Mihir Shah, Founder and President, UE LifeSciences
Interviewer: Beth Kowitt, FORTUNE


Brainstorm Health 2022 - In The Palm Of Your Hand: Innovations In Women’s Diagnostics 

Conferences

Innovations In Women’s Diagnostics 


Brainstorm Health 2022 - In The Palm Of Your Hand: Innovations In Women’s Diagnostics 


Okay, so let's, let's context here, what gave you the inspiration for this device? Um, when something happens to your mother in law, it's a pretty eventful thing in the family, I had to pay attention. Um, really after her, um, saw a friend and a cousin. Um, and it seemed like it was coming closer and closer to home and I was in med tech, working on academic technologies from penn and Drexel, um, moving from translational research into commercialization. And I was just fascinated as a computer engineer by the power of science and technology to really leapfrog access to healthcare. So roll up my sleeves and decided to jump in to help out this tsunami of cancer that's coming our way. So tell us a little bit more about the tsunami. What are some of the specific numbers we're seeing, especially around breast cancer? Yes. So, I mean, you know, seven out of 10 breast cancer deaths now are from developing world. And the biggest challenge is that while you are having it, not only is it the number one cancer in the world, men and women combined, um, the, the impact it's having on younger women. Uh, and, and by virtue of that really on, on the communities and countries and globally is magnanimous. Um, we're losing something like half a million women a year to breast cancer. If you think of 10 years lifespan taken away, that's five million life years being lost every year. To think of the impact of that. And if you look at the outcomes survival rate in majority of the world is 50%. So you're losing one out of two women to breast cancer when survival rate in some of the better places where access to treatment and early detection is well established outcomes are nine out of 10 women survived. So you clearly have a pathway to better outcomes. But the access is just not there. So to me you know it's not a question of health equity, it's a question of health tech equity. So okay, how do you how does your device do that walk us walk us through? So when I when I I mean I know my team looked at this with a very open mind although we are all from engineering background. We we looked at mammography, breast ultrasound, breast M. R. I. The staple technologies that are being used and are being developed by U. NoG Healthcare's and Demons and the logic of the world. I talked with a number of breast surgeons and gynecologists, radiologists to learn how are they fighting today, breast cancer and what are their plans for the future? Because clearly there are gaps here in the U. S. And overseas. And I got a lot of shrugs like we don't know. Big tech big big MedTech companies would like to sell equipment that's worth their while and radiology is set up with training of those equipments uh and and training is difficult and expensive. So when we looked at the problem we recognized a few very clear layered cake issues that we're creating this lack of access. First one is that the barrier to entry to just technology, the cost, the maintenance of it, you need willpower, you need highly trained staff, we need radiology, who knows how to interpret these images and that. Education is expensive and it can only spit out so many uh you know supply so many workforce members every year. And then you have the whole issue with dense breasts and young women and you know in in access because of biology of the way breast health is. So due to all these challenges come, you know, combined one stack on top of the other, there is the lack of access. Okay, so show us how show us how it works. So um we'd like to give you a live demonstration but before I do that I just wanted to talk a little bit about the technology and what it is. Um we looked at the the lowest common denominator of access to preventive healthcare which is frontline health workers, community health workers, technicians, nurses who are available in the most numbers in every country in the world. And we looked at the most basic intervention in breast health which is a clinical exam. So a clinician would do a clinical exam or a nurse, a trained nurse would do a clinical exam by trying to pick up stiffer, harder lumps in the breast. So we thought of engineering a technology that would emulate that electronically through a device to make that process completely objective, more sensitive with higher efficacy digital and something that could be shared, you know by the care providers and um the patients alike. And with a notion that hopefully one day this technology can be put in the hands of women directly. So with that, let me give you a quick demonstration. Hopefully this would this would work. So what you're seeing on the screen hopefully. Are you okay? There you go. So what you're seeing on the screen is alive. Tactile imaging pressure map. The technology that we've built is a capacitive sensor, very much like a touch screen of your phone with a soft pad on it that's able to feel breast lumps in real time. What it's doing is it's measuring tissue elasticity in real time. It's got 648 sensors that are running at 20 frames per second. So there are 12,000 data points that are being created. So as I put my finger on this on this sensor, you're seeing a live response, a tactile response on the sensor onto the screen. Um So I'm gonna do a quick couple of checks on myself and we'll see how the device performs. I'm going to put the sensor on my knuckles and we've trained this technology to weed out all the noise and find the hardest structures in a given surface that it is examining. So here I go when I put it on my knuckles, you would see, I'm sorry, you would see them appear in real time. And the pressure is guiding the test so that it auto captures that tissue elasticity elasticity difference in real time. Here's a quick tongue in cheek test. So I'm going to put the scanner to my cheek where there's really nothing going on and then I'm gonna take my tongue to it in a way to emulate a love. So if I put it on my cheek, let's pick another location. It's really nothing going on there. But if I were to have a lump there, it gets captured in real time within seconds. So this technology has the ability to standardize clinical breast exams for any care provider, any health worker anywhere, virtually. And it doesn't need any infrastructure. It is completely wireless, battery powered point of care tests. Um, it costs pennies on the dollar compared to some of the other interventions. And the training curve is literally a few breast exams. So we are. Now, if I may, um, I rest exam is now FDA cleared in the U. S. It's cE marked in europe. It's cleared 10 different regulatory barriers in different regions and countries Over 600,000 women have received breast exam to date. So who's who's who's using the device. The device would be used by care providers of the level that you have available. If you have a gynecologist, he or she could use it if you have a frontline health worker. If you have a community health worker. We have lots of nonprofits that work with us that are providing 1st 1st line defense um in these communities where side by vaccinations, they were doing breast exams. Okay. So what are some of the current challenges you're trying to solve for? You mentioned access obviously being one of them. But but what else? So we're trying to integrate with health systems where gaps exist in developing world uh regions. These gaps are very wide because there is just here in access to mammography that we take for granted Here in the us. We are trying to fill the gaps for specific niche areas. For example, women below 40 years of age, corporate health through corporate health and wellness programs. Women that get a mammogram and learn that they have dense breasts. Apparently that number is 40% of all women have dense breast. Women that are reluctant to get a mammogram because of sheer pain or the radiation that it brings and and the fear that it brings women that are non compliant because of that. Women that are disabled or for a variety of different size of the breasts are not able to get in front of the standard of care. And then there is just you know remoteness locations, um inability to access healthcare because of physicality of it. So are you trying to replace the mammogram. No, our our goal is not to really replace mammogram. We are actually partnered with some of the companies that make mammogram. Uh, we are really optimizing where the gap exists, which are real. Um, so so long as we can all appreciate the health disparities, the health, health inequities that are real and are all intending to improve outcomes and survival, then I think there's a fair game for eyebrows to exist alongside the portfolio of breast care that exists. Iris exams has been studied in 78 studies now, all independent studies over 7500 women enrolled across studies done in us Nigeria India brazil. These studies are reporting negative predictive value of 98%. So in other words, if I risk exam you get and you get a breast exam and it shows that there is nothing going on. The likelihood of you being truly okay is 98%. So that's a very high measure. If you're looking for a global health or public health intervention like this, I carry sensitivity of 85 for a handheld device like this with minimal training, that's a phenomenal measure. And we are seeing specificity in Upper 90s. So 92-95%. Um, sent specificity if I may also talk about a measure that I'm seeing through a few implementation programs happening around the world. We are detecting breast cancer at 3-4 times the rate of clinical exam. So it's truly making a difference. We have found hundreds of cases of early stage breast cancer in women that had no idea who had no access. And we were able to bring them into treatment. So we were seeing with a little bit of work that we've done there is actually improvements in outcomes. I want to see if our audience has questions but first break the cost down for us. How does it work? So um for sure. Um what is good for the community? What's good to make impact? Should also be good as a business strategy. It has to make sense in the commercial world to attract investors to scale to partner. So we have applied the do well do good model. Uh the razor razor blade model. So the sensor technology which is at the heart of my breast exam is a removable sensor that's field replaceable. Any health worker can snap one in and go to work. So we are developing our revenue model, our business model based on a paper use paper impact business model where you could pay a small fee for a breast exam instead of having to pay thousands of dollars for this fancy equipment and everything that goes with it. So we are now doing programs where the scanners are free and the breast exams are the cost of a physician appointment in that country. Okay, So in the us it would be $20 in India it would be $5 bucks in um in Ghana and Nigeria It would be a couple bucks. So it's really cost effective. It can the pricing is contextualized to the region and I call it the the Pepsi you know the Pepsi coke model? It depends on where you have the beverage besides the price of the beverage. Why why make it any different? You know similar model for iris exams. It's where you have to access it. It needs to be affordable. And so we have a very flexible pricing strategy. Do you have any questions from our audience? See you around the room here. We have one with you in the back. Hello? So I know the breast tissue could be lumpy and dense but still be healthy. I was curious to know if you have any um steps on um false positive results. This device could have because of you're saying false positives because of dense press. Yeah it could um sense the like some like dense parts but it could not be cancerous. And since this is like designed to be that can add home kit for people to first like do a self diagnosis and then go to the hospital or like see a doctor. Um I was wondering if like you have some results or like false positive in that area. Um We've trained the sensor to manage a certain levels of tissue elasticity differences that create the threshold for tumors. So for example, simple cysts for example. You know fluid exists are very common in women residence city is very common in women but that gets ignored automatically because of that threshold we've created. We've done extensive amounts of research on humor, tissue elasticity to to develop that threshold level. And now you're building A. I. Algorithms so that it can do it on the fly. Ah the other thing is we have 648 sensors running in parallel. So there is lots of comparative algorithm. We can run in real time on board in the scanner that weeds out the noise. And so our specificity is very high by not calling out these other lake conditions that are common in terms of uh you know, breast tissue complexity and we are really finding the fiber adenoma or the L. C. I. S. Or the I. D. C. S. Which are which are the ones you want to find and highlight. Think we have another question in the back too. Thank you. Okay, thank you very much. I think that this is a brilliant product. I think my question is the flip side of what she asked. Um So if you have like an ultrasound done it sometimes able to let you see some breast lumps that might seem a bit more risky or alarming? Right. Um So is this able to pick that out? So for example you do an examination with that. Is that able to say ok, this looks like a fibroid adenoma while the other one it looks a little bit more, you know fishy, maybe we need to check that out more. Can this device do that? So we do not characterize breslin's. We we try not to distinguish between them between malignant or benign nor do we try to characterize them. We're trying to think of this as a blood glucose monitor that you have or a blood pressure monitor that you have. Its goal is really to highlight uh you know in triage population and highlight a few women that are likely to have a lump in their breast anatomically at that very time and bring them into care earlier. Um And and that's the big puzzle right, How do you find those suspected cases from a vast population of healthy people? Did we have another question in the back did I say? I guess um I have two questions. One was like are you trying to also um build the same technology out for other types of cancer or other types of diseases? And the second was like kind of building off what everyone's asked like um compared to ultrasounds, mammograms? Like what all the other stuff, What's your resolution where you pick it up compared to them? is there like two x 1 at cetera? So um if I may answer your second question first, you know, efficacy compared to the gold standard um all our studies that have been done by these independent researchers is using the gold standard, the gold truths for comparison and we're seeing that our sensitivity is significantly comparable to mammogram and ultrasound for these uh you know, tumors that are present anatomically, other technologies that are trying to develop. We are trying to develop exciting technologies for cervical cancer detection. We are also trying to bring this technology to women at home. Um so if I'm a bath, um I literally have something in my pocket. So this is selfie, selfie is a at home version of iris exams. It's built with the same technology that is in the eye, breast exam is built with the same scientific rigor except that it has a user interface that women can use with their mobile phone. So very soon, hopefully later this year, women will be able to purchase selfie FDA cleared and they'll be able to download a mobile app and do self breast exams at home and share their breast exams directly with their care provider. So that's where we are headed. Um And thanks for that question because it gave me the opportunity to present healthy. Do we have time? We have time for probably one more quick question from the audience. Do we have any Oh right there. Great. Hi, I'm darci McConnell. My question is the advocacy um that corresponds with practitioner breast exams and self breast exams at home because I remember being quite disappointed when I did read studies in the past about how these breast exams that we do on women may not actually be that useful for detection. So I'm curious about whether or not utilizing this actually improved So versus clinical breast exam. Uh, we have shown sensitivity somewhere in the range of 20-25% improvement in sensitivity while our specificity is also improving over clinical exams, so fewer false positives and higher detection. And we are seeing that in our implementation programs in real time where it is being used in practice That we are finding cancer at a rate 3-4 times greater than clinical breast exam programs previously. Great, right here, thank you so much for joining us for showing us how your device works. And um, thanks for being with us today. My pleasure. Thank you very much.