Video Transcription
Anastasia Rigas 00:02
I'm the founder and CEO of Heteron Biotechnologies. We're based in New York, and we're developing in vitro breath diagnostics for self-testing. The need for our products stems from the fact that the group of people with gastrointestinal, liver, and metabolic diseases would benefit from being able to self-test for screening, diagnosis, and monitoring of disease progression and efficacy of treatment. These are the people: celiac disease, non-celiac gluten sensitivity, 50 million people, both EU and US; carbohydrate malabsorption; Irwin syndrome; SIBO, small intestinal bacterial overgrowth; metabolic syndrome; liver disease, 1 billion people in the world and rising. This is liver disease which is due to obesity and metabolic dysfunction. It's called MAFLD, metabolic dysfunction-associated liver disease. It used to be called non-alcoholic fatty liver disease. It's the same entity. A third of those, and it's not a small number, will progress to the most serious, the other hepatitis, NASH. Used to be called Nash. The same thing. There's no way right now to predict who is going to be in that third of the population. We have the answer to that: an H. pylori infection, an infection which is carcinogenic. The bacterium Helicobacter pylori was discovered in 1982. A breath test for diagnosis and monitoring of efficacy of treatment, because there is treatment with antibiotics, was developed in the early 90s, high efficacy, high sensitivity. In the early 90s, three and a half to four billion people in the world carry this carcinogenic bacterium in their digestive tract, and that is because the current diagnostics are invasive. They're at times non-specific, like the blood tests. They're high cost and high risk. Imaging studies, sophisticated imaging studies, and endoscopies with biopsies, and there is a breath test with an old technology, excellent technology, but older with drawbacks and limited availability. Out of all those five groups of people with all these hundreds of millions and billions of people, only two are being serviced by breath tests: carbohydrate malabsorption, lactose, fructose intolerance, SIBO, IBS, and the H. pylori infection. And based on the numbers, the staggering numbers of people affected by them, you can see how this particular technology has failed the mark. Now our products that are, as you can tell, multiple have multiple billion-dollar addressable markets in the US, similarly in Europe and in Asia. These are the numbers you can see, the multi-billion dollar markets, the H. pylori. This is a device that we have, the only one that we have at the point of care. The rest of it are over the counter and the metabolic syndrome, which is the largest, understandably, based on assumptions on the left-hand side. We are projecting that the company can reach 800 million to 1 billion net income per year in the US. Now, what is our technology? Our technology is disruptive. We are changing the status quo, and indeed, we are operating in a chaotic situation right now. We're interfacing medicine, engineering, chemistry, and recently AI to develop our smart disease-specific devices. This is the old technology that we are trying to take out of business. It's a large piece of equipment, hundreds of thousands of dollars to purchase, centralized; they're located in central labs like Quest Diagnostics and other lab cores and universities. One of our major competitors developed this piece of equipment based on that old technology and sells it for $13,500. It used to measure one gas; now it measures three. And this is us with a handheld device, less than $300. We can do what the others can faster and more accurately. Within about a minute, the diagnosis is rendered. As you can see, the devices are handheld. They're standalone, and they're autonomous, like the smartwatch, the Apple smartwatch, which means they collect, they analyze, and they store the data, they calculate the results, they display them, and then they transmit them. They're 100% accurate. They're low cost to manufacture, and they're reimbursable. Our business model is very simple. We decentralize breath testing. We take it out of central labs and place it in the hands of the people who need it. This is a trend now, a trend adopted by large corporations like Abbott and Becton Dickinson with their own diagnostic products. By producing simple, user-friendly breathalyzer devices for self-testing to be sold over the counter. That's our goal, and we're in discussions with the FDA to allow us to do this, and they have concurred that we can do it at the point of care. Now we have nine products in our pipeline because we're dealing with a lot of diseases. We have developed breath biomarkers. We're the first and the devices to test for those biomarkers. These are the areas that we're addressing: first, celiac disease; the liver disease that I told you about with 1 billion people and rising; and we have a predictive biomarker, a biomarker that predicts who, within that 1 billion people, will end up developing the more serious other hepatitis, NASH. And, of course, the H. pylori. This is my personal goal. I'm a gastroenterologist by training, and I have seen how we should have been able to take care of this bacterium, this carcinogenic bacterium, but we haven't been able to. So this is a breakthrough device. It's the device you can hold in your hand, buy it for less than $300, hold it in your hand. The method of testing is on the device. You follow it very simply. You swallow a liquid urea, and then 20 minutes later, you take a breath, and then the device gives you the result: yes or no, positive or negative. And then you get treated because there are antibiotics that can take care of this carcinogenic infection that causes severe illness and gastric cancer. Now we have results. We have done clinical pilot studies, over 120 patients diagnosed with the standard methods and with our devices and methods. On the left is celiac disease. On the right is the H. pylori infection. We have 100% accuracy in classification using ML algorithms, but we don't only depend on ML algorithms; we're using statistical methods like regression analysis. And this is the test for the liver disease. Additional devices: two gas device for carbohydrate malabsorption and SIBO; six gas device for metabolic syndrome; and our master device, which is a device that measures 30 plus gases and volatile organic compounds. We call it Breath Bad. It's a tablet and a breath analyzer together. It has the capabilities of a tablet and the capabilities of a breathalyzer. It's geared to the point of care, basically to the healthcare providers, physicians. Now multiple breath tests can be done using the device and for multiple diseases, including IBD. We are in discussion with the FDA, and we project to have the first three devices cleared by early 2026 and the remainder in 2027, upon which we will exit. These are in early R&D for asthma, another infection, which is an infection of the lower intestine, Clostridium difficile, and a cancer. The second cancer we're attacking, actually more than two, colorectal cancer, high incidence in patients less than 40 years of age is rising. We have patents; we have protected our technology with patents issued in both the US, Europe, and Asia. And we have multiple pending patent applications. Competitors? No one. The over-the-counter, yet,
Anastasia Rigas 10:02
I believe we will be the first at the point of care. There are competitors that are using the old technology. Number one is Quintron. This is the gold standard technology for us gastroenterologists, but they have limited scope of applicability. And in number six, you see the current point of care diagnostic, which goes for $25,000. We have a competitive advantage, I believe, which is a disruptive, low-cost, autonomous technology, which is 100% accurate. We have novel validated breath biomarkers, which make our devices disease-specific, and we are the first worldwide. We have a nimble operation because we're a small team, and we make changes right away, and we're dedicated to carrying out the mission of the company. I am the manager of the company, founder and manager. We have a board of advisors with key opinion leaders and corporate executives, and we're looking for AI experts to join us. We have an engineering, technology, and science team and our consultants to help us carry out the project. We're seeking $7.5 million in Series A to validate, to take our validated products through FDA approval and launch 1,000 units of each. Thank you. Applause.
