Peter Bloch Presents BresoTEC at LSI USA '23

Transcription

Peter Bloch  0:04  

Good morning, everyone. I look forward to telling you more about BresoTEC medical. We are revolutionising sleep apnea diagnostics. Before getting into more information on our technology and our product, like to give you a little bit of background to the sleep apnea market, and also where we are on this journey. So sleep apnea is a cessation of breathing during sleep. It is a large disease affecting 54 million people in the US market. And the reason it is important is that it increases the risk of death from stroke and heart disease fourfold. This is a large market it's $1.4 billion addressable diagnostic market and it's growing at about 9% per annum. The standard of care in this market is a PSG, which is accurate, and it's a inlab test where the patient has to sleep overnight, and the capacity constraints on the inlab. Together with patients preference for being tested at home leads to approximately 80% of patients currently be going undiagnosed. Also, the at home portion of this market is growing very quickly and rarely accelerated through COVID. Prior to COVID, approximately 30% of patients were tested at home. And this has increased currently to about 70% of the market. So our product, the Bresa DX one received FDA clearance in December of last year, and we offer a superior at home diagnostic option. As the only at home test, which is based on respiratory airflow. We've got a strong IP position with multiple follow on products. And the company was founded by one of the foremost leaders in this era of sleep apnea, Dr. Doug Bradley, and I have led companies in the past and had exits. To date, we have raised $14.7 billion. A big chunk of this is from a strategic investor. And I'm seeking to raise an additional $5.5 million to find commercialization of the product. So now more about what we do. So we have a novel approach to home diagnosis, and we provide in that quality with the convenience of an at home test. And what what is unique about what we're doing in this market is that we the only FDA create diagnostic with at home validated respiratory airflow and this is the key data that is used by sleep physicians to diagnose sleep apnea. A value proposition includes the fact that we have an accurate estimate or of respiratory airflow. And the way we do this is from an accelerometer and microphone, which measures motion and breath sounds to detect the changes in respiratory airflow. We have the industry leading accuracy with a 2.5 measured error rate of assessing in changes in airflow versus the PSG which is the current gold standard. And we provide a seamless experience for the physicians. The data is presented in the very familiar format. And it fits easily into the workflow and is similar to the PSG gold standard, which they used to. Also, there's no help that the clinicians need to provide to set up the devices easily set up in the unattended setting by the patient at home. So this is what a product looks like, includes a small pressure sensor, which affects fixes above the windpipe on the sternal notch and an increase unit directionals very sensitive microphone, and a three day accelerometer, which record body position and movement and also includes an oximeter, which fits on the fingering and record blood oxygen saturation and heart rate. And both of these devices send data wirelessly to a hub, which stores the data and then uploads into the cloud after which is processed through AI software and produces an automatic report for the clinician. So we provide an accurate and transparent diagnostic information for the clinicians. We fit into the workflow, and our report includes the data that's key for the doctors to diagnose sleep apnea. So looking at the competitors, our competitors fit into two groups. First of all the older products which are traditional ad which I'm calling the traditional ad hoc tests. These products have fairly good accuracy, but they have very common a very often failures occur. They have no published risk Research validating the airflow in a home sleep setting. There have nasal cannulas, which do not record breathing during when when a patient is breathing through the mouth, which is fairly common in sleep apnea. And there's often signal loss due to the cannulas becoming dislodged. They also have wireless wires and cables, which make it difficult for the patient to set up at home. And in many cases, actually going to the clinic before going home to sleep in the conditions or setting it up for them. It makes it's very uncomfortable night's sleep. The second group of competitors are new products and the leader in this space is edamame medical. And they have very convenient and easy to use products. But they have no measurement or reported on airflow. And they use indirect surrogate signals. And they provide Black Duck a blackbox diagnosis where they do not provide full transparency of the data to the clinicians. And we provide that full transparency. So a fundamental advantage of a product is that we've addressed the deficiencies of the atom tests by making changes in airflow central to the way we diagnose. Also, through our artificial intelligence, we've developed composite signals from tracking motion and breath sound, that is increasing the accuracy of measuring airflow. And we continue to improve our model, even subsequent clinical trials, we we've had initial unpublished results, which are increasing as we add patient data to our model. In addition, in the future, we're going to be adding additional signals. And we believe this will put us in a position we have where we have the industry leading correlation to the gold standard. So where are we? We're going to launch in q3 of this year. With a controlled launch, this will give us the opportunity to gain additional Kol support, we already do have support but this will improve it. In addition, integrate into the healthcare systems and get additional feedback on our product before we invest in a full launch. We'll be targeting the sleep physicians, this is 74% of the overall market will do this with a direct small direct sales team. You know, in total, we're not going to need more than 20 to 25 reps to cover the whole of the US will then address the rest of the market which are dentists, personal care physicians and other specialists with partnerships and key account managers before moving on to other international markets. important factor here is that there is current reimbursement codes, the two codes that cover home sleep tests in the US market, and we you know, we will fit into the criteria for these codes. So on the funding side, I've raised we've raised $14.7 million to date. A big chunk of this has come from a strategic investor which understands the market we N and is in peripheral market. And I'm looking to raise an additional 5.5 million to fund the commercialization. In addition, the continued development of the product. So the team we have an experienced team, I've led other pharmaceuticals, biopharma and med tech companies in the past. Dr. Doug Bradley, who is chief medical officer, and co founder of the company is a world leader in the areas has over 275 pe of published papers. And I haven't spoken to a sleep doctor that doesn't know who he is yet across the US. We also have a strong group of advisers. And I just like to point out Dr. Richard Bogan, who started the largest sleep group called Sleep med in the US, and we're working very closely with these advisors as well as other clinics in the US to prepare for a market launch. I'd also like to mention we've continued to build the team. We've added an executive Alan Erlich, who comes from one of our largest competitors and has many industry connections. So to summarize, we targeting a large market, there's a significant market gap. And this has been validated by speaking to the largest players in the market that have products they agree that it is that clinicians are looking for products that diagnose based on on airflow. We have a management team that's led companies in the past. We have good technology was with IP protect Question. And we have multiple growth drivers to the future revenues in this market and the size of the market. I'd also like to point out that there's been a good amount of consolidation in this market in the last year and a half the two of our competitors getting acquired by the larger companies, and they looking for simple, easy to use and accurate solutions. And we began discussions with those companies already. Thank you.