Is your body becoming more frail? Are you worried about fractures? Do you want to improve your bone health? Osteopenia and osteoporosis are very common problems that don’t have completely effective solutions, yet.

In this episode of the Global Medical Device Podcast, Jon Speer talks to Laura Yecies, CEO of Bone Health Technologies, about the product journey of OsteoBoost, a vibration belt that aims to prevent osteopenia and osteoporosis that has recently received the FDA’s Breakthrough Device Designation (BDD).

Learn what the BDD experience was like and how their team is currently navigating the FDA regulatory process and collecting the necessary clinical data with the hopes of soon placing OsteoBoost on the US market.

 

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Some highlights of this episode include:

  • More than 50 million Americans are suffering from osteopenia and low bone density. Half of all women will have a fracture from osteopenia and osteoporosis - that’s more than heart attack, stroke, and breast cancer combined.
  • As people get older, especially women, shrinking is a real issue that is usually due to a fracture that causes pain as well as breathing and digestive problems.
  • People with hip fractures have a 20-plus percent mortality rate. Hip fractures are difficult to recover from and a high percentage of people lose their independence.
  • Currently, there are no approved treatments for osteopenia. Basically, your only options are to get enough Calcium and Vitamin D and do high-impact exercise. Give your bones enough stimulation to lessen the decline.
  • There are medications for osteoporosis. However, the side effects, the way they work, and indications for use are for people with osteoporosis.
  • When vs. If: Most people will eventually get osteopenia. Heredity is a factor that influences less dense and smaller bones. Lifestyle matters, such as excessive drinking and smoking or steroid use can have an impact on bone density.
  • Also, if you are an astronaut or go into space, bone loss is accelerated. Evidence from NASA shows that using whole body vibration improves bone density.
  • People must use such a device regularly, it is expensive, and it requires doing nothing for a period of time. Bone Health Technologies is developing OsteoBoost, a more practical and easy-to-use product that leverages whole body vibration.

 

Links:

Laura Yecies on LinkedIn

Bone Health Technologies

OsteoBoost

U.S. Food and Drug Administration (FDA)

FDA: Breakthrough Devices Program

Greenlight Guru Academy

The Greenlight Guru True Quality Virtual Summit

MedTech True Quality Stories Podcast

Greenlight Guru YouTube Channel

Greenlight Guru

 

Memorable quotes from Laura Yecies: 

“Osteopenia is an incredibly common problem, and we have over 50 million Americans suffering from low bone density.”

“If you walk around a nursing home, people are there typically for one of two reasons - they have Alzheimer’s or they have a hip fracture.”

“Most people will eventually get it.”

“There’s a body of evidence from NASA about using whole body vibration essentially to improve bone density. Astronauts lose a lot of bone when they are in space. Their bone loss is accelerated.”

 

Transcription:

Announcer: Welcome to the Global Medical Device Podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Jon Speer: It's not often on a Global Medical Device Podcast where we dive into an actual medical device company's journey and learn more about their story, but we do so on this episode. I talk to Laura Yecies. She's the CEO of Bone Health Technologies, and Bone Health Technologies is developing a pretty cool product called OsteoBoost. The goal, or the intent, or the idea here is that eventually, they'll be able to go to market. They're in clinicals right now, and when they go to market, they hope to be able to make claims around helping with osteopenia and osteoporosis, so pretty exciting. And Laura shares a little bit about their story and their journey today, and I hope you enjoy this episode of the Global Medical Device Podcast. Hello, and welcome to the Global Medical Device Podcast. This is your host and founder at Greenlight Guru, Jon Speer, and joining me today is Laura Yecies. Laura is the CEO of Bone Health. So Laura, welcome to the Global Medical Device Podcast.

Laura Yecies: Thanks, Jon.

Jon Speer: All right. Well, maybe a great place to start is, tell the folks a little bit about who Bone Health is, and then I want to get into... through our conversation, learn a little bit more about your journey and navigating FDA processes and getting your product to market and that sort of thing. But I guess, first and foremost, who is Bone Health?

Laura Yecies: Yeah, so we are a company that is working to really improving... people's bone health and focusing specifically on the problem of low bone density, osteopenia and osteoporosis. And osteopenia is an incredibly common problem, and we have over 50 million Americans suffering from low bone density.

Jon Speer: Yeah, I remember when I was a young child, I was growing, but I just remember my grandmother was shrinking. I don't remember how many inches she lost in her later years of life, but it's a real issue, isn't it?

Laura Yecies: Yeah, so half of all women will have a fracture from osteoporosis or osteopenia. That's more than heart attack, stroke, and breast cancer combined. And that shrinking is usually caused by vertebral compression fractures, so your spine holds you up tall, and if the vertebrae are compressing, you will shrink, and it's a big problem, causes a lot of pain. People have breathing and digestion problems because of their loss of height. And hip fractures, which, fortunately, are not as common as vertebral fractures, but they're quite common, have a 20 plus percent mortality rate.

Jon Speer: Yeah, man, it's those big issues that, as we get older and older and we start to get into nursing care and facilities of that nature, I've heard that hip fracture is also a very big issue because the recovery is so challenging and difficult, and not to mention loss of bone. I'm sure that complicates things a great deal.

Laura Yecies: Yeah, I mean, I'm not an orthopedist, but I would imagine that repairing the hip fracture on bones that are more hollow can't be very easy. But yeah, the recovery from hip fractures, a high percentage of people lose their independence. And if you walk around a nursing home, people are there, typically, for one of Alzheimer's or they had a hip fracture. I mean, that's not a hundred percent, but it's a pretty big percentage. And those are both really important problems, and we're excited to, hopefully, make a difference on the bone density one, and we're actually very optimistic about our ability to do so.

Jon Speer: Yeah, so tell us a little bit about the product that Bone Health has developed, because you're trying to get ahead of it. Before this becomes a problem, you're trying to prevent this from becoming an issue altogether, if I understand your product correctly.

Laura Yecies: That's correct. So we're, right now, running a clinical trial for postmenopausal women with osteopenia. So right after menopause, this loss of bone, which happens, essentially, your whole life after about age 35, accelerates. The hormonal changes of menopause lead the osteoclast, which remove bone, to go into hyper-drive, so this is a really important period of time. And right now, when someone has osteopenia, there's, essentially, no approved treatments. There are medications for osteoporosis, but given their side effects and the way they work, the indications for use of those medications are primarily for people with osteoporosis, so there aren't really medications that are indicated to use in the osteopenia period. So if you're diagnosed with osteopenia, typically, your doctor will say," Make sure you're getting enough calcium and vitamin D. The supplements, if you are already getting enough, are not proven to be helpful, and try to get high-impact exercise." And high-impact exercise, most people don't do. Walking is not high-impact exercise. Swimming and biking are not high-impact exercise. So if along the decades of your younger years, you messed up your knees or you aren't willing to do jumping jacks and things like that, you're probably not giving your bones enough stimulation to lessen the decline, so you're left with not much to do. You're really at a precipice, waiting to lose bone and become osteoporotic. And it'd be the equivalent of, you have very, very high cholesterol, we see your arteries getting narrower, but we're not going to do anything till you have a heart attack. So we're really motivated to find something that is safe, but shows efficacy, that people can start to use earlier. And based on our trial, we're hoping that people will use it once they have osteopenia, but I can imagine and hope that in the future, this can even be used before, if someone is at risk, to intervene earlier. But right now, we're focused on osteopenic stage.

Jon Speer: Yeah, and is this a heredity thing or not necessarily?

Laura Yecies: Well, it is influenced by heredity, so if you have a family profile of less dense bones or people who have smaller bones, like skinny wrists like mine, we all have a higher rate of osteopenia. If you are of Asian descent, you have a higher rate of osteopenia. So there is a hereditary component. There's probably elements of our metabolism, and for nutrition, that are hereditary. But lifestyle matters, so smoking and drinking to excess can have an impact on bone density. And then if you're unlucky and... and took steroids or had bad asthma and took inhaled steroids, there's actually a long list of other conditions and medications that can put you at greater risk. But I don't want to leave listeners with the impression that this won't affect them if they think that they didn't have these diseases or genetics, because most people will eventually get it. The heredity or these other... tend to affect when, not if, so the average American woman gets osteopenia in her late 50s, so even if you're on the better side of the genetics, you might get it in your late 60s. Well, if you hope to live into your 80s or 90s, then this is still a problem for you, so it's so common that it tends to catch up with many of us. And by the way, about half of all women get an osteoporotic fracture in a number of minutes, one in four. That's still pretty high number. They just tend to get it later, right, because their peak bone density is higher, so when they lose bone, they're losing from a position of more dense bones.

Jon Speer: I see. And so, the product that is currently in clinical trial, it's called the OsteoBoost, correct?

Laura Yecies: Correct.

Jon Speer: I guess, what can you share about the product, because, I mean, obviously, you have some information on your website and I'm not asking you for any trade secrets or proprietary information, but I mean, when I see the product on your website and I read about it, it seems so simple. And maybe that's the whole idea, right? I mean, I know it's way more complicated than maybe it seems, but it's a pretty straightforward product.

Laura Yecies: Yeah, it is quite straightforward. So there is a body of evidence from NASA about using whole body vibration, essentially, to improve bone density. So astronauts lose a lot of bone when they're in space. Their bone loss is accelerated, and if they go to space a few times, this can be a very big issue. So leveraging some... cellular research, NASA did studies of astronauts using whole body vibration platforms, and there was some very good evidence, it was published in Nature and there's over a dozen peer-reviewed papers, that showed efficacy. But the caveat to this is that what was found was that you had to use the device regularly, and that turned out, NASA astronauts, who are very unique in many ways, people tend to not to comply with the protocol enough, and there's a number of reasons for that. One is that, first of all, the devices are very expensive, the good quality ones. Second, you have to stand with your knees locked because your knees will damp in the transmission of vibration. And finally, you have to stand there, doing nothing, and kind of annoying to have to do that, so people just tend to not do it very much. And so, we saw this, where we saw good science, but from a practical point of view, not successful. And then we start to focus on, how can we make this a more practical, usable solution? And one of our founders, who's a PM& R doc and sees a lot of vertebral fractures and all the pain and problems that comes from that, was really motivated to solve this. And he and the co-founders of Bone Health Technologies came up with the idea of putting it in a belt. And the belt form factor has a few important benefits. First of all is convenience and ease of use. All you need to do is strap it on, and when you're doing your chores or going for a walk, you're getting the treatment. So as long as you remember to use it, which we'll help people do that, of course, with reminders, it's pretty easy to use. Secondly, they like it. So we get reports from users that it feels good, that it feels like a mini-massage, and it's not terribly noisy, so you can be on the phone or you can be talking to people. And then the other benefit is, it applies the vibration directly to the hips and lumbar spine, so essentially, we're concentrating it in the part of the anatomy that is the most vulnerable. And I often get questions," Will you have devices for other parts of the body?" And I see no reason why we won't or can't do that in the future, but we're a startup company. We need to focus, and so we're focusing on what we believe is the most important problem to solve, which is vertebral and hip fractures.

Jon Speer: Sure. And so, Laura, I've done a little bit of research on your background. So you're a serial entrepreneur, and I guess I'm curious, how did you find out about Bone Health Technologies, or what was the attraction that lured you to come join their team?

Laura Yecies: I was connected to the company through a recruiter who I knew, and I told her I was very interested in products that were really working on problems that would have a big impact. But once I got introduced to the company, there was a happy coincidence that two people who I really have high regard for, a marketing professional who did some consulting for me in a prior company, as well as a regulatory professional, both of them who had done some work with the company were very positive. And then the next step was, well, I had some good connections with good recommendations. I felt instinctively that this was a huge problem, and then my market research simply corroborated that. And then the next question was the science, and so I spent some time with our CTO and really dug into the data, and it was early. We've since gotten even more positive confirmatory data. And with that in mind, I was all in, because to me, when I work on an important problem and I want the product I'm working with to have a good chance of efficacy, and I believe that once we demonstrate the efficacy and get our FDA clearance, the commercialization is going to be very straightforward.

Jon Speer: Okay, so let's talk a little bit about your journey so far, navigating the regulatory pathway and hurdles and obstacles and all the things that a medical device startup needs to go through. But before we dive into those details, I want to take a quick break. I want to remind folks that I'm talking with Laura Yecies. Laura is the CEO of Bone Health Technologies. You can learn a lot more about Bone Health Technologies and their product that's currently in clinical research, called the OsteoBoost, by visiting their website. It's pretty simple, bonehealthtech.com. And you'll learn a lot more about Laura, the team, the product, the problem. It's a very informative website, so check that out. And while I've taken this quick break, I want to remind folks that at Greenlight Guru, we're here to help you. Greenlight Guru is the only Medical Device Success Platform on the market today, designed specifically and only for medical device companies. And it's been designed by actual medical device professionals, so within the Greenlight Medical Device Success Platform, there are workflows to help you manage your design and development activities, your risk management, document and record management. Basically, everything that you need within your quality management system can be found within the workflows within the Greenlight Guru system. So if you're curious at how we might be able to help you, then I would encourage you to go to www.greenlight.guru. We'd be happy to have a conversation to understand what your needs and challenges are and share some of the products and services that we have that, hopefully, can help you in that journey. So Laura, let's talk about that regulatory pathway. It sounds like there was early-stage research, maybe a little bit past that, when you joined the team. Obviously, the OsteoBoost is in clinical studies right now, but there's been a lot of steps that have happened from when you joined to that point. So what are some of the biggest challenges that the team had to face in navigating this journey to commercialization of your medical device?

Laura Yecies: The first thing is to up a device that was very comfortable and practical for users, and so there were a number of prototypes and different test devices that were created and developed, and usability was worked on. And so, that was, obviously, a key phase of development. Then the next phase was to look at efficacy, and one of the challenges to do that in bone health is that bone processes take time to accumulate. So our clinical trial is a one-year study and we're looking at bone density at the beginning and end of one year, but that's a long time to wait in an early-stage startup where you're trying to get feedback, is your approach working? In the endocrinology field, there is some well-established bone turnover markers that you can use, and so we did a short-term study effect of our device on those bone turnovers, and that's a study that we published. It was small, but we showed very good efficacy. And based on that, then we applied for an SBIR grant and that gave us enough money to do our pivotal trial. Because of COVID delays and some other factors, we ended up also needing to raise equity to complete that... but that gave us a big boost. And we are in the middle of that trial. We finished enrolling, and we're pleased with how it's proceeding. But working on something where it takes a while to show results, obviously, is challenging. Other challenges, I would say, in the early days of fundraising, identifying the errors. So a lot of medical device investors have gotten out of devices or focusing on pharmaceuticals. But fortunately, there is, especially in the angel groups and some of the micro VCs, a cadre of investors that are passionate around devices and more and more interest in women's health. Now, we are not only a women's health product, but the disease... more, and so we were able to get a fair amount of interest from those investors. And I would say COVID was a challenge for us. We had to pause enrollment for six months. We're not the only one, obviously, that's dealt with that, but it's a real issue.

Jon Speer: Yeah, absolutely. I know that's created a lot of challenges, especially for technologies like yours where you need the clinical investigation to basically demonstrate the use case or the product. It's been a huge, huge challenge, but it sounds like you're back to, not necessarily on schedule, but you're back according to plan, you're back to getting that clinical data now. Laura, I think if I recall, too, that weren't you were awarded the breakthrough device designation as well?

Laura Yecies: We were, we were, and that had a really important boost for us. First of all, we were able to get these sprint meetings with the FDA, and so that helps us stay really on track and on path. We're hoping that if the MCIT rule passes, that that will give us some benefit on the reimbursement side, which both of those things give us a lift, from a fundraising point of view. So I'm a big fan of this Breakthrough Device Program, and I think it's really good from a policy point of view because from a public health point of view, we need startups to focus, or big companies, actually, a breakthrough can apply to big companies as well, to work on problems where there's unmet need, right? We more need a safe and effective treatment for osteopenia than we need the Nth slight variation on a drug that's in a category where there's 20 effective drugs. And not that those variations aren't useful, and I wish those companies success, but we really need to encourage the gaps in the market to get filled. And so, that's been helpful, and we're excited and proud of that.

Jon Speer: Yeah, absolutely. I totally agree with you. I think sometimes, the historic regulatory framework almost prevents or precludes people from thinking a little bit more innovatively with respect to solutions and needs, so I agree. The breakthrough program is a really, really good program. As we're getting toward the tail end of our conversation today, let's shift gears a little bit. Imagine that you're speaking with other medical device startups out there. What sort of tips or pointers or advice or suggestions would you give those other startup companies as they're trying to navigate their own medical device journey?

Laura Yecies: That's a good question. Well, I have a few, so one is that I see a number of medical devices that I think are incomplete in terms of providing a fairly comprehensive solution, so they might have their device part of the treatment, but they don't think about the full platform and how to involve the doctors and patients appropriately. I think that's starting to change. And for instance, when I joined Bone Health Technologies, and I have more of a software background, I focused on adding some of those elements to our... I would also call their attention to the opportunities in women's health. A number of women's health, or conditions that primarily affect women, I think are undertreated, but they're big markets and women are really looking for solutions. They're great patients to market to because they congregate online around these solutions, they are searching, they tend to be more active. So I would encourage people to look at that area and also to be transparent in their marketing, and even on the regulatory side. I'm sorry. You were starting to ask something, Jon.

Jon Speer: No, go ahead. Keep going. I'll hold my next question.

Laura Yecies: I mean, I think those are my main tips for early user research, and I think this is not just medical device. I think this is for startups in general. Entrepreneurs get so passionate around a problem, and they feel so strongly, and that is part of the motivator, so I don't want to take away that part. They often feel so strongly around their perception of the problem, and there can be some really important early learnings around that from both the doctors and the patients. And I've encountered this challenge and made some of these mistakes, so I'm saying this from a position of, some of these things, I've learned the hard way.

Jon Speer: Absolutely. I can remember quite a few times myself, very early in my career, where I thought I understood the need that I was solving. I was quick to jump to a solution. Well, I kind of fell in love sometimes with the solution that I came up with. I put my head down, I focused on the next steps, except that I left the user out of the conversation that followed, got to the end of that process, and the user group was like," What is this?" It didn't really resonate with them. If I could piggyback on what you're suggesting, don't fall in love with your solution. Make sure that it meets the needs and keep that user voice a part of your process throughout.

Laura Yecies: And there's such a risk of, I think behavioral economists or psychologists call it confirmation bias. So you're in love with it, you do some user research, and there may be some confirmatory user research, and there may be a lot of non-confirmatory user research, and it's easy to misread the balance of that. Oftentimes, this is not a black and white thing, the balancing of the feedback, because oftentimes, you're not trying to sell to all users or all doctors at the beginning. You are selling to the early adopters, but you need enough early adopters to start.

Jon Speer: Yeah, absolutely. Laura, my last question for you today, and you sort of alluded to it earlier in our conversation about the funding or fundraising process. I mean, I know that's super challenging, especially in this medical device industry, for lots of reasons. Any practical tips or pointers or suggestions for folks that might be struggling to find investors for their products and technologies?

Laura Yecies: Well, I think finding investors, there's essentially the market research process. So when I think back on right and wrong in fundraising, a lot of it has come down to the right targeting, and sometimes you don't know that until you try a few groups. So for instance, what I found for our first money in, and of course, that's the hardest money, you have the most risk, the most unknowns, I needed to find people who were the most passionate about our product and the problem that we were solving. And it turned out that there were a couple of micro VCs that had a very patient and medical innovation focus that overlapped with ours. But our biggest investor was Astia Angels, an angel group that... It's not only women investors, but it's a good number or a high percentage of women investors. And they do a lot in women's health and they understood what we were doing immediately, and it was great working with them. And Golden Seeds and Portfolio were similar. We have a nice balance of investors that are investors in women's health or women investors, which by the way, those two overlap, but they're not the same. And we have venture investors, but they're investing in our type of product or stage.

Jon Speer: Yeah, that's great advice. Laura. I appreciate you sharing a little bit of your story, but really, the Bone Health Technologies story. And I know we're all going to be paying attention to the progress of the OsteoBoost product. I know it's premature and I'm not trying to put you on the spot, but I assume there's some follow-up with patients after their clinical study is completed. I'm guessing this is a product we can expect or hope to see in the market, probably within the next couple of years. Is that specific enough or fair enough?

Laura Yecies: That's my hope, that's my hope. Yes, I very much hope so for business reasons, but also for patient... Ever since we announced our breakthrough device status, we're getting requests from patients and doctors every day. And by the way, if listeners are interested, they can sign up on our waiting list. And that's really what drives our urgency, is getting those messages from people who really want the product or really want something that they can use, that will work. And so, hopefully, it's not too far away.

Jon Speer: Awesome. Folks, if you want to get added to that list, it looks like it's pretty easy, from what I could tell. You go to the Bone Health Technologies website, which again, is bonehealthtech.com. If you click on OsteoBoost near the top of the screen, you'll see a little bit about the product and there's a pretty good-sized button that says add me to notification list, so looks like that's pretty straightforward if you're interested in learning more and following progress of OsteoBoost and its journey to market. Again, I want to thank Laura Yecies. Laura is the CEO at Bone Health Technologies. And folks, thank you so much for listening to the Global Medical Device Podcast, the number one podcast in the medical device industry, and the reason for that is quite simple. It's because of you continuing to tune in and listen, and to spread the word to your friends and colleagues, so thank you for doing so. As always, this is your host and founder at Greenlight Guru, Jon Speer, and you have been listening to the Global Medical Device Podcast.


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