Video Transcription
Marijn van Os 00:02
So good afternoon. I'm going to present Scinvivo. We have developed the next generation cancer discovery tech, as we call it. It's basically a very tiny catheter where we apply a kind of ultrasound, but then we use light waves, and that's called optical coherence tomography. With the catheter, we are able to slide up through the working channel of a standard scope. So with this, you have still the image of your scope, but we provide the depth information of the tissue as well. Sorry. So this is usable in every location in the body where you want to look to the front and you want to have more information on the tissue you see on the camera at hand. So, and that can be done in the colon, bladder, in your brain, or with social operations. But we have decided to start with bladder cancer because, in bladder cancer, there's a huge need in diagnosing the invasiveness of the bladder cancer. So in the center, you see here the image; the normal camera just sees, in the center of its image, there's a tumor. But once he sees this tumor, he has to know—he wants to know how far this tumor has been growing inside the bladder wall. Because he wants to know, is it muscle invasive or non-muscle invasive? That is directing the treatment plan you are going to get. The current standard is that you have to go for surgery, you have to plan the surgery, you have to take out the tumor, you have to do the examination, and you have to plan another result, and you have to do the consult for what is the treatment plan. That takes, on average, six to seven weeks in the Netherlands due to all kinds of restrictions. So what we provide with our catheter is, on the fly, this depth structure information. So the urologist, once he sees this image and he sees a suspicious area with the tumor, he can directly determine muscle invasive or non-muscle invasive, and that is speeding up the diagnosis time and better treatment plan dramatically. The current standard of care results in the following aspects: one out of five bladders which have been treated for muscle-invasive bladder cancers are all removed, but one out of five, they don't find any tumor back, and they are looking for ways to determine which bladder can be preserved and which bladder you have to take out. But just imagine that you have a bladder taken out; one out of five, which is taken out, the rest of your life you have to live with all the complications in the follow-up surgeries for recurrence. A large investigation from Denmark, with more than 10,000 patients over 60 years, proved that half of those surgeries were not necessary. Just imagine one out of five. When you talk to urologists, they will tell the patient, "Good news, there was no cancer." But they have used this operation space; they have used you as an old patient that you went for operation, all kinds of complications. You don't want to have that. So huge savings you can get here. But very important also is once you come for the first time to the doctor, to your desk, and you have an expectation of bladder cancer, and it is muscle invasive, you need to know as soon as possible. So once you know it earlier, instead of the seven weeks, that is saving lives because you can start much earlier with the treatment, the right treatment. So our product is a disposable catheter, single use, for all kinds of reasons, but it's safer, and doctors like to use single use. Compared to the number of surgeries, we prevent the waste of this single-use catheter; it is nothing compared to the whole waste of one surgery. Besides that, we have a base station, so that's a machine—that's the console where we hook up the catheter, and we also hook up the image we get from the standard cystoscope. So we always provide the image from our OCT with the camera, so you always have stored distinct images. Bladder cancer is a huge market. Nobody is expecting that. So when you go to your local conference, it's all about kidney stones, prostate, and then we forget half the population called the women, and then bladder cancer is a little bit under, well under the radar, but really huge. So when you just take the US and Canada and Europe only, that's a huge market on its own already. It's pretty much scalable. I said in the beginning, you can look forward and you have this depth information, which is really, really important. Even when you look to a Da Vinci robot, for example, when you combine our OCT catheter with the camera view, and you can discriminate between nerves and muscle layers, you can do a much more precise surgery than you can do nowadays because you don't have this depth information. We provide the depth information, so it's scalable, very nice. So where are we in our development? We just recently got our ISO certified, ISO 13485. We are about to start with the first in-human clinical trials in the coming weeks in the Amsterdam Medical Center. So all the preclinical studies have been done, and very good results. We have an approach for FDA and for CE, and we are continuously working on getting more key opinion leaders in the US and in Europe on our site. And the funny thing is that people start to approach us themselves; when we go to conferences, urology doctors come to us, "Hey, can we do a clinical trial with you?" They are really eager for this because they all understand every urologist, "I need this information." This is really the huge unmet need in bladder cancer diagnostics. So, a nice, diverse team from the variation of women and men, and also from age. We get here a woman starting first of October, also more or less my age; we have a lot of experience. So that's very diverse. We also have the OCT knowledge base—20 years of OCT research really at hand and at our desk. So that's good. Then we have also a clinical advisory board, where we have members from California, Germany, France, and the Netherlands. So we have the spread around, where we have a quarterly meeting with them. We have some advisory board members, including a person from Sontag, which is the last management deal or investment deal, part of our advisory board. And we have a huge list of suppliers, and actually, that's the difficult thing of a startup—just managing those suppliers. We are starting to raise money for a round next year, so we are looking for a round of around 7 million euros. And, yeah, well, everybody who's interested is invited to send an email or a phone call, whatever, to make contact and see what can happen. Do.
