Peter Bloch, BresoTEC - Diagnosing Sleep Apnea | LSI Europe '22

Transcription

Peter Bloch  0:09  

Good afternoon, everyone. I'm excited to be presenting Bresotec. We are revolutionising sleep apnea diagnostics. This is significant opportunity in the home sleep apnea market. First of all, Sleep Apnea is the recurrent sensation of breathing during sleep. And the market is growing for three reasons. This is a large opportunity space with a growing demand for at home testing, and where current solutions are compromised. And therefore there's opportunity for a new, more efficient technology. We focusing initially on the US market and the 54 million people suffering from apnea in the US market. And 80% of those are untested and undiagnosed, and the total available market is $1.4 billion. There's a growing demand for at home testing, driven by three factors. Firstly, large increase in sleep apnea patients for many reasons. And then there's an increase in penetration of home testing. As technologies become more accessible and easier to use. Through COVID, there's been a significant shift from prior to COVID 30% of testing was done at home two years later, 70% at home. And as I mentioned, current solutions are compromised. And I'll provide more information about that further in the presentation. It's a serious issue, it increases the risk of death from stroke and heart disease fourfold. And then this is a fourth most expensive disease to treat in the US market costing on average $5,200 per patient for an untreated patient. And in one year post treatment, these costs can declined by up to 50%. There are two ways for testing for sleep apnea. The first is the gold standard, which is the in lab PSG. This highly accurate, has high reimbursement rates for the clinician, however, it is being resisted by patients, especially through COVID. They do not want to spend the night sleeping in a lab. The current at home tests have a reasonable cost, and they're much easier to use. And this is beneficial for the patients. However, they often have trouble setting up these tests at home, and therefore there's opportunity for new products. And this leads to a large number of failed tests. Risk respiratory airflow is a cornerstone of sleep apnea diagnosis. And this is what really differentiates our product that we have the most direct and accurate measure for airflow. And if you look at our competitors, they generally have a surrogate signal for airflow. Accuracy and convenience are the key to adoption of a new home test. And those attributes that are important in a new test include accurate diagnostics, simple for the patient to set up by themselves, providing a turnkey solution for conditions. And obviously that this is reimbursed in the current insurance system. And our product does meet all those criteria. This is what our product looks like we have a small box which sits on the sternal notch and together with a finger oximeter which sends data wirelessly to a hub wirelessly to a hub. From the hub. It's uploaded to the cloud prices through our AI system. And we produce a report that is very similar to the PSG gold standard. The physicians are used to this and it fits into their workflow. So at Bresotec, clinical rationale and evidence support our technology, the most important signals that are used by the PSG gold standard for the testing. Sleep apnea is changes in respiratory motion and airflow are sensor measures, which includes a microphone and accelerometer and sits on the sternal notch provides a direct measure of both of these signals. We've conducted research on 643 patients to date, and we've demonstrated a 97.5% agreement with a PSG for assessing changes in airflow during apneas and our partners and this degree of accuracy is stronger than the other Herm tests in our formal clinical trials. For FDA approval, we demonstrated a 93% accuracy on our older scoring software. So looking at the market, first of all, we think we've got an ideal solution for the market. Our product we have high airflow accuracy, provide full transparency of signals to the clinicians, reliable, easy to use and comfortable. We have two groups of competitors. Firstly, the mainstream home tests. These products are out of date in many cases with compromises and reliability, and usability in my medical has a new solution, which is transparent, which is not transparent but reliable, easy to use and comfortable. Where we differentiate ourselves versus enema is that with the absence of airflow and low diagnostic transparency, this is problematic for many physicians. Everything is covered, we've covered by IP and as well as patents pending and we've conducted if a thorough freedom to operate. So turning to reimbursement. So in the US, there are two CPT codes that cover reimbursement, first of all, 95 806, which covers a simple sleep test, and 95 800, which is a sleep test, including sleep time. So, up to this time, most of the tests are 95 806, but the market is quickly transitioning to 95 800. Because of the proved economics, and this is where we expect to generate our revenues in the future. Our plan is to charge a fixed fee for the equipment and a reusable fee per test. So go to market strategy is initially early next year to target the US physicians, which are 74% of the market with direct sales team will then follow on with the balance of the market through partnerships and key account managers before moving on to the European market. So moving on to where we are at present we are in the final stages of FDA approval, we expect to have a 510 K by the balance of this year. We'll launch in February next year with the controlled launch which gives will give us the opportunity to gain Kol support and add software features before investing in the full launch in July of next year. This will be followed two months later with the launch of our sleep time product DX 2, and in early '25, a fully disposable version of the product. Company is led by an experienced management team. I've had experience leading medtech pharma and biotech companies in the past, and I've had exits through public listings, as well as through strategic sales. I just like to point out to Dr. Bradley, who is co founder and chief medical officer, and he is a world leader in the area of Sleep Medicine. And we also have a strong group of advisory doctors in the US. So moving on to the funding. To date, we have secured $14 million. And we have further capital committed to take us through FDA approval. The funding has come from one large strategic investor together with a number of seed investors. And the last round was done in the form of convertible note structure. I'm looking to raise $5.5 million post FDA clearance and this will go to you know 2.4 million for development clinical and regulatory for future development 1.6 million to the US launch and commercialization and 1.5 million for general corporate purposes. To summarize, we are addressing a large market. There's a market gap for new technologies. We have a proven management team who have scaled and built companies in the past. There are multiple growth drivers for new revenues. And we've got strong technology with full IP protection. Thank you. Happy to answer any questions