Video Transcription
Toon Overbeeke 00:00
Don. Thank you very much. I'm Don Overbeeke, the CEO of Vitestro, and today I'm going to tell you everything about the future of blood drawing. So blood drawing is the most commonly performed invasive procedure in the world. Over two and a half million samples are collected each day, which is over 1 billion samples in the US and Western Europe alone every year. And then 70% of the clinical decision making is based on blood. So although this procedure is of critical importance, it has lacked innovation for the last centuries. If you look at the errors that are made in the sample collection procedure, so basically, from the test request to the results that are reported to the patient, we can see that 760, to 70% of the errors occur in the pre-analytical phase, and that is because blood drawing is the only step in the whole procedure that's not automated. It's still done manually, and that is very error-prone. The next problem is that we do not have sufficient people to do the actual blood drawing. So we see that there is a huge staff shortage. It's not only in Europe, but also in the US. In Europe, 85% of the healthcare employers, and specifically the phlebotomists, face staff shortages. And in the US, we see that there is a high turnover in getting those phlebotomists, and this trend is worsening because we have an aging population, and at the same time, we see that there are fewer people. So first of all, there are more tests required, and secondly, there are fewer people that can actually perform the blood drawing. We have seen that robotics can help us in healthcare, and that's why we will revolutionize the blood drawing collection. So please meet our device. It can fully autonomously perform the procedure. So basically, the patient puts their arm in the device, presses the start button. The device picks up a new needle, picks up a new bandage, goes through the arm of the patient, looks where the veins are located in the arm of the patient, determines where to puncture the patient, fills the blood tubes, and then applies a bandage on the arm of the patient. And that's all done autonomously by our device. So where are we actually in this transformation, and what are we transforming? So first of all, we will increase the capacity, and we also increase the reliability of the capacity. So you can imagine that if a phlebotomist is ill, it results in long waiting lines. That's not the case with our device. Secondly, we reduce the staff shortages, so one person can supervise several devices at the same time. Then we can improve the quality and we can increase standardization. So if we, for example, look at the quality of blood hemolysis, we see that our hemolysis rates are significantly lower than when the blood is taken manually, which really improves the blood quality. And then there are 40 we will enhance patient satisfaction, and I will get back to that in a bit to support it with clinical data. So we have a massive market that we are going after. It's a five to 10 billion market, and we will take the following approach. So first of all, we focus on the Netherlands and Denmark, which is a 100 million market. Then we expand in Europe and have a pre-launch in the US, which is a billion market. Expand in the US in 2027 and then work on next-generation devices, which will enable us to open another three to 7 billion market. We offer a flexible operating model consisting of two parts. So first of all, we have an upfront investment, so it's basically the capex part. We try to keep that as low as possible. And then next to that, we have a well pay-as-you-go model. So it's first of all, a fee that we charge per bottle, but also an annual maintenance fee, which is all OPEX based. So we have been advancing rapidly towards our vision. So where are we now in our journey? So we conducted over 3000 blood draws with our device to date, and our first-time success rate is remarkable. If we look at the first-time success rate of a human, we see that it can be as low as 80 to 89%, and in some cases, it's 93 to 97%. We are on the upper side of that range with a 95 to 96% success rate. Then we also demonstrated that patients really want to use the device, so we have a high patient acceptance rate because eventually you're going to place your arm in a device that can automatically insert a needle in your arm, right? So after doing the trials with patients, we did randomized trials, we asked patients, okay, so how was your experience in terms of pain with the device? We see that 46% of the patients experienced less or far less pain with our device than with a manual blood draw, and 43% said it was comparable. And if you ask patients, is this method of blood drawing going forward acceptable to you? Then we saw that 92% of the patients said it was acceptable to them, and it was only a small percentage that was neutral. We have used this data and provided it to the notified body, and we received CE mark two months ago, which we're very proud of. So how are we conquering the market? So we will launch first in Europe. We will start, like I said before, in the Netherlands and in Denmark. We already sold our first 10 devices to our first four customers, and we're going to place those devices in the next six to nine months at our customers. And we have an active pipeline in Europe for hundreds of devices that we can sell to customers we are going after right now. Then, in terms of the US, we are laying the foundation for early commercialization. So we are currently engaging with leading US hospitals to have clinical collaborations with them. We are targeting to do our FDA submission mid-next year. So we already did four different Q steps to understand the feedback of the FDA, and we are now preparing our findings to submit our de novo next year, and we started to build our US team. So we have already hired our first person in the US, and we're now looking for a head of commercialization in the US. We have a very experienced leadership team, and on our board is Fred Moll. So Fred is the co-founder of Intuitive Surgical and well known from the Da Vinci robot, and he has also worked on ORs and a couple of other medical robotics. He's really the medical robotics guy, and we have a lot of experience in the team to build this company. Going forward, to date, we raised 50 million US dollars. 40 of that is equity, and 10 of that is non-dilutive funding, and we are looking for the right partner to join us in our journey. We would like to raise a 60 to 70 million dollar round, our series B round. So what are we going to do with this money? So first of all, we would like to achieve three different milestones. First of all, we would like to hand in our de novo submission and get the de novo grant, so get FDA clearance. Then we would like to scale in Europe 200 to 250 devices and install them in the field, with a potential of another 100 devices for potential lab chains that are going to join us. And then we will start with the initial commercialization in the US. In addition, we will be ready to scale commercially, both in Europe and in the US. So we're going to build a commercial organization in the US, and we're going to publish, together with leading US hospitals, data on our device. We will validate our sales and service models in Europe, and we will work on our next-generation products and continue to file distinct new patent families. Thank you very much. Thank you.
