MedTrace Pharma | Martin Stenfeldt, CEO

(Transcription)

Martin Stenfeldt  0:01  

Good morning everyone. My name is Martin Stenfeldt, CEO and co founder of MedTrace and I'm going to take you into a little bit of Journey to nuclear medicine. So at mychoice, we help doctors diagnose hot patients 50% more accurately and four times faster than today's clinical workhorse, which is SPECT imaging. And we do this with a tracer in water. traces are used by doctors to follow the flow of blood in the human body. And that's of interest to doctors because all major diseases, effects or are affected by the blood flow. Now our case is about quantification of blood flow. Because when we can start quantifying blood flow, we can start quantifying the disease that increases accuracy, but it also opens up interesting business opportunities in AI and with machine learning. Now, 50 mil water or radioactive water is the only tracer that can truly be quantified. On top of that, it's also the only tracer that can go into any part of the organ looking at any kind of diseases. The company was founded back in 2015. In Denmark, so apologize for my Danish accent. Where are we today? We have already now despite we have a regulatory approval yet, we have some megestrol exemptions for clinical use in Denmark and Sweden, we have done more than 2000 patients with our technology. We have for commercial contracts, we raised a series B funding last year of $30 million with a pension fund, European Innovation Council, a private equity fund from Switzerland and even Mayo Clinic Foundation injected cash into the company. We have had us operation since 2017, in Minneapolis, and our current staff is 35, who will be at least double as many by the end of the year, we estimate to have regulatory approval in the EU, Europe, PY 2023. That's next year and two years from now also in the US. I have a small breaking news. And that is that the FDA, this Friday or last Friday, they gave us greenlight to go ahead with our phase three study, the r&d was approved by the FDA, which we are obviously very happy about the clinical pain to go back to where it all started is cardiovascular diseases is the leading cause of death. If you look at this room, approximately a quarter of you will eventually die of heart related diseases. It's a cost a direct cost burden of the US society of at least $110 billion a year and then comes all the indirect cost. It's a global problem. And one of the reasons are poor diagnostics. In our field, which is functional testing, the clinical workhorse has office less than 60% sensitivity, that means four out of 10 patients will not get the right diagnosis has a lot of downstream extra cost has a lot of issues, obviously for the patient and the family. The reason for this is that all the traces needs algorithmic corrections to mimic the flow of blood. Whereas 15 A water which is based on water, which is a major major substance of blood has a one to one kinetics and give you the truth. It's also called the true standard for that reason. There's however one drawback and that is that radioactive water has a half life of only two minutes, so you have to produce it and use it. And the way we come around that is this little pink machine you see in the middle, where you it's kind of a point of care chemistry system automated point of care hotsale, where when the patient and the PET scan has read it, it will automatically call on gas rejects with gas from the nearby cyclotron, and converted into radioactive water and injected automatically into the patient. This is where we have the productivity increase, because with the current standards, you will have a scan of 30 minutes maybe up to 55 minutes, then you'll need to wait five times the half life between the two scans for rest and stress scan, sorry, and we'll today's tracer that's six hours times five, that's 30 hours with hours, it's five times two minutes, so you can let the patient be on the bed. So at least four times productivity increase if we look at Justice scan time. On top of that we have a software analysis platform that can analyze the images from the Pitkanen. This is how our hotsale looks like when you sit up in the morning for a day's production. And making fentanyl water practical available will give you three distinct value propositions accuracy and efficiency I've already told you about. But on the safety side, the hospital no longer needs to rely on third party logistics. They can manufacture as many doses they want. And for the patients and the staff there is 17 times lower radiation you can barely measure it with 50 No water. Our business model is a subscription model. So we own the equipment hospitals. They sign up for a license agreement to manufacture a number of doses from the European contracts we have signed and the ones we're about to sign ng we can see that the trend is going towards more than five years of contract period. In the US with the contemplated prices we are seeing, it's around 1.2 million in recurring revenue and an average hospital every year at a pretty decent profit margin. Our focus is right now on Europe exploiting the exemption possibilities onto regulatory approval. And then the US is our focus its largest single market, one regulatory body. As you heard, we already have the green light to start our phase three, and we will have a new drug approval, exclusivity, six years of approval for exclusivity, adding three years for each new indication we can add, there are plenty new indications in cardiology. Mayo Clinic and Osaka University Hospital in Japan have already started some studies in oncology. And we can do much more in neurology and other types of diseases. Looking back at the market in the US, I set $110 billion is the direct cost. We are in that small niche that when you have had your first line but haven't found out what's wrong, you go to the functional testing in nuclear medicine here the addressable market is around $5 billion. If we assume down to where we can go in right now. Today, it's around $300 million annually that we can say is our serviceable obtainable market. To that you should know that growth in the industry on cyclotrons alone is around 10% For the last 15 years. We can add Europe we can add Asia we can add oncology neurology to these numbers, it will grow significantly. pathway forward. We already secured financing to complete our clinical trial you Rypien STS has started, we will commence enrollment of the phase three in next month already. We will begin the CE marking next year or not begin who will finalize it expect to have the new drug approved we only need 182 patients for our phase three trial. And then our current investors have set us up for an IPO based on European pace, proof of market regulatory approval from the US oncology pathway that has been defined. And also early licensing with Big Pharma as companion diagnostics. To do all this, we have a stellar team of radio pharma and medical imaging experience from around the world actually from us from Europe. We have both industry and clinical experience. I'm here today to see if I can find additional investors. We don't have any US investors right now. But US is our major market. We would very much like to welcome any kind of US investors could participate in pre IPO or maybe even before and then if I could get some leads for any big pharma introductions as well. Thank you for listening