Jannis Fischer, Positrigo - Ultra-Compact Dedicated PET System | LSI USA '24

Jannis Fischer  0:01  
Thank you very much for attending this session about Positrigo. With the goal of imaging everyone. Let me start with a small personal story when I was 18 years old, just finished high school I went on to serve for my civil service in a home for 21 patient with dementia. And that was a very formative experience. For me, I have to say, seeing all kinds of different stadiums from very mild to quite severe. And a couple of years later, once I was finishing my graduate studies, I again engaged in that topic, because in dementia, you need to do something. And Positrigo is doing something about that because we provide a device that can make visible the plaques in the brain that cause Alzheimer's. That's relevant nowadays, because last year, the first drug was FDA approved for removing those plaques. And now there is a wave of patient coming, that of course, wants to have the treatment and they need confirmatory diagnosis. The limitations of current system is they are quite large, quite complex. And we counter that by giving the physician that hand very small device which is also affordable. And in the development, we have put a big focus on usability. And with that it can actually be scaled it can then be used to serve this upcoming unmet need of Alzheimer diagnosis. Few words about the problem and of Alzheimer's, its concerns nowadays, dozens of millions of patients already. And with the demographic change that's going to grow even further. So by 2050, we'll have 1.6 out of eight people will be age 65 Plus, and thus be at risk. The good news is, as I mentioned before, we now have a drug at hand that was FDA approved last year, that can be by ECI. And another one is to follow by Eli Lilly this year. And Roche also announced last week that they have very positive phase two results of one of their drugs. Those are just three out of the 140 drugs in clinical pipeline. And so since Medicare decided also to cover the can be, that's very, very good news for all those patients suffering from Alzheimer's. The reimbursement on the other hand, is dependent on confirmatory diagnosis. And one option is a spinal tap, which is unpleasant has side effects and the other one is Positron Emission Tomography or short pet. That's what we do. We foresee a real boom of the diagnostic market right now, because the therapeutics already now 2.2 billion. And now with the new treatments that's expected to grow to 13 billion by 2031. Now pain points of the existing solution is then on the whole body systems, they were developed and mostly used in oncology where you look for metastasis, and so you need to scan the whole body. And it's usually combined with a PET CT or pet Mr. So they're quite complex. This is all facilitated with very high cost and thus, we see a great bottleneck in scanning capacity coming towards us. Now that the treatments are being rolled out and the patients are coming to get it with our system, it becomes possible now to move this patients from hospital settings or imaging centers, to auto neurology clinics. So basically from an inpatient and outpatient setting, which is also favored by reimbursement. And so we enable now a new market of in office PET scanning in neurodegenerative diseases. The market size, we see two markets. One is the existing global pet market that's estimated roughly 2 billion US dollars. And now with the advent of those new treatments, we have a new blue ocean market for brain dedicated pet in office, we estimate this to be at least around 3 billion until 2030. And this is something where we can tap in now with our device. This is a competitive overview. There are the big players that have the whole body machines that's mainly Siemens and GE HealthCare but also Toshiba and genetic imaging. We don't see them as direct competitors because they solve different problems of the problem of diagnosing precisely oncologic diseases. Now on the blue ocean market side, we have also three other companies. But none of those are as fit as our system to serve this new Alzheimer diagnosis problem right tonics and aqua vision have a very complex, expensive system that's probably over engineered for the purpose and pressure and imaging on the other side has over simplified the system such that, for example, the field of view is only 10 centimeters so the brain doesn't completely fit. And that makes it rather rather cumbersome to use in a clinical setting. The next step for us is tech transfer and industrialization and we have great partners to do so. So we have a handful of very known heart for suppliers of for our system. We've also partnered up the software that to image analysis, symptomatic Hermes, and we are also setting up a partnership with Sanmina as our system supplier in order to be able to scale up production next year. We've also taken care of after sales support we have partnered with BC technical now Alpha Sophia now problematical to the technical service of our devices in the US. The company is nothing without a team and I just have a small overview here we are 20 people overall, plus the board. In the management side, I'm supported by my co founder Max Annan and also Stefan Bucha, who has long experience in commercialization of medtech devices, and Delaria Saku as Chief Technology Officer. Very important also to notice we have founded a subsidiary in the US out of our headquarters in Zurich, and that's led by Ron lisec, who has more than 25 years experience in the nuclear medicine field in the US. On the board of advisors and directors we have people like assuta I used to be the CEO of Siemens Healthineers in Switzerland, Michael Rafa, he was Professor of Neurology at the University of Southern California, and Simon cherry who develops Pet Systems at UC Davis. Past and Future milestones include around Christmas time, we completed our 6061 tests for safety and electromagnetic compatibility, we prepare to 510 K submission at the beginning of the month, we have also successfully passed the clinical emulation stage of the CE marking process. And we also install the system and hospital check first images. Next week. We have scheduled our C audit end of May we are also expecting FDA clearance by then and the CE mark over the summer. Now that's the point where I need your help, because we need funding. And one is a 4 million extension round right now based on the existing round off which was designed to be 12 million total eight already invested. So we're looking to get the remaining four as soon as possible. And then we're also preparing a larger 20 million round towards the end of the year for the commercialization stage. And if that's something for you, I'm really hoping that somebody find this interesting and then come to me and help me bring the great product to the patients to the doctors and then make ultimate diagnosis more available. Thank you very much