Medsider: Learn from Medtech and Healthtech Founders and CEOs - Regulatory Rigor as a Competitive Moat: Interview with Osteoboost CEO Laura Yecies

Episode Date: April 6, 2026

In this episode of Medsider Radio, we sat down with Laura Yecies, CEO of Osteoboost.Osteoboost is the first FDA-cleared drug-free prescription treatment for osteopenia in postmenopausal women.Laura brings over 30 years of experience across technology, digital health, and medical innovation, with a focus on overlooked gaps in women's health. She previously served as CEO of SugarSync (acquired by J2 Global), Catchsold (sold to Apple), and Neurosync, a neurotechnology company. In this interview, Laura discusses why choosing a Class II prescription path creates a regulatory moat, how designing for daily comfort and a frictionless experience drives commercialization, and how channeling early patient demand turned a waitlist into a launch strategy.Before we dive into the discussion, I wanted to mention a few things:First, if you’re into learning from medical device founders and CEOs and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you’re ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Laura Yecies.KEY MOMENTS FROM THE INTERVIEW(02:49) - An overview of Laura’s background and her transition from consumer tech to medtech (04:53) - The problem Osteoboost is solving — and why bone health remains a massive unmet need (08:31) - How Osteoboost designed its device with the consumer experience in mind (15:44) - Why Osteoboost chose a Class II regulatory pathway over an easier path (19:50) - How to design clinical trials that reflect real-world use and drive patient compliance (25:01) - How early demand and a waitlist validated strong consumer pull before full commercialization (28:48) - Why Laura believed the problem wasn’t demand — it was lack of options (33:57) - How patients can become a powerful “sales force” in healthcare (38:20) - Why shifting consumer behavior is making self-pay more viable — with reimbursement coming later

We had excellent compliance in our pivotal trial. It's 30 minutes a day. Most patients find that it actually feels good. It feels kind of like the massage. And you can wear it while, you know, you're walking the dog or chopping vegetables in the kitchen. I use it. I have a standing desk. I tend to use it at my standing desk.

So no medical treatment works if you don't use it. And we found that our patients were very successful in using the device. Welcome to MedSider, where you can learn from the brightest founders and CEOs in medical devices and health technology. Join tens of thousands of ambitious doers as we unpack the insights, tactics, and secrets behind the most successful life science startups in the world. Now, here's your host, Scott Nelson. Hey, everyone, in this episode of MedSider, I sat down with Laura Yisi's CEO of Osteo Boost. Osteo Boost is the first FDA-clear drug-free prescription treatment for osteopenia and postmenopausal women. Laura brings over 30 years of experience across technology, digital health, and medical innovation with a focus on overlooked gaps in women's health.

She previously served as CEO of Sugar Sink, which was acquired by J2 Global, Katch, which sold to Apple, and Neurosync, a Neurotechnology company. Here are a few topics we explored in this conversation. First, how do you decide when a more rigorous regulatory path is worth pursuing? second, how do you make a prescription device as easy to access as a consumer product? Third, what should drive form factor decisions when daily unsupervised use is the goal. And last, how do you turn early patient demand into a physician adoption strategy? Before we dive into the full episode, if you're a MedTech founder or CEO preparing to raise capital, you should check out the MedSiter fundraising cohort.

This four-week live workshop combines small group sessions with real-time feedback to help you sharpen your investor story, build a targeted investor pipeline, and run a focus. fundraising sprint instead of a never-ending slog. Over the month, you'll walk away with an investor-ready narrative in deck, outreach scripts that actually get responses, a refreshed LinkedIn profile, a simple content plan that keeps you on investors' radar, and a repeatable system for running your raise. You can join the waitlist at medsider.com forward slash fundraising cohort. Again, that's medsider.com forward slash fundraising cohort. All right, let's get to the interview. All right, Laura, welcome back to MedSetter Radio.

Thanks, Scott. Glad to be here. I always like repeat guests. So good to have a round two. We can get caught up on the latest with osteobo boost. So with that said, for those that didn't listen to the first interview we did, gosh, it was probably four or five years ago now. Give us a one minute, two minute kind of elevator pitch on your career leading up to kind of

where you're at with osteo boost. So I had a career in tech, enterprise, and consumer software, starting in 19. 1988, worked in the database business, and then I led the Netscape Browser Division. I led Yahoo Mail, and then was CEO of two tech startups, both of which exited. SugarSink was acquired by J2 Global and a company Catch. I sold to Apple. At that time, the catch team became essentially the leadership of the Apple Watch team, and we had this vision around, frankly, consumer health and wearables. And so that's what I decided to focus on. And I've been doing that for, I guess, the last eight years, focusing on health care. And I joined Osteo Boost five and a half years ago.

The company was in the beginning of its clinical trial, the pivotal trial for the device. I was the first employee of the company that the corporate structure existed. We spun out of an incubator. And so I wrapped up the trial. We used. He analyzed the data, which was very compelling. Submitted, we also got a breakthrough designation along the way there. We submitted to FDA in 23 and got a de novo clearance in 2024. We launched the product after we built the commercial version in 25. And here we are.

We're kind of off to the races. Thousands of patients have osteo boosts. That's awesome. Always love to see the success of a, burgeoning kind of med tech startup, especially when there's like a, I would say, more of a consumer sort of bent. These stories are especially interesting, I think, considering sort of the groundswell movement amongst, of wellness, kind of amongst most folks these days, at least here in the U.S. So with that said, osteobo boost. I'm looking at the website now, osteoboost.com,

just as it sounds, osteo, and then boost. Give us a sense for kind of what the product is, for those that have never seen it, haven't hit your website yet. What are you solving for? Yeah. So we are working on a huge problem. In fact, you know, one of the biggest public health issues that we face as a country and that, you know, low bone density. So 60 million Americans suffer from either osteopheny or osteoporosis.

So those numbers are similar to, you know, high blood pressure, high cholesterol, diabetes. And it's similar also in that it's a chronic condition, something that worsens with age. and as you lose bone density, you become at greater risk of fracture. And that's really, you know, what we're concerned about because these fractures can be life-ending or life-altering. So, you know, about 30% of people who have an osteoporotic hip fracture will not survive a year, half-lose their independence. Vertibral compression fractures are the most common osteoporic fracture. when we see older people hunched over significant loss of height, which of course is very common, that's those vertebral compression fractures and there's no great treatments for them.

And so we see this problem and it's a problem where we've made minimal progress. So, you know, in the last 60 years we've had these dramatic improvements in, you know, reduction in cardiovascular disease, pretty significant, you know, improvements in death from breast cancer. from hip fracture, minimal change. The death rate from hip fracture hasn't changed much and the fracture rate has not changed much. So our goal, as you can imagine, is to change this. And the approach that we're taking is really very novel. So the standard of care prior to osteobuse was, you know, we know that women are losing

bone density, but we don't really check how much unless something dramatic happens. And so at 65, we do a dexas scan. We find out maybe that you already have osteoporosis or that you're close. And then typically, you know, a few years later, we'll recommend a bisphosphonate drug. Phosphamax, you know, is the brand name, you know, of the most commonly used one. And use those for sort of three to five years. And, you know, the result is we haven't had much change. And yet it's a chronic condition.

So our belief is that we should be checking early, intervening early, and then providing a comprehensive solution. And so the core of our offering is the osteobo boost device. And it is the first and only non-drug treatment for bone density that has been approved by the FDA. We got a de novo approval and I'm super proud of that. We were the 14th ever de novo. in the orthopedic division. It's very, very rare for startup companies to get Genovo's because the process is just so difficult and rigorous. The approval rate is much lower than 510Ks. But, you know, we were able to accomplish that. And our, what we showed, we did a gold standard randomized control trial. And what we demonstrated is that we reduce bone loss by over 85% grade

statistical significance. This was over one year measured by CT scan, so a highly, you know, accurate endpoint. And that's for women who used it three times a week or more. If you used it, you know, five times a week, your results were even better. And so we did see about 30% of women gain bone. Those are the kind of the highlights. That's the device. And this is a wearable, right? So I definitely curious people to check out the website, osteoboose.com. But I mean, this is like, it looks like, it looks like something that goes around the waist. I mean, almost like I wouldn't even know it was a device if I kind of saw someone out walking with it as an example. Correct. So it is wearable. And the mechanism of action is vibration. And it's actually a precision vibration.

So NASA, you know, the inspiration for this technology was NASA funded research on using vibration to maintain bone density for astronauts who are in space for a long time. They lose a lot of bone. They used whole body vibration platforms. And, you know, the data there was very promising, but none of those devices on earth with regular people were able to achieve good enough results to get a class two device clearance, but the science was promising. And so our founder, who is a physical medicine and pain doctor, Dr. Shane Mangram out of

Atlanta, he saw, you know, all these women with vertebral compression fractures, terrible pain and he had the idea of taking this vibration mechanism and putting it in a wearable. And the belt form factor gives you two really important benefits. One is that the vibration is applied to the vulnerable anatomy, the hips and lumbar spine. So we know that, you know, we're getting the vibration where it's needed. If you think about a whole body vibration platform, you're standing on it. You get most of the vibration in your feet. and it dissipates as it goes up the skeleton. In fact, your knees are designed as shock absorbers to absorb things like vibration. So we're applying it to the hips and spine. We have a lot of

technology built into the belt, pressure sensors accelerometers to make sure that the vibration is actually transmitted through the skeleton. So for instance, we have a patented system where there's an accelerometer in the back, one over the hip bone, the Iliac crest. We measure the transmitted vibration, and then there's like a closed loop dosing system to optimize the vibration. And then additionally, you know, and this is easy to understand. As a wearable, you can do the treatment very regularly. So we had excellent compliance in our pivotal trial. You know, it's 30 minutes a day. Most patients find that it actually feels good. It feels kind of like a massage. And you can wear it well, you know, you're walking the dog or chopping vegetables in the kitchen or like I use it.

I have a standing desk. I tend to use it at my standing desk. So no medical treatment works if you don't use it. And we found that our patients were very successful in using the device. I presume that the distance from the vibration does impact efficacy, right? So like as an example, say I wanted to specifically target an elbow. I'm just throwing out like a man. Don't treat the elbow.

Got it. There will be osteobo boost arm or osteoboose, you know, ankle. So the mechanism we've demonstrated it works. We could do future devices. You know, wrist fractures are very common, right? You know, we could, I think, do a device for the wrist. So, but we're starting with this part of the body that has the most serious fractures and the most common fractures.

So hip fractures, like I said, you know, can be a sentinel then. to changing or ending someone's life. And the vertebral compression fractures, you know, there's just not great treatments. You can do kipoplasti and open up the vertebrae to relieve pain, but then you're risking the adjacent vertebrae because that vertebrae becomes stiff. So those are not that commonly done. And so people just fracture. And, you know, I hear about women who have had 12 compression fractures. And so you fracture the front of the vertebrae, right? That's the most common. And then think about the physics that you have that wedge fracture and then you're leaning forward. And then you're putting more pressure on the front of the skeleton and you get more fractures.

And then, you know, we've all seen people with, you know, very serious kiposis. So that's what we really want to avoid. We really want to avoid virtual real compression fractures. You know, the wrist fractures, they're terribly inconvenient and painful, but actually people tend to recover well. So that's why we prioritized. Makes sense where you start. Yeah, you started sort of the core, if you will. And if I'm a patient learning about this for the first time, I've obviously mentioned

your website, but is that the best place to sort of like get access? I mean, is it cash pay? Is it covered by insurance? Tell us a little bit about sort of the pathway. It's a prescription device. Okay. But we have a very consumer-friendly way to get it. So you come to our website.

You can order it. It is today still self-pay. we're working on insurance, but we don't have reimbursement yet. But you can use your FSA and HSA account. You go through the process, and then at the end it will say, okay, you need to submit a prescription. And there's kind of two ways you can do that. You can go to your personal physician,

and they can order it through their EMR or they can fax or call in. We have a single online pharmacy health warehouse that will ship then directly to the patient. So once you get your prescription in, you've ordered, we ship the device to you. We also have a telehealth option, which is super easy. You know, online, you answer some questions and you can get your prescription that way. And, you know, we also have the traditional mechanism. You know, patient might go to their doctor. The doctor says, oh, you have osteopenia. You know, I want you to, you know, start with proactive intervention here. I recommend osteobo boost, you know, and then they just go ahead in order.

Got it. That makes sense. And before we kind of go back in time and learn a little bit more about, you know, some of the insights, right, that you've gleaned over the past handful of years, you mentioned the launch, the full launch, the full commercial launch in 2025. So are you currently focused on the U.S.? Is this a global launch? Give us sense to kind of where the company's at as of, you know, Q1 of 2006 here. We have only sold in the U.S. so far. We have tremendous demand overseas. And that's one of, you know, our objectives is to, to put the infrastructure in place for that. Particularly Asia has high rates of osteoporosis. Japan has the highest rate in the world. And Asians tend to have lower bone density and more side effects from the bisphosphonates. But of course, Europe, Australia, Canada.

So, you know, that is ahead of us and something that we're excited to do in the future. Sounds good. Again, everyone listening, osteoboost.com is the website. Really cool technology. With that said, Lord, let's spend the next maybe 20, 30 minutes covering some kind of some key functional areas, you know, based on kind of the consumer bent, right? The patient first kind of bent here with your technology.

I think we'll hit on some interesting areas for sure. But let's start out with reg and clinical. Our notes, you know, mentioned that the breakthrough designation was 2020. Feel free to correct me if I'm wrong here. I think you were starting to collect clinical data, you know, even just a couple of years later after that, 2022 timeframe. and then clearance was early 24. Is that sound about right?

Exactly. Yeah. And then the de novo, of course, right? What you mentioned is there's not too many de novo's in the orthopedic world it sounds like. So with that said, like when you think about kind of the Red Cling journey over the past, you know, a handful of years here, are there a couple of things that really stand out that you think would be helpful for other med tech, you know, founders and CEOs to learn from

your experiences? The first thing to consider is class two or class one. right? And we made a decision to go down a class two prescription path. And I often get questions, why did we do that? Because the device is very, very safe. You know, you can find vibration belts that are not medical devices. And that was a very deliberate decision. And the reason why we made this decision is we wanted to be able to really partner with doctors, be able to make medical claims, even though the treatment is low risk, the disease is serious, right? The impact or fracture we talked about before. And so we wanted to be able to tell patients this important condition,

here's how we treat it. We want you to get assessed before, right? So get the Dexas scan. So you can be monitoring this. So it really reflects the seriousness with which we view this condition. And, you know, We think that being able to know exactly, you know, how effective it is, how it's working is important for patients and for us. So that was a big decision that we made. And I don't regret that at all because it's not only the money. Of course, before they invest that money, but they're investing the time, right? So you want to spend the time on something that you know has scientific data behind it. And then, you know, there was a lot of sort of interesting, you know, decisions around how to conduct the study, right?

How do you have, you know, a true sham controlled or placebo controlled study? And so we told patients that it was gentle energy. And even the people who are administering the trial and giving the devices to patients didn't know if they got active or sham. And the sham device emitted sort of a, you know, electric sound, like a static sound. So we knew that we were very well blinded. We also put a lot of thought into compliance. So of course, the design of the device, so it's comfortable and easy to use, but then also, you know, some reminders and things like that. We really wanted to replicate the real world use. And, you know, interestingly, if this was during COVID. And so patients were doing

this at home, they were not going very often into the clinic, of course, for their dexes and CT scans and blood work, but they were able to use the device independently and successfully. And what was the size of the trial again? 126. Okay, 126 patients. Yeah. And you said it was randomized. It was randomized postmenopausal women with osteopenia and, yeah, half active, half sham. Like I said, we had very good compliance in the trial. It was conducted. at University of Nebraska Medical Center.

And the principal investigator, Dr. Laura Beulik, was a dean of the PT school there. So she is a PhD in physical therapy and is an expert in the use of exercise to treat osteoporosis. And if you think about it, the mechanism of action here were essentially mimicking exercise. And so, you know, she really had, you know, a great expertise for this. And for other CEOs that are developing a device that's used outside of the clinic, right, outside of the hospital, whether it's a wearable or something else, but they're interested in running a robust clinical trial like you did. Any other things that kind of came up through your experience? Because this is unique in the sense that you ran, you know, a full RCT, you know, with a really solid number of participants. So I'm sure there's probably some interesting things learned, but anything else that you can think of?

So Nebraska was an excellent site. As I mentioned, you know, the investigator was terrific. But it did take us a while to enroll. So it would have been great maybe to be able to enroll faster. Maybe two sites would have helped. That being said, we're a really small company. And we wanted to, you know, be pretty strict on budget learnings. Yeah. Did you leverage a CRO? Did you, did you largely run it in-house? We ran it in-house. We used some consultants who, had expertise, but not a CRO firm. So, you know, our director of clinical operations is a career, you know, clinical trial person. So she had tremendous expertise, but she was an independent consultant. And then, you know, we did, we did a lot in-house. Do you think that was advantageous to kind of keep, keep that functional function, that clinical function in-house versus, you know, because I think that's a question that most of us face running a startup is do you, do you keep the internal team relatively small and leverage a CRO or do you, you know, do you kind of run with the opposite approach, right, where you try to build out that, that expertise internally? So would you do it again?

We did option three, small internal team and not use the CRO. Yeah, I guess there's a hybrid, a little bit of a hybrid. The one thing I wonder, I mean, it worked out well, right? The study in the end had a great result. We did it efficiently from a cost point of view. Could we have moved faster if we had put more resources to bear and then perhaps actually spent less money because time is money. I don't know the answer to that. I do wonder, we don't have a RCT on that. But that's in hindsight a tradeoff I think about. Yeah.

Since the data read out in October of 22, we submitted to FDA in February of 23. if we did like spent more money during that time, right, with more resources? Could we have submitted faster? I don't know. Maybe that's actually a reasonable amount of time. So these are things I wonder, but, you know, in the end, I think the study was well run. Our PI, you know, had done studies, different kinds of studies, but studies that were relevant. And we brought in individuals with that expertise.

Yeah. Yeah. Well, you end up with some what sounds like some pretty, really. some really solid data and ultimately what matters, right, which is a de novo a de novo clearance, right? So congrats to you and your team. I would presume that that path, right, to pursue class two with this de novo probably presents sort of a moat, right, for the company, for the device specifically, right? And just, yeah, I would imagine. Yeah, I mean, hard things give you some moat, right? I mean, I assume at some point we'll talk about investments.

you know, when you are doing hardware that reduces the pool of potential investors, right, because hardware is hard and there are costs to that. But then it's more patentable and you can build a stronger moat. And part of our mode is the regulatory strategy. So if you look at the special controls from our approval, anyone who wants to use us as a predicate, they actually have to run a one-year RCT. Now, that's significant. And the reason for that is, I think, kind of straightforward, which is, you know, most vibration

devices have not had good enough data. And ours was done in a thoughtful way with using the science, the, you know, what was proven in the science and the application in a way that we know that works. And we have patented features such as the calibration that I spoke about before, which is why it works, right? So we, we are ensuring in the way we design the product and the way patients use it, that critical mechanism of the 30 Hertz, 0.3G of force is getting to the bones that we want to treat. You know, if it's on wrong and it's going elsewhere or too loose and not transmitting, what's the point? And so between, you know, the regulatory requirements and our patents,

I think we've built something very valuable from, you know, a business point of view. Yeah, and you mentioned the special controls with your de novo. So, so crucial if you're listening to this and not familiar in considering the de novo path, you know, if you can get that right, right? And it does definitely ladder up and it helps kind of build a deeper, wider, wider moat, right, those special controls. So with that said, let's jump to commercialization, right? So you mentioned you launched in, I think maybe I mentioned this, you launched in late 2024 with pre-orders, I believe. And then the full commercial launch was mid, mid-25, correct?

Exactly. Yeah. So what we did was when we announced the FDA approval in 24, at that moment, the company was two people, literally, two employees. And we had some consultants, like I said, on the clinical. And we put out a press release, and our website, which had a little form on it, kind of blew up. And people were just so excited about having a non-drug clinically proven therapy. And maybe just a brief aside, the astroporosis medications, which are effective and generally safe, do have, you know, some serious side effects. And for whatever reason, because I'm not, you know, against the medications, they have a pretty low adoption rate. And we knew this when we, when we built the company that there was really strong interest in our non-drug treatment.

So we announced this, you know, first and only FDA-clear non-drug treatment. And, you know, the interest was just very strong, you know, thousands and thousands of patients signing up. And, you know, so we're going about building the commercial version of the product. So, you know, of course, all the mechanism of actions are the same, but we improved the aesthetics and made it more manufacturable. and patients just wanted it. And so we, to people who are on our mailing list, we offered what we call the founders program.

Because in my view, this early community, they're really part of the founding and establishment of the company and the brand and the data. And so we gave them the opportunity to pre-order and be kind of first in line. And then we shipped a small number of devices out to the first of the, you know, founders. And then, you know, we started chipping in more volume shortly after that. And that's when

we made the public announcement. I'm such a big believer in, in sort of tapping into that, that community element, right, that you mentioned. It sounded like you had to sort of a, a groundswell of interest from whether you want to classify these folks as innovators or early adopters kind of on the, on the adoption bell curve. But nonetheless, they're your, your early supporters of your brand, right? And so it sounds like you found a, you know, a creative way to kind of let them, Let them get first access. When you think about your full commercial launch, you know, call it mid-20205,

anything else that maybe came up that was surprising or that you prepared for and it went as expected or maybe didn't go as expected, any other interesting kind of insights or learnings that you can share kind of leading up to the full commercial launch? Hey, everyone. Let's take a quick break to talk about Fastwave Medical, the company I co-founded and lead as CEO.

We're developing next generation intravascular lithotripsy or IVL systems to tackle complex calcific disease. Over the last few years, we've closed a series of oversubscribed funding rounds, bringing the total investment into FastWave to over $50 million. Corporate interest in the IVL space is growing to, the $900 million acquisition of Bolt Medical by Boston Scientific in 2025, and Johnson and Johnson's $13 billion acquisition of Shockwave Medical signal a lot of attention on emerging IVL startups like FastWave.

And we're making serious progress. In addition to recently receiving our ninth patent, we've successfully completed peripheral and coronary feasibility studies and are gearing up for pivotal trials. If you're interested in investing in the fast-growing IVL market, head over to fastwavemedical.com forward slash invest. Again, that's fastwavemedical.com forward slash invest. Now, let's get back to the conversation. Overall, I actually think it went as expected.

When I was recruited to the company, my first thought was, okay, if this product works, and we didn't know then that it worked. I just had this gut feel that there would be tremendous interest because we need an early intervention, right? The unmet need was there. And the fact that women were not using, you know, that the utilization rate on the drugs was low, you could look about a couple of ways. One way is that you can decide, oh, you know, women don't care. They don't care about their bones. Or you can say they care. They just don't have the options available that they're looking for. And in my heart of hearts, I was convinced it was the second that they cared, that they cared. They didn't want to wind up like their aunts and grandmothers and, you know, that to be their future, right? They wanted to stay strong and active.

And so in terms of the patients and the consumers, I always believe strongly that the interest would be there. And, you know, the timing of, you know, focus on women's health, you know, postmenopausal women specifically, non-drug treatments, wearables, home use. I was really bullish on the opportunity to really get our message across. And we were so glad that a number of, you know, widely read periodicals picked up on this story. I'd say if there's a surprise or an unknown was I wasn't as sure how the doctors would react. So the consumers, I had a strong point. of you. But for the physicians, it was like, well, on the one hand, we have excellent clinical data, we have FDA approval, we have a publication. So, you know, they should be positive. On the other hand,

doctors are not always quick to adopt novel treatments. They tend to focus more on pharmaceuticals. So I wasn't sure how that would go. And what we've seen is, and we still have, you know, work to do here to get the word out. But overall, we've seen a very positive response from physicians. And as I've spoken to them, the reason is very clear. They see their patients fracturing, right? They know what happens, right? This is not a surprise that, you know, you have this loss of bone.

And so they're, I think, pretty open to, you know, almost anything that is safe, right? So it's one thing to adopt a novel device or novel treatment. that has a lot of risk, osteo boost doesn't have a lot of risk, right? We had zero serious adverse effects in the trial. And so I think, you know, a lot of the doctors are like, we need more, more options. We need early options. I saw a presentation by one of the leading osteoporosis experts out of Oregon, and he was talking about how we need to have kind of a lifelong management of osteoporosis. And he shared data that if you use the most of osteoporosis, and he shared data that if you use the most powerful drugs. So we're talking like the biologic anabolic and, you know,

follow that up over 10 years. You'll improve bone density on average about 10%. Now, you'll reduce fracture risk by more than 10% because you have kind of a leverage there. But 10% if you think about it, that's not that great. Right? That's a half a T score. So that's like going minus 3.5 to 3. and then you still have osteoporosis because osteoporosis is 2.5 or below. So we need more. We need earlier intervention to narrow or lessen the bone loss. You know, we need ways to increase efficacy. So in the future, you know, we plan to do trials of combinations, osteoboose and medications.

And so I think, you know, and these physicians, especially the experts, you know, the antocrinologists and rheumatologists, they look around and big pharma has mostly exited, right? So it's not like there's five new drugs coming down the pike, right? There's, you know, two branded drugs. Everything else is generic. The companies with the generic drugs are really not investing. And so here you have this startup, Austria boost, like, okay, we want to change this up. And also at focus. So we've had a webinar series where we've, We are bringing in experts who are talking about medication, right? They're not osteosuribus commercials.

They're educational. And it's reinforcing my first hypothesis. Women care. People care about their bones. They want more information. And, you know, thousands of them are listening to experts from UCSF and Tufts, you know, and they want to optimize their musculoskeletal help. They want to be, you know, active in their 70s and 80s.

When you think, I want to ask you a little bit about, you know, a couple of things you've learned related to consumer behavior, like, knowing that this is a, this is, this is a cash pay device, but yet it's still prescription based. But are most of the physicians that are in sort of the osteoboost ecosystem at this point, do they hear about osteoboose through their patients then? Was it kind of more of a bottoms up sort of approach or are they hearing about osteoboose elsewhere? It depends. It's some of both. So we have over 2,500 doctors prescribing. And I'm guessing about 80% of those prescribers are because the patient, you know, I talked about that journey, right? So the patient heard about it. They order osteoobos. They go to their doctor and they say, you know, would you write this prescription? And then we're seeing a pretty significant percentage of those doctors, essentially learning about it from the patient and going on to repeat prescribed.

Those are most often primary care, internal medicine, family practice, OBGYN. But then you have the specialist, the endocrinologists, sometimes rheumatologists, they're geriatricians, but especially the endocrinologists who are reading the journals where we've had publications and, you know, we've been covered in, you know, some of there are other periodicals. also have exhibited at the Endocrine Society show and at the American Society of Bone and Mineral Research Show. And so many of those doctors are learning about us through, let's call it, traditional medical communication channels. And, you know, I mean, we have a few of those doctors, or actually more than a few, have prescribed 30, 40, you know, 50 times. So, and, you know, some of them

are basically saying everyone should have this in addition earlier on. Now, that's not our marketing label. Our label is premenopausal osteopenia, but we're seeing a lot of doctors be very proactive about trying to integrate osteobuse into their care pathway. Got it. Sounds like your, your patients have become almost a de facto sales force, if you will, right? Which is a great, a great thing to have. So I had an aha moment on this because yes, the patients are the sales force. And I get a lot of questions or people will bring this up as kind of an unusual or almost a surprising thing because we traditionally think of, you know, the doctors have all the information and then they make recommendations to patients. And, you know, that's, that of course is very important.

I don't know about you, but I'm not a big television person. So, I watch like Netflix or Prime, but not sort of TV shows. So I don't see a lot of commercials except for the Olympics. I love the Olympics, especially the ice skating. And so I was watching that. And for the first time in a while, I was seeing all the commercials. And I don't know what the percentage is. But well over half, I'm convinced of the commercials during the Olympics are for

medications. It could be plaquesorizes. It could be, you know, a rare, you know, cardiac genetic condition. We're not talking, you know, high blood pressure. We're talking these rare things. I'm like, oh my God, they think the same thing we do that they need to get the patients to advocate. So I think this has been a really critical mechanism for osteo boost, but this is sort of part of the communication patterns and education patterns, you know, of many products and conditions. Yeah. I think it's only going to, I mean, personally, I think it's only going to accelerate in the era of AI and LLMs, right? I mean, it's, you know, more and more consumers slash patients are, and that's where they're starting, right? And if you can get a really,

really, I would say, pretty good answer, right, from GPT or Gemini or, you know, name your, name your, your LLM, you know, that's where a lot of people are starting and they're going to their physicians, right? Or they're going to their physicians with some suggestions at least, right? Or a lot more knowledge kind of in their hands. So I think it's only going to accelerate. On that note, the device, I'm looking at your website again a bit, and the device looks like it's $9.95, right? So about $1,000. Most people, at least that in my network would say, whoa, whoa, like a patient's never going to pay $1,000, right? Consumers never going to pay $1,000. And the company I found it before Fastwave, we developed a class two device, but commercialized entirely online, direct to patient.

It wasn't a prescription device. But our AOV, this was kind of 2016 through, I led the company through like 2020-ish timeframe, 2015-2020. So a little bit ago anyway. But our average order value online was $1,400, $1,400, right? And so my counter to anyone that says that is like, no, no, I mean, consumers are willing to pay up. if they believe in the device. So has that been your experience as well with osteobo boost? Absolutely.

And I mean, I can tell you so many stories. We had a patient on the phone with support, you're sort of like asking questions and deciding. And they basically said, you know, my husband's getting golf clubs for what I want. Right. And, you know, I'm pretty sure golf clubs are more than $1,000. Yeah.

You look at the supplement world and people spend. a lot of money on products that, frankly, oftentimes don't have much data, right? I take calcium citrate. We, in our randomized control trial, both the active and the sham got calcium, vitamin D, calcium to get to 1,200 milligrams. But, you know, I get my calcium at Costco.

So I'm probably spending, you know, a dollar or two a month. but people are buying calcium online for, you know, $80, $90 a month. So osteo boost is less expensive than that. And we have, you know, outstanding clinical data. So yes, I think patients are willing to do it. Now, that being said, not everyone can. You know, we know that. And our goal is not just to improve bone health for people who can afford the device.

It's to do it for everyone. And so we're working very hard to try to, you know, have coverage in place. don't have it yet. And we're also looking into other payment mechanisms to make it more accessible. So accessibility is important to us. It's a priority. But yeah, I think it's important to people. I mean, people pay for the gym, the trainers. I mean, it's just what are your priorities? By the way, you know, we've done demographic data and the average income of our patients. It's above average, but it's not as high as you might think. So people are prioritizing their bone health.

That's really interesting because the folks that are cynical would say, well, Laura, your base of patients, your base of consumers, right, are fluent, right? So that's where they're willing to pay $1,000. But you're telling me that's not necessarily, I mean, there may be above average, but generally speaking, like kind of middle of the road. Yeah. Yeah, yeah, that's really interesting. I want to ask you about your experience is raising capital,

But just real quickly, on the note of coverage and reimbursements, that sounds like that's something you're actively pursuing now. That's a slog. It's arguably like one of the probably more challenging and more expensive than certainly regulatory approval in most cases, even if you're having to run an RCT. And so anything that you've gleaned so far in your efforts trying to get coverage and reimbursement for osteo boost?

You know, I would say that it's similar to the discussion. around regulatory, right? We have run this company, you know, in a pretty lean manner. And I think if we had hired more or spent more with sort of reimbursement or market access consultants, maybe we could be further along, but, you know, we, you know, had capital constraints. So it's hard to know. It's hard to know. Yeah. But it is a complicated area and you need expertise, right? Same thing as regulatory. When I look at your story, though. I mean, I think a lot of traditional met tech folks would say, would have said, hey, let's rewind the clock and we're back in 2020, right, when you're considering, you know, making the move to Austria boost. They would have said,

oh, without a doubt, if you're, there's no way that you can, you can sell a device for $1,000 to a, to a consumer. We have to get, you know, coverage and reimbursement, right? I think that's probably where a lot of traditional folks would have framed up the discussion, but you've kind of proven else, elsewise, right? You've been able to run the company pretty lean, get it de novo, lost the device, cash pay. And it sounds like you're, I mean, 2,500 physicians prescribing, that's a lot. That's a big number. Yeah. So I'd say, I completely agree with your supposition. So I think there is a lot of traditional med tech investors and med tech leaders who have raised, you know, huge amounts of capital.

they deploy it, you know, full core press on regulatory, full core press on reimbursement. And that's the go to market. And frankly, I think, you know, if you look at how much capital goes in versus the exits, the exits are good, but not, but it's all the ratio, right? And so, you know, I believe we're building something that's more valuable on the exit side, but we're also going about it without as much capital. And I think it's because I come about this, I don't come out of traditional met tech, right?

I come out of consumer tech. And now, of course, hardware does need a little bit more capital than, you know, SaaS or whatever. But, yeah, I thought that it could be done this way. I agree with your question. And frankly, you know, when I've talked to investors, I still hear from investors that they won't invest unless we have reimbursement. A common refrain is I don't believe in self-pay except for weight loss and cosmetic.

I've been told that by multiple, you know, really strong, you know, people who I really respect MetTechBCs. Now, if you sell a device for $5,000, you know, that may be true. If you have a device that's a surgical device, it's certainly true. Because the universe of people who will pay for the OR, the surgeon, the anesthesia, and the device, self-pay is almost zero, right? So there are cases where that's true, but it's not all cases. And I didn't think it was our case.

Yeah. Yeah, it sounds like you're proven some folks wrong. Let's talk about investors, right? Because we don't have a lot of time left. It looks like you raised your last round of financing in the first half of 2024. It was roughly about $5 million or so. When you think about your capital fundraising journey, right, over the past five or six years now with Osceo Boost, what do you know now, right, that maybe you wished you knew a decade ago, you know,

with less experience under your belt, raising financing? So I sort of have talked about staying lean. and overall I think that's been a good strategy, but I think a little bit more capital before we got the FGA approval, which would have been expensive capital, would have allowed us to move a little bit faster on getting to market.

Once we got that FTA approval, that being said, it was a time in the market where that capital wasn't really available. And back to this question of, can you build a business without reimbursement? the best way to convince people of that is to do it. And so, so that's what we focused on doing. Yeah. You bring up an interesting point, though, like the cost of capital pre-regulatory approval for you was, like, was very high, right? Because like most investors are going to just deem that as too risky,

right? So they're going to expect a lower valuation. They want more for their, more for the money. It makes sense. But I just think it's, it's really, really worth highlighting, right, to other folks that are listening that if you're at that stage where if you can sort of get to the next major milestone as lean as possible, right, that really truly value inflection milestone, that capital is going to come typically with a lot. It's going to open up more, open up more investors for sure, but it's going to be sort of less expensive capital, if you will, as it. Yeah, I mean, if you think about the different risks that are on the table at the beginning and you start to take them off the table. So the first is, you know, the science risk. Does it actually work? And, you know,

know, when we raised money in 2021, we had some preliminary data, but, you know, it was not certain. And then in 2022, we had the data, but we didn't have FDA approval. And we raised capital late 23, early 24. So we still had the regulatory risk because we got our de novo in January 24. And then you have kind of the commercial risk, like, will people want it? I mean, just because I was sure, that they would. It doesn't mean investors are sure. And then I'd say there's sort of scaling operational risk. And then there's potentially reimbursement risk. So if you, and certainly reimbursement will accelerate our business. So, you know, I think those are the different risks. And you can hopefully get more access to capital, you know, when you change. On the other hand, you lose certain potential

investors, right? As you do larger rounds, you know, you're not going to get, you know, certain angel groups, right? It's different stages of investors. Mm-hmm. Yeah. With that said, I'm looking at the clock. I know we only have a few minutes minutes left here. I want to leave time for the rapid fire portion of the interview here. So for everyone listening again, osteoboost.com is the website, just as it, as it sounds, osteobo boost.com. We'll link to it in the full write-up on MedSider. If you're new to these interviews, the actual write-ups on MedSighter are kind of more longer. summaries of the actual discussion where we really try to pull out and highlight some of the

insights like our guest share like Laura has over the past hour or so. With that said, Laura, a couple of rapid fire questions to wrap up the discussion here. When you think about the next 12 months for the company, what is what's the most, what gets you most excited? Is there a certain milestone or inflection point that you're looking forward to? Yeah. So we're going to be bringing on, you know, we're working to increase our capacity. You know, we've been back ordered. And So we're catching up there. And I'm very excited about that because we want to bring this to more people, you know, a lot more work with physicians that we're doing. I think it's just really about scaling the business. We want to bring this to more people. There's, you know, there's millions

of people. We're still in the thousands. That's exciting where we've started. But, you know, that's going to be a big focus for us this year. Good problem to have, right? That you're back orders are the biggest challenge, right? I much rather have backwater problems than demand the demand problem. So, all right, next question. Is there one lesson, right, that you think is most important for other med tech, you know, founders and CEOs to understand, right, that are running their own startup? I think it's what you focus on.

Is the problem, is that unmet need as impactful as it needs to be? Because if that's true, right, if you are really solving a problem, that isn't solved and it's important to people and they prioritize it, that will sort of compensate for other things, right? That will bring you demand, that can bring you investors, that can help you recruit employees because they're focused on that mission. You know, I've definitely heard from founders where it's like, well, we think this will help in this way and it's slightly better and it's very clever and that's great and if you were a big company and you had like a product line extension you could maybe be successful with that but as a startup it's not enough to get you

you know we talked about do you go over it or do you go through it oftentimes with startups you got to go through it right like in the bear hunt story and what gets you through it is that the strength and the importance of that unmet need and the pull from those patients, the pull from those doctors, the enthusiasm by the employees. Yeah, yeah, you know, getting to a point where you truly do have that market pull, right, versus having to push something on the market makes so much difference. Maybe, maybe all the difference in the world in terms of whether or not your venture successful. Early in my tech career. So I worked at a company that was in the database world, right? And so you might have a big company, take high at hotels,

they replace their online reservation system database with our database. We were a much smaller company. And it is risky. It's hard. And so, you know, it's how do you get a company to do that? And this was a lesson I learned early when I was at Informix. You have to be solving a very important problem for that company. There has to be something that they can't do, you know, something important in their business that we're really solving for them that's going to give them,

that motivation. Well, the same thing is true for patients and doctors, right? You need to be able to motivate them because as a startup, you don't have the money to grease the skids. Really good advice. And with one more question here. If you had the chance to go back in time, right, and whisper, whisper something in the ears of the younger Laura. Anything that you'd say to her? Well, I don't regret any of the stages of my career. I've learned from everything, but I really am enjoying startup life. And, you know, I didn't do that until my 40s. And I'm really enjoying working in healthcare, which I didn't start doing until my 50s. So maybe I would have done both of those things sooner. But I don't spend a lot of my time thinking that way. There's too much in front of us to focus on.

Yeah. It sounds like maybe you would have said if I could, if I could paraphrase, maybe if you're, maybe, maybe take a swing right in healthcare or, or a startup right earlier on. So with that said, I appreciate your time, Laura, for coming on the show again. It's been fun to kind of, uh, yeah, fun to, fun to get caught up right on, on, on, on osteobos. And congratulations on all the, all the success so, so far. It's fun to, fun to see. Thank you, Scott. All right. And for everyone listening, appreciate your attention, uh, as always, until the next episode of MedSetter goes live. Everyone, uh, take care. Hey, it's Scott again. One quick thing before you go. You see, I love bringing you insightful

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