Medsider: Learn from Medtech and Healthtech Founders and CEOs - You’re Never Too Small to be an Acquirer: Interview with Hera Biotech CEO Somer Baburek

Episode Date: November 12, 2025

In this episode of Medsider Radio, we sat down with Somer Baburek, CEO and co-founder of Hera Biotech. Hera is developing AI-driven tissue diagnostics for conditions that disproportionately affect women, including endometriosis and cervical cancer.Before launching Hera, Somer spent nearly a decade in venture capital, where she evaluated early-stage medtech startups and learned what separates the survivors from the rest.In this conversation, Somer explains how Hera designed global clinical pathways that balance cost and credibility, why boutique CROs can outperform big names, and how a pre-commercial startup completed three strategic acquisitions using equity and brand trust rather than cash.Before we dive into the discussion, I wanted to mention a few things:First, if you’re into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You’ll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you’re interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Somer Baburek.

You'll hear founders who, you know, are like desperate to raise, right? Because they're running out of cash or whatever and somebody's like, well, don't take bad money. And it's like, didn't give me good money. I mean, that's such a silly thing to say. It's like, you know, telling somebody who's starving, you know, don't eat that. It doesn't look good. Yeah. That's me.

I'm hungry. So I think that we need to quantify those differences. Like, just because somebody has never invested in your space before does not not mean that they are not a valuable investor. And it also doesn't mean that they are stupid money. It just means they don't have domain expertise in the very specific thing that you're working on. So if you're struggling, quantify that correctly. Welcome to MedSider, where you can learn from the brightest founders and CEOs in medical devices and health technology. Join tens of thousands of ambitious doers as we unpack the insights,

tactics, and secrets behind the most successful life science startups in the world. Now, here's your host, Scott Nelson. Hey, everyone, it's Scott in this episode of MedSider. I sat down with Summer Babarck, co-founder and CEO of Hara Biotech, a company developing AI-driven tissue diagnostics for conditions that affect women, including endometriosis and cervical cancer. Before founding Hara, Summer spent nearly a decade in venture capital, evaluating early-stage med-tech startups and shaping investment strategy at targeted technology funds.

She previously served as Director of Clinical Operations at Centales, Pharmaceuticals, managing regulatory, and commercialization efforts. Here are a few of the key things that we discussed in this conversation. First, global trial design isn't a cost shortcut. It's a strategy. FDA requirements allow flexibility in terms of where patients are enrolled. In fact, only about half of study participants must be U.S. based. By running portions of its studies in regions like Latin America and Puerto Rico, hair biotech can lower per patient costs while pursuing parallel regulatory pathways.

approvals through agencies such as co-friest can open multiple markets at once, stretching budgets without sacrificing data quality. Second, with investors don't chase prestige, chase alignment. Quote-unquote, smart money from investors with deep domain expertise or name recognition can be alluring, but it isn't always the best fit. Early on, Hara adjusted its positioning and outreach to attract investors who understood its science-driven model and shared its long-term goals. The best capital comes from clean terms, realistic expectations, and aligned incentives.

Third, use brand equity to grow before revenue. Here I completed three acquisitions in 18 months using equity rather than cash, adding competitive technology, a biobank worth roughly $8 million in trial savings, and a cervical cancer screening platform. Moves like this are only possible when partners trust your reputation and transparency. In life sciences, stealth mode protects little if your IP is strong. Credibility and visibility create far more leverage. All right, before we dive into this episode,

I'm pumped to share that volume 7 of MedSider Mentors is now live. latest edition highlights key takeaways from recent Medsider interviews with incredible entrepreneurs like Bill Hunter, CEO of Canary Medical, Brian Lord, CEO of Pristine Surgical, Don Crawford, co-founder of Safion and current CEO of Corvista Health, and other proven med tech founders and CEOs. Look, we get it. Keeping up with every MedSider interview isn't easy. That's why we created Medsider mentors. These ebook volumes distill the best practices and insider secrets from top founders and CEOs, all in a downloadable, easy-to-digest format. To check the latest volume out, head over to MedsiderRadio.com forward slash mentors.

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Learn more about Medsider Mentors and our premium memberships by visiting MedsiderRadio.com forward slash mentors. All right, without further ado, let's dive in the interview. Summer, welcome to Medsider Radio. Appreciate you coming on. Yeah, thank you so much. having me. I'm excited to be here. And if we were recording this in South Texas, I maybe should say Samir, Samar. Yeah, yeah, give it a shot. Go in hard with your Spanish accent. I love it.

I did take, I think, what was it, four or five years of Spanish, so I should be a little bit better than speaking the language than I actually am. But with that said, we're not here to talk Duolingo. We're here to talk Hera. So with that said, I recorded a very, a very abbreviated bio at the outset of this episode. But let's start there. Give us kind of a two-minute elevator pitch on your background and leading up to starting Hara. So I fell in love with women's health in my undergrad. I invented a medical device around the labor and delivery with my first daughter. Got picked up by a local VC fund for life sciences here in San Antonio, worked for them for about 10, 11 years, doing diligence on companies seeking funding, worked in a couple of the fund

companies as the director of clinical ops. We sold those companies. And I, I really wanted to get back into the women's health space. And so Hara was born, and we are off to the races. That is a great elevator pitch, you know, short and snappy. But I'm looking at your LinkedIn profile now, and we'll certainly link to it in the full write-up on Medsider. But you've been at, we're recording this in what's called mid-2020, just for rounding purposes. But you've been at Hara, or you started it back in, looks like, tail end of 19, early 2020. So about five years.

Hold your applause. Yeah, hold your applause for my perfect timing, because I started it in February of 2020, and then in March, the world ended with COVID. And I was just like, oh, but I will tell you all, I have a beautiful business plan as a result of all of that time at home to do nothing. Definitely, definitely threw a wrench into a lot of a lot of play. Good thing you didn't have everything mapped out, I guess, before then, right? Because that probably changed the game quite a bit. But yeah, you're getting close to the magic five-year QSBS number, it sounds like, as well.

So, but anyway, I always like to kind of mention that just to give people that are listening an idea of kind of how long, how long you've been at it, right, building the company. But on that note, the website, which I'm looking at right now is HeraBiotech, H-E-R-A-Biotech.com. So Hara, biotech. We'll link to it again in the full write-up on MedSider. But give us a sentence for kind of the two products that you're developing at Hara. And maybe friend that up as if, like, I'm completely unfamiliar with, you know, women's health or endometriosis and, you know, like I'm a sophomore in high school.

You'd be surprised how the sophomores in high school might actually know more about that. 60-year-old people. Anyways, not to throw shade on anyone. Anyway, so at our core, Pera is a precision diagnostics company. We use machine learning algorithms to power diagnostics. That's just core business, right? We are focused on diseases that uniquely or specifically impact women. And our first two products in our pipeline address gaps in diagnostics in cervical cancer

and in endometriosis. Most people know what cervical cancer is. For those who don't know what endometriosis is, which don't be ashamed, it is a disease where tissue similar to that which would normally grow on the inside of the uterus actually invades outside of the uterus and forms lesions kind of like little tumors all over the peritoneal cavity. It affects between 10 and 20% of all reproductive aged women. It's more prevalent than diabetes.

And on average, it takes eight years for a patient to get a diagnosis because the only definitive diagnosis is a surgical procedure, which we lovingly refer to as the Where's Waldo approach to diagnosis, because the surgeon is quite literally trying to go look for these lesions growing anywhere and find them and identify them as, in fact, endometriosis with pathology. Super helpful overview. And the two products specifically, it's Metra DX, I'm assuming DX diagnostic, right? And then the Hara, the HaraFM, which does which, I guess, for those listening to I heard you describe those two scenarios.

Yeah, HaraFM is our device that looks at cervical cancer. So right now, the means of diagnosing cervical cancer is a pap smear, which is a physical sample scrape, yada, yada, gross. Our device doesn't take a physical sample. We use electrical and optical spectroscopy to distinguish disease tissue from non-disease tissue. We have the most comprehensive cervical cancer screen in the industry because we read the entire effacing portion of the cervix and get a seven millimeter depth. Highly, highly sensitive test. So 91% sensitivity compared to biopsy and colposcopy. Really, really strong results there.

The Mitri-DX is our endometriosis product. That product relies on looking at MRI in expression in the endometrial lining. So we take an endometrial biopsy and we're analyzing it for a gene signature that is shown about 95% specific in diagnosing endometriosis. So really strong results there as well. Gotcha. So Mitri-D-X for endometriosis, Hair-O-F-M for cervical cancer. I find the patient potentially interested in either option, right? Herefm, I would go to primary care, OB-GYN, like where would I get this?

So today, if you're trying to get diagnosed with cervical cancer, it's OB-GYN, right? They require an OB-GYN specialty because they're needing to collect a sample from a very specific location on the cervix. Herofim doesn't need that because we're looking at the whole cervical effacing portion. So anyone that can perform a vaginal exam can use our hair fm device. That device is commercializing in Latin America first. It will be in market at the end of this year. And so then we'll be looking to bring it into the U.S.

and doing an FDA supportive study. Got it. And then Mitri-D-X, I mean, is the same kind of treatment pathway or diagnosis pathway kind of apply with Mitri-D-X in as well? Yeah. So if you can, you know, place an IUD or take an endometrial biopsy, you can do this test. So a GP technically could do it in a rural area. The majority of people that are going to be doing it are reproductive endocrinologists and OBGYNs.

That test should be available in early 2026 in the U.S. As a lab developed test, obviously funding dependent, but yes. Got it, got it. And you kind of took the next question out of, or answer the next question, I guess, before I even got to it. But Harofim, just to be clear, Harifam, you hope to commercialize this in Latam in, by the end of 25, right? And then eventually do a supportive study here in the FDA. And then Mitu DX, are you taking the same approach in Lidam or just going straight to the U.S. next year, hopefully? We're going straight U.S. with Mitri DX.

And then we'll cross-pollinate into our Latin American distribution as well with some minor regulatory tweaks there. Okay, got it. Got it. Okay, so about five, a little over five years in the making and on the precipice of commercialization here. So exciting, exciting times for Hera. So with that said, again, before we get to the kind of the next sort of topical or functional set of questions, you know, we'll spend about 20, 30 minutes going through those. Again, for everyone listening, herab biotech.com is the website.

We'll link to it in the full write-up on Medsider. If you're new to Medsider, these full write-ups accompany these podcast episodes and are meant to kind of serve as a refresher, right and highlight a lot of the key learnings that our guests share like Summer on this that we'll get to throughout the rest of this conversation so I really encourage you to check that out but again it's hera biotech.com if you don't get a chance to get there or just listening to this this particular interview so with that said summer let's get to the first question on the list here which is really really kind of rooted in your your your previous experience right you know starting it starting another company and then your time spent right

inside kind of the world adventure so when you when you think think about either your direct experiences at HERA or your prior experiences, right, seeing a lot of startups. What do you think are like some of the biggest mistakes most entrepreneurs or CEOs make, especially when it comes to kind of iterating on their early versions of their product, oftentimes with pretty limited resources? So I think there's about three different veins that you could take with it. It's just a result of me having worn different hats in the arena. So the one is from a VC perspective, you know, I like to, I try to bring levity to things, because my goodness, what else are we going to do? But, you know, the dirty little secret of

life sciences is the number one risk is that the tech doesn't work, right? Like, your drug's going to fail in phase two, but we're going to have spent millions of dollars to get it to this point. If we just take that out of the equation, because that's true for everybody, the second biggest thing is the team. I have watched more teams explode companies than I have watched tech not work. And it's a crying shame because you have really great technology that then typically just, it's almost like an albatross sits over it because it failed, but it had nothing to do with the tech. It had to do with, and this is going to sound terrible, but usually it's like a Napoleon CEO. I remember one specific investment that we made, this little guy was the CEO. And I literally was like, he,

is Napoleon. What is wrong with him? Why does he think that he owns the world and everybody's just going to cater to him? So I think it's making sure that your team is cohesive in terms of cultural fit and that you bring a diversity of background and thoughts to what you're doing so that you really encompass a lot of different viewpoints, which may experience your product in different ways. But it's also checking your ego, which I find shocking now that I'm a founder. I don't know how founders have egos because every day you get like sucker punched and gut punched and you're like told how no you're just no no we're passing it's terrible you know whatever and you're like okay but they do some of them do and so I kind of equate it

if you know anything about my background I used to rodeo professionally and I kind of equate those founders to bull riders like you aren't a bull rider if you aren't almost a complete narcissist because no rational person would go, like, get on the back of this 8,000 pound animal and be like, all right, try to buck me off. No, that just doesn't happen. And so they have these massive egos because they have to, otherwise they couldn't do what they do, right? So maybe that's the circumstance that we're dealing with. I think that's a core thing is making sure your team is there and that you've got your ego checked. And then I think the other big mistake that I see people doing, especially with limited resources,

is trying to piecemeal things together instead of actually hiring that consultant that really, I know it's a capital expenditure. And sometimes that just absolutely is not possible. But I think if people will actually do kind of a retrospective analysis, they would see that they've spent these like $1,000, $5,000, $7,000, $200 here, there, and whatever. And if they had just spent 15, they would have had what they needed. Yeah. So that's a good point. I definitely want to circle back around to kind of the team aspect that you mentioned earlier. But that's a really good point because I think as every startup kind of evolves, right, and hopefully, you know, begins to maybe knock down milestone and another milestone, et cetera, at some point, you're going to sort of have

to level up certain kind of functions, right? So even if you maybe were previously sort of piecemealing, and often, you know, let's be fair. Like that sometimes is needed, right? In the early stages, but it's a really good point that I don't think probably is maybe, is discussed enough right? on a particular podcast is like at some point you kind of need to lean into kind of like making a decision around leveling up something, right? Or committing to something rather than kind of to steal your phrase piece of meaning things together because that's hard to scale, right? Especially if you begin to move faster against certain milestones.

So yeah, a really good point. But it's so interesting that you brought up the team, the team too, not that that is, you know, it's often used and sometimes can sound cliche, but so so crucial. It's really sad to think about like all of the all of the startups, especially in the life sciences or med tech that are built around what could be really, really promising technology that just get blown up, right? Because of like human behavior, right? Or egos that are too big, right? And I think it's, the reason it's kind of resonating me with me right now because it can be, it's easy to talk about in retrospect, but maybe

when you feel like you're on to something, right, with a group of founders early on. And it's hard to like um sometimes it feels like you don't want to necessarily address the elephants in the room at that point because you just just want to kind of get to the next thing or see if this you know it feels like it may work and you kind of just want to get you know pass forward maybe another three or six months but if you don't if you don't address that alignment right or those those personalities early uh it's going to most likely bite you down the down the road oh yeah it doesn't like it starts as like a little hobgoblin in the corner and if you you ignore it, it becomes this like huge, all-encompassing black hole that then distracts so much

from the business. And that's just, you know, and I do want to say, though, and I hear this all the time. And it, again, I'm going to go back to my background as someone who used to barrel race professionally and barrel racers are essentially jockeys, right? But we're more talented because we have to turn circles too. And so it's kind of like the difference between Formula One and NASCAR like I'm going to go here and take a left yeah that's cool I'm going to take it right and then a left and then another left and then you know it's a good analogy actually yeah yeah and so I hear so many investors say like oh we bet on the jockey not the horse whole story bro that doesn't make sense because you can take the best jockey in the world and if you put them on a

donkey they're not going to be a bad jockey on a thoroughbred like it's just not going to work so while it's a nice, fun, cheeky statement to me, there has to be a combination. You have to know that you've got, you know, I would take a solid founder with a decent technology or a solid technology with a decent founder all day over an incredible founder with questionable technology, you know, because it doesn't matter how good the jockey is if the horse sucks. You can't will it to be better than the other athlete. leads from the space. So I think we also have to bear in mind that it is a balance between the two things as well. Yeah, no doubt. It reminds me of the, I can't remember if this was like Ben Horowitz

that kind of popularizes this phrase of like, you know, what's most important product market or team, right? And sometimes, you know, product can, you know, can kind of maybe product or I kind of personally believe that like ultimately, especially in that tech market matters the most because you have to be solving for you. The market has to be big, right, to justify the amount of this sheer amount of capital kind of being infused with the company. But to your point, right, if you pick, you know, an egotistical founder and put them on a really hot product, that product probably is not going to see the light of day. Right. That talkie's not going to be able to ride that horse. And so, yeah, it's a really, really good point. Let's shift gears and talk

a little bit about the clinical function, right? Because it's right in your wheelhouse. And as you kind of laid out kind of the approach, both with Mitri-DX as well as Harefm earlier on. But when you think about, you know, some of the choices that you've made, you know, take, take Herrfm, for example, commercializing in Lanham and then eventually kind of bringing that into FDA. And it sounds like maybe it's a, it's a non-clinical pathway, but you are doing a supportive study at least, or I'm not entirely sure if I got that right. But give us a sense for kind of how you've thought about that approach at Hara Biotech. And, you know, what do you think maybe considering this is like, you know, right in your wheelhouse? Maybe, maybe, you know, your greatest strength as the CEO,

right, is like mapping out, you know, Clint Reg, you know, kind of kind of roadmaps. What do you think are some of the things that other founders, CEOs really, really need to get right when it comes to kind of this area? So there's two things here. Every decision that you make, I think our team has done this really well to date, and I hope we continue to do it well, is you need to take that macro-level view of what is the global. Let me go backwards. Our company is building products that can be adopted globally. And that was always, always, always at the core. For example, some of our technology started in very complex, like single-cell analysis, right, for our meat tree DX product.

That is not something that can be adopted globally because that is a tech limitation, right? India doesn't have that, neither does sub-Saharan Africa in many places in Latam, or it becomes cost-prohibited even if they do have it. So we always took the approach that we don't think it is sufficient anymore, especially for, or even for U.S. companies, to build solutions where they're like, oh, we're going to build this. It's going to go gangbusters in the U.S. and then we're going to get acquired. Yeah, that's just our world has gotten too small for that. And to really capitalize on the true value of the market that you're dealing with, it has to be more than just U.S., right? So that's a core belief of what we're doing. And so when we look at the, we started with endometriosis. That was our first, our first area. Through our work in endometriosis, we saw that endometriosis

is associated with over 60 comorbidities, many of which suffer from gaps in diagnosis. So, and then you look at the women's health space and you see there's only a few key players in the space. And then there's all the startups. We don't have that like middle class, you know, person that's acquiring startups that then can feed into the big dogs, right? And so when we looked at it, there was so many point solutions for different things. And we decided this is what digital health did about seven years ago, let's say. And then the aggregators of the point solutions were the survivors. So let's get ahead of the curve and let's be the aggregator.

Cervical cancer is a comorbidity with endometriosis and it increases your risk of getting cervical cancer if you have endometriosis. 94% of cervical cancer deaths occur in low to middle income countries. Hence, we picked up a solution that was built by a team in a low to middle income market that was familiar with the challenges of using what we use now, which is a Patsmere in those market and have engineered a product to circumvent that issue and knew the cost structure, right? You can always put a less expensive product into a richer market, you know, and you add some bells and whistles or whatever you think you need to do, but it's much more difficult to go

the other way. And so that was the choice behind picking up the Herod FM device. And it was already in the process of regulatory approval in Latin America. So you don't mess with something that that was that close to revenue, right? It will be an FDA-approved product in the U.S. It's a med device that's going to be regulated. We're hopeful we can get 510K, but we may end up needing to go to Nova. But with all the work that we've done in Latin America, the FDA requires that only 50% of your population be American. So essentially, we've cut the trial potentially in half because of all of the data that will have in our Latin American population. Got it. That's super helpful. So it sounds like the pathway for Hare of Fem 510K, at least at least right now, you're maybe operating under

that presumption that is a 510K may go de novo, but it's a clinical 510K. So you use a combination of Latam clinical data in conjunction with data here in the US. Got it. Correct. Correct. And you know, like the Mexican version of FDA, right, is called Copa priests. Well, if you think about what that clearance does for you, an FDA clearance gets you into the U.S. and then it makes your path easier in other markets, right, like the European market, etc. But a COFEPRIS approval gets you into Guatemala, Honduras, Chile, Dominican Republic. Like, so many Latam countries recognize the COFRIES approval, it made a ton of sense. And then there's other markets that view that approval process similarly to the FDA,

and it expedites your approval in other markets, like the Southeast Asian market or the Indian market. And so that was another strategic decision. And why not get into revenue while we perform what we need to do, clinically in order to get into the U.S. market. Got it. Makes a ton of sense. When you think about your experiences, and it sounds like obviously this was a kind of a pathway that was already started, right, when you, when you acquired the technology, but when you think about your experiences, either dealing with copra priests or just choosing a certain geography to run studies in, you know, Central America, South America, let's just call it broader Latin Am, any particular

kind of insights that you might be helpful for other CEOs that are considering to be starting off there? Yeah, I will tell you the most expensive place in the world to run clinical trials is in the U.S. I think close second might be Europe, but you need to know what is required by the FDA for your approval, right? So like I mentioned, 50% of your subjects have to be American for the FDA to consider it. That means if you need a 500 patient study, go do 250 somewhere else. 250 patients in the U.S. is very, very expensive, even for a really low. hurdle clinical trial, you know, oh, I just need you to, you're going to do a my hair FM device and we're going to do a PAP smear and then we're done, right? You're still probably

talking about $3,000 a patient in the U.S. versus, you know, I don't know, maybe $1,000 for a person to do that in the Dominican Republic or in Puerto Rico or in Latin America. So take advantage of that. And then there's other things to consider like tax credits. R&B credits. So in a lot of geographies like Puerto Rico is really, really good about giving you incentives from a taxable standpoint to run your clinical trial there. And there's all sorts of R&D credits to offset your expenditures. The Australian government has a lot of incentives where they will match dollars spent on a clinical trial. So essentially, you get double the clinical trial for half the cost. So those considerations are really important because I have watched

companies die in the middle of a clinical trial because it's taking longer. You need more patients. You're not reaching statistical significance as soon. And then you can't raise the money. And so then it's over, right? If you run off the cliff, it's over. So I think those are important considerations. Just on the topic of Puerto Rico, out of curiosity, is that, does that, like, what is the regulatory authority in Puerto Rico? I mean, did they kind of fall under, you know, a different, they're, I think they're FDA because they're a U.S. territory. yeah okay um but the cost of clinicals is much less yeah got as much less there so yeah it's kind of like if you think about it it would be the equivalent of if you were running a clinical

study in manhattan versus if you were running a clinical study in norman oklahma probably different costs yeah yeah no doubt so so is it safe to assume that like um i don't want to i don't want to paint a too broad of a stroke here but um is it safe to assume that if you're let's say taking your 500 patient example, right? If FFTA is going to require a 500 patient study, in most scenarios, you would strongly consider doing at least a healthy percentage of those, obviously less than 50% elsewhere, right, in a lower cost geography. Hey, everyone, let's take a quick break to talk about Fastwave Medical, the company I co-founded and lead as CEO. We're developing next generation intravascular lithotripsy systems,

or IVL for short, to tackle complex calcific disease. The IVL market is valued at over $10 billion, but there's currently only one major player. In early 2023, we opened up an investment opportunity to our community, and within a month, we secured close to $10 million. Then in early 24, we closed and oversubscribed $19 million round in just a few weeks, bringing the total investment into Fastwave to over $40 million. Corporate interest in the IVL space is growing too, the $900 million acquisition of Bolt Medical by Boston Scientific, and then,

J&J's $13 billion acquisition of Shockwave medical signals a lot of attention towards emerging IVL startups like FastWave. And we're making some serious progress. FastWave recently received its seventh patent for our differentiated laser IVL platform for coronary applications. On the clinical side, last year we completed the first inhuman study of our advanced electric IVL system with some pretty compelling results. Next up in 2025, we have IDEE trials plan for both our peripheral and coronary IVL platforms. So if you're interested in investing in the fast-growing IVL market, sign up for our investor waitlist at fastwavemedical.com forward slash invest.

Again, that's fastwavemedical.com forward slash invest. Now let's get back to the conversation. I would, but you also, I would be remiss if I didn't say you also need to look at prevalence of what you're dealing with, right? So if you're dealing with something that, let's just say you're doing a diabetes study, right, you're going to recruit that way faster in the U.S. or in Latin America, than you are in Europe or in India or even probably Puerto Rico. So you don't want to oversimplify it in the sense that you're like,

okay, well, we can get patients for a fraction of the cost there, but there's no patients that have this condition there. Because then your recruitment is going to be so slow, it's not going to matter because the overhead costs will eat up the difference, right? So you have to balance those factors. Yeah, yeah, of course there's going to be nuances. But the reason I bring that up is I think it's, at least in the world of cardiovascular, right, which is, which is, you know, my, my domain.

But I think it generally, generally kind of applies to most of med tech anyway. You think about these, this journey, right, going from maybe a first in human study to maybe a slightly larger feasibility study and then eventually maybe into some sort of IDE trial here in the U.S. And the reality is if you can align those, if you can align those out of the gate, right, and spend time kind of thinking through that, that process with a, you know, with kind of a mindful, kind of a very methodo, kind of mindful approach. If FDA is eventually going to require 500 patients, as an example,

and you've already done maybe 75, 100, right, through this early kind of feasibility work, that's going to save not only a lot of time, but also most likely a lot of costs down the road. Absolutely. Absolutely. And I think it's also really important that, especially like first-time CEOs, you think that if you go with the big guys in the space,

like the big CROs, you're safe, right? They are big. They know what they're doing. They've been around forever. Everybody knows their name. Let me tell you, you are getting the C squad. You are not getting the A squad at some of those big CROs because you're not the big name. The big names are getting the A squad.

And you're getting the people they're training to be the A squad. So I would also encourage CEOs in this space to look at smaller, more boutique CROs that actually will typically have multiple functions. like we use a group out of Atlanta, I'm not, I mean, no plug, I'm just saying something, we use a group called Tamnet, and they do all the pieces of it and they're boutique, so they can do regulatory, they can do reimbursement, they can do clinical trial. And having all of that capability in the same house where you're not competing for attention with, you know, the J&Js of the world or the, you know, bears of the world is incredibly helpful because there's a continuity of understanding what impact this in the clinic will have on the regulatory, what impact this.

claim will have on the reimbursement and understanding that whole those all work together. And what you don't want to do is finish your clinical trial and you realize that your endpoint doesn't support what you wanted to get in terms of the claim. So it's important to have all the pieces together and make sure that the money that you are spending is being spent on experts, not trainees. Yeah. Such a such a good point, right? Because it sometimes can feel oftentimes maybe can feel safe, right, going with some big grand. Yeah, but the harsh truth about that is you're right. Like, oftentimes you're working with, especially if your startup,

you're going to be working with folks that are pretty early in their careers and, you know, not going to add as much value as maybe you're hoping. Just on the topic of that boutique, CRO that you're utilizing, when it comes to choosing, whether you opt to go with a big one or, you know, maybe a smaller boutique shop, how important do you think it is domain expertise, right? So like in your example, did you specifically look for a partner, right, that had, you know, pretty deep experience in women's health? No one has a whole lot of deep experience in women's health because we've only been allowed in

since the 90s. So that is what it is. But yeah, I think more so than women's health, it's what are you going after? Like, we knew we were developing an LBT that will eventually become, you know, an IVD. So lab developed test, moving to in vitro diagnostics, regulated. by the FDA. So have my group done in vitro diagnostics before, are they familiar with lab developed tests and that entire transition process going from one to the other? Yes, great. That's all I need to know because it doesn't matter who the gender of the patient is. It's more about

do you understand the process of what it takes to get these types of products through all of these regulatory gates? And if the answer is yes, then you're in good hands. If it's oh, you know, we've done IBDs, but no LDs, or we've done all LDs, we've never done an IBD. Well, then there's going to be a gap in the knowledge. Got it. Got it. That's super helpful.

Let's transition to capital raising, the topic of capital raising, right? Because any... What's the least favorite topic. But you've been a perspective, right, of kind of sitting on both sides of the table, right, through your experience and venture as well as, you know, as an operator, right, on your, you know, with multiple startups now. And so what learnings, I guess, have you. you've taken from the world adventure, right, and applied those to Hara. And maybe a better way to put

this would be, you know, what do you know now, right? Raising capital for, you know, for, for, for, for, for, for, for, for, for versus maybe what you, you wished you knew 10 years ago. Yeah, I would say that the biggest lesson I learned is that my experiences in a VC was not, not common. I mean, we were an early stage VC and we meant it when we said early stage. Like, we were funding things that had safety data or rat data or whatever and now you hear early stage is like are you six months from the fdaa like what no i'm not and that's not early stage you don't know it's like i feel like i'm in the princess bride i don't think that word means what you think it means so i had to learn really quickly that that my experience in bc wasn't universal i also think uh an important lesson for me was

not oh gosh how do I say it sometimes who you think is going to be the right audience for you is not going to be the right audience for you and you need to let go of that preconception if you're if you're approaching the same type of VC over and over and over again and you're not getting anywhere with that and you think like these guys should what like these guys should love this this is right for us like for me it's it's women's health investors you know we hear that all the time, and I said this on another podcast, but it's like, oh, well, there's all these women's health funds out there right now. Why don't, why aren't they funding you? And I'm like, well, do your job. And then we wouldn't have to have women's health species. But second of all,

if you look at their portfolios, they say women's health, but when you look at the portfolio, it's very heavily direct to consumer products, digital health type products. I'm not a direct to consumer. I'm not a digital health. I'm a hard science, life science, traditional regulatory pathway company. So while the idea of a women's health VC makes sense that they would want to fund Hara, what their funding is not a fit for the type of company that we are. So I think you have to very quickly learn your lesson of like, oh, I need to let that go and I need to focus on companies that invest in those spaces. And there's biases in all of these things that you have to overcome, hence why we're an AI-driven precision diagnostics company in. Oh, by the way,

we do women's health. So, you know, you just have to, you have to know your audience really well. And I think that was a big lesson of like the obvious folks. Yeah. So if I'm tracking kind of with what you're saying, if let's say, let's say if I'm, if I'm in your shoes or maybe in an adjacent category in kind of women's health, right? The natural, the natural move if I'm going to go target a bunch of VCs to raise, you know, raise a seed round or maybe I'm onto my series A or something like that is, well, of course, go to the women's health funds, right? the ones that publicly, you know, really try to position themselves as, you know, as women-friendly, you know, they're focused on women's health, et cetera. That would be very natural right to start

there, right? But if you're, if you pitch 10 of them and they're all like, the message you either isn't resonating, you're getting no second meetings, right? And maybe they're not even responding to your email. Something's off. Something's wrong. And so maybe not, not wrong. That's probably not the best way to try. But there's misalignment, right? And so don't get stuck there, right? Go, go broader. Go, go, you know, extend, extend sort of the, the width, their breadth of kind of your target audience. Exactly. Exactly. And I also think on the fundraising side, something that I've learned that's kind of a funny learning is, you know, everybody talks about like, don't take stupid money, right? I've heard that a lot. Like,

you don't want stupid money or there's bad investors, right? I would say, as long as stupid money is neutral money. It's not bad money. So I think we need to, you know, and you then you'll hear founders who, you know, are like desperate to raise, right? Because they're running out of cash or whatever. And somebody is like, well, don't take, don't take bad money. And it's like, didn't give me good money. Like, yeah, I mean, that's such a silly thing to say. It's like, you know, telling somebody who's starving, you know, don't, don't eat that. It doesn't look good. That's me. I'm hungry. So I think that we need to quantify those differences, like, just because somebody has never invested in your space before does not mean that they are not a valuable investor.

And it also doesn't mean that they are stupid money. It just means they don't have domain expertise in the very specific thing that you're working on. So if you're struggling, quantify that correctly. And I think especially female founders who tend to have to, you know, knock on more doors and and beg for crumbs more often, need to have that mindset more so than guys who, like, you know, throw up an idea and everybody's like, that's amazing. I can't wait to fund that, you know? So, yeah, sure, you can say no to everybody. Women carefully consider who you're saying no to. Got it. I'm so glad you brought that up because oftentimes, right, to get to even a Series A

these days, right, because the goalposts keep shifting back. But let's call it Series B or Series C, you're often going to have to take money, not from your prototypical or your, you're classic investors, right? There's just, there's, there's like the whole, the gap, right, is getting very, is getting larger and larger by the month, by the quarter, by the year in these, you know, in these early, earlier stages. And that's not necessarily a knock on med tech BCs. It's just thrality. But, but you bring up a really good point because, you know, sometimes others will scoff at that, right? Oh, you took, oh, well, that, that's, that's not legitimate money because they don't have, you know, domain expertise. But the reality is like, you could, you could be

taking money, quote unquote, smart money, right, from maybe a name brand investor. But it could be stupid money if there's too many hooks in it, right? And it prevents you and, you know, handcuffs you down the road. So the opposite is true as well. If you're taking quote unquote smart money, it could be, it could be kind of dumb money, dumb, dumb, dumb in terms of, you're dumb to take it, you know? Yeah. Yeah. So that's a, that's a really, that's a really, really good point. And I just think maybe the, that maybe the biggest takeaway is like the phrase that you used, right if you're if you're starving you know as a as an early stage you know company um you got you got to eat right so it's either take take money hopefully it doesn't come with too many too many

handcuffs too many guardrails right but who cares if it's not from uh you know from from someone that everyone everyone knows in the space yeah i mean it's this is so colloquial and silly but my dad is a old south texas guy and he has all these funny little sayings and one of them and we say this all the time in our team it's like if you're not going to be the prettiest girl at the dance you have to be the easiest to dance with to fill your dance card so maybe we're not the shiny glittery thing in the space and we don't have some big you know fancy name behind us or you know whatever but we're easy to work with we're nimble and you know we're doing our job keep those keep those things coming they're good yeah

they're really good. And it, yeah, they help, they help frame up like a topic. It's, I think they're, they're really, they're really, they're really, they're really valuable. But it's, um, you know, I guess before we kind of move to the next topic here, I was just, I literally was just reading a newsletter. I'm not sure if you've heard of the company called B-high, but they're in the, they're kind of the email SaaS space. But Tyler Dank is the founder and he's like, he's just really like, like, smart guy. Like you, like he's one of those newsletters that I, I usually, I typically read every, every week. It's always, it's always good. And I think they just, I think they they raised their series B. Don't quote me on this.

I think NEA led their most recent rounds. You think, oh, N EA, right? I mean, it was probably some name brand investor in their A round, too. And it's like, nope. Like, I've never even heard of them, right? And in his seed and Series A, like, most people wouldn't have. And his point was like, yeah, we raised from NEA in our series B, but, like, no one knew who our investors were in our seat and Series A.

And it doesn't matter, right? It doesn't matter. As long as you, the money, again, the money doesn't handcuff you. You continue to make progress, hit your milestones. like a lot of those more name brand investors are going to be there if you if you continue to execute right so um yeah so you've got to be in the game if you're not in the game you're never going to get a name brand investor and I don't know how much value to put on that so yeah yeah yeah no doubt yeah if you're listening and I'm curious about that newsletter I

mentioned it's um the name in the newsletters big desk energy which is kind of a funny it's actually it's actually really good stuff it's actually a really good newsletter but it's a funny name for sure so I know I'm looking at at the clock here. We don't have a ton of time left. I do want to leave a little bit of room for the rapid fire portion of the interview. But one of the questions I've got here, which I'm super curious to get your take on, is these strategic kind of acquisitions, right? Because you mentioned even HaraFM, right? Was acquired technology? You touched on the aggregator model, right? So for an earlier stage company that's pre-commercial, that's a bit unique, right,

in comparison to most startups. So give us a sense for kind of, I mean, I know you touched on the aggregator idea, but how have you been able to kind of pull these acquisitions off, you know, in these earlier, earlier days. I get that question all the time. We've done three acquisitions. We've been around for five years and we've done three acquisitions. And those three acquisitions have come in the last 18 months. So it's kind of a funny thing.

I initially thought I knew what I needed to look like and sound like as a founder. And I felt like that needed to leave my VC piece behind because I found it intimidated some people when I would talk to them as investors. And I'd be like, well, what's this? What's this? And they're like, uh, I sat on that side. Hang on a minute. This should be a good thing. But anyways. And so I thought I needed to just kind of leave that piece behind me other than just using it to our advantage. But then as I looked at the space and I talked about that aggregator, I thought, no, I know how to build portfolios. I know how to do that. So I should bring that piece of it in. And I should look at this as we're building a portfolio. And so our first acquisition was the only competitive technology in the world, in my opinion. And it was the only other tissue-based technology in endometriosis. and now the lead scientist that would have been the CEO of that company is now our C-O.

Thank goodness she's on my team. I would not want to compete against her. Anybody else I'll compete against her, no. And then we acquired a bio bank, which saved us about an $8 million clinical trial. And then we acquired the hair of him. The way that we have done this, and this is where I think my venture background really served me, is creatively. So when you think acquisition, everyone thinks like, oh, you've got to go, write them a big check up front, and then there's, you know, whatever it is in the background. We've leveraged our equity.

And you can do that if you build your brand equity. So we positioned ourselves really early on as a hard science company. We're not chasing trends. We're defining new patient care pathways and things of that nature, right? Going to change the standard. And I think that we did a really good job of building. and maintaining a solid reputation in the space, one of transparency, one of honesty, and integrity.

And so because of that, we've been able to utilize our stock for the majority of these purchases. Little cash here and there, but not like what most people think when they think acquisition. And so that's how we've done it and been creative. And as such, like Hara itself has only raised about $4.7 million. We've run really lean to get these things done. but the aggregate of dollars spent to develop the technologies that now sit under the Hara Biotech umbrella easily over 12 million. So it helps you a bit, and no pun intended, obviously, because of our logo, but you peek on.

Yeah, no doubt. It speaks to the importance of establishing a brand early, right? And I think it's one of the most, maybe the most common mistake I see how their founders kind of underappreciate or miss on early on is they feel like they need to stay stealth too long. or literally their website is just like text and a logo baby or something like that. It's like, well, maybe, I mean, I guess maybe that could work, but it does not, it doesn't, it prevents, you know, some optionality, right? And maybe on this topic alone, right, it sounds like the, you know, establishing a brand,

right, allowed you to maybe do deals that you wouldn't have otherwise done, right? And there's certainly a lot of other things that sort of factored into probably those transactions, right? Your experience, you know, on the venture side, you know, kind of understanding how a lot of these transactions can come together and mechanics of those. But, but yeah, I mean, my hunch is if I'm on if I'm being acquired by Hara, right, I'm less inclined to do a deal with a company I've never heard of, like has no presence, right? But the fact that you did, we're kind of building out something and there's a, there, like a real, a real there there, right? Probably those other

companies were more inclined to kind of listen early on, right? And begin to kind of work on something together. Yeah. I think so. I think so. And I also just want to, if you don't mind, something that you said, which was stealth mode. I have very strong opinions about stealth mode. 90% of the time it is stupid. 90% of the time it is stupid. Like the only times I think it's acceptable is if you are in a highly competitive space and you are doing some sort of kind of iterative improvement on existing tech, let's just say it's a broad term, right? Then sure, you don't want to deteriorate your moat early on. So stealth works. But in life, I think it's pretty dumb.

Where's your IP? Why do you need to be in stealth mode? And normally when I see that and I see these companies that are like, we're in stealth. And then you go to their website and it's like, oh, we do things with stuff and tests. And you're like, what are you talking about? And then they raise these egregious amounts of money on air.

It's like, guys, really? And then you'll ask them about it. And they're like, oh, but it's so important. so it's so and so as a CEO and I'm like pretty sure people probably felt that way about Adam Newman and about Elizabeth Holmes and we want to go down that road like we didn't learn our lesson about diligence like I it just weirds me out because I think if you're in stealth mode to some degree it's because you haven't figured it out yet you don't actually know what you're doing you're just raising on an idea and then you're going to go use this money to develop the thing that

you're selling and that's I think that's a dangerous spot to be in in life sciences you should have your IP. You should have your processes. You should have, you know, a scientific rationale, some benchwork, maybe some animal data, something to show me that there's substance to what you're doing and not just my name is summer fabric and I'm amazing. And obviously I'm going to do things that I'm talking about. Well, okay. I love hearing your riff on that. I was waiting for maybe a phrase, you know, from your, you know, from your dad or like a, like a Texas phrase. to sum that up. But I'm right there with you. I think most of the time, you know, there may be some rationale right for very early, kind of staying in very early kind of

stealth, but most of the time it makes no sense at all. And I don't, I don't get it. And I think it's probably a mistake most of the time. So with that said, I know we've only got a few minutes left. I want to get to the rapid fire portion of this interview. But I get hera biotech.com is the website, H-E-R-A-Biotech.com. Highly encourage everyone to check out the company, as well as the devices that are very close to commercialization, hopefully, at this point in time as we're at the time of this recording anyway. So with that said, though, first question on the list is let's fast forward to mid-20206, take us out a year from now.

What are you most excited about looking out over the next year? Oh, my gosh. I'm most excited about get a commercialization. Like, this is like the dream, right? Like to get to see patients using your device outside of clinical trials because it's just so, so meaningful. I mean, pap smears in low to middle income markets, accuracy is around 40%. You may as well have a Ouija board, you know.

And so the idea that a woman is going to be able to go into her doctor's office, not going to have a physical sample taken so much more comfortable exam, and going to be immediately treated, should she have cervical cancer? This is huge because cervical cancer shouldn't kill anyone. It really shouldn't. And we also shouldn't conflate HPV and cervical cancer, but that's a different podcast. And then on the endometriosis side, endometriosis is really personal to me. It's in my family.

My sister had a hysterectomy at 32. They didn't get the lesions. So then they had to go back and she still has all these knock on effects from it. I have three girls all staring down the barrel of what the heck is going to happen to me. I mean, my oldest said that. What's going to happen to me when I start my period? What's going to happen? And it's like, I don't know what's going to happen to you.

It shouldn't be anything. It should just be maturity is happening to you. But we'll figure it out. my niece suffers, we're pretty sure for endometriosis, but doesn't want to have the surgery. She's been through nine different types of birth control. I want to be there when she has her test so that we can tell her definitively, this is what's going on with you, and now we can address it. And I can't wait to see, I think, what's going to be a waterfall happen after we have a solid

diagnostic in the space in terms of meaningful drug development and actual changes, not only in clinical pathways and patient protocols, but also in how they're going to be. disease is viewed, you know, when diabetes got classified as like an autoimmune disease, there were a lot of accommodations made for patients. You know, you can stay home one day a week or whatever. Women with endometriosis lose 11 hours of productivity a week. Like, we need to, we need to be making adjustments so that they can operate in the world around them and deal with this disease in their life. So that's what I'm excited for. Yeah, I can feel the, I can feel the the energy for sure. All right. Since co-founding the company, you know, a little over five years

ago now, is there anything surprising or unexpected that's come up? Or maybe what has been the most surprising or unexpected thing? Oh, well, there's a lot. Let's go with something good. I think one of the most surprising things is how many people specifically in this space will work together. It's pretty unique. You know, I've been, I've watched traditional pharma companies. I've watched traditional med device companies and it's very, you know, elbows out and this is my little grape and you're not going to mess with it. In women's health, I have seen more founders promote competitors, promote, you know, collaborate with what could be perceived as a competitor in order to just push the space forward. And I think that's actually really surprising, but really

exciting too. I'm not in the women's health space, but that's that's kind of refreshing to hear about. There's a certain, certain amount of kind of camaraderie and collaboration. Yeah, so that's cool. All right. I'm going to combine the last two questions just because I know we're short on time, but let's say we're in, maybe we're in South Texas. Maybe not during the middle of summer, but maybe in, maybe in January, February. Maybe in February. And we just sat, we just, you know, wrapped up a dinner with a group of other, you know, life science or med tech entrepreneurs. What's the one thing that maybe you wished you knew, that you could whisper in the, you know, the years of your younger version of yourself that you think would be extremely valuable for that group to really know and take home? Your intuition is right way more than you think it is because I wanted to kind of take intuition out of things and be very analytical and I may or may not be accused of being a robot from time to time.

But take the data, right? Take the data from your mentors, from your team, from whatever. but your intuition, your gut instinct is right so much more often than you think it is. So bet on it. Yeah, that's really good. And we were, yeah, you know, you were just talking about kind of unexpected or surprising thing. That's one of those, that's, that's probably something that, that I personally, right, have, has been surprising to me, right? Over the past maybe, you know, five to 10 years in the world of startups is, uh, is, is you're exactly right. Oftentimes, your, your intuition is, uh, you're onto something, right? And you should lean into it. So,

with that said, um, can't thank you enough for coming up. on the program summer. Again, for everyone listening, it's herabiotech.com. H-E-R-A-Biotech.com. We'll link to it in the full write-up on MedSider. But again, thanks for covering out some time to do this. Thank you so much for having me. I so appreciate it. All right. And I'll have you hold on the line here. But for everyone listening, you made it this far. Appreciate your attention, as always, until the next episode of MedSider goes live. Everyone, take care. Hey, it's Scott again. One quick thing before you go. You see, I love bringing you insightful conversations with the best founders and CEOs of medical device and health technology

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