switzerland. I'm sure you know more about these statistics. Can you tell me more, how common is premature birth?

Dr. Sabrina Badir, Pregnolia: 1:28

Worldwide, I usually say one in 10 babies are born prematurely and in fact we have to separate what type of premature birth it is because we speak about spontaneous preterm birth and about medically induced premature birth. So it's actually a statistic that brings both groups together. While for the medically induced premature births, you cannot prevent them because there are medical reasons for the mother or the baby that lead to a premature birth. Alex, X-Health. show: And they should be safe right?

Dr. Sabrina Badir, Pregnolia: 2:02

Dr. Sabrina Badir, Pregnolia: Yes, for example, if there is pre-eclampsia that leads to a premature birth. The spontaneous premature birth – that's the topic we are addressing because these babies are born prematurely and the symptoms that lead to that premature birth are usually not recognized.

Alex, X-Health.show: 2:21

And spontaneous sounds actually nice, what it really means is unexpected, right?

Dr. Sabrina Badir, Pregnolia: 2:28

Exactly, it means the baby is born spontaneously but before the estimated delivery date. So before 37 weeks of gestation is considered a premature birth. And then you can also separate it very early premature birth and moderate premature birth or late premature birth. So there are basically three categories.

Alex, X-Health.show: 2:52

Right, and some of them are preventable if you know this may happen. You designed a tool that helps to diagnose or predict premature birth. How does it work?

Dr. Sabrina Badir, Pregnolia: 3:07

e built a device on an idea that exists for many, many centuries. We measure the stiffness of the cervix with a medical device that is used by a gynecologist. And what I always like to say is doctors use their fingers to palpate the cervix and get an idea if the cervix either soft, medium or stiff and we went on this idea to improve that assessment by a quantitative way. To make it independent of the doctor that needs to train a lot and understand if a cervix is stiff or soft, and make it this way easier and also less intrusive for the woman with a medical device that gives more privacy.

Alex, X-Health.show: 3:56

Let's cover a bit of the basics at the beginning. The cervix itself. Let me just ask you, why it's so interesting that you actually spend now, what 15, 20 years working on?.

Dr. Sabrina Badir, Pregnolia: 4:12

It's a funny topic in that sense because when I was starting this journey at ETH as a Master's student going into a PhD, I never thought that so many years later I would speak about the cervix. I'm a biomedical engineer and at that time I was very interested in characterizing human soft tissue in vivo. So at the Institute I was first working as a Master's student and then started a PhD. We developed methods to quantify and characterize mechanical properties of soft tissue in vivo. So we were not interested in extracting human tissue and put it into a machine but really trying to find a way how we can define and characterize mechanical properties of the tissue in the human body. And that's where it started.

Dr. Sabrina Badir, Pregnolia: 5:07

And very soon, when I started to dig into the literature, I got very fascinated by the cervix because during pregnancy it has at least a dual function. It has to maintain pregnancy for nine months. For that it has to stay closed, stiff and long. And then, as the delivery date approaches, the cervix has to do a fascinating remodeling towards a soft, short and at the end also a dilated cervix that finally builds the birth canal. So it's dilating up to 10 centimeters and from a mechanical point of view that's just incredible what nature is doing in order to make that process from a closed organ to a completely open organ within nine months.

Alex, X-Health.show: 5:59

Could you describe it mechanically? What changes inside? Like, I don't know the stiffness, how do you measure that?

Dr. Sabrina Badir, Pregnolia: 6:08

So we are basically measuring the result of that cervical remodeling, which is on a micro level. I mean, the cervix is connective tissue and it consists of different components and these components are changing and make the cervix softer throughout pregnancy. And that's what we are measuring.

Alex, X-Health.show: 6:29

How do you measure softness? What's the measure for softness?

Dr. Sabrina Badir, Pregnolia: 6:35

We've been looking into different methods to define the stiffness of the cervix in particular because the methods we've developed were also used in other applications on other human organs. So we were really looking at the cervix, which is a rather small organ. It has a diameter of about two centimeters. So you have quite a lot of boundaries and you have to make sure that the method that you are developing is working in these boundaries. So we've been focusing on the so-called aspiration technology. We have a tube that we place on the cervix, it's in the dimension of the finger and then it's connected to a control unit that creates a very weak vacuum.

Alex, X-Health.show: 7:23

Yes, that's the scary part! It's not really right, is it? But the vacuum... when you hear a vacuum inserted into your vagina and attached to your cervix when you're pregnant, it might be a bit worrying.

Dr. Sabrina Badir, Pregnolia: 7:40

In fact it sounds worrying but it's not. The vacuum is so slight that we've never heard that a patient said she's actually feeling that we are already measuring. They always ask: when are you starting? And then we're almost already done. So it's a very weak vacuum and we are really slightly pulling on the cervix, a very small area. The cervix, or the cervical tissue is pulled up to four millimeters, it's a very short distance but that allows us to define the cervical stiffness. So we basically apply a weak vacuum and it increases the stiffer the tissue is and we pull it up to four millimeters and at four millimeters we then have a correlation between the vacuum needed to pull the tissue and the stiffness because it's directly proportional.

Alex, X-Health.show: 8:40

Okay, and you can quantify actually the stiffness, right? Because do what gynecologists say? What do they say? They say: soft or stiff, or is there anything in between.

Dr. Sabrina Badir, Pregnolia: 8:56

Moderate or medium. medium three categories are soft, moderate/ medium, stiff. And they do that with a finger. So I hear from very experienced gynecologists that over the years they have learned how soft, moderate and stiff tissue feels. But in the end it's subjective because you don't have a sensor on your fingertips.

Alex, X-Health.show: 9:24

You said eight years ago that it's difficult to find pregnant women who are willing to participate in clinical trials for the tools. I think a lot have changed since that. But did you think this eight years ago that it might be over with the device you build? You realize it might be some game-changing device and then you couldn't find people to participate in clinical trials.

Dr. Sabrina Badir, Pregnolia: 9:57

I think in the end, it's not the device that you're using in a clinical trial, it's the condition, the situation pregnant women are in. I mean, pregnancy is a very delicate process, situation and most of the women don't want to get involved in clinical trials because of being pregnant.

Alex, X-Health.show: 10:23

Some even don't exercise right.

Dr. Sabrina Badir, Pregnolia: 10:28

I mean there has been shown that pregnancy doesn't need that. You step back and kind of lie in the bed and wait for the baby to come but there are still a lot of mysteries, and kind of says that people think they're valid. But I think, just thinking about the routine that gynecologists have and how dense their program is throughout the day, it's actually hard to consent all these women for clinical trials because our consent patient information contains four pages and you have to explain to the woman everything about the study and potential risks. I mean the risks are very, very small. We did over 2,000 measurements and we did not have any complications, but nonetheless you still have to do that consent and therefore you have to inform the woman about all the potential risks. And that's scary because one of the risks are that you have a bleeding, and which pregnant woman wants to have a bleeding?

Dr. Sabrina Badir, Pregnolia: 11:36

Because they know that's a risk for their pregnancy. So I think there are a lot of pragmatic problems in the end that makes it hard to recruit pregnant women and that has not changed., t's still the same situation and that makes medical devices to be approved for pregnant women very hard to get the clinical data together.

Alex, X-Health.show: 11:59

So you managed to have some clinical trials at the beginning. And I remember I was reading about one of the studies when you measured cervical stiffness with a Pregnolia device and there were some, I think, 30 obstetricians measuring with their fingers with this category soft, medium and stiff. Could you tell about these studies? What was the outcome?

Dr. Sabrina Badir, Pregnolia: 12:32

The arguments against our product have changed over the time. But very early, we always got the comments, but why do I need a device that can measure the stiffness if I can use my fingers? Alex, X-Health. show: Exactly, yes. Dr. Sabrina Badir, Pregnolia: Exactly. And I'm not a gynecologist and I don't have experience in palpating cervixes. So we thought let's do an experiment and see what's the outcome.

Dr. Sabrina Badir, Pregnolia: 12:58

We developed silicon cervixes based on our first clinical study where we showed how the cervix changes over pregnancy, and then, based on this clinical data, we modelled the cervical stiffness at the different gestational ages and we had five silicon models which we asked gynecologists to palpate and categorize between soft, medium and stiff. At the same time we measured the stiffness of the silicon cervixes, all blinded, of course, so neither doctors nor the investigators measuring knew which cervix it was. And the results were quite interesting because we've been showing that our device measures so accurately that the differences between investigators varied between 4%, while palpating the cervix gave a big mess, let's say, because for all the cervixes we had the categorization stiff, soft and medium, which really shows the problem. But we did another round, so we gave one of the cervixes again to the gynecologists, so they had to rate a randomly assigned cervix again and most of them did even not categorize the same cervix from before, with the same feeling, how stiff or how soft it was. Alex, X-Health. show: So they basically categorized it differently?

Dr. Sabrina Badir, Pregnolia: 14:36

Yes. A stiff cervix was soft or medium in the second rating, which really showed the subjectivity of the palpation, which is not to discriminate, but just really to show what value a device could bring into that assessment.

Alex, X-Health.show: 14:56

And I read the testing with Pregnolia takes a couple of seconds. I can imagine for the doctor it can take a bit more and it's not then quantified as you say. So it's faster and you can not only have the feeling that it's soft or it is stiff but also a number that can change or not during the pregnancy or how it should change. I'm just thinking now, do you have a chart, how it should change – the stiffness? Yeah, I can imagine you do.

Dr. Sabrina Badir, Pregnolia: 15:35

Yeah, in fact we do have a reference curve which we derived from the first clinical study where we followed 50 pregnant women throughout pregnancy. So we basically have a reference curve with quantiles where we show at that gestational age the median is X and 25 percentile is Y. So it actually helps the gynecologist to contextualize the measured stiffness with that reference curve and gives an idea, is the cervix that I measured now rather stiff, soft or median normal.

Alex, X-Health.show: 16:12

Who are the first adopters of Pregnolia system?

Dr. Sabrina Badir, Pregnolia: 16:17

It was a particular gynecologist here in Zurich and I remember it very well because she really recognized from the very first beginning that this is an essential tool for improving preterm birth diagnosis. While at the time when we approached her, and still today, we are a measurement device, so we measure the stiffness and we can interpret the stiffness result based on that reference curve but we are not yet there where we can do a diagnosis, a risk assessment, and give a percentage of risk for preterm birth. So we are more on the side where we give a quantitative stiffness value and the doctor has to interpret what this now means for the clinical decision.

Alex, X-Health.show: 17:10

Could you describe her a bit. I'm just curious, who is someone who wants to adopt what's coming new – first?

Dr. Sabrina Badir, Pregnolia: 17:21

First of all, she was already convinced that stiffness is relevant. She was palpating the cervix, so for her it was obvious that quantifying cervical stiffness gives a value. She also was interested in getting cut off value, so a risk assessment based on cervical stiffness. But she acknowledges that this is a long way to go and she wants to be part of this new innovation and bring this early to her patients, because she already saw a benefit by quantifying cervical stiffness and comparing it to the reference curve. Alex, X-Health. show" Anything like I don't know age interests, anything, characteristics of her.

Dr. Sabrina Badir, Pregnolia: 18:08

Dr. Sabrina Badir, Pregnolia"She herself is also an entrepreneur, so she really started to establish a new way of how she provides gynecologic advice. She really involves the pregnant women in the whole journey. She provides a lot of extra information. She's evidence-based. She sees gynecologic and pregnancy care as a holistic approach, so she really tries to bring in all the knowledge that is available and not just focuses on what she was taught at some time during the studies and I think she has an entrepreneurial spirit and I think this is definitely one of the drivers. Besides the fact that preterm birth is an unsatisfied situation and she experienced in many cases women not being diagnosed or over diagnosed. I mean, she keeps telling me that there are so many women I have the feeling they're going to have preterm birth but they're not. So I bring them into the office more frequently and in the end, worry them that they're potentially having a risk, but they're not. And at the same time I miss women that have a risk of preterm birth but with the current methods there is no way to diagnose them.

Alex, X-Health.show: 19:37

Just thinking, did you see the reaction of the doctors when you presented them with the result, the ones that were doing the blind testing? Or you just informed them with an email or something? Were there any reactions?

Dr. Sabrina Badir, Pregnolia: 19:58

I remember we also had not just gynecologists but also midwives, and some of them were really curious. They immediately wanted to know how they rated the cervixes and they were so surprised that they did not rate the cervix correctly. And then they were also trying to find out from where this could be coming. They said, in reality it feels slightly different, so maybe it's coming from there but maybe my feelings are not as accurate as it could be with a device. So they acknowledged that the device could actually bring added value into their routine.

Alex, X-Health.show: 20:37

And you didn't stop with studies, right? I saw that, I think a couple of months ago, you published at the American Journal of Obstetrics and Gynecology, which is, by the way, congratulations on that, that's like a huge achievement. Could you tell a bit more about these studies? What were the results?

Dr. Sabrina Badir, Pregnolia: 20:59

I'm very proud that the Pregnola system got the chance to be published in the American Journal of Gynecology because I published more than five papers in the past but I never got accepted in this journal, which is that journal you have to publish in Gynecology and Obstetrics. I'm very happy that the team of Michael House and Julie Stone got accepted with their publication in that journal because we've been doing a very nice study at Tufts Medical Center and they've been looking at women with risk factors for preterm birth, and they were curious to see if these groups have different stiffnesses and different roles that were gestational age matched. They really could see that women that have short cervix also have a soft cervix, which confirmed our hypothesis that you need to have a soft cervix in order that the cervix shortens. And that we already saw in the first study when we followed the women throughout gestation

Dr. Sabrina Badir, Pregnolia: 22:11

the cervix actually softens already in the first trimester and the shortening is kind of a consequence of that softening which is only seen in the third trimester, which gave us the idea measuring cervical stiffness could actually give us earlier information about a risk of preterm birth than measuring cervical length.

Alex, X-Health.show: 22:34

So you were a scientist working on that and then why you decided to found a company. How did you gather the team? I met your co-founder, dr Francisco Delgado, just briefly, but I already can tell that, at least temperamentally, you are completely different.

Dr. Sabrina Badir, Pregnolia: 22:56

I remember the first time I met Francisco was at a start-up speed dating and originally I was so skeptical because I thought how ridiculous is it to go to a start-up speed dating?

Alex, X-Health.show: 23:13

It's like, how can you find a partner speaking for what, a couple of minutes, five minutes, ten-fifteen?

Dr. Sabrina Badir, Pregnolia: 23:19

Yeah. But then something very interesting happened. He got really interested and he followed me even to my office where I was doing the PhD and said, Sabrina, I'm really interested in this. And I got scared because he said, I'm looking for a job, and I thought I don't have money, I cannot pay you, go away. But in fact I was looking for someone to start that journey with me or at least evaluate if there is a case to make and start a company because at that time I did not have a company yet.

Dr. Sabrina Badir, Pregnolia: 23:55

I finished my PhD. I knew that there is something that can be explored and potentially could become successful at some point but that was at a very early stage. I had the support from the gynecologists that told me you can't go away now, I mean, PhD done but we want you to keep working on this. So it was thanks to Francisco in the end that we started founding the company together because if it would have been me, I think I would not have had that persistence. I was kind of overwhelmed with all those requirements you had and I had money to pay certain expenses for the activities but I didn't have money for myself. I didn't know how to do that.

Alex, X-Health.show: 24:45

So that was the ETH support, wasn't it?

Dr. Sabrina Badir, Pregnolia: 24:48

Exactly. But at some point, when we decided to sit down together and think about it and he actually put also a little bit of pressure because he said, I got now a job offer in another startup, and I really felt, because he was volunteering and we were working together, I felt this is a really nice match and we should find a way how to do that. And in the end, with that pressure, we found a way to finance both of us and, yeah, to start together.

Alex, X-Health.show: 25:19

What's his background?

Dr. Sabrina Badir, Pregnolia: 25:22

He's a biomedical engineer. And one thing I learned at the very beginning you should not found a company with two people with the same backgrounds. But we have so different philosophies and personalities that we were such a good synergy that I thought we have to keep going and do what we plan to do, and if at some point we need other backgrounds, I'm sure we will get this as forming a team.

Alex, X-Health.show: 25:52

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Dr. Sabrina Badir, Pregnolia: 26:06

Alex, X-Health. show: So the two of you started. What was the hardest at the beginning? Dr. Sabrina Badir, Pregnolia: I was very focused on the work I did during the PhD, which was, in fact, a very narrow part of the whole story. So we really had to kind of zoom out and understand it's not the technology, it is the business around that technology. And at first hand is there really a need for a better preterm birth diagnosis? And what in essence is a preterm birth diagnosis? What population? What's the case for reimbursement? So really building the entire business case. And I found this very hard because I'm a scientist turning an entrepreneur and at that time I was so focused on the device and how it works and people telling me this is just a little piece of the whole puzzle and I could not really understand yet what this means. So I think it was that transition from being a scientist becoming an entrepreneur.

Alex, X-Health.show: 27:18

There were quite a few questions at the beginning! Are you managed to build a business case, and quite successfully so, as I read, in 2015 you actually won the best business idea award and, I just wanted to ask you, how did this idea change over the years? Or did it?

Dr. Sabrina Badir, Pregnolia: 27:38

I mean, at the beginning it was very helpful for us to expose ourselves to all these competitions because you get feedback and with that feedback you can move on and kind of make things more clear or improve.

Alex, X-Health.show: 27:52

Competitions, like startup competitions in Switzerland.

Dr. Sabrina Badir, Pregnolia: 27:55

Yes, mainly startup competitions in Switzerland but for some also abroad. That was very helpful in forming the entire business model, business case and also exposing ourselves to investors to get their feedback in order to know, once we really need investors' money, what are they expecting from us.

Dr. Sabrina Badir, Pregnolia: 28:17

I mean, the entire business model did not change a lot from what we pitched at the very beginning.

Dr. Sabrina Badir, Pregnolia: 28:26

What changed is from the learning we got from the market is our go-to-market strategy. At the very beginning I was having that vision to improve preterm birth diagnosis in normal pregnancies, because 50% of the premature births happens actually in that population. And from the interviews we did, I really got that feedback that the big impact with the Pregnolia system is going to be in that population. But on the other side, I also got the feedback that completely changing the way how preterm birth diagnosis is done is a very hard job for a startup. But I still thought let's try it. And on the way, we really learned that you cannot nail it down in one step and that we have to focus on a more daily challenge, which is the triage of the symptomatic pregnancies. And that's how we changed our value proposition for a go-to-market strategy, while my vision is still to make the big impact, which I believe is still on the normal pregnancies. So we did not skip that but we just said this is a more long-term vision.

Alex, X-Health.show: 29:45

What would you say were Pregnolia's milestones business-wise.

Dr. Sabrina Badir, Pregnolia: 29:51

There are many milestones on this pathway, which started in 2016. From forming the first team, which brings all the experience and skills you need as a medical device manufacturer, which is quite a lot of information you need to bring together in order to certify a medical device. And then, without money, you're not going anywhere. So we successfully raised two rounds and we got significant grants that really helped us to pay all the bills and the salaries. In total, we raised 10 million, and raising funds is kind of a continuous job I have. So that's where we are right now as well, raising our next round to keep going and bring our product also to the US market after the CE certification in Europe. Then reimbursement as a medical device is also very important, so I'm very happy that we managed to get the voluntary insurance from three leading health insurers in Switzerland.

Dr. Sabrina Badir, Pregnolia: 31:01

What makes me most proud is the collaboration with these world-known key opinion leaders in gynecology and obstetrics at one side but also all these very important private offices that already are part of our early adopter base that are using the Pregnolia system in their clinical routine while the world-known key opinion leaders are supporting us in gathering the relevant clinical evidence in clinical trials. So it's kind of both sides. The stories I hear from the clinical routine where Pregnolia already had an impact. So the stories of the pregnant women that could already benefit from these early adopters that are using it in the clinical routine. Alex, X-Health. show: Could you tell one of them or a couple?

Dr. Sabrina Badir, Pregnolia: 31:48

Dr. Sabrina Badir, Pregnolia: There are some which for me are really emotional because it shows in a qualitative way what impact we have on the clinical routine, the impact we can have once we roll out our product broader. So one pregnancy was considered at risk because she had also a short cervix, but the stiffness was high and this gave the doctor the confidence that she can keep her in the private office, doesn't have to send her to the hospital and just makes more frequent visits. And the stiffness kept stiff. So this woman in the end delivered at term and that makes me very happy because she did not get interventions that are unnecessary.

Alex, X-Health.show: 32:36

What could be an intervention?

Dr. Sabrina Badir, Pregnolia: 32:39

I t could be progesterone, a hormone to maintain pregnancy but it has side effects. So you really want just to give progesterone to women that really needed it. Or she could have been hospitalized and that's very bad for the women if they're just lying in the bed for many weeks without any reason. And then there was another story, actually on the opposite side. This woman was considered a normal pregnancy. She had a long cervix but the cervix was soft. And we always have the discussion can we already send women to the hospital because of a soft cervix? Because this is not a well accepted criteria yet for kind of triaging a woman and hospitalize her.

Dr. Sabrina Badir, Pregnolia: 33:28

But this doctor said I sent her and she was kept in the hospital and the day after her cervix was very short and she got an emergency cerclage, so basically the doctor sued the cervix. That's a surgery. You mechanically close the cervix that it cannot open anymore. And I'm very happy that this happened. So you have these two examples where Pregnolia can really have an impact in better triaging women that really have a risk but also excluding those that will get unnecessary treatments.

Alex, X-Health.show: 34:06

That's amazing because basically what happened, the preterm birth was literally prevented in this case. It sounds amazing, you know, because, again, it takes a couple of seconds. I mean the device is not that big and the situation changed the next day, which is kind of scary on one part, too. I heard you pitching at the Women's Health Innovation Summit in Basel and you actually, quite visually, showed how the cervix works – with a pink balloon. Could you tell how does it work on a balloon and how did you come up with the idea to show it on a balloon?

Dr. Sabrina Badir, Pregnolia: 34:56

So going to the balloon and how I use it as a visual. For me the balloon is uterus and the knot of the balloon is a cervix. I explain that this knot of the balloon, or the cervix, has to maintain closed to keep the fetus in the uterus and let it grow until it's time to be delivered. And then this knot opens and builds the birth canal and the baby is born. And if this happens too early, the baby is born prematurely. And that basically visualizes the important role of the cervix and this dual function it has maintaining closed for nine months and then, from one day to the other, it has to open to 10 centimeters and build the birth canal. How did I come up with that balloon idea?

Alex, X-Health.show: 35:48

When I'm thinking about it, when you're pitching, you're pitching not always to people who know how cervix works or what cervix should look like during different phases of gestation. And, being a scientist, you had a completely different attitude. So, coming from science and what you described a bit, I also think you went down the level, the scientific level already for all of us here to understand it, but then coming to the balloon is again a different level.

Dr. Sabrina Badir, Pregnolia: 36:31

This is what I learned at the very beginning to break down science in a way that investors and all the stakeholders understand what I want to build with Pregnolia. And the balloon actually had another level on top of it because I got nominated for the Falling Walls Conference. This is an international conference for business ideas that have a science background, and I got nominated for the 100 Falling Walls Lab winners. So, from all over the world, there were 100 business idea innovators invited to pitch for three minutes.

Alex, X-Health.show: 37:17

It's kind of a lot, right, it's 300 minutes of pitching.

Dr. Sabrina Badir, Pregnolia: 37:21

Yeah, an entire day. So basically you were there for three minutes to pitch and of course I wanted to kind of stand out of all of these entire crowd and I thought how can I do that? Because I'm sure there are a lot of great ideas, so how can I get the attention? And then, just as a joke, I was saying I could use a pink balloon and kind of explain the cervix or the role of the cervix with that and maybe it's kind of a visual that people'll keep in mind. But on the way I thought, nah, it's kind of maybe also too funny and people won't take me serious.

Dr. Sabrina Badir, Pregnolia: 38:01

So I was on the way to the airport but then I thought, maybe I just get a package of balloons and then, if I change my mind, I could still use it. And then I was at the hotel and I started to train how I could hold the balloon that you could see the knot. And by that time my partner was also there and he was giving me feedback and he said you should really do that, I think a very nice visual. And then I thought, let's try it. And that was the first time I officially used the balloon to pitch Pregnolia and I think it was not the reason why I was one of the winners of that competition but it certainly helped me to differentiate.

Alex, X-Health.show: 38:46

I can totally confirm that because it's so easy, then. A balloon is not a complicated visualizing tool, but then it's truly very simple, well, simpler even when you realize that, when you see it.

Dr. Sabrina Badir, Pregnolia: 39:08

And now we use the balloon everywhere. So we have it basically incorporated into our corporate identity, which for me is very emotional because it was a personal decision out of the need to make a distinction from all the others. And now it has become part of Pregnolia, which is very nice.

Alex, X-Health.show: 39:28

Quite recently you pitched at Roche, which is, again, a huge step, pitching in front of corporate pharmaceutical company. Did you also pitch with the balloon there?

Dr. Sabrina Badir, Pregnolia: 39:41

Of course! A nd it makes people always very curious what I'm going to do with the balloon. Some knew that I used this already in other presentations but some don't and then it detracts their attention because they really want to know why am I coming with a balloon?

Alex, X-Health.show: 40:04

Do you know how many times did you pitch or have you pitched, because it's not the end, right?

Dr. Sabrina Badir, Pregnolia: 40:09

I stopped counting it but it's been seven years now since I started to use it the first time and I'm certainly doing that 20 to 30 times a year. So you can calculate it yourself.

Alex, X-Health.show: 40:26

Would you have any advice to younger startups? What's important in pitching?

Dr. Sabrina Badir, Pregnolia: 40:35

I mean, the first step is to understand to whom you're pitching. I think that's very important and, in general, making things easy. So when I pitch I try to tell a story and I use the slides supporting my speech. But I don't put a lot of text on the slides because I really want to tell a story and I want to catch the attention of the people to listen to that story.

Alex, X-Health.show: 41:04

Totally. That's very important because when you put too many words out there, people basically start reading.

Dr. Sabrina Badir, Pregnolia: 41:11

But therefore it's very important to know to whom you're presenting because if you're presenting to an investor, he has another expectation than when I present to a corporate company. Or if I present to an insurer. You have different requirements. So you really have to do your homework and understand, in the best case, what the expectation or what's the goal of that presentation.

Alex, X-Health.show: 41:38

So you check the backgrounds of your listeners, if you can.

Dr. Sabrina Badir, Pregnolia: 41:41

Yes, and also the goal. I try to define if I have some more information, what's the goal of that presentation. I really try to shape that and then adjust the storyline and presenting.

Alex, X-Health.show: 41:55

I was just thinking, if there's anything that you wished you have known before you founded the startup? When you're thinking back, it's like, OMG, if I only knew that I wouldn't do or I would do.

Dr. Sabrina Badir, Pregnolia: 42:14

If I would start again with the current situation, political situation we have in Europe, I think I would focus on the American market first. No one knew what would happen with the introduction of this new Medical Device Regulation, which is in force for some years now, and with the political situation we have here in Switzerland, with the European Union and the UK. It's quite complex and it consumes a lot of resources. Not knowing what would happen and stepping back, I think I would probably not risk it to go in an uncertain situation and shift to the American market.

Alex, X-Health.show: 43:00

Would that be faster? Or what were the uncertainties?

Dr. Sabrina Badir, Pregnolia: 43:05

I think US approval is stricter, so it's not faster I would expect, but the pathway is clearer, while we did not know what's going to happen in Alex, X-Health. show". you didn't know that if you would be approved or not,

Dr. Sabrina Badir, Pregnolia: 43:23

Dr. Sabrina Badir, Pregnolia: The funny thing was we already had CE mark but we lost our notified body because the framework agreement was not put in place. So we lost our notified body, which decided that they will not continue under these circumstances. They were based in Switzerland, so we had to go out and find a European notified body which re-certified our product because we would have lost certification.

Alex, X-Health.show: 43:53

Okay, you were on the way and then the environment granting the certification changed, so something completely not under your control.

Dr. Sabrina Badir, Pregnolia: 44:06

Yes. So then of course, we already had the CE mark and we were trying to save that CE mark and we were looking for a new notified body and we were successful doing that. But then more things happened. As a Swiss startup, you now have to export, you have to have a representative in Europe. You pay more fees exporting, you have to pay a person that represents you in Europe. I mean, it's just so complex and time and money consuming that I think I would next time focus on a country where you have kind of more stable conditions with FDA. This certainly is true.

Alex, X-Health.show: 44:54

Where is Pregnolia system available now and how? Because you mentioned reimbursement systems, so it is reimbursed already in Switzerland. Where is it available and how basically women can get access to that?

Dr. Sabrina Badir, Pregnolia: 45:09

It's available here in Switzerland and in Germany. We are not sending the product to any other European country unless it's for clinical trials, and it's available for all the gynecologists in those two countries that want to use the Pregnolia system. While the reimbursement is restricted to the voluntary insurance parts, these women have to have the insurance of the three companies that are reimbursing it, and for all the others it would be an out of pocket payment. Alex, X-Health. show: Depending on how much the doctor would charge. Dr. Sabrina Badir, Pregnolia: Exactly, exactly.

Dr. Sabrina Badir, Pregnolia: 45:49

And of course the doctor has to have the Pregnolia system in their office, which is not so frequent. Yet we have about 20 products placed in Switzerland and the same also in Germany. So it's still a very small market share, but for us it's not growing the business, we are more in the testing phase, where we have a small but confident group of early adopters. We are really testing different scenarios to better understand the positioning of the product and in parallel we are working on the clinical evidence because for me it's essential to have evidence- based medicine.

Dr. Sabrina Badir, Pregnolia: 46:31

Alex, X-Health. show: So you're still a scientist a bit. Or deep inside. Dr. Sabrina Badir, Pregnolia: Yes. And I think the healthcare system is moving in that direction. At some point we want official reimbursement, on the national level. One of the big next steps is also to get into the guidelines of the associations of obstetricians that they really get the recommendation how to use the Pregnolia system. I think in establishing a new method even besides the fact that palpation... I mean we are not inventing a completely new way of doing it, but it's a new product it has different reimbursement pathways. For me that's very important to really have a sustainable success story.

Alex, X-Health.show: 47:18

So what are the next steps now for Pregnolia? You mentioned that you're still looking for funding, and I was thinking expansion, but you're saying now digging deeper into knowing how you can approach the market, I think.

Dr. Sabrina Badir, Pregnolia: 47:36

We have different next steps. One of the big focuses is to learn from our testing environment in Switzerland and Germany and understand how we can move forward in the market. What we already have learned is for hospitals it's very essential to use the Pregnolia system in women with symptoms that come into the hospital and they have to triage them. So that's definitely one of the focus points we have. But at the same time it's also important for us to move on with the private offices and support them in establishing a routine how to use the Pregnolia system because there the use case is slightly different.

Dr. Sabrina Badir, Pregnolia: 48:19

And while moving forward on those two fronts, hopefully the Pregnolia system will be adopted more and more. And then we have the clinical evidence and the guidelines, and the reimbursement which is going to be essential to make the Pregnolia story a success. So we are gathering clinical data in Europe but also later in the US. We are making sure that the clinical evidence is strong enough that we get the chance to be covered in the guidelines and with that that facilitate reimbursement negotiations. One big step for Pregnolia as a whole entity will be approaching the US market. We are about to prepare our communication with the FDA to understand what FDA wants to see in order to get market approval for the US market. So that's one of the big steps and for that, as I mentioned before, we are raising funds to cover all these activities.

Alex, X-Health.show: 49:26

Any dates you could speak now about, because I can imagine you know there are people who are listening to us and they are like, okay, when could I have it in the US? Or when could I have it in France?

Dr. Sabrina Badir, Pregnolia: 49:39

This is a very good question and I've been thinking about it many times recently. And with that entire momentum we have in women's health, also the big corporate companies stepping into that industry and actually shaping that industry together with the startups, the more and more I believe Pregnolia needs to partner with a strategic partner in the next two, three years to make that big step. So my goal is to kind of build that backpack with all the ingredients that it needs to kind of exploit the full potential of that device. Then I would like to hand it over to a bigger corporation that has the means and also the reach to really make this more successful.

Alex, X-Health.show: 50:33

I wish you that. I'm really looking forward to that and to see it available in doctors' offices, like it was a common tool to use. So also for you guys listening, if you want to follow how Pregnolia develops, please go to en. pregnolia. com. Thanks very much, Sabrina. Dr. Sabrina Badir, Pregnolia: Thank you, Alex. It was a pleasure speaking to you. [POST-ROLL] I'm totally impressed by the audacity of researchers turned startup founders, doctors turned entrepreneurs or ordinary parents turned healthcare innovators. People battling the battles that no one fought before. For the eXtra health of the future. So if you see a startup posting on LinkedIn, show them some love. Hit: Like, comment: That's fabulous. If you have a couple drops more of that altruism, follow the X-Health. show, leave a review here, I'll be able to bring more of these visionaries to you. So a big thank you. You're awesome. See you next week.

Speaker: 51:45

The information in this podcast is for informational purposes only and should not be considered medical advice. If you have any medical questions, please consult your healthcare practitioner. The opinions on the show are Alex's or her guests. The podcast does not make any responsibility or warranties about guests' statements or credibility. While the podcast makes every effort to ensure that the information shared is accurate, please let us know if you have any comments, suggestions or corrections.