Jannis Fischer Presents Positrigo at LSI Europe '23

Transcription

Jannis Fischer  0:05  
Hello, my name is Jannis Fischer CEO and co founder of Positrigo. And today I would like to present you dedicated brain PETs at the point of care. This is our revolutionary neuro imaging device called neuro lf it's a brain positron emission tomography scanner. And it's specifically designed for the diagnosis of brain related disorders that might include Alzheimer's, brain tumors, Parkinson's, epilepsy, and many more. It features an ultra compact device, and high patient comfort and intuitive usability. And this makes it a very good product for in office use for doctors. We embedded in an ecosystem with everything a doctor needs, including a picture archiving, system, isotopes, analytics, software, Image Reader, and service and support. The need is there, because at the moment, we have 2 million scanning hours in the US on those devices at the moment. And this is done on two and a half 1000 scanners which run at 90% capacity. Now a few new things come to that 500,000 New hours and Alzheimer's scans 400,000 New hours in oncology because of newly approved PSA prostate cancer tracers, and then, of course, more and more clinical trials. And so we think there's a foreign 60,000 hours under capacity at the moment that has to be resolved. And with our device, you can do that you can relieve the existing whole body systems for the brain part at least, to the same images, same quality as before, but a much smaller space. One prime use case is ultimate disease, one in three seniors dies for that disease or another dementia. We have 48% of all unpaid care give us provide for somebody with that disease. And this is estimated to be 18 billion hours of care per year. And then if there were no treatments, it's estimated that in fact, by 2050 13 million Americans will live with that disease costing society almost a trillion US dollars every year. Now, the good news is we can do something about that because the FDA has recently approved, they can be the second drug of its kind, removing the plugs from the brain that play a major role in Alzheimer's disease. And not only has the FDA Now traditionally approved that but Medicare has also announced that it will pay for the drug. And it will also pay for the required amyloid assessment amyloid other plaques in the brain and you can either do a spinal tap or PET scan. And the PET scan is of course, the much nicer way of evaluating the emulador status of the brain. Now our system neural F has been specifically designed to detect and document those blocks. And this is required for Medicare coverage. It's not the end of the story on the drug side we have besides the can be and another one that was had the approval before a third one which had very good phase three clinical trials just published in May, the anonim app which will be approved around the turn of the year. And there's 143 drugs in total in clinical trials 68% of phase three trials sponsored by a biopharmaceutical industry, and we see a wave coming of treatments here. Now coming back to our system, we see the market opportunity as follows. We have if you go to the point of care which you can do with our device for the first time with this imaging techniques, you can bring it to the neurologists office that at the moment have to schedule pet exams at another clinic at the radiology or nuclear medicine department. They cannot take it in house, get a new revenue stream, treat the patients faster, and get the results earlier of those neurology sites and yes, there are around 3000 1700 eligible 2000s in the hospital 1200 private practices with at least three MDS and 500 alternate care sites. If you're not taking those sites, this is a market opportunity of 3700 sites in the US alone for the ultimate case alone. And the visa think we can get up to 25% of the chair because there are not many competitors around there that do have a similar offering of VF. So we estimate our market at 787 million US dollars. Do we then add the rest of the world and other indications? This total global opportunity amounts to 600,000 sites and 5.2 billion US dollars. Now Yeah, I put the cash study because how can the question you always have to ask is how can a doctor make money with it? What we did is we assumed the neural lf the leasing costs for a five year amortization lease plus the operational cost personnel and so on. And then at the other hand, put the Medicare reimbursement rate reserves around 1500 US dollar Last year, the example is Pennsylvania fee schedule. What we do not include here is that you can actually make much more money for each patient if you use research patient and also if you put other neurological diseases onto the device. Now, if you do this case that didn't slowly ramp up the patient numbers from 40 patients a month in the first Yep, 210 patients a month and the three to fifth year, then you can generate five and a half million positive income for that clinic. Positive ego is led by this team. So on the left hand side, you can see the management team for a senior management officials in Zurich or homebase. We have now recently hired drawn lisec in the US is the first person there as the general manager there because we see the US market as the most important one at the moment. And we are supported by a strong board and advisors. Just to mention two of those. Dr. Michael Rafi from USC is our head clinical advisor for the US. And Dr. Simon cherry from UC Davis is our main advisor in the US for instrumentation and technology. Couple things we have reached to find 2023 years we have talked to key pharma partners that are those that have the answer my drugs, say ISI and Lily, and then those that have the radiotracer to detect the amyloid that, for example, life, Lily, and Lily, we have several patterns. The first was granted this year, the Medicare and CMS have announced that they will cover the duck we are now working on a full service program for maintenance for the yes talking to a major provider for that and close to finalizing the contract there. And we have seen a lot of interest from geologists and other clinics. Up next year is E mark and FDA approval in about six months time. We will also establish full yes operations get on the ground there deliver our first system the first half and then from June to December scale up production capacity 2025 to system outlook, there's a mobile unit plan that you can drive around in the truck, we will establish US manufacturing capabilities that's necessary. And we'll also have a joint venture with alternate sites to go into the providing business as well. So the first one, the first step now is to deploy Verizon the bridge round of 5 million now to reach those milestones here. Some very significant tests a 6061, a NEMA test in the clinical trial for this patient, which will then culminate in the submission of the 510 K and early next year and the MDR audit which is already scheduled for March doesn't work anymore, they're just and then this will bring us to the end of next year. major milestones here is the FDA clearance e marking and first customers and we think we have two paths that we could follow one is partnership up to m&a with a major player. And the other one would be to raise a significant funding round of say at least 20 million to enter the market ourselves. And this will be to be to have to be decided end of next year. So with that, I'd like to thank you for your attention and please come contact me if you have questions you'd like to invest. Thank you very much