Anastasia Rigas Presents Heteron Biotechnologies at LSI USA '24

Anastasia Rigas  0:04  
I am the founder and CEO of Heteron Biotechnologies. I'm a gastroenterologist. And in my company we are now developing in vitro breath diagnostics for large markets of Gi diseases, gastrointestinal liver and metabolic diseases and some renal. Our mission is to create diagnostics that will replace the painful invasive and high risk procedures. And with that to make a dent in the incidence of diseases that affect hundreds of millions and billions of people worldwide to lower health care costs with our low cost devices, and to create wealth for whatever it gives us money. We to do this, we need to reinvent breath testing. And why do we need to do that because the breath testing so far has failed all the cohorts that we know need to have products like ours, we believe that okay. Okay, so we believe that a breath test can be a successful diagnostic. And especially in our hands, because it's non invasive, it's accessible, anyone can give a breath sample accurate, available with our devices at point of care. And over the counter. We can screen for diseases, especially chronic diseases, we can establish breath biomarkers that are very important for specific diseases. And we can empower patients to make decisions at home in the era of individualized medicine. Hi, how do we do this, this is a prototype device. This is not the final product, but it does the job. We are going to do this by taking the breath testing out of the centralized labs and placing it in the hands of the people who needed now we're going to do this of course by producing smart autonomous that's the catch all word stand alone, handheld breath analyzer devices that are disease specific. We have the technology which make we with which we make accurate, stable to operate a room temperature. With repeated tests and simple to operate by lay people they provide results within about a minute and our low cost and reimbursable. We will sell them over the counter and at the point of care. Now who benefits what are the markets we know the markets have taken care of these people for decades. First, we have the people with celiac disease and non celiac gluten sensitivity. They do undergo a lot of invasive testing and endoscopy endoscopic procedures throughout their life. These are the people with metabolic syndrome, high risk for heart disease, liver disease and diabetes. This is just in the US you can multiply that many times for the world over. These are the people and they do undergo invasive testing and high cost imaging studies. This is the cohort with people with put them all together lacto amine carbohydrate malabsorption and they do undergo multiple invasive tests are 1 billion people and rising these are the people that have fatty liver disease due to obesity obesity rates go up. fatty liver disease goes up now. It's called ma SLD Mal, Mal Fung. Anyway, it's a new term without any way of predicting who is going to be in that 25% Who are going to develop the metabolic dysfunction associated Seattle hepatitis, which is a severe steatohepatitis that can lead to cirrhosis and cancer. They also undergo a lot of invasive tests and high cost procedures and imaging studies. And lastly, a four and a half billion people It's unfathomable rate. Four and a half billion people in the world two thirds of the world's population that I have are infected with Helicobacter pylori, a treatable disease that undergo testing with precede endoscopy procedures and blood test. And the breath tests that were really going to replace both the cohort for the 200 million people and the four and a half billion there is a breath test that has failed this these people. Now, the current diagnosis I alluded I diagnostics, I alluded to blood tests, imaging studies, there are quite high cost liver biopsy, high risk procedure, and endoscopic procedures with biopsies and the breath test, which is an old technology of risk centuries old. Even though it is effective in some ways it is it has limited value. And of course you need to go to hospital or an institution or a laboratory to get it done. This is where I trained in GI New York Hospital 68th in New York. Beautiful. Can we replace the current diagnostic tests? That's our plan. I believe we can replace the blood tests, I believe we can replace a large number of imaging studies, lowering the health care cost. We can replace a large number of invasive procedures, lowering costs there and alleviating suffering for the people and show you how badly the breath test the current breath test has failed. In the US with our health care system, only 1% of the people who needed get breath tested. Now what is that gold standard? It's an excellent technology, gas chromatography mass spectroscopy. Universities have those equipment. For research purposes, they evolved throughout the decades. In the 90s. One of our competitors Quinton came up with this smaller instrument for one gas sold it for $5,000. The same company now has another one of those, they test three gases. And it costs 13 and a half $1,000. And here it's us with a less than $300 piece of equipment that we can do accurately we can measure accurately where they can. How do we do this? We're interfacing medicine, chemistry, engineering and AI. But I can tell you the reason why there is a product is because medicine leads the way. And I'm I don't mean to be egotistical because I'm a gastroenterologist however, we know the need, we know what our patients need. And in our company, we have integrated chemistry, very important engineering and recently, very happy to have AI to help us with our products to produce these smart handheld breathalyzer devices that will make the diagnosis. We choose Chemical Materials carefully to have high sensitivity and specificity with our sensors. We have of course electronics machine learning capabilities to analyze our data and wireless transmission. We have six products that we're developing the left or the clinical stage validated products. The right is the r&d products with aim. Wow, I only have a minute, we aim to put all our products through FDA approval by 2027. Perhaps device D might need a few more months. These are some clinical data we got from our three devices. This is the first device the ciliate, you can see with principal component analysis, we can cluster the red or the affiliate diseases or pilot studies. These are not the final clinical studies. But with machine learning classification, we have 100% accuracy of our tests. On the right is the addressable market for each of those devices. This is our second device. This is for the 1 billion cohort that has the liver disease, we're trying to identify a biomarker to see who is going to be in that 25% of develop that very seriously how to hepatitis A we have very good results. And actually this test, which is the first in the world can be used for renal disease because it has ammonia in breath. This is very proud to announce this. This is the device for the infectious agent, the H Pylori, it's a handheld device. It's like the one I showed you in the picture. And we have not only the device and you can see the PCA analysis and ml classification gives us again 100% accuracy. And we correlate 100% With that gold standard. But we now have and novel method of the breath test itself which is much less expensive than the current. Now I have to go really far I have no more time. These are the r&d two gases, six gases. Just to say a few words about this device. This is an extraordinary device is a breath I call it the breath pad, because it's a tablet breathalyzer. It does a test north of 30. It needs a lot of r&d north of 30 gases, and you will be marketed to the health care providers. We have competitors there in the carb malabsorption hydrogen they're not like us they don't have our get our capabilities. We have a competitive advantage over them because of our technology because our in depth knowledge and understanding of the needs of the people that we service. And we have the team that has the expertise and other things this is a team doctors and engineers and we're looking for funding to take the three validated products through FDA clearance and begin sales Thank you very much and I'm sorry it took so long