Thank you for having me here today. I'm going to introduce you to FluoGuide, and for those of you knowing FluoGuide, they give you a brief update. So what we do is that we light up cancer principally, and if you look at this image, that's how the surgeon will look when they have a patient. They open up the patient, and they have to make a judgment: will there be cancer here or not? What we do basically is that we light it up. So this is an example, real-life example, where we have a patient. We have given our drug before surgery. We have the camera, and we switch it on, and the surgeon can clearly see that this lymph node is filled with cancer. So this is what we do, and please make your own assessment of what I'm presenting.
So in short, cancer is frequent, as we know. It will occur locally frequently as well, approximately half of the time for the surgeons, and not because they're bad at any time, but because you only have the fingers and the eyes. So precision surgery is really important, and there's a huge need for that. We have a unique uPAR-targeted imaging that is proven. I mean, from scientific rationale, it should work across all solid cancers. We have proven it in three indications: lung, head and neck, and brain cancers. We have orphan drug designation in the U.S., and we have interaction with FDA. I'll come back to that. So we have a home run in that indication: first product, first market, and yeah, first product. So we have a partnership with large medtech companies. It's Intuitive Surgical, the world's largest robotic equipment manufacturer.
We have Olympus, that is an imaging, I mean, they work with scopes and also equipment, and we have some that will come up, and then we have some catalysts that will come back to them at the end of the presentation, but we have some interesting catalysts coming up soon, so as I mentioned, cancer is unfortunately a frequent disease, and about 20 million patients every year will be diagnosed with cancer, and about half of them will be offered surgery, or 12 million, and then half of them have recurred afterwards, but there's 45 expectancy of 45 million procedures to be done because some of the patients that today are not offered cancer surgery will be offered surgery in the future with the right techniques that are offered to them.
Further, some of them are offered surgery more than once, and we can help every one of these 45 million procedures worldwide. This is just two examples from our clinical trials with some imaging. We are focusing in on aggressive brain cancer, high-grade glioma it's called, and then head and neck cancer, all from squamous cell carcinoma to be precise, and this is an example of what it looks like. On the left side, you will see how it looks in white light as we see it, and then on the right side, you will see it with the equipment, and up there is a microscope, which is the way the microscope presents it, and it's black and white, so what is white in the middle there is a cancer.
There's a very dense white area on the left side, which really is where there's a high concentration of cancer, and then there's a more light white area on the right side. There's still cancer, but on a lower concentration, and this is very important for the surgeon when they do surgery in the brain. They have to make an on-the-fly decision because if they remove too little, it will come back, and if they remove too much, they disable the patient, and now they can see there's still some cancer on the right side here on the cavity, so what is underneath here? Is that a sensitive area? Is it the movement? Is it speech or something else that is important for the patient? or will it be a less important area where they can just take it out?
They can make that decision on the fly, which is really an important thing. If you look at the left side, it's how it looks today, and it can really be hard for them to see what is cancer or not. The bottom, that is an example I showed before. That's in head and neck trials, and you can see the camera there present the light in different ways. It's an overlay to the white light image, so you can see the left image below, and then you see the overlay on top of it. The different equipment manufacturers have different ways of presenting it, and that's why we work with many of them, and there's a huge opportunity to work with this overlay together with the image manufacturers. As I said, we have a kind of a home run. We have the indication.
We have very good feedback from FDA. We have a very solid primary endpoint, and we know what is needed to be done. So the key thing for us is to risk mitigate, and there's, of course, the technical risk and the commercial risk. On the technical side, we have designed the molecule in a way that we have used and known fluorophore, and that is important for us because we know that it was very well tolerated, and there's no long-term toxicity of this fluorophore, and that is giving a high or low risk of failure in phase III because of side effects, and that's also what we have seen in the preclinical studies as well in the clinical trials where we have more than 100 patients now that have extremely well tolerated the product.
Then we have shown that it works across three different indications, and also we now have the discussion with FDA. I'll come back to that in a second. On commercial, it's also important for us to de-risk it. There's two things we have done there. One thing is, again, the fluorophore we work with has been designed so it works with all the hardware of all the manufacturers. So we chose a fluorophore that works with the laser system, the detection system in the hardware, which means that basically it's plug and play. It can work with any equipment out there, but they can change the overlay, as I mentioned before, the software they put on top of the images. This they can change, but that's only software. All the hardware works as it is. The other thing we've done is that we have started this non-exclusive agreements.
We have done the one with Intuitive Surgical, Olympus, SurgiVision, and one to two more to come in the next six to 12 months, and that is a way for us to partner up with all the different kinds of equipment manufacturers, so the microscope, endoscope, robotic surgery, and that way we can actually have a much stronger push into the market when we get to that stage, so the feedback we got from FDA, it was one of the meetings where we put everything on the table. We took all our reports, everything on the table, so they could see it, and actually we could see in the question that they also read it. We got a face-to-face meeting with them, which is really rare at the moment because they're squeezed for resources and time.
By offering this to us, it was a sign of they recognize that we were serious, that we put things on the table, and of course they like that, that we do that because even if there's something you don't like to ask them for, it's nice to get the answer now rather than three years' time. So we get everything lined out. We have all our preclinical work done. We know the clinical trials to be done, and we have a primary endpoint that is very comfortable. It means that it's very robust. So it's not that we just got on the borderline to get approved. We really have a robust primary endpoint.
So we are on track then to make our IND filing at the end of the year, and we put actually some of the clinical stuff into that pre-IND meeting already now, so we have that ticked off. It will be a 40-patient study. The endpoint will also be the one we use in the phase III. So it's gross total resection, meaning completeness of the surgery measured by MRI measurement 48 hours after surgery, and the comparator will be white light, and that's why it's very robust because there's about, I mean, we can see in a previous study that about 20% or so for white light patients will have a complete resection after surgery. It's 60%-70% with our product, so there's a huge gap between the two.
We got feedback from FDA that they quite appreciated our approach, and we also have that echoed by the investigators we are setting it up with, so we have very good feedback. As I mentioned, the agreements we have done. It's Intuitive Surgical, it's Olympus, and all the equipment on the left side you can see. It's a very nice partnership actually we do with those because it benefits the surgeon, the society. We can help more patients more, but also it helps the manufacturers, and that's why they like to go into these agreements because they can sell more equipment.
As an example, in head and neck cancer, today approximately 15% of it, in the oral cavity, is offered surgery, but if we have good equipment, you have our product, then you can also offer surgery to the more complex location, sitting in the pharynx, the larynx, the more difficult-to-reach location. You need a thin scope. You need to get into the small space cavity in the back of the mouth to get down to that cancer, and you need a drug to actually light up the cancer so you can see the cancer, and that's why we enable them with our product to get into those cancers. The surgeon is happy the equipment manufacturer can sell more equipment, and we, of course, get pushed into the market.
When we get there, we have the possibility to prepare the equipment so we do the right overlay, have one button on the equipment saying FluoGuide, so the surgeon doesn't have to adjust all the equipment, and that, of course, makes a huge difference when we get to that stage. So the market potential is quite huge, and we're actually only starting in a small corner of it. I talked about the 45 million procedures. If we slim that down to the 9 million approximately, that is highly relevant for our product in near term, then slim that further down to the head and neck and brain cancer, slim that further down to the Europe and U.S., which we have the two areas we are focusing in on.
We have just three times block buster potential in the very end, and that actually means what we have to do is two things. We have to de-risk to get there, and we have to penetrate the market. That's the two key things we have to do. Last year, in November, we put out what we expect to achieve this year, and we'll do the same in November in our quarterly report for November. We put out for next year, and we're actually on track with that, so we have the data for the low-grade glioma, high-grade glioma, meningioma, two other brain indications that will be announced later in October the 5th, and we have the pre-IND meeting ready to do IND filing, initiated our head and neck trial. We were on track for our 15-patient readout end of the year. We've done one to two more partnership agreements.
With this, I'll just say the very last one, some very interesting interim phase II data coming up, IND filing, and more partners will be expected.
Thank you, Morten, for a very interesting presentation, and it's always nice when you see some moving images, and it looks remarkable. So I have to ask, is there any competitors? Is there anyone doing anything similar?
Yes, there are competitors in the market. You have, for instance, you have different first-generation markers that is, and then you have the second one that is more specific to cancer. I think what is differentiating us from the other ones is a couple of things. One thing is that it's equipment independent, so it can be used on all types of equipment. One thing is it can be used across all the solid stage cancer, and last is the safety one, which is quite important because we can push up the dose, so we actually enable even less good equipment that they can see our product because we can push up the dose because we are not limited by toxicity. So I think we are on a very interesting spot.
We need some time to develop the market, and we're just coming at the right time with a very good marker.
Yes, because there is also a question on how you plan to position yourself in the market.
Yes.
Let's see. Yeah, turning a bit to the U.S., how important is the U.S. regulatory process for the overall development and the commercial sales? I've been talking too much today. Strategy?
Yes, as always, the U.S. is important. I mean, they pay more. They are, from a hospital sales point of view, more homogeneous than the European market. The regulators in the U.S. have both a combined device and drug in one entity, meaning, of course, you have to have this in notified bodies and EMA. So the FDA feedback is more qualified than Europe at the moment. And last point is that some of the other imaging agents are being approved in the U.S., so that means that the FDA has a lot more experience with endpoints. So for us, it's to set the bar the highest. We went for them first because we got the most qualified feedback, so they're very important.
So U.S. first, Europe second. Are there any specific markets within Europe, or you view it as a?
It would be the typical approach. I mean, it would be the large markets first.
Let's see. We also had a question on pricing. So two to three times blockbuster given what product price, and how does that price sort of compare to the alternatives on the market?
Yeah, well, the alternative to the market, the price point in the U.S. is about $5,000 per treatment. That has been roughly the level where competitors have landed on, and there are competitors approved in lung cancer, ovarian cancer at the moment that had that price, so it's roughly where it ended up. In Europe, it's a little bit lower, and we would anticipate that will be the price as well for our product, so around $5,000 per treatment. And then we have a treatment aspect of it as well. If you increase the power of the laser light, you can kill the cells as well. That's something that comes after. Then the price point will go much higher, but it's a longer development. So for now, $5,000 per treatment.
And then we take the next step, hopefully.
We take that next step.
Take it when it comes.
Yes.
Thank you so much, Morten.
Thank you.