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Laura Yecies, Bone Health Technologies - Wearable Belt to Reduce Bone Loss | LSI Europe '22

Speakers

Laura Yecies

Laura Yecies

CEO, Bone Health Technology
Read Biography
Bone Health Technologies is developing OsteoBoost, a wearable belt that applies mechanical stimulation to the user in order to reduce bone loss and encourage bone growth in the hips and spine.

Transcription

Laura Yecies  0:06  

Good morning. Thanks for being here. I'm really excited to tell you about what we're doing at Bone Health Technologies. We are passionate about solving the problem of osteoporosis, which is one of the biggest public health problems we face as a society today. 64 million Americans have low bone density, that's either osteopenia or osteoporosis. In Europe, the number is actually over 100, over 100 million people, half of all women will have a fracture from osteoporosis hit. That's higher than heart attack, stroke and breast cancer combined. How many of you saw the pictures of the Queen lately? Right? You saw her with you know, the Prime Minister, did you notice what happened? She shrunk, right? I can't afford to shrink, we need this product to work. But No, but seriously. Vertebral fractures are extremely common. And that leads to that loss of stature hunched over tremendous amounts of pain. Hip fractures are deadly. More than 20% of patients don't survive a year. And by the way, this is not just a problem for women, one in four men will have an osteoporotic fracture as well. And this is essentially because Osteoporosis is a disease of aging, it's a disease of luck and exercise, poor diet, and by the time they reach their late 50s, most women have osteopenia, or the average and late 60s, the average woman has osteoporosis, men get it as well, but you know, 10 to 15 years later, and that means this very heightened risk of fracture. And actually most of the fractures happen in the osteopenia stage, the rate is lower, but the n is so high that we're seeing a lot of fractures there. And this is despite the fact that we've had medication treatments since essentially the year 2000, but due to side effects, very few women are willing to take them unfortunately, supplements are there's just the New England Journal of Medicine study vitamin D, bit the dust excess calcium, if you go beyond the RDA, doesn't help but does help as I high impact exercise. But many of the target patients truly can't or won't do that. In fact, this is really reached a crisis point. This is the rate of osteoporosis treatment initiation. And with the aging population and low rates of treatment, where there's an expectation that hip fractures are going to double in the next 30 years. Fortunately, there is a solution. I mentioned before that high impact exercise does work. So NASA paid for a significant amount of research on whole body vibration, and that showed that you could improve bone density for those who are compliant astronauts lose a tremendous amount of bone density and space. And they were the original subjects for this experiment or series of experiments. Unfortunately, if you don't comply, and it's difficult to comply, it doesn't work. And so this has led to the innovation of Ostia boost, where we've put this proven mechanism of action, the mechanical vibration and put it in a belt form factor, which is easy to wear 30 minutes a day, you can wear it while you're doing the dishes or going for a walk. And the vibration also targets the most vulnerable part of the anatomy, the hips and lumbar spine, which is where there are so many of those fractures we were talking about before. We're doing we just completed our pivotal study, we've seen the interim analysis, and the results are excellent. We're seeing improvement in hip bone density as well as our timbral strength, we are cutting the rate of bone loss in half. And for every 1% improvement in bone density, you have a two to 8% reduction in fracture probability. Our regulatory pathway has been de-risked and accelerated, we've received breakthrough device status. All of our endpoints have been agreed to through a pre submission process. And in the interim data we saw, essentially we're on track to meet both our primary and secondary effectiveness endpoints. We're building an entire connected health platform to help people not only use the device but have optimum nutrition and exercise so that they have the best possibility to improve their bone health and as we do this, we will be building the largest longitudinal database of bone health data. You know, there are no new drug agents and late stage clinical trials. The pharma industry has not entirely but mostly given up on this. It is a greenfield for a non pharmacological device approach. So our strategy is just target osteopenia, first or indication for use as postmenopausal women with osteopenia Yeah, they'll get the device, they'll get the comprehensive platform for nutrition and exercise, diagnostics and telehealth prescribing will be an option in addition to getting prescriptions from their primary care doctor, as I mentioned, it's class or didn't mention class 2 prescription device. And I fully expect that we're going to see a lot of patients also with osteoporosis who are highly motivated to use this solution. And so what is that reduction in decline or that one or two or 3% improvement mean? It means that we can be on the top orange curve, or if someone starts when they use osteopenia, they'll be on the second orange curve. So essentially, we won't live out outlive our bones, right, we can slow the rate of loss, keep enough bone density, you know, 10, 15 20% improvement in bone density could be dramatic in terms of people's likelihood of fracture, and health and wellness. This is also going to be economically I think, very beneficial. fractures are expensive. Just the hospital costs alone for hip fractures, over $50,000. Half of those patients lose independence if they survive. So we're talking years of nursing home care, and the device will be will be priced at such a point that we're looking at a very, very attractive 20 to 40 times ROI. We have a strong team of people with expertise in medical devices clinical regulatory manufacturing, marketing. My background is the last seven years in health tech, but before that in software commercialization. This is my third role as CEO. My first two companies exited the second one was acquired by Apple, and I'm especially proud of the scientific advisors who have gathered around us to support us. Dr. Rosen heads the Osteoporosis clinic at Harvard, David Karp heads the Osteoporosis clinic at Stanford, he led the first clinical trial for Folsom exit Merck, Delores shoberg is RPI for our follow on study at UCSF. She's the most published researcher on osteoporosis in the US. Dr. Bielek is an expert in exercise for osteoporosis. People have asked me how did you get these people to work with your company? It's because they don't have a good solution. Right now. The field is not successful right now in treating osteoporosis as a whole. They recognize that new options are needed. The progress that we've made has been recognized. We've won multiple entrepreneurship competitions. And I'm especially proud of the fact that we've received almost $5 million in SBIR grants. The government is mostly paying for these fractures. They see this as a huge public health problem. And that's also why we've gotten breakthrough device status. We have great investors who have supported us. We've been very capital efficient. We've gotten this far with about four and three quarters million of equity and convertible notes. And we now have a follow on funding of 2 million that we're looking to raise led by a major strategic out of Japan. So in summary, this is an enormous market with very high unmet need. And just a tremendous amount of demand. We have 1000s of people on our waiting list and we've done no marketing. Our pivotal trial data is looking excellent. The endpoints agree with our FDA submission. We have a proven management team. We're very capital efficient. And most importantly, we are working on an unsolved problem that where there's tremendous patient interest patient demand, and I think we have an opportunity to make a big difference in their lives. Thank you very much.

 

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