Video Transcription
Jannis Fischer 00:02
Jan, so my name is Jannis. I'm the co-founder and CEO of Positrigo, physicist by training, and I want to talk to you about how to revolutionize Alzheimer's diagnostics. As you may or may not know, there have been by now, two drugs approved in the US to treat Alzheimer's disease and slow down cognitive decline, but as you can see from this article, thousands are to miss out on those drugs for three reasons, one being the lack of so-called positron emission tomography scan capacity, and this is what we are going to solve. So to get back to Alzheimer's disease, it's a huge problem. There are millions of patients, and it's growing because societies are aging. And good news, as I mentioned before, two FDA-approved drugs as of today, and one thing both need is a confirmatory diagnosis. You can either do a spinal tap or a PET scan, and patients and doctors usually prefer a PET scan. A PET scan looks like the image here on the bottom right; you can clearly distinguish the brain with amyloid depositions from the one without amyloid depositions. And if you have a brain with amyloid depositions, you can now treat it with one of those two drugs. The current solution is those large room-filling, very expensive devices, which are also complex to install and use, and this is creating a bottleneck, as we can see in the West. Already, the backlog of PET scanners is radically improving and increasing. Our solution for that is a small, dedicated in-office brain PET device. It is very small. It is quite affordable. It's a factor of two to three lower in price than the cheapest PET systems that are available now, and it's very usable. We have received FDA clearance in July, and now can actually give this to doctors to treat the patient more efficiently. The FDA clearance letter came on July 15, and since then, that's only a few weeks ago, we have received more than 13, I think by now it's 20 requests for quotes, and they have already signed one purchase order for four devices, another one I heard coming today, and yet another one by the end of the week. So I'm quite proud to announce that, and thank you, and we are ready to enter the market and scale up. What we do is we want to bring this device out of hospitals into the in-office setting, because we have neurologists that are wanting to treat their patients, but now they have to send away their patients to another doctor. You have months of wait time in the worst case, and it might be too late, even once you have a diagnosis, to initiate the treatment. So we want to give them the tool at hand to treat the patients directly themselves, just this year as a dentist. And want to get an x-ray. You get in the next room, and now you can get your PET scan in the next room. Also, the reimbursement is favorable. You get $1,500 under Medicare for the procedure. That means 20 patient months pay for the device and the person needed to operate. Also, CMS is changing the reimbursement to our favor to also now include hospitals, so another customer segment is opening up for us as of January 1 next year. This constitutes a whole new market for PET imaging. The existing market is $2 billion; that's mainly oncology, metastasizing diseases, so you need a whole-body PET scanner to actually find all those metastases. The brain-dedicated market is another huge market; we think the total is almost $3 billion, and that is only Alzheimer's, not including Parkinson's, epilepsy, glioblastoma, traumatic brain injury, and other brain diseases you can imagine that would benefit from such a scan. There are a few companies out there. The bottom half of the slide are the big companies having whole-body PET systems; we see them rather as potential acquirers than competitors, and on the top, we have listed a few other companies doing dedicated brain PET, but none of those have this product market we have. They are either too simple or too complex and thus too expensive or are not ready to commercialize. Our technology is protected by eight patent families, some of them granted, some of them pending. We also have an exclusive license for a microchip, digitizing the signals that we can produce, and overall, all of the designs are in our hands: mechanical, electronics, software, firmware, microchip. We can modify and adjust everything and produce everything as we like, for manufacturing and service. We have partners. So we have suppliers for the hardware. We have a system manufacturer that's done, and that will act as a contract manufacturer and enable us to scale up rapidly. And we also have a service partner to actually service our devices once installed at the customers. The management team led by myself also includes Ronald Lissak, a very experienced US-based General Manager who has 25 years of experience in PET imaging, operating PET centers, and bringing technology to the market. And we are supported also by a strong board of directors and advisors, including Or Suther, former CEO of Siemens, Switzerland, Michael Raffi, and Simon Cherry on the US side as well. Now the past year was very exciting for us. We have reached several milestones, starting with safety and EMC compliance, then moving on to clinical evaluation for the CE mark, first brain images, and the CE and MDR audit in May. In July, we received FDA clearance. The CE mark assessment is completed. We are just waiting for the issuance of the certificate to come any day now, and we are ready to launch our product. The first device sold will be installed in November, and we are now raising a $25 million growth round to set up production, industrialization, deployment, build 10 devices for the first year of commercialization, and then prepare for the hard launch in year two, which we encompass to have 40 devices. With this, I'd like to finish and please reach out to me if you're interested in general, but particularly if you want to invest. Thank you very much. Applause.
