Medsider: Learn from Medtech and Healthtech Founders and CEOs - How to Convince Investors, Payers, and Patients Your Device is Worth the Cost: Interview with Bone Health Technologies CEO Laura Yecies

Episode Date: July 19, 2022

In this episode of Medsider Radio, we sat down with Laura Yecies, CEO of Bone Health Technologies.Laura is a Silicon Valley veteran with more than three decades of experience at major tech companies and startups. She’s always had an interest in improving people’s health and wellness and was drawn to medtech startup Bone Health Technologies, which is developing a vibration belt intended to prevent osteoporosis. In this discussion, Laura shares why you should look for investors who are passionate about your mission, how FDA clearance can boost consumer confidence in your technology, and why patients should be at the center of everything you do. Before we jump into the conversation, I wanted to mention a few things:If you’re into learning from proven medtech and healthtech leaders, and want to know when new content and interviews go live, head over to Medsider.com and sign up for our free newsletter. You’ll get access to gated articles, and lots of other interesting healthcare content.Second, if you want even more inside info from proven experts, think about a Medsider premium membership. We talk to experienced healthcare leaders about the nuts and bolts of running a business and bringing products to market.This is your place for valuable knowledge on specific topics like seed funding, prototyping, insurance reimbursement, and positioning a medtech startup for an exit.In addition to the entire back catalog of Medsider interviews over the past decade, premium members get a copy of every volume of Medsider Mentors sent to their door at no additional cost. If you’re interested, go to medsider.com/subscribe to learn more.Lastly, here's the link to the full interview with Laura if you'd rather read it instead.

There are a lot of advantages for class two. It opens up the path to reimbursement. And also, we believe that this is a serious medical intervention. It's a true therapeutic treatment and that these patients have a significant or serious condition. They're under the care of the doctor. We want to be part of that doctor-patient journey towards improving their bone health. And so we made the decision to go down this clinical prescriptive. path, especially for our initial launch.

Welcome to MedSider Radio, where you can learn from proven med tech and healthcare thought leaders through uncut and unedited interviews. Now, here's your host, Scott Nelson. Hey, everyone, it's Scott. In this episode of Medsider, I sat down with Laura Yisi, a Silicon Valley veteran with more than three decades of experience at major tech companies and startups. She's always had an interest in improving people's health and wellness, and it was drawn to MedTech startup bone health technologies, which is developing a vibration belt intended to prevent

osteoporosis. Here are few of the key things that we discussed in this interview. First, identify the right investors. Find people who will connect with your company's message and mission and are passionate about your product. Second, consider getting the old FDA stamp of approval, even with a consumer-centric device. Taking your products through the regulatory process is expensive and time-consuming as we well know, but can boost patient and provider confidence in your technology. Third, think about how patients will pay for a product and price it accordingly. Bonehill Technologies is pursuing and making a commitment to an affordable self-pay path, at least for now. Okay, so before we jump into the discussion, I wanted to let you know that we just

released the first volume of Medsider mentors, a print-based book that summarizes the key learnings from my favorite Medsider interviews over the past six months. Look, I fully realize it's tough to listen or read every Medsider interview that comes out, even the best ones. But there are so many valuable lessons you can glean from the founders and CEOs that join our program. So that's why we decided to create Medsider mentors. It's a way for you to learn from the best thought leaders in our space in one central place. Here's a teaser of what you'll see in this first volume. Gar Hong Kong, founder of Health Quest Capital, teaches you how to successfully pitch your startup.

Patricia Ziliak, CEO of Ivinsens, discusses what you really need to know about clinical trials. Jared Bauer, CEO of Ionic Sciences, shares best practices for avoiding obstacles in your startup journey. That only scratches the surface, so if you're interested in learning more, head over to MedsiderRadio.com forward slash mentors. If you're a premium Medsider member, you'll get free digital access and a print version sent straight to your door. If you're not a premium member yet, you should definitely consider signing up. In addition to every volume of Medsider mentors, you'll get full access to the entire library of interviews dating back to 2010. This includes conversations with experts like Erica Rogers, CEO of Silk Road Medical, Dr. David

Albert, founder of LiveCore, and so many others. Learn more by visiting MedsiderRadio.com forward slash mentors. Again, that's MedsiderRadio.com forward slash mentors. All right, without further ado, let's get to the interview. All right, Laura, welcome to Medsider Radio. Looking forward to the conversation. Thanks, Scott. Really happy to be here.

Yeah, absolutely. It should be a fun discussion, especially regarding your story, your story background in traditional tech and now kind of running bone health. But before we go kind of too deep into the conversation, let's start with a little bit more, learning a little bit more about your professional background leading up to your current role as CEO of bone health technologies. Hopefully we'll spend just a few minutes. The point here is not to kind of go through each sort of job transition line by line. But just help the listeners get a better idea of kind of where you've spent most of your career leading up to now. Yeah.

So the general arc is that after business school, I came to Silicon Valley and I immediately started working in tech primarily on the product management, marketing, some sales, business development, so kind of that whole commercialization, from product to commercialization. And I did that initially in enterprise software companies, so large scale relational databases, and then move over to spend a lot more time on more of a consumer technology. So I was VP of the browser division of Netscape. So I worked on many browser launches, but I led 6.1 and 7.0. And, you know, the spinout to Mozilla.

I then ran, I was GM of Yahoo Mail. And so, you know, major consumer technology products, productivity tools that, you know, touch hundreds of millions of people. I then went to checkpoint. I was at a startup briefly, but then I went to checkpoint where I went back into enterprise software, but also did a big consumer-oriented product called Zone Alarm, one of the first Freemian products. And then I became CEO of SugarSink, also millions of users, a sync and share productivity tool. That company was acquired by J2 Global. I was CEO of another productivity tool called Catch, which is a note-taking application. And that was really a great outcome. We sold that company to Apple. And Apple used

that team and technology, but particularly the team is the basis for the Apple Watch. And most of the technology leadership group from Catch is actually still there and still building products at Apple. That was a nice exit and gave me an opportunity to think about what do I want to do next. One thing I didn't mention is that I grew up in a family of doctors. Both my parents, my mother was always a working physician, two of my siblings, and then lots of aunts, uncles, cousins. I was kind of the black sheep went into business. But I always had that interest and you know, worked a couple summers in the nursing home where my dad was medical director and I volunteered with doctors as a translator. So I always had this, I think, deep-rooted interest in people's health

and wellness. And, you know, then just, you know, as things in life happen, you start to really appreciate even more the importance of that. And so after the catch exit, I started to rethink, what did I want to do? I've briefly considered more of a clinical role. and I took some classes at the time. I was interested in genomics. I took chemistry and bio. But what was going on at that time was this, you know, the beginning or the beginning at a large scale of the tech and medical convergence.

And I started to see, huh, using my skills around technology, using technology to help people's health, that seems really cool. And what I like about doing it through technology is, you can do it in a very leveraged way. So while there's something sacred about that individual doctor-patient relationship and helping that individual human soul heal, there's, I think, also something cool about if we can make this technology or product or application improve people's health and their lives,

and you can do that for millions of people, that's exciting in its own way. And so that was, you know, the trajectory I decided to pursue. And I started doing that initially with some consulting. I consulted with a startup in genomics and MS. And then I had my first CEO role with a diagnostic company called Syncthink. That company just got its FDA clearance for a concussion diagnostic. I then consulted at Achille Interactive, which is a digital therapeutic for neurological conditions, initial product with ADHD, and I worked on a lot of the marketing and sales strategies.

And during that time, I was really looking for what's the next thing I can put my passion behind and really lead? And I wanted to do a therapeutic and something that I could personally connect with. And then I was introduced to bone health technologies. And it was very clear to me that this was something that if it worked, could just have a huge impact. And of course, we'll talk more about this later. But the unmet need in low bone density is just tremendous. We need new therapeutic options. And so my only question, frankly, not of could this be big if it worked.

My main question to the founding team and who was recruiting me is like, what's the data? Why do we believe that a vibration belt is going to treat this serious condition? And it seems almost too good to be true. And so I dug into the data, dug into all the research that's been essentially transpiring for dozens of years on vibration and a cellular level, whole body vibration, and the early data that the team captured. And then the rest is history. The rest is history.

No, no. Thanks for that. Thanks for that overview. And before we kind of dive in to learn a little bit more about, you know, the osteo boost product, how that sort of how that came to, came to life, so to speak. I'm dying to know, though. You ran, you were the GM of Yahoo Mail. Do you still have a Yahoo.com email address?

LEC's at yahoo.com. There we go. It's not my primary, though. Okay. It's more of an eclectic, you know, email address for a keepsake, right? I have a lot of email addresses, you know, even at Netscape, I worked on an email product because Netscape communicator was an email reader. So I've always loved these, you know, communication and productivity tools.

And I still joke around every time I try to schedule a meeting with participants from multiple companies. Like, in my future life, I'm going to do a better cross-company scheduling tool. I do love those products. I try them all out. but my my heart right now is in is in the healthcare space. Yeah, doing some research on your background, which is,

you know, you typically don't find, you know, folks like yourself that have, you know, that type of resume from traditional tech that are now doing, you know, working on,

on health technology, medical device companies. So it was really cool. But I saw, I did see the, the sugar, the, the sugar sink,

you know, experience. And I was like, I haven't heard about, I haven't heard that company's name it in such a long time, you know, but I do recall it back of the day. I'm a bit of a,

productivity kind of app nerd as well. I like to try a bunch of different apps. And it's kind of a kind of a kind of nerd out as well on that sort of that sort of stuff. But, um, well, you see a lot of people with that trajectory. I think it's, it's a pretty interesting one. Yeah. Our product has two components. There's the biomechanical part, right? That takes sort of the, the biomechanics to understand the mechanism of action, develop it. And then the electrical engineering and mechanical engineering and software engineering to the firmware to actually build that. But without some way to get people to use it and understand how they're using it and to track it, I think the efficacy will be much more limited because the nature of our product is it needs to be

used on a pretty consistent basis, right, nearly as close to daily as possible. So getting people to use a device and intervention daily is. is not trivial, especially if you think about bone density where the consequences are serious, but they're not tomorrow, right? Yeah. We are cumulative. And so having the connected health platform that helps with motivation, helps with tracking, encouragement, as well as the other components, like your body's not going to make

more bone or have optimum bone turnover if you don't have the proper nutrition and things like that. So, you know, so reminding someone to, for instance, like, let's take the zone alarm example with Internet security software, right? It's hard to get people to remember to use it and to use it properly. And there were a lot of learnings in my career around that or how to use a product more regularly or more frequently. Some of it is encouragement. Some of it is pure usability to make sure that all the screens and windows and language is good. And so I do think that those skills are directly relevant here and complementary and synergistic with the traditional device component. There's no doubt. I spent most of my professional career in traditional med tech and more

specifically the cardiovascular space, but I did start a company called Juve, which is a consumer, a consumer in-home medical device, how long has it been now, five, six years ago. We had a really good ride. But kind of understanding a lot of those, all of those learnings, right, across, you know, those five or six years of running that company on how consumers use your technology in the home, it's super interesting, right? And it's hard to find people that have both of those experiences, right, like yourself, right, that have a lot of those consumer learnings, right, and can leverage those and pull those into,

you know, a medical device product. So that's, that's really cool. And I completely agree that there's a lot of things that can layer in that. I think those skills will be in greater demand because the trend is towards home use devices. No doubt. So, you know, what we need in terms of compliance and utilization is becoming increasingly important. Yeah, 100%. Well, let's talk a little bit more about bone health. You mentioned, you mentioned sort of at a high level what your core product is attempting to do. But give us a little bit of the backstory before we go too deep on kind of like your approach to running the company and how you're thinking about different functions. How did this idea come to be? Tell us a little bit more about the inception of it.

Yeah. So the founders of the company are part of a medical or leaders of a medical device incubator called Theranova. So they do a lot of novel devices. Dr. Shane Mangrum, who was really the inventor of the device, he's a practicing physician. He does physical medicine and rehabilitation, focusing on spine. And one of the common conditions that he would see in his practice are vertebral compression fractures. So those are, you know, one of the more common fractures that people get from osteoporosis or osteopenia. And they're a big problem, right? They're extremely pain. the treatment. You can do kifoplasti, but then that risks fractures in the other vertebrae.

And he also observed that people were for various reasons not taking the medication, or maybe they weren't a candidate for the medication. And so, you know, he got a pretty strong flavor of the unmet need. And by the way, I think clinicians in general understand, you know, hip fractures are deadly. These fractures are common. And so anyone that's truly in a clinical role where they're working with a lot of older patients, they know that this is a big problem with big unmet need. Except he had that, well, what could we do about it, you know, inventive side.

And he saw the literature around whole body vibration really did some analysis on that. And the science there is pretty good. There are a number of studies that show improvement in bone density or slowing the loss of own density using whole body vibration, but the compliance has been pretty poor, and those interventions have not been a large-scale commercial success. They're used modestly. So he had the observation that it's hard to comply with these devices. They're expensive. The vibration often dissipates if people, you know, don't lock their knees. So how can we directly target the hips and spine. And so the idea was to put the same kind of specific vibration type, same frequency,

same amplitude, but into a belt form factor where you're targeting the hips and lumbar spine. And obviously, lots of prototyping and testing and iterations is with any good invention process. And then the company, part of us getting us to this point, got a very modest proof of concept grant from the NIH. They did a proof of, you know, an initial study saw improvement in biomarkers, so bone cell turnover markers, which was encouraging based on that, got $2 million grant from the NIH for the pivotal study. That grant didn't cover the full cost of the study, but obviously was really important to getting underway and, you know, we're in the process of wrapping up that study now. And then I'm really pleased that we've gotten yet another grant of

2.7 million from the NIH this fall to do kind of the early commercialization readiness. And so, you know, while, you know, there's been a lot written about that it's hard to get funding for women's health, both from investors and pharma and even the government, Medicare is paying for the vast majority of these fractures. And, you know, as tax payers were paying for it. And fortunately, there's recognition that there's significant unmet need. By the way, the fracture rate in the U.S. is going up, not down, despite medication's availability. Not enough people are using them, and there aren't safe early interventions. So, yeah, it's exciting. I think, you know, big problem, good kind of creativity and invention to solve it.

Yeah, yeah. That's great. And congrats on the, on the grants, it sounds like, you know, if I heard, if I heard your right, you're, you know, close to $5 million or $5 million plus in grant. Yeah. That's great. I need to, we can have a whole separate conversation around your keys to success for writing successful grants. But with that said, help be, I want to ask you kind of a series of questions around how you're thinking about different, different functions inside, inside Bowen Health as you look to commercialize your, your devices and run various clinical studies moving forward. But give us a sense for kind of where you're at now. You mentioned a pivotal study, but what, like, are you, are you, are you currently selling

the device? Like, what, you know, where are you at from a clinical roadmap perspective? Give us a high level overview. We're not currently selling. We had done a test market of an over-the-counter device. And people were very interested in the device. But what we saw is that when they were going to buy, we didn't have the clinical data. And so it was very clear that to convince people to spend reasonable amounts of money and to use it daily, they need to have confidence that it would work. Now, we're confident or fairly confident based on our interim data and the concept data, but it wasn't as much as we would want to have for marketing purposes. And so essentially, we need to do the trial.

And we need to do that trial for both the clinical and the OTC. And so the thought was, let's focus on that. And let's use that to get our FDA class two clearance, even though this could be class one. There are a lot of advantages for class two. It opens up the path to reimbursement. And also, we believe that this is a serious medical intervention. It's a true therapeutic treatment and that these patients have a significant or serious condition. under the care of the doctor, we want to be part of that doctor-patient journey towards improving

their bone health. And so we made the decision to go down this clinical prescription path, especially for our initial launch. Now, we want to have this product be available widely. You can imagine the opportunity for it to be used as a preventative tool for people at risk, but who don't have a diagnosis yet. And so part of our journey will likely be an OTC device, but our initial go-to-market, we're planning this class two prescription device. Got it. Okay. That's super helpful. And you're, when do you expect, is that, is that on the, in the near term horizon? I'm hoping for like early next year. Okay. It's on, you know, doing, finishing out the study, doing our submission, FDA review. We do benefit from breakthrough device

status. Okay. That can help speed the process. But of course, you know, there's always some unknowns on timing with FDA processes. Got it. All right. Great. Well, let's use that as a transition point to talk a little bit more specifically about some of these kind of core functions and how you're approaching them. And you mentioned sort of this regulatory and you touched on reimbursement lightly there.

But it sounds like your team has weighed that pretty heavily, right? Class 1, OTC device versus a class 2 device and being a little bit more aligned with kind of that physician, patient sort of relationship and, and potentially seeking, seeking reimbursement. So can you talk to a little bit more about like your approach, right? Because they're, they're very, two very different paths, right? And so what ultimately kind of led you to go down this path of pursuing this, you know, this class two status and eventual maybe getting a, I would presume a CPT code specifically

for this, for this device? Well, okay. The reason not to go down a class two path is to, typically that it's a lot of work, it takes a lot of time. You lose some control over the timing of your launch because you have this FDA dependency. It's expensive. There's the expense of conducting the trial. Then there's the expense of all the submission process.

Now, as I mentioned you before, we saw that we needed to conduct the trial anyhow. So I wouldn't put that on the weighing scale as a reason to do OTC because we believe that even the OTC marketing strategy would require having good clinical data to share to separate ourselves from, okay, look on Amazon for a vibrating massager, right? And that's not what we are. This is a significant clinical intervention. So switching gears to, you know, the class two advantage. You know, one thing is, you know, with a device like ours, and people sometimes don't ask me,

but there's some inherent skepticism, right? Vibration belt, you know, they think of like some of these old Jacqueline gym things. You know, there's some inherent skepticism does this really work. Now, despite the skepticism, there's actually a large, body of evidence around vibration at the cellular level with animals, whole body vibration, you know, dozens of papers, including papers published in top tier journals such as nature, showing the efficacy of whole body vibration. So the science is good, but from a market perception, we recognize that there's this potential for skepticism, all the more reason to hold ourselves

to the most rigorous data standards and standard of approval. And generally doctors and hopefully patients, you know, respect that the FDA does a rigorous analysis and is objective and is conservative and that that approval is meaningful in terms of their confidence in the efficacy. And so I think that that supports a clinical strategy. And it also supports a later OTC strategy. There's lots of products more on drug than device, but probably device too, that have started with a prescription path and then, you know, move on to OTC.

And the OTC benefits from sort of this good housekeeping seal of approval of the prescription. Yeah, sounds like a smart play. And if I can, if I'm attempted to put myself in your shoes as you're evaluating, both paths. It sounds like you and the rest of the team felt the need to establish, you know, some sort of clinical, clinical data, right, for your device specifically. And so you're already going to check that box, right, which led you, which led you down this class two path to help create, you know, some differentiation between, you know, some random generic, you know, vibration. And remember, it's not just the purchase. The patient when they go to purchase is, is making

a self-projection around, am I really going to use this all the time? So let me give you a contrasting example. Let's say there's some OTC wearable device that claims to treat migraines. Actually, this is kind of a hot field right now. There's some subscription devices, some OTC. And let's say you go to the website and the website says, you know, money back guarantee, see if it works for you. Okay. Let's say I get migraines once a week. I get the device. and three out of four times the device helps my migraines. That's all I need, right? Migraines are terrible.

I find that the device is helping me. Do I care a whole lot about what the FDA says? I just want to know it's safe. If it's safe and it's working for me, why not? That's great. But we have a very different kind of product, right? They don't feel better or, well, actually, many patients say that the device does feel good, but they're not using it for that purpose.

They're using it to improve their bone density. And it could take a good year for them to see those results. And so they really want to feel some level of confidence that it works because it's not just spending the money. It's spending the time and commitment. And so, you know, that really reinforced my thinking that we needed, that we wanted to be able to share this level of evidence and proof and external validation. Hey there, it's Scott, and thanks for listening in so far.

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