Charles Allan Presents MY01 at LSI USA '23

Transcription

Bryan Nolan  0:05  

Good morning. My name is Bryan Nolan. I'm the founder and CEO, myBiometry. And we're in the business of preventing asthma attacks. This is Christie, Christie is our Director of Quality. She's got two beautiful girls, they both have asthma. And this is really a horrifying disease, because most of the time you feel fine, but it deteriorates very rapidly. And then you have an asthma attack. And when that happens, you're suffocating. And as a parent, watching your child go through this, it's absolutely terrifying. And I can assure you as a patient, it's not something you ever want to live through more than once. So patients and parents living in constant fear that this could happen at any point in time. So our business is preventing this, how do we do it? It's a breath test. So a diagnostic at home, we're measuring airway inflammation, that identify somebody at risk up to 20 days in advance that data is actionable. And it helps us deliver proactive interventions, which we'll talk about in a second. This is a massive problem, there's 339 million patients globally. 62% of them are uncontrolled, that leaves about 210 million patients at risk, the savings from preventing or from improving somebody's asthma control is roughly $4,700 per patient per year in the US. Uncontrolled patients think about their asthma every single day. And they do that and when their symptoms start to become bothersome, they panic. So this is as much a mental challenge for them as it is a physical one. The way that it's managed today, 68% of patients prefer to self adjust their medications based on how they feel and how they feel or what they feel are symptoms and obstruction of their airway. And unfortunately, we're still tracking this predominantly on paper. The problem with the approach is that symptoms and peak flow or obstruction change two to three days before you have an asthma attack. And the medications that they're self adjusting take one to two weeks to have a full therapeutic effect. So even if patients track themselves closely, they don't necessarily catch the problem early enough to intervene. So our solution is about empowering patients to better manage their asthma. It's focused or it's based on the asthma guidelines. We're focused on Diagnostics at home. So that's what makes us unique. I'll talk about that in a second. But we wrap digital solutions around that as well. So algorithms that help identify and warn you of your triggers to think if there's a trigger in the forecast on Friday, we'll warn you on Monday to start taking your medication. We have a partnership with the American Lung Association where we take their evidence based education programs, we digitize them and incorporate them into our solution. We also provide access to their long helpline or their care team of certified asthma educators all available in the app. So let's talk about the diagnostic. So what are we measuring we're measuring a biomarker called fino. It's part of the US and the asthma guidelines and it's incredibly valuable. It's a biomarker of type two airway inflammation prognostic of exacerbations predictive of therapeutic response. Using it in the diagnostic process will increase the likelihood of a correct diagnosis by up to 7x. And tailoring therapy based on it can reduce the number and frequency of exacerbations. The relationship between the biomarker and risk is basically linear. You can see the graph on the right that's the pillion ABS phase three data. The gray line there is the placebo group and almost a linear concentrate or linear relationship between exacerbation risk and concentration of the biomarker. We've got a market enabling technology. This is a novel gas sensor. We invented it in house. So there's 12 issued patents filed globally. We own all of it. What's novel about it is the sensor chemistry in the manufacturing process. So we make these like diabetes test strips, so low cost single use disposable sensors, they pair with a simple connected device, and that enables us to measure this biomarker at home daily. That matters because fino changes up to 20 days before a patient even has symptoms. And early detection enables proactive intervention. So the data on the left is from an AstraZeneca phase two study 287% increased risk per two fold change the biomarker in that 20 day window. And that data is actionable. Patients can reduce that risk in a dose dependent manner with the medications that they already have. They've already been prescribed. So we're enabled, enabling them to do what they're already doing, which is self dosing their medication in a timeframe where that medication will actually have a therapeutic impact. We're the only technology that enables people to do this at home. We've got the best clinical performance at higher concentrations. You can see some of our clinical data on the right there. Those are the highest risk patients. Our competitors were the easiest to use. So our competitors require a patient without asthma to blow into the device every single day to rebase line the sensor we don't need that our sensors are disposable, and then we're the lowest cost so we can fit within existing reimbursement structures, our competitors cost 1000s and 1000s of dollars. There's two markets that we're going after both of them have existing reimbursement. At the point of care, it's about $21 per test, our gross margins are well over 95% there. And in the home market, we can reimburse or we can bill for remote physiological monitoring codes. It's basically subscription. It's $64 per patient per month and our margins about 73% there to simple regulatory path 510 K class to as I said, it's a market enabling opportunity. So we really open up the whole market that markets driven by number of uncontrolled patients in the US about 15 million of them. Our target customer here are payers. directly we can access them through sales or through platforms, so telehealth platforms like Livongo or TelaDoc, or RPM platforms. The point of care or to customers are the retail pharmacy and the physician's office. That market is driven predominantly by number of prescriptions containing inhaled steroids and number of office visits. We've got traction in the in the home market already we have a pilot coming up with point 32 Health their large regional insurance plan about 2 million members. We work with them to identify at relative relevant patients via claims. We do an outreach to the patient, they self enroll in the program, and we build the insurance company $80 per patient per month, we're really looking for two primary outcomes here clinical outcomes and economic outcomes through improvement of control for reduction of exacerbations in reduction of ER visits, hospitalizations, etc. If we can deliver the savings at the bottom there, it's a 6x ROI for the insurance company. The commercial strategy is pretty straightforward at home. It's a subscription based model, very similar to what others do for chronic chronic disease monitoring. Point of care. It's razor razor blade, we want to find distribution partners and channel partners in both markets. The next year and a half is really focused on expanding our pilot, our pilot pipeline, using that data to find a channel partner and then if we're able to get to 57,000 patients. It's a $50 million ARR business for us. Our team has a lot of experience developing and commercializing medical technologies. We've done it at startups, we've done it at Fortune five hundreds we've been part of a number of exits. The technologies that we've developed perform billions of tests annually and generate billions of dollars for the companies that sell them. Our advisory board and clinical advisors are global thought leaders, the clinical advisors at the bottom there the work that they have done has literally led to changes in the global and US asthma guidelines. These are complete paradigm shifts in the way that asthma is being managed. So where we are today we've got fully functioning prototype so sensor device software, we've piloted that with with a group of patients, we're in the process of transferring the sensor to our contract manufacturer, we've got one spin on the device. Once we get to our early engineering verification, we will start the formal pilot with the insurance company and submit our 510 K towards the in q1 of 2024. We do have a financing open it's a small round about three and a half million round, we have 2 million of that open. The goal here is to complete the device, submit our 510 K and start the payer pilot and then we will do a larger early commercial round in q1 of 2024 to support the point of care launch and the payer pilot expansion. And I'd like to welcome anybody that wants to help us on our journey please feel free to reach out to me. Thank you