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With over three decades in telecom and IT, I've mastered the art of transforming social media into a dynamic platform for audience engagement, community building, and establishing thought leadership. My approach isn't about personal brand promotion but about delivering educational and informative content to cultivate a sustainable, long-term business presence. I am the leading content creator in areas like Enterprise AI, UCaaS, CPaaS, CCaaS, Cloud, Telecom, 5G and more!
What's Up with Tech?
Revolutionizing Bone Health: Bone Health Technologies on OsteoBooth, NASA-Inspired Devices, and the Future of Non-Pharmacological Treatments
Interested in being a guest? Email us at admin@evankirstel.com
Can a wearable device truly revolutionize bone health? We promise you'll find out in this episode with the CEO of Bone Health Technologies. Laura shares her inspiring journey from the tech industry to spearheading innovations in bone health, focusing on the development of the OsteoBooth. Learn about the pressing issue of bone density loss, particularly in postmenopausal women, and the significant results of the OsteoBooth's pivotal trial that led to FDA approval. Laura provides a compelling look into the urgent need for non-pharmacological treatments and how OsteoBooth is poised to fill this critical gap, much like chronic treatments for conditions such as high cholesterol.
The spotlight also shines on a groundbreaking device inspired by NASA's research, using low-frequency vibration to enhance bone density in both men and women. The discussion emphasizes the often-overlooked issue of osteoporosis in men and the adaptation of space technology for everyday use. We also explore the future roadmap for clinical trials, the importance of early diagnosis through DEXA scans, and how listeners can stay informed and participate in upcoming pre-order programs and webinars. Tune in to gain invaluable insights into the future of bone health technology and how it can impact your life or the lives of those you care about.
More at https://linktr.ee/EvanKirstel
Hey everybody, Fascinating discussion today, diving into the world of bone health, with bone health technologies addressing the decline in bone strength and bone density in men and women with bone health. Laura, how are you?
Speaker 2:I'm great Thanks. Thanks, evan Hi Laura.
Speaker 1:Well, thanks for being here with Irma and I at Avira Health. Really interesting technology and story behind your wearable technology OsteoBooth. Maybe give us an introduction to yourself and the big idea, the mission behind Bone Health.
Speaker 2:Yeah, so my name is Laura Yeeses. I'm the CEO of Bone Health Technologies. I've been with the company just about four years, so I joined when we were in the process of running our pivotal trial. My background is I spent about 25 years in tech, so enterprise software, but I also led some major brands like Netscape and Yahoo and ran marketing at Checkpoint, was CEO of two startups, sugarsync and Catch. Catch was acquired by Apple and then after that I saw this convergence of health and technologies. That I found very exciting and that's what I've been doing the last eight years.
Speaker 2:And when I was approached to join Bone Health Technologies, I was just immediately very excited because I grew up in a family of doctors. I actually worked in a nursing home when I was in college during the summers and pretty much end up in a nursing home for one of two reasons. I mean, I'm oversimplifying, but you know Alzheimer's or you break your hip and my grandmother had osteoporosis, I have osteopenia. It's just such a common problem and we really lack solutions. And my, my, really my only question to the, the founders, was why should I believe this thing's going to work? Because if this works, it can really impact a lot of people and at that time we weren't sure. We had some good scientific background behind us. So there was a body of evidence from NASA on whole body vibration and we had bone health technologies, had done a proof of concept study, a small study that had some very promising data. But it seems such an important opportunity, such a big opportunity that was like well, there's some good scientific principles and we're going to know the answer to this in a couple of years, after we do the pivotal trial. And so fast forward. We saw the results from the trial in November of 22, and they were really outstanding. We reduced the loss of bone strength and bone density by well over 80% and we went on to apply to the FDA for approval and that was granted in January of 24.
Speaker 2:And so let me just kind of give you a little bit of perspective on this approval. It's a Genovo. We are a breakthrough device. So FDA grants us breakthrough status because we are working on, you know, an area of such unmet need. Genovo means that you are really creating a new type of device. So there have been 16 orthopedic de novos in the history of the FDA. These are not easy to achieve. So that was very exciting. And then you know it's the first and only prescription treatment for bone strength and bone density. That's not a pharmacological product. So you know, let me kind of switch gears to talking about. I've mentioned a few times how big the problem is and the unmet need, and maybe I'll just, you know, give some more perspective on that.
Speaker 2:You know, loss of bone density is part of aging. So, oh, this is exactly the right chart, right? So you see that very steep decline for women. This is occurring during menopause. So the loss of estrogen leads to a rapid loss of bone and then we continue to lose bone and so half of all women will have a fracture in their lifetime. Most women will eventually get osteoporosis.
Speaker 2:It's one of these, when not ifs, and this is for average bone density. So the peak bone mass is achieved in your 30s. Well, what if you don't achieve peak bone mass? What if you had poor nutrition or you had to take a lot of steroids for bad asthma or you're undiagnosed celiac? Then this curve is even lower and the bone loss therefore hits the dangerous bone earlier.
Speaker 2:The other thing that's interesting is that osteopenia is more common than osteoporosis, kind of like prediabetes to diabetes 50 million Americans roughly with osteopenia, another 12 million with osteoporosis. But even though osteoporosis has a higher hip fracture risk so eight times normal or higher risk of fracture there's so many patients with osteopenia that there's actually more fractures in the osteopenia population. So you know, we this is a very big problem and we really don't have any treatments for osteopenia other than lifestyle. So if you have osteopenia or you're at risk, of course you want to optimize your nutrition, get enough calcium, get enough protein, get weight-bearing exercise, but most women will still lose bone, right, even if you're optimizing on all of those fronts, and then, of course, not everyone can even do all those exercises. So we really need something else.
Speaker 2:There are medications for osteoporosis, but generally speaking, they're indicated once you have osteoporosis, not osteopenia. So what we don't have is the equivalent of like statin or metformin or where you start early to slow the progression and take that medicine essentially indefinitely Right? If you have high cholesterol in your forties, you're probably taking a statin until you die. We don't have anything like that for osteoporosis, right? The first line medications bisphosphonates typically are used for five years, and then you need a drug holiday, maybe 10. Five years and then you need a drug holiday, maybe 10. So that, yeah, there's this big unmet need and we saw an opportunity to try to take a novel approach.
Speaker 3:Oh, that's such a fascinating foray into the reasons behind your company and the huge unmet needs. So let's dive into your actual product and how what it is and how it works and how it's different from other treatments or tries to address this condition, maybe in ways other conditions are addressed early on. Yeah, sure.
Speaker 2:So I mentioned weight-bearing exercise, that that's one of the you know, guidances for patients with at risk of fracture, low bone density to weight-bearing exercise. So we know weight-bearing exercise is important because it provides natural stimulation to the bones. Bones are like muscles use it or lose it. Right, stimulate them, that gets them to increase their cell turnover and density. So there's a body of evidence on using whole body vibration and a lot of that research was done by NASA and a scientist named Clint Rubin. So astronauts lose about 2% of their bone density per month because they're not stimulating their bones, they're gravity. Post-menopausal women are losing 2% to 3% per year. So this was an urgent problem for astronauts and NASA studied use of whole body vibration platforms and they were effective for astronauts, whole body vibration platforms and they were effective for astronauts. And there are also further studies showing that whole body vibration platforms that are specifically, you know, designed and calibrated improve bone density. You know, in postmenopausal women, however, the very good whole body vibration platforms are quite expensive but, more importantly, the compliance has typically been low. Right, you have to stand there, you're not doing anything, are shock absorbers. It, you know, absorbs the vibration and then, frankly, you know, we're mostly vibrating our feet and lower legs, where the most serious fractures are hips and lumbar spine. So, that being said, there's good science behind them, but we had the idea of improving upon this research from a more practical and innovation standpoint.
Speaker 2:Our founder and inventor, dr Shane Mangrum, is a physical medicine and pain doctor. He was seeing all these patients with vertebral compression fractures. By the way, when we talk about little old ladies or we see that hunch kind of kyphotic posture that's typically from vertebral compression fractures, right, they didn't start little, they became little or they became little right and the front of the vertebrae collapses from, you know, weakness and that's what leads to this hunched over position. So, as you can imagine, it's very painful painful, and he didn't have a lot of solutions or treatments to offer his patients. He read up on the whole body vibration and had the idea of putting this vibration in a belt. Vibration is applied to the hips and lumbar spine and those are the most vulnerable and most important fracture sites. So hip fractures are deadly. Vertebral compression fractures are very, very painful and debilitating. We're really putting the treatment right where you need it and applying the vibration locally.
Speaker 2:The other thing is, because it's a belt, we consider it a wearable you can wear while you're doing other things. So in the pivotal trial, we asked patients you know, when did you use the belt, how did you use it? And it was, you know, walking the dog, doing dishes, cooking, brushing my teeth in the morning so they could incorporate it into their daily life. And this led to greater compliance. And in fact, we saw in the study that those who used it three times a week or more throughout the year, they were the ones that had this greater than 80% reduction in the loss of bone density. But we did see even a better effect for those who used it four and five times per week. As you would expect, and you know, treatments only work if you use them. So you know, we're not a lot of innovation or research that we've built upon, but we really want to take this and put it in a form that can get to tens of millions of patients, which is how many people need something like this.
Speaker 1:Wow.
Speaker 2:What really, really amazing work and what's the response been like in terms of feedback from users or health care providers physicians, friends, family very hard for several years and trials take a long time and the FDA process, but it's been worth it. We announced the FDA approval in January and since then we've had over 10,000 patients mostly patients, but also physicians and other healthcare providers on our waiting list. We just did a webinar for patients and I think we had 1,700 patients sign up to listen in. The most amazing thing is during the webinar, there were over 650 questions in the chat. Wow, oh wow, wow. People are really excited.
Speaker 2:Before we announced I was there a number of groups on Facebook, you know, osteoporosis education, osteoporosis exercise just as you'd expect for many diseases. And there's this one post someone wrote is you know when is someone going to do something new or try something new or reimagine? The field has become kind of dead right. There's no new drugs in late stage clinical trial. There's only two companies with branded drugs Amgen and Radius. Everything else is generic and Radius, everything else is generic Big Pharma, with the exception of Amgen, who I guess is Big Pharma.
Speaker 2:Radius is a relatively smaller pharma company, has abandoned this field and I don't know if it's that they just think that, oh, ladies, it's okay that they get frail and fracture, or that it's too hard, or the FDA sets the bar too high, the studies are too expensive. I'm not sure exactly why, but as a result there's really this hunger for something new, something non-pharmacological, something that has proven efficacy, and so we've been very gratified by the response. So now we're just working really hard to get the devices ready for the market. We've also recently acquired an osteoporosis exercise company called Wellin, and we are incorporating that into our solution. We have a companion app that goes with the belt. It also provides education, helps patients track their use of the device calcium consumption, nutrition, and now we'll also give them exercise guidance that is customized for their diagnosis and their level of fitness.
Speaker 3:That is very, very exciting, and isn't it interesting how women have traditionally been underrepresented in clinical trials for all kinds of drugs and devices, and it's so disheartening to see that such a huge numbers of people who will suffer from these preventable conditions related to osteopenia, osteoporosis, are not really being served by traditional pharma or even med device companies. So you want to respond to that.
Speaker 2:Here's an interesting statistic In the last 50 years we've reduced death from cardiovascular disease, I believe, over 60%. Oh wow, which is amazing. Right, we've reduced cancer deaths not as quickly, but we've made progress. Guess what?
Speaker 2:the death rate um guess what the death rate the death rate for hip fracture is unchanged in 50 years. One year mortality, all cause mortality, depending on you know which study you look at or which population it's. You know 20 to 30 percent and half of patients are who survive, lose independence right, and then the fracture rate. So there's the death rate from fracture, right, but the fracture rate itself it had been going down. I think it went down, you know, something like 10 or 15 percent when the medications were. You know fosamax was first released, um, the utilization the medicines has gone down because of concerns over side effects which you know, frankly, may be overblown.
Speaker 2:I'm personally not anti-medication. I think we want, you know, a multimodal approach. You know different combinations of interventions at different stages of disease. But despite what I think, stages of disease, but despite what I think, patients are not using them as kind of indicated for the guidelines, and so fracture rates have stopped declining and by some numbers are going up. So this condition stands really in contrast with a lot of the progress we've made, really, um, in contrast with a lot of the progress we've made, and I know it's. It's a difficult condition, um, but I also think we need to to change our mindset around, right, I think I see comments from patients that, well, osteoporosis is a natural part of aging.
Speaker 2:Well, that's certainly true. And heart attacks are a natural part of aging. Well, that's certainly true, and heart attacks are a natural part of aging and actual part of aging Right, and we don't accept those. Well, we, to a certain extent, we have to accept them, but we, we fight against them. I want our mindset to be that we fight against frailty and fracture. And you know, and I don't want to just live long, and I do want to live long if possible, but I want to live actively and strong and be able to do things right, and fractures really get in the way of that.
Speaker 3:Yeah, it's this whole contrast between lifespan and health span, and we certainly want to be able to continue to live vibrant, healthy lives and continue to contribute to society, family etc. So it should be a pretty understood goal to afford this opportunity to women and men, because this is not just a problem for women, although to a larger extent it's a problem for women.
Speaker 2:Yeah, and it does affect women more. So remember that curve we looked at. So the male curve essentially starts. It peaks higher. So men tend to have more bone density. So when they lose it they're losing from a higher place. Now, of course that's an average. So men can have low bone density at a younger position, but when they fracture they fare worse. So there's kind of a reverse discrimination. So there's kind of a reverse discrimination. Men are not screened as much as they should be for osteoporosis, so they're underdiagnosed and they're undertreated, more so even than women. So by now our FDA approval is for postmenopausal women. We started there not because we don't care about men, but we are just trying to kind of Pareto, optimize, you know, work our way down that curve of where the biggest need is, and we are very concerned about and interested in you know, researching our device for men as well, right.
Speaker 3:So speaking of research, and then also people wanting that new breakthrough technology to address an old problem, so let's talk a little bit more about this specific technology, this space age, space technology that is now being applied in real life through your device. Can you talk a little bit more about the science behind your device?
Speaker 2:Yes. So there have been people postulating, even hundreds of years ago, that could be therapeutic. So people notice things like riding in carriages over cobblestones. You know it gives you vibration that sometimes it would make them feel better. So there have been concepts, even before modern medicine, that maybe vibration is helpful. And so research, you know, began once we got it to the modern age, in animals, looking at a cellular level, what triggers them to strengthen and grow, and it was known that it's mechanical stimulation.
Speaker 2:When you remove mechanical stimulation, when you remove any force on the bone, they lose bone density. Even if you look at an athlete, like the famous example is a tennis player, the dominant hand has thicker, stronger bones than the non-dominant hand using it. So we know that bones, they're not static, they're not predetermined, completelyetermined, completely right. So you know your two arms would be the same, but if you're using one more, that that bone gets denser. And so then the question is what? We know that loss of bone density is such a serious issue. What can we do to essentially mimic right that mechanical stimulation of exercise and jumping and running and vibration essentially is a form of mechanical stimulation. And so then the research started in animals. It started, they researched sheep and rats and saw that it improved bone density. So there's all this precursor science and um, and, if you want to delve deep into that, one of the company founders, michael Jasma, who's our chief scientific officer. He literally did his PhD in how bone cells respond to vibration and mechanical simulation, so he's the go-to. I know what I know from listening, from listening to him, so I'm sort of channeling him right here. And then, you know, as we started to have astronauts being in space for a long time on, like on the space station, this became a critical problem for NASA, and NASA funded research on the whole body vibration platforms, and so this is actually on the space station, this image you're showing. And, as I said, that research showed that it, you know it had a positive result, right, it improved bone density, and so then the next step was okay if it works in astronauts.
Speaker 2:We have such a big problem here on earth with, you know, older adults and especially postmenopausal women and bone density. And so the research has been replicated and there've been many, many research projects on whole body vibration different forms, different strengths, different durations, and you know the. In the final analysis, it appears that you know a low frequency vibration like 30 hertz or 33 hertz, and a certain amount of force over with high frequency, in the sense of frequency of utilization so close to daily as possible, is what works. And that last point of utilization is kind of the gotcha Right. And so we've seen the studies on whole body vibration have been inconsistent. And that last point of utilization is kind of the gotcha, and so we've seen the studies on whole body vibration have been inconsistent.
Speaker 2:There are good results out there. We saw that possibility. But what our founder and Dr Jasmine observed was we know the mechanism works. How do we make it so that it works consistently in the most patients? And that's how we got to the idea of the belt. And, by the way, multiple form factors were tried and this was sort of Fantastic.
Speaker 1:Well, it's great to see space age technology on earth today. Another great uh, nasa uh, a spin-off, spin-out or or benefit of space technology right pens I'm sorry say it again the pens that
Speaker 1:run upside down, so dehydrate joke about. We joke about some of the moon landing benefits, but uh, they're real in terms of uh, so many innovations. Speaking of living in the future and futurism, I mean, what's next for you guys in terms of your roadmap or technology, anything you're excited about that you can share. You must have a lot going on behind the scenes.
Speaker 2:Sure. So top priority for us is, in a sense, is getting the current device out to patients. Now you may wonder OK, well, you did the pivotal trial, you should have them. So the devices were very effective in the pivotal trial, but that was, you know, 126 patients. So we needed, we wanted to make some essentially improvements based on things we learned in the trial and also put them in such a fashion that they would be easily manufacturable at scale.
Speaker 2:We were lucky to get a US government grant for that. By the way, I want to mention, we have gotten three NIH National Institute of Aging grants. So I don't know for today if it weren't for that. So the government recognizes how big a problem this is Right, and Medicare is paying for all these fractures. So getting the you know, scalable, improved belt on the market, the app I mentioned, we've built that. So that's pretty much done. We are going to integrate in this exercise program. We are going to integrate in this exercise program. So that's what the team is really focused on now.
Speaker 2:I talked about all the questions in the webinar. So the number one question was what about osteoporosis? Our pivotal trial was with postmenopausal women with osteopenia. We focused on osteopenia because, frankly, those patients don't have as many treatment options. Right, there's this very big unmet need. There's a lot of those. But we got a lot of questions about what if I already have osteoporosis? And you know the as a regulated class two device. The FDA is very specific. You can only claim what you research. So one could hypothesize if it works for osteopenia, it could work for osteoporosis, the whole body.
Speaker 2:Vibration platforms have worked for osteoporosis in addition to osteopenia. They've worked for men. They've worked with patients with cerebral palsy. They've worked in a lot of situations, but they're not a regulated class two device we are, and so next on our roadmap is where we want to do a pivotal trial so that we can you know, know with confidence, you know how well it works, safety and efficacy for osteoporosis. Also, for men, we have a lot of requests and there's a big unmet need for patients who are on aromatase inhibitors. So women breast cancer survivors if they had HR positive breast cancer they're typically medicines like letrozole which really cause rapid bone loss. Medicines like letrozole which really cause rapid bone loss. Men on androgen deprivation therapy for prostate cancer also typically have rapid bone loss.
Speaker 2:And you know they are often given medications. But you know the medications for osteoporosis they reduce fracture risk quite a lot. You know 50% or you know varies by medicine but it's not 100%. So you know we want to prevent even more fractures. So that's another area that we'd like to research is combining the device with medication treatments. So there's a lot of work to do.
Speaker 3:Indeed, very, very exciting. So, in wrapping up me being a woman of a certain age that is starting to really think about, you know, the premenopause and menopause and all the consequences of that coming. So, as a patient myself and also as a patient advocate, how can I advise people? How can this be prescribed to them? Is that now available? Do you just ask your doctor?
Speaker 2:Yeah, well, the first thing is to get a DEXA scan. So, um, you know, as you're going through menopause, you want to really know, I believe, where where your bone density is, so that you can intervene early if appropriate. Um, um, you know, over the last 15, 20 years, we've had a reduction in the use of HRT or menopause hormone therapy, which is its own controversial topic that I will not weigh in on. But okay.
Speaker 2:The fact that we have used hormone therapy much less means that there's earlier bone loss. In general, More women need this in their 50s than was the case, you know, maybe 30 years ago. So first step is to get a DEXA and see where your bone health is. If you have osteopenia and this is, you know, appropriate you will. It will be very easy. So your doctor can.
Speaker 2:We have an online pharmacy who will be dispensing. It's a prescription product, so we'll get dispensed by a pharmacy and you can either have your doctor prescribed through the electronic medical record, through fax, through phone, and we will be also deploying a telehealth solution so patients can get a prescription also through telehealth. We will be launching a pre-order program in about a month. So what people should do if they're interested is come to our website, osteoboostcom or bonehealthtechcom, and sign up. There's a notification list and that will, you know, get you in the know. You'll get invited to. If we do webinars. We'll be hosting a webinar for physicians, clinicians, probably in the next month, so we're doing that as well. We want to get the word out both to patients and to physicians.
Speaker 1:Well, thank you for the incredible mission and the work you and the team are doing and sharing this important story. We always hate to see our family members mothers, grandmothers, sisters suffering in this way, and so what an incredible advancement and opportunity for us all. Thanks for your time, Laura. Thanks for the work.
Speaker 3:Thanks for having me and thanks everyone for listening.
Speaker 1:And look forward to our next episode as well. Thanks everyone, take care.
Speaker 3:Thank you.