New Approaches for (Finally) Funding and Solving Unmet Needs in Women's Health | LSI USA '25

Allison Komiyama  0:05  
Hi everyone. I'm Alison Komiyama. My background is actually in neuroscience. I am a regulatory consultant with our QM plus, worked at FDA, so I am very intrigued on all FDA pathways and submissions, and we work on a lot of women's health devices at R, QM plus. But I want to introduce briefly my speakers here today, I want to thank you for joining the panel. Carrie Burke, start you're a healthcare venture investor and an executive with more than 25 years of broad experience delivering results for innovative technologies. Her recent work was with radiant oximetry, which helps support innovation for the safety of women and babies during childbirth. She is also a senior partner at intuitive ventures, which is the VC arm of intuitive and through its inaugural 100 million dollar fund, intuitive ventures invests in and is advancing the digital device therapeutic and diagnostic ecosystems of minimally invasive care and beyond. All right, sorry, I'll try not to smack my gums like that. That's really annoy Matthew. Matthew VESA is the Vice President of Strategic and business development at Hologic. Think we've all heard of Hologic before. He is a seasoned healthcare executive with deep, rooted passion for improving human health. Has spent 25 years at the forefront of innovation, and his expertise lies in identifying, investing in and developing transformative technologies that expand access to quality care. All right. Kayla sadikova Is the co founder and chief strategy officer of Illumina lucell ai dedicated to democratizing fertility care and advancing the use of sperm as a biomarker for male and Family Health. Her career spans BP and McKinsey and Company where she worked primarily in the energy sector before before transitioning into health innovation, entrepreneurship. And last but not least, we have Masha Duran us, who is the Senior Vice President and CO leader of Medtech practice at KX Advisors, a, Bg, B group company. She has over 14 years of experience in healthcare strategy, consulting, supporting companies with growth strategy, go to market strategy, commercial due diligence, market access, M and A corporate strategy list goes on. Masha has extensive experience across Medtech and digital health, with deep expertise in women's health, and has a passion for mentoring and proud lead, proud to lead women at KX group. So I think this group is well suited to discuss this topic. We had a meeting before this, and I was really excited with some of the topics that everyone brought up. So I'm going to keep this fairly informal. I'm going to start with one question. We'll start here at this end. And if there are the questions and you guys have questions that you'd like to ask each other, I'd welcome that. So first and foremost, what are ways that your organization or you personally have worked on reframing the subject of women's health to not be a space that people shy away from?

Terri Burke  2:59  
Yeah, happy to be here, and this is a great panel to really talk about what's changing in women's health. I think for me, first and foremost, I come from a marketing background, so I always think about patients, and I think about the markets we're trying to serve. And so for me, the framing of women's health is really a broad one, and it always has been. There's certainly technologies that are exclusively for women, but there are an awful lot of diseases and markets where women are a large component of the patient population. They're under treated, they're under diagnosed, and we've under invested in understanding how those diseases impact women. So I start with characterizing kind of the populations that we're thinking about, and really try to drive conversations within any organization I've been in around, how do we help the patient population in need, and where is the big unmet need? So it's much broader for me, women's health than simply women specific diseases or organ specific diseases. So that's been an important part for me, and then certainly being on the board at radiant, and now an advisor to the board. I've really enjoyed that last five years or six years or so, to see how that company has grown, and how they've attracted venture capital, and how they've been able to tell their story in a meaningful way. Excellent, have you?

Mathew Vessa  4:29  
Yeah, so maybe building on that, it's interesting being in a platform now like Hologic, like you said, that's focused mainly on women's health, and we've really took a look at what that has traditionally meant, and started to appreciate that there's a connection of the woman, obviously, in being a leader for the family, but also the connection point of mammography as a center point for routine and annual screening and is. At A intersection for other screening we've seen a lot of companies that are recognizing that intersection saying, Hmm, lung cancer or cardiovascular disease, a lot of these are really coming to for as affecting women differently. And can we take advantage of those routine screening protocols to optimize, really, the point of intersection screening is not effective if people aren't getting there. And so there's a lot of companies out there that are recognizing those points of intersection, which I think is smart. But then just for for my team and I, having looked at, what else could we do within the platform, it's public, we've made an investment with Ajax to build a lung cancer platform with Ajax, and it gives us an opportunity to start looking at other diseases. Lung cancer is kind of interesting. As more men who have traditionally been smokers are starting to fall off, we're seeing a frightening and alarming rise of women with lung cancer. And I think understanding why getting ahead of it, trying to solve with when unsolved with men before and routine and early screening is really going to be important to help change that.

Jeyla Sadikova  6:12  
Thanks. Kayla, um, just want to comment on what Mathew just said. It's um, amazing to hear that, because there's a lot of conditions where that affect women differently, such as colon cancer, or affect women more, such as depression, migraines, and that really impacts productivity in the workspace. So as a limit solid AI, as a male health company, women's health is at the core of what we do, because the interplay of male and female is essential to building better technology. So for example, right now, as we're building new models for our AI, we're trying to collaborate with women's health companies so that we understand the interplay of male and female data from the early on and not just ignore 50% of the puzzle. So besides just that, I think the Women's Health is extremely well positioned right now, specifically for conditions that affect women. We see the first unicorns emerge in 2024 Maven clinic. We see 2 billion in funding going to women's health companies. So I think it's an extremely exciting new space.

Allison Komiyama  7:25  
Excellent. And I just because I know we've had some people join, the question was, what are ways that your organization, or you personally have worked on reframing the subject of women's health to not be a space that people shy away from? So Masha,

Masha Dumanis  7:38  
so you as as a strategy consultancy, as a growth consultancy firm, often we're working with clients to help them understand the opportunity, right, and size the opportunity. And part of that, I think, alludes to what Matthew said is, and I think we'll talk about this more, is that women are often under diagnosed, and so there's conditions even within women's health that we still need more education on. Or sometimes it's like, hey, we don't actually, this is not coded in today by clinicians. And so inherently, they're not coming into the funnel of what we think of patients. And so when we think about what the opportunity, the dollar size opportunity, is, historically, it might look smaller than it actually is. And I know this group is really eager to talk about it, but there's been two reports by two major consultancies, art McKinsey, which came out and saying that women's health is a trillion dollar opportunity. BCG, their competitor, who came out saying, you know, it's at least $100 billion opportunity. Either way you put it, it's a massive opportunity. I think part of it is because there is an under diagnosis and there is a, you know, today we're not necessarily looking at and framing women's health the way that we should be. And on a personal note, if I may, part of what I do, and it's sort of a fun passion project on LinkedIn, I do a hashtag, Women's Health Wednesday, and part of it is about educating my followers, anyone out there on LinkedIn, about what Women's Health is, the issues that we're facing in women's health, whether they be financial, whether they be clinical. And so that's you know, how I like to contribute a little bit, but I think there is a much bigger opportunity to educate. And as you said, Alison, I think that the theme of this conversation to reframe women's health,

Allison Komiyama  9:28  
yeah, and that actually dovetails really nicely with the next question, because I know as part of our pre discussion we had that McKinsey report was brought up, and I have the quote here that better diagnosis and treatment could push the US market for key women's health conditions past 100 billion by 2030 and 2030 is just around the corner, right? So this is something that I don't know, if that dollar sign doesn't, you know, resonate with a lot of the folks who are looking at financial opportunities. It's also, you know, this is something we should all. Be thinking about as as we move forward in the next years. So the next question was, what are ways to encourage business opportunities or provide incentives to organizations to promote women's health initiatives? And I'll start down at that end and come back this way.

Masha Dumanis  10:15  
Oh yeah, I won a prize. I think one thing to acknowledge that I wanted to bring up first is actually how underfunded Terri mentioned and under reimbursed women's health has been historically. So there was actually a study conducted by a group of women's health physicians, so gynecologists out of I think Mount Sinai was the lead organization, but essentially what they found is that equal male and female procedures. So they did like a vaginal biopsy versus a penile biopsy, urethral reconstruction. And essentially what they found is that the female procedures, both the physicians and the facilities, were reimbursed about 30 to 40% less. And so there's this historical bias on the physician side. It was about RV use, so the RV use were actually lower. And there's a historical bias against women's health. So I think partially there is a need for us as organizations, you know, to come together collectively and to think about what that means. You know, whether it's physician groups to advocate for increased or at least equal reimbursement, right? Because if we're going to invest in if we're going to want to have companies who are going to innovate, and then we're going to have strategics who are going to acquire and even clinicians who go into practice for women's health, we need to reimburse them, and we need to reimburse them fairly,

Allison Komiyama  11:45  
almost like a reverse pink tax we hear about of you know, having to pay more. It's the opposite sense. So Jayla, your thoughts, yeah, totally

Jeyla Sadikova  11:53  
so rightfully said that all the health data has been trained on male body, which is why we since the 80s, about 30% of drugs were removed from the market because they did not account for women's health risks. Women react differently to certain things. Seven times more likely to get misdiagnosed for heart conditions. And I think so all of this is to me in the past, because I think, as an innovator, what I see in the market is that there's multiple incentives already existing to make sure that we integrate female data into healthcare, therapies, pharmaceuticals, et cetera. And I think that's mainly because with the advent of AI, there's going to be a tech and business push towards it, because the more diverse your models are, the better they will perform, generally and even within our company, we try to always go for large and very diverse data sets to make sure that the models are robust. So I believe that this will be one of the pushes that comes from the tech industry to make sure that they have defensible technology. Well, the second one is economic output. So for every $1 it was projected that you make free dollars if you invest in women's health, better productivity for companies, better for for governments, when 50% of your workforce is healthy, and obviously there's also social incentive, right? Because this is exactly how lower wages are being justified. You're less productive, you're more affected by depression, you have PMS. So that all influences the way women are perceive their career opportunities. So but I'm very, very hopeful about what's to come, and I believe the major part of that is the business push to make sure our technology is better suited for everybody.

Mathew Vessa  13:54  
It's really an exciting time. I think the green that's an enormous Greenfield opportunity, to put it plainly, right? Because what you have is an awareness that 50% of the population can be affected by some of the biggest diseases differently. Okay. Well, what does that mean? And if you take the problem and you break it down into the fundamentals that makes any business successful, and you really go at, okay, is it that the device that we're using on men is not fit for women. Okay, well, and if we're going to reconfigure that device or take a different approach to it, what are the different outcomes that we're going to seek, and can we demonstrate and prove that those outcomes are different and that they matter? It's a you know, if you're looking for venture funding, you're looking for strategic interest. Everyone looks for the same thing, regardless of gender. Quite frankly, it's that uniqueness in the market. It's the ability to create a value proposition that customers will embrace, and now recognizing I'm the only male on this panel, the pattern of being able to build you. Business Case, and your business around real, provable data is is almost an immutable truth You can't lose by by taking that approach. And it's exciting actually to see. We've We've met a lot of companies along the way who truly are treating it like a different clinical disease. You know, the way you build a bottoms up model, where you take different cuts of data patients who have certain type of cancer versus not, and you're focusing only on those patients that you can select for. You show the outcomes, you prove the value, you get reimbursement, and that's how you find the success. 

Allison Komiyama  15:33  
Yeah, well, we're happy that we have a male on this panel. If anyone hasn't noticed, at this conference, there's a lot of men here. And I always like, you know, the lines for the bathrooms are much shorter at conferences, like we also really need to have. This is a collective effort for everyone. So appreciate presence. Yeah, all right. Terry,

Terri Burke  15:54  
maybe from the investment side, I would agree with the comments around what is investable. I'm really excited by the number of funds that have joined into women's health or women led companies, and are really helping fund early stage companies. I see one of my colleagues from investor ventures in the front row. I think it's driving an interest and an awareness that we haven't had before. And then, as I think about what are these untapped markets, right? So I pulled some data from the BCG report, and I'm sort of fascinated by this. Two thirds of osteoporosis is not diagnosed, and 80% of that is in women, right? So it's back to your early comment around mammography, maybe being a perfect opportunity where you're detecting and you have a unique interaction with a patient. So I sort of wonder, like, why is that? And as a venture capitalist, when I think about markets, we're really trying to think about, what are those big, big unaddressed markets that maybe have not optimal Clinical Solutions, or under diagnosis, under treatment. There's a lot of different places where patients can fall out in the continuum of care, but there's a lot of data out there showing that it's not just osteoporosis, it's Alzheimer's, it's autoimmune diseases, it's cardiovascular medicine. We know from my years at Edwards that women with valvular disease are under diagnosed. It's women who show up in the ER having a heart attack, but are diagnosed instead with anxiety and sent home. So there are big markets. And as a venture capitalist, we look at the business case, right? And so I think it gets back, Matthew, what you said around like, put a good business case together for who are your patients? Why are they not treated well today? What is your unique value proposition for why your technology or solution can can help, and how are you Unlocking Potential? And I think with that, then you work on the reimbursement angle that, that you mentioned around women's health, but I think it's just a reframing and a time for all of us to think about this as just a broader business issue that brings a lot of opportunity

Masha Dumanis  18:11  
and Terri if you, if you don't mind, I'll add on to that, to use osteoporosis as an example. My other passion area is musculoskeletal. It's actually a really interesting one, because if we're not catching osteoporosis early enough, there's actually not a lot of great treatments for osteoporosis, and the downstream costs of the implications of osteoporosis, the fracture care and the mortality associated with it, are really high. And so while there's also the opportunity now that you've created for kind of earlier diagnosis. So there's kind of value to capture there. There's also value to capture from the downstream of not treating, you know, all of the horrible, horrible effects, and if you catch it, even in the osteopenia stage. And I think there's a there's a company here, osteo boot with an osteo boost product a medical device, which is really exciting to treat osteopenia, and if you treat it at that stage, you have a lot more opportunity to capture that value. So that's another way to create that business case. Yeah,

Jeyla Sadikova  19:15  
and if I may, I think for there's two buckets to me, in women's health. So the first one is products targeted specifically for female conditions. Let's say fertility trackers, ovulation trackers, artificial wombs. And this is where we see real clout. And I believe that in this bucket, we see a lot of venture driven funding, VC funding, because it's a very exciting new business and but the second was the really capturing female data and integrating it into the healthcare system. And here, I believe the push will come from strategic from pharmaceutical companies that want to capitalize on that opportunity that is not captured today, if you don't have to recall your pharmaceutical products from the market. If he can develop better drugs that see the differences between men and women, that's a huge business opportunity, but I believe more for established companies, perhaps also for government funding as well.

Allison Komiyama  20:14  
Excellent. I'm going to pick one word that you said, which is reframe, or reframing, because I think that's an important phrase here. I think a lot of and it kind of dovetails on the last question of, you know, how is, how are ways that we can help people see this as a really viable pathway? One of the things that we've seen in the pediatric space, right in different indications, is that, and I've seen this in my role with FDA is, how do we provide incentives for people not to keep a certain population at arm's length? Because if you hurt a kid or if you hurt a pregnant woman, right, most of the labels say this has not been tested on pregnant women, so it's almost made it's a it's a black box warning for that population. So what are certain ways that that we can either lower, like, help lower that bar or that burden, and reframe the discussion? And I'm going to open it up, if anyone likes, like to start, I

Terri Burke  21:14  
would say, from my perspective, when I work with companies, one of the questions I'm regularly asking is, tell me about your clinical strategy, and how are you balancing your population in your clinical study, and not just, you know, a traditional women's health company that maybe is focusing on maternal health, but you know, is there a balance? So you know, if a company's looking at COPD, which does impact women more than men. What does their population look like in their first in human study? I would hope that 50% are women. And I think just asking those questions and being a little more informed, it's actually good business, because then the data you get in those early studies is more representative of the ultimate market. And if you can come back and and fundraising for a later round and say, Boy, we did a first in human study. We've done 60 patients. 30% are, you know, of this ethnicity, or 50% are women, you know, you really can showcase that. You've thought about how your product impacts patients. And they say, patients, period, whether they're they're men or women, and I think that's one thing for me, that as an investor, I ask a lot more these days, just so that the companies are really aware of, how are they thinking about their development pathway?

Mathew Vessa  22:34  
Excellent. Building on that, if you think about any business, you really want to know your customer, and you want to know your customer from a physiological standpoint, for the problem you're solving with your device. But as we've seen with the waves of digital health, and we're just talking to a company this morning, sometimes the device is something that patients will seek. So if you're a hospital or a doctor, you're going to advertise that because you know, patients are looking for it. I don't have the data like you, Terry, but we know that women will shop around more for devices than men will. Men will either go wherever it's convenient or wherever the their wife sends them. So you really have a unique opportunity with a population that does the research that might likely be more compliant, and then when you carry that forward, so when you again, kind of build out your business models, even to your point, on a clinical trial, you need to follow patients. Well, isn't it nice, if you have a patient population that's interested in follow up, because they want to see the outcomes, it feels like there's probably so many opportunities with the women's health category, not only for the Greenfield, nascent building devices, but also understanding your customer and how they engage in trials and how they engage in digital health in different ways that have been challenged

Masha Dumanis  23:50  
before. And I think that the other thing, or kind of two things, to build off of that one, is the use of real world data. So as an example outside of women's health, I think we all know about GLP ones, right? Their popularity right now, and all of a sudden they're blowing up in other indications, cardiovascular health, osteoarthritis, and the way they came to that right is that they looked at the patient populations within their diabetes trials, and they started to see these phenomenon where it's like, again, musculoskeletal health, but they saw in one trial that patients were getting their total knees much, far, much farther down the line than typically would have been expected. So I think you can have companies go back to their data and exam it and say, what are you seeing in subpopulations in your female populations. How would you sub segment that data? So that's one thing and then the other. And I'm seeing, you know, a lot of companies presenting here about continuous monitoring, or non invasive monitoring, we've really come to a world of wearables, right? And I think using wearable data, or using data. From a lot of those wearables will be really impactful. And Matthew, as you mentioned, the woman is a much kind of more discerning consumer, and they are really interested in their data. And so I think that that is one thing that makes this idea of using real world data and using wearable data. I think ora recently came out with a study with UVA showing data from their monitors that perimenopause symptoms are actually starting much earlier than women previously saw. So I think there's a lot of power in that data. And I think you were kind of alluding to that too earlier. So it is, as you mentioned, a really exciting time in women's health,

Jeyla Sadikova  25:43  
and women are more loyal, like, once they like something, they're going to stick to it. So you just have a better customer base. And also, sex disaggregation of studies is very important, and traditionally, all the findings were aggregated, so you don't really know how many women were tested for those therapies, many men versus men, but I can see how the cataloging for data sets to build AI models is so diligent. The everything about you is a data point, not just medical history, but demographic, how you look, what is your what lifestyle you have, so we're so diligent at cataloging this, and we also see that in the last few years, the sex disaggregation of the studies have gone up by 20% so we already see that happening, and I believe that it will be massively accelerated, not just for women's health, but as I mentioned, just for better healthcare in general.

Allison Komiyama  26:43  
Love it. Yeah, I think that real world data and everything you've said, but the real world data thing is something that we've seen at FDA as well. Of them really pushing that. What else do you have? What else can you give us? What other places have you studied? It is outside the US, and how can you leverage those data for other populations or for other subgroups. So we only have two minutes left. Two minutes, 40 seconds. I'd love to give final words for everyone to give you a chance, just to say, like, what would you like the folks in the room to take away from this panel? Start here again. Sorry, yeah.

Terri Burke  27:19  
I mean, I think we've talked about it, but these are big untapped markets. They're growing. There's an increasing need. We've got active consumers who really want more solutions, and so think about those unmet needs, talk to physicians, figure out where those opportunities are, and put solid business plans together that put numbers to who your customer or patient is. And I think there's a lot of opportunity for companies to succeed and find funding,

Mathew Vessa  27:52  
echoing everything that Terri said, I would add be creative. See, look for really the opportunities. The great sign of any entrepreneur, obviously, is finding the opportunities and the noise. But look deeply for those opportunities. Treat your future customers as different, obviously, for all the reasons we've talked about, but find a way to really trigger that make your business model more successful, really deliver on the promise that you're trying to ultimately

Jeyla Sadikova  28:21  
build. Yeah, I think, like, Women's Health is not isolated. It really penetrates into everything within our healthcare system. Once again, I'm very positive about what's happening, and I would say that do not think about it as a solely women's issue. For example, at illumicel Ai, we're tackling the male health aspect of it, and we see how interrelated both are, how interrelated it is with all the other data, such as race, geographic, location, age, etc. So I would urge to look at this not as just women's health, but also creating better healthcare products. In general,

Masha Dumanis  29:04  
we talked about how large an opportunity, whether it's a trillion or 100 billion, it's a really big number. But I think if we have the industry understand that, and we have strategics and investors understand that, we will absolutely be moving in a positive direction. But I want to say we talked a little bit about the pink tax. We need to move away from this idea that women's health the burden of paying for it should be, you know, out of pocket, direct to consumer, on the women. So we really need to advocate for and as a community, really make sure that women's health gets gets paid for

Allison Komiyama  29:48  
wonderful look at that perfect zero. I want to thank everyone for attending this panel, and thank the four of you for joining this has been very informative. I welcome everyone to go to the. Session starting at 320 which have a lot of also maternal and pediatric health devices that I will be presenting. So thank you again.