Laura Yecies 0:04
I'm really excited to share with you what we're building at Bone Health Technologies. Our goal is to help people not just live longer, but live stronger. And we're working on one of the biggest unsolved health conditions that exists today in public health that have low bone density. 64 million Americans suffer from low bone density, half of all women will fracture in their lifetime, due to low bone density. These are millions of fractures per year, a million spine fractures alone. And by the way, when men are not exempt, either one in four men will fracture. These fractures are very expensive. This is a nearly $50 billion expense in terms of direct expenses, not to mention all the nursing home costs, and it's also deadly hip fractures. Over 20% of people don't survive a year after a hip fracture. And the vertebral compression fractures yield that kyphotic hunched over position that we're all familiar with. Really, it's something that we want to avoid. And early like many chronic conditions, early intervention is critical. You start with normal bone, peak bone density in your 30s. And then in the menopausal period, most women will develop osteopenia. 52 million people in the US have osteopenia 12 million with osteoporosis. But actually most of the fractures happen in the osteopenic population, because it's so large. And before before bone before asked you this, there were no FDA approved treatments for osteopenia. There's no equivalent to a statin or you know, beta blocker, no early intervention that you could use, pharmacological treatments are for osteoporosis, and even then only 6% of patients are willing to use them due to side effects, like the one we see over on the right supplements. Really only helpful if you're deficient. taking extra doesn't help lifestyle interventions are really not enough to move the needle. Fortunately, there's a body of evidence from NASA showing that whole body vibration platforms can improve bone density, but they never got good enough adherence or an FDA clearance. But what we did is take this specific vibration mechanism that was proven, put it in a patented proprietary form factor, and lips. And now we have something that is easy for patients to use and comfortable. I call the ultimate habit stack because you can wear the belt while you're doing your chores while you're taking the dog for a walk. It feels good. Patients say it feels like a massage we had over 80% compliance in our pivotal trial. And we now have it accompanied by an app to further help with compliance, nutrition and exercise. And the most important thing is that it works. In fact, this was a homerun we reduced the loss of bone strength and bone density as measured by CT scan so highly objective endpoint by well over 80%. Our patients were clinically stable, the sham group lost practically 3% per year of their bone density. We also saw other structural improvements in the bone such as increased cortical thickness, which is really important for fracture prevention. And based on that we have achieved the first ever FDA approved prescription device for bone density, there's never been a non pharmacological treatment approved for bone density. It's also the first ever prescription treatment for osteopenia, the first proven safe and effective early intervention. Now we're not stopping at just the device and the app. There's no comprehensive solution for bone density, there's no Livongo out there for bone density, we're going to be providing that we're going to wrap the device and app with telehealth fall risk assessments. We have multiple accelerometers on the belt so we can see what people's balance is like if you can prevent falls. That's another way to prevent fractures. And so that's an important part of what we're doing. And our goal is to really head off this descent into osteoporosis. Looking at the commercial opportunity, while with 64 million patients, it's a big opportunity. We estimate over 30 billion in the US alone. And now is the time. There's a lot of attention to menopause. There's a lot of attention to this demographic of postmenopausal women. I like to call them primetime women as a personal member of the demographic. There's now even celebrities Gwyneth Paltrow is osteopenia. Emma Stone has had nine fractures she talked about on The Tonight Show. These women are searching for non pharmacological solutions. And guess what they're finding our website we have 8000 patients signed up on a waiting list demanding treatments. We have P people showing up at our co working space looking to buy belts, they really want a safe and effective solution, we can reach them very efficiently. And so to quickly get the business started, we're going to make it available, they can upload their prescription from their doctor or upload their T scores, and we can get them a telehealth prescription. But we want to provide a comprehensive solution to all patients. We know many patients have a personal relationship with their physician, we're going to work with our physicians as well. And the physicians are also coming to us we have 800 Doctors signed up on our waiting list, doctors don't sign up in a lot of lists. This is because they know that their patients are going to fracture and do poorly and that they want to prevent this. We did a survey as part of our FDA submission. And we saw 84% of doctors said that they would prescribe we're being invited to the top bone conferences to present our results. We have a path for reimbursement immediately through remote therapeutic monitoring device doesn't cost very much to build. And at $106 a month, we will be providing the telehealth monitoring service not counting on the patient's physician who's busy. And we can do this where this is profitable. After three months, we're also applying for DME we would be a new code. And if someone doesn't want to participate in our care program, they can get the device covered. We believe nearly immediately with commercial and within a year or two for Medicare. And we have a broad and bold vision to end the problem of osteoporosis. We're starting with the largest market postmenopausal women with osteopenia, but the mechanism of action has been proven broadly. We want to bring this to men to patients on chemotherapy adjunctive with medicine, and then of course, not just the vibration intervention but a comprehensive solution. We have a strong team. I've sold to companies and had been in tech and med tech. We have an experienced CMO, head of marketing and engineering. But I'm also particularly proud of the fact that we have the top Kol is in the Osteoporosis community working on our trials and advising the company. And why is this as a small startup, because there's no pharmacological treatments in clinical trials right now, other than what we're doing, the field is dead. And so these Kay wells are so excited to see that we are coming up with a safe and effective intervention. We're raising a commercialization round right now. This is focused on manufacturing, of course sales and marketing. We have raised in our history, seven and a half million to get to this FDA clearance point in time. And part of that is because we've gotten almost $5 million in government grants. We have strong investors that have worked with us so far, some small VCs and angels, also Terumo medical company was Truman, medical invested in our last round. Japan has the highest rate of osteoporosis in the world. That could be a whole separate presentation. And so we're prioritizing entering that market, likely with them. And like I said, it's the only FDA approved non pharmacological treatment. We have immediate reimbursement, demonstrated demand. We've been very capital efficient. I think there's very attractive exit opportunities. In both medical device acquires women's health, pharma and digital health acquires and I would love to have you as partners as we are on this important journey. Thank you
© 2024 Life Science Intelligence, Inc., All Rights Reserved.
