Bone Health Technologies | Laura Yecies, CEO

Laura Yecies  0:00  
Thanks, everyone. I'm excited to be here and share with you what we're working on at Bone Health Technologies. We are on a mission to change the trajectory of osteoporosis and loss of bone density that affects almost all of us at some point in our life. In fact, 64 million Americans suffer from low bone density, more women will have a fracture from osteoporosis then heart attack, stroke and breast cancer combined. So this is half of all women and one in four men. Hip fractures are very serious, 25% don't survive a year and half of all people who have a hip fracture, lose their independence. And the reason for this is bone density declines are essentially a challenge of aging. Our bone density peaks in our 30s, the average American woman gets osteopenia at 58, and osteoporosis at 68. And with with that loss of bone density comes the higher risk of fracture. This is an enormous market, the osteopenia market in the US alone is estimated at over $20 billion. And once you look at all of the bone density issues globally, it's clearly at least $100 billion market. And what's interesting is that, you know, these numbers are persisting, despite the fact that there has been medications for over 20 years. They're all generic, the problem is no one takes them. Fewer than 10% of patients who qualify for osteoporosis medications, even if a fractured will take these medicines, because the side effect profile really contains very serious risks. This picture is an atypical femur fracture, you're not supposed to fracture your femur. And that's something that can happen from the medications. There's no safe early intervention for loss of bone density like there are for some of the other conditions. One of the few things that we know works is high impact exercise. Except most of the people who have this condition probably can or won't do that. We are focusing our efforts initially on the osteopenia market, the largest market over 50 million patients. But our vision is to start early with prevention and treat patients throughout the course of this disease. Fortunately, NASA invested in research on loss of bone density because astronauts lose bone density and space. And what they proved is that whole body vibration platforms do improve bone density. And what we've done is taken that specified, all the you know, the exact type of vibration that was proven by NASA and put it in a convenient form factor, which is the belt, the vibration is applied to the hip and lumbar spine, the places where you have the most frequent and serious fractures. It's a connected platform. So we will have an app that will encourage compliance as well as help patients with all the other lifestyle factors to optimize their bone density. We've we're in the middle of our pivotal trial. But we've been able to do an interim analysis of our data which show which is showing that we're meeting our endpoints or on track to meet our endpoints with improvements in both hip bone density as well as vertebral strength. Essentially, we're cutting in half the loss of bone density over time, and similarly reducing fracture risk. Our regulatory path has been de risked through pre submissions, we've achieved breakthrough device status. And as I mentioned, we're on track to meet our endpoints. I talked about the comprehensive application, which will have compliance community, as well as exercise and nutrition.

So we are aiming to change the trajectory of bone health. What you see here is that same chart that we looked at a couple of minutes ago, where rather than on the original curve, we are cutting that decline in half, and essentially allowing us to not outlive our bones. Using the device for 10 years would delay the onset of osteoporosis by over 20 years. And for every 1% improvement in bone density, the reduction of fracture risk is double that. And so you know it can have a very dramatic impact in 10 years cutting your fracture risk by 30% or more. It's also fractures are expensive. The average fracture costs over $56,000. And that's just the medical cost. It does not include loss of independence, nursing homes and things like that. With the our plan pricing of the device at just under $1,000 If someone is able to use the device for 10 years improve their bone density by 15% and cut their fracture risk that puts a 20 to 40 times ROI on use of this device and we are aiming by pricing it this way we are aiming to address is a broad segment of the market. It's a patient driven model. Patients are seeking out non pharma effective and safe solutions. They'll be able to get a prescription from their personal doctor or hop on a quick telehealth call to quickly get the device. The model, the economic model, as I've mentioned before, is attractive, very high ROI. And we believe that we can achieve our first three years of revenue forecasts based on self pay. But I think that, given the ROI, the opportunity for reimbursement is very strong. And then finally, we'll be collecting data, patients will be inputting their DEXA scan, and other bone turnover market data. This will be a unique longitudinal database of bone health. We have a strong team. My background is 25 years in tech the last five years in health tech, our CSO literally got his PhD in bone health biomechanics and using vibration to improve bone health. And we have a strong team, an engineering, marketing and clinical. And I also want to point out that we have put together an incredibly strong set of clinical advisors, Dr. Rosen and Karp, respectively run the Osteoporosis centers at Harvard and Stanford, Dr. Karp did the first clinical trial for Fosamax and we're about to launch a clinical trial at UCSF with Dr. Shoback and Schaffer. They are the most published doctors in the Osteoporosis field right now and our pivotal trials taking place at University of Nebraska, with Dr. Bilek as the PI. She's an expert in the use of exercise, which is essentially what our device mimics to reduce osteoporosis. We've gotten a lot of recognition for our work, and most importantly, over $4.7 million of SBIR grants, the government has noticed that this is an expensive and important problem, as well as other recognition by number of competitions. We've raised 4.7 5 million to date. And right now we're raising another 2 million series A2, which is being led by a strategic investor out of Japan. If this is something that's of interest, please see me afterwards. In summary, this is an enormous market with very high unmet need. Over 64 million Americans suffer from this condition. The interim data in our pivotal trial is excellent. The endpoints are on track, were the results are on track with our endpoint, which had been pre agreed to with the FDA. We have a proven management team with the right experience set and it's a very capital efficient company based on being able to leverage all the SBIR grants. Thank you very much.