Video Transcription
Niels van Rheenen 00:02
Steve, first of all, I want to talk about the issue we're trying to solve with Thom attack. Annually, over 12 million people a year receive invasive mechanical ventilation to save their lives. Even though mechanical ventilation is a lifesaving intervention, it can cause a lot of issues too. It causes lung damage, and it really fastly reduces the volume of the muscles you use to breathe. This can cause death even, and it really makes it difficult for the patient to rehabilitate if they are on the mechanical ventilator for a longer time. There is a solution to individualized mechanical ventilation, and that's called esophageal pressures. The only issue is the current technology on the market that measures this pressure is very outdated. It's time-consuming. It takes over an hour to insert into the patient, and every measurement takes 15 to 30 minutes. So it's not clinically capable. It doesn't fit in the clinical workflow of the physicians. This lack of individualizing mechanical ventilation for the patients is a really big issue, and that's where PulmoTech comes in, because we decided to revolutionize, first of all, pressure measurement, and we created a feeding catheter with an integrated pressure sensor. You can see it here on the screen. What we actually did is we fixed all the issues I just talked about. Because we measure directly inside of the body, we increase the accuracy and the reliability of the catheter. Furthermore, within five minutes, you can calibrate and insert our catheter into the patient, and then you will have five days of continuously real-life data. This makes it so that finally, the physicians have the tools necessary to individualize mechanical ventilation for their patients and make sure they get the best chance of survival. Mechanical ventilation is a rapidly growing field, especially after COVID-19. It became apparent that there needs to be a change in this field because a lot of patients suffered from bad mechanical ventilation, which was just there because the technology wasn't there. PulmoTech has invented the technology that really will not only improve it, but it is just a necessary evolution in mechanical ventilation for the future. I'm really proud to announce that at the beginning of this year, we received our CE MDR certification. Furthermore, we also already got our ISO 3485 certification, really showing our team has a focus on quality and safety for the patients that are going to use our product. At the beginning of this summer, we already closed out our second clinical investigation, which really showed promising results, and we expect at the end of the year to have a full publication about these two studies. I want to talk a little bit more about the clinical impact. We have created a device that is clinically relevant and finally capable of being introduced in the clinic at every hospital. A really big study showed it's done over the data of 10,000 people, and it showed that using esophageal pressure to individualize mechanical ventilation for patients will reduce mortality by 7%. What does that mean? An average hospital that will admit 700 patients in their intensive care will have six people that are dying now, this year, who will be able to walk out of the hospital and get to their family back. That's what really flows the blood in our company, and that's why we are working our butt off to create this device. So we have CE certification, so it's clear that our first go-to-market will be the EU, and we're already collaborating with the leading hospitals in the EU to get our pilot study of pilot sites done. In January, we will be submitting to the FDA, and then the next big phase will be the US market. In order to facilitate an easy way to the US, we're already setting up a clinical study again with NYU. To make it easier for FDA submission, currently, we are seeking funding of 2.8 million. What we would like to do is grow our company, and we need the money to invest in marketing and sales for the EU market and also for the US market. In order to facilitate the demand for the catheter, we also need to grow in operations. So we need to invest in our production facilities. This is our team. This is the team that made it possible to achieve CE certification and to achieve ISO 3485 certification. They designed the catheter, and we all did it just in five years. I hope some of you are interested enough to come to the booth and join during our venture, join our team. We are really a team that has a proven product, we have a proven market, and we're ready to revolutionize the chances critically ill patients get in the ICU. That was my presentation. Thank you very much.
