Malcolm Hebblewhite, Atmo Biosciences - Ingestible Capsule for GI Assessment | LSI USA '24

Malcolm Hebblewhite  0:03  
What if assessing gut health was as simple as taking a pill, we have an ingestible capsule that senses gases as it travels through the gut, providing valuable insights about the health of a patient's GI system and then microbiome. And that's going to result in improvements to personalize their therapeutic approaches to common and debilitating gut conditions, and hence improvements to diagnosis and outcomes. We're developing the world's first ingestible gas sensing capsule, and it provides unique insight into the function of the microbiome. But the microbiome is inaccessible and really difficult to interrogate. Our ingestible capsule is changing that, to invite people in the world have gi problems, and a third of patients remain undiagnosed or have ongoing symptoms. We've administered more than 1000 of our capsules in a range of clinical trials. And there are a number of applications that we're pursuing. I'm going to tell you about the first of these, which is measuring the motility or speed of transit of food through the GI tract. We've completed a pivotal trial targeting a 510 K submission and regulatory clearance this year for this initial indication. And the exciting thing about this application is that Medtronic have recently discontinued their predicate device. Gi disorders are very prevalent with high unmet clinical needs. Because of the reliance on symptoms for diagnosis and management. 40% of the world's population suffer from a functional gut disorder as an example. Irritable Bowel Syndrome, or IBS happens to be the largest chronic condition that is treated in the US. And these patients are frequent fliers, two thirds of them have visited a doctor in the last 12 months. So a lot of Gi practice time is taken up by managing them. And this is made more difficult by the lack of tools available so third of these patients remain undiagnosed or misdiagnosed. So how does it work? Well, you will be relieved to know that it is a single use consumable device, you do not retrieve it. After swallowing it travels through the GI system, it's continuously monitoring gases, and transmitting the data wirelessly to a small receiver. It's measuring the gases directly at the source of production. This is important because it's otherwise not possible. And these gases provide insight into the location of the capsule as well as gi health and microbiome function. The capsule exit is detected through a change in temperature when it's excreted in a bowel movement and the data is sent to the cloud for aggregation and analysis. We're building the only gi gas data set to which we're now applying machine learning and AI. Now the capsule is just one component of an entire integrated system. In addition to the capsule, we have a receiver to collect the data, a standardized meal to measure motility and transit time, and a tablet and software to set up the patient download the receiver after the test. The data are then sent to the cloud for aggregation and analysis and diagnosis. The clinician logs into a portal to view the results generate a report and make the diagnosis. We have a robust IP position which consists of the original patent licensed exclusively, and which has been granted in the US and other jurisdictions. But we also have filed five new patents which include things like Bluetooth communication direct from the capsule to a phone, and targeted drug delivery using our capsule as a therapy delivery platform. So why are these gases important? Well, the GI tract is a 30 foot long tube with very different numbers of microbiota along its length. And these microbiota produce gases as they digest food. And the gases are clinically valuable biomarkers of microbiome function and gi physiology, and they can be used to assess an individual's gi health or dysfunction. Bowel capsule can detect various gases throughout the GI tract, and we can also detect where the capsule is and how fast or slow someone's motility and transit time is. Now depending on which gases are produced and where they are produced, this provides insight into an individual's gi function. Now until now this information hasn't been available because the GI tract is so in inaccessible deep inside the human body. Now the atma capsule uses data from the gas sensors and other onboard sensors to determine its location in the GI tract and measure motility and transit time and this is used for the diagnosis of gastroparesis, which is delayed gastric emptying, emptying from the stomach and slow transit constipation which can then be treated. Now we have a predicate in Medtronic smart pill and the most direct way to show equivalence to the predicate is to simply swallow the two capsules together and compare their speed of transit through the gut. And we successfully did this in a pivotal trial complete they did last year. And that approach allows a regulatory path involving a 510 K. But it also validates the ability there capsule to determine its location, which is important for additional indications because you want to know where the gases are being produced in the gut to make use of that capability. And this is valuable as it will allow us to explore other applications for understanding and evaluating microbiome function, such as IBS. Now, we recently successfully completed a pivotal trial involving 209 subjects enriched our primary endpoints. And as you can see, these are prestigious institutions. And the reason that we've been able to attract investigators of such high standing is because they're excited about the potential of our technology and the impact they think it can have on clinical practice. And these trial results will feed into a 510 K submission. In the next couple of months. We have a medical advisory board with some of the biggest names in functional gastroenterology from world renowned institutions including key opinion leaders like Professor Ayman Quigley who was a past president of the ACG Medtronic has created a fabulous opportunity for us by discontinuing the predicate device citing component obsolescence, and this has left a gap in the market with a large unmet clinical need which we can fill in existing reimbursement code exists which is applicable to us. And we intend to capture the smart pill business and pursue the large under penetrated addressable market of more than 200,000 gastric scintigraphy procedures per year. The value proposition that we're offering to gastroenterologist is we're providing them with a reimbursable profitable test with increased clinical utility that allows them to maintain control of their patient instead of referring them to radiology, for exposure to radiation and sitting in a clinic getting imaged for five, five hours. Now, over 1000 capsules have been administered across the range of clinical studies that have been conducted by us and by independent research groups. On the left here are the commercial indications that we're focused on and initially developing the capsule form. And on the right are some of the studies that have been conducted by third parties using our capsule. The first thing to notice is that the reason these groups are using our capsule is that they can't see can't get the information any other way. And that they see the information and insights, it provides a really useful. Second thing is that some of those parties want that data so much that they've actually paid us and they're purchasing capsules, validating the utility. And finally, the diversity of indications shows that it has broader utility than the initial indications that we're pursuing. We are a private company. We were founded in 2018. As a university spin out. We've incorporated in the US we have an office in San Diego, but the majority of our 30 person team are in Melbourne, Australia. I've raised 16 million in equity funding to date, and we're currently raising a $10 million round. And I have more than $7 million in the bank in this round from existing investors, leaving $3 million available to new investors. A register includes strategic shareholders like the large Japanese multinational Otsuka, pharmaceutical and VC breakthrough Victoria, who priced and led the current round. The offer consists of the same preference shares that have been issued in all previous rounds. They carry at one time liquidity, pref and anti dilution protection, and our pre money valuation is 35 million. So in summary, we're developing what is a unique tool for gut health and microbiome functional analysis. We're targeting large market opportunities with few competitive alternatives. We have a clinical portfolio which has yielded valuable data after more than 1000 capsule ingestions and peer reviewed publications. We're targeting multiple indications with the first one in motility, with a 510 K 510 K submission to be lodged shortly. And we have an excellent team of talented and experienced people to execute on our strategy. Thank you