Thanks, everyone, for being here. Our next company presenting is Photocure ASA. Here to present, we have the CEO, Dan Schneider. I'll hand it over to you.
Appreciate it. All right. Good morning, everyone. Thank you for joining us today. All right. Just some reminder, disclaimers are in place for today's presentation. A little bit about Photocure. You probably can tell from me that I am American. However, this is an Oslo-based public company, formed in 1997, public in 2001. We have 105 employees. We are global in commercialization in terms of Europe and the U.S., and approved for over—Our product is approved in over 30 countries. Photocure began as an R&D company focused on photodynamic therapies and photodynamic diagnostics, and that's where it's led us here today. A little bit, what we're going to talk about today is bladder cancer. More than 10 years ago, you barely got a mention at AUA and EAU.
It just was sort of out of the picture. People were kind of happy with good is good enough. That has rapidly changed. There's a lot of new therapies coming to market. It's very exciting the place to be in the urology space. But specifically with bladder cancer, there are over 573,000 new cases every year. There's still 200,000 deaths. Patients are constantly having issues, and it's I think what surprises a lot of folks, it is also the most expensive cancer to treat. It's because of the way the disease recurs and progresses. Recurrence rate up to 80% within 5 years. So basically, if you get bladder cancer, it's probably going to return. However, we think we can make and have made a difference in that.
The most important part of it, the progression rate from non-muscle invasive, which is treatable, to muscle invasive, which becomes a, you know, a much more difficult situation for patients. Our product specifically is a diagnostic, drug device combination. We sell the disposable. This is a razor, razor blade business model. On the left side of the slide is the product that we sell. It's called Hexvix or Cysview, depending on where you are in the world. The product is, lyophilized powder that is reconstituted and instilled into the bladder. It is preferentially metabolized by the cancerous cells, and under a blue light cystoscope, it, it makes the cancer glow bright pink, basically identifying all the cancer throughout the bladder itself. On the right side is the hardware that is used with it, the large devices. In the case of the US, it's KARL STORZ.
Worldwide, it's KARL STORZ, Wolf, and Olympus, but soon, others are joining into this space. It comes in a rigid scope that is used in the operating room or in a flexible scope that is used in a physician's office. The whole idea of this is that we sell our product once the device has been installed into a hospital or physician's office. So what does it do? I think this is the most dramatic. If you go back two slides, you think about progression rates up to 80% within five years, or recurrence rates up to 80% in five years and progression up to 50% within five years from muscle invasive. There's obviously been a gap in the way physicians have been able to identify, stage, and detect the cancer. Our product, because it is...
It unequivocally finds and displays the cancer throughout the bladder, can save and make a difference in patients' lives, up to 35% more cancer. So think about going home and being told that you have no more cancer in your bladder after the physician took a look at it, only to have missed it under a white light. Using a blue light scope with our medicine, they're able to detect 100% of that cancer within the bladder. So what's the patient journey? Typically, what happens to the patient, usually has blood in the urine or so there are pains or complications in the urinary tract. They go see the urologist. The urologist will initially scope their bladder with a white scope inside the physician's office.
They'll also take some other tests to see if there's anything suspicious. If they do think something's suspicious, they'll book the patient into the operating room for a TURBT, which is a resection of any cancers and biopsies within the bladder. There are over 700,000 of those procedures in the U.S. and in the EU. After doing that procedure, they then give a chemotherapy, and as I mentioned early in today's presentation, there are a lot of new therapies coming onto the market. They'll use therapies, and then the patient is asked to return on the bottom of that loop, which is the recurrent, the recurring surveillance that has to take place for that patient for the rest of their life. Depending on the risk, stratification will determine how often they come back to see their physician.
If you're high risk, you're probably back every three months. If you're low risk, you might be back once a year. Again, the whole key to this is identifying the cancer, detecting it completely, and staging the patient so you get the right diagnosis and treatments. Our product is used in the operating room and the surveillance setting, where there are about 200, about two million procedures being done in the U.S. and EU. The whole idea is to keep that patient to the left of this chart and not allow them to go into the red, the muscle invasive, where life expectancy drops significantly and quality of life is significantly affected. So what about the product itself? It's in a highly supported environment. It's on all the major guidelines.
Basically, they state that if blue light cystoscopy with Hexvix or Cysview is available, it should be used. We have a lot of media going on, and as I said, the bladder cancer space itself is drawing a lot of attention right now. But the key to all the therapies coming out and everything that starts and begins in bladder is to get the right diagnosis from the very beginning and get a complete and proper TURBT resection and staging in that patient. So we believe that we can affect that. In the U.S., we do have a challenge. There's only one manufacturer. It's because of the way the FDA had approved the product. It's a Class III device. However, KARL STORZ has submitted a Citizens Petition. We expect a reclassification and all the other manufacturers coming in.
We know of at least 12 other device manufacturers who want to come into this space. We think it'll have a significant, inflection point for us. In Europe, we're approved with Wolf, Olympus, and Karl Storz. All the major manufacturers are upgrading all their systems to the latest technologies in high def LED. And we expect, again, other, manufacturers also to join this space. So how has it grown? You know, the new system with Karl Storz just upgraded in the U.S., it's now about 35% of the installations in the U.S. You can see a nice, steady growth, path on the rigid scopes in the operating rooms. It continues to draw tremendous interest. This is not cheap equipment.
It's around $200,000, so it does have to go through a, you know, proper process in the hospital systems with capital budgeting and P&T committees. But once it's installed, then we can start selling our product. A little bit about Europe. When... Like I mentioned early in, we were an R&D-based company. We actually commercialized the Nordics, but then partnered out the rest of the world. Since doing that in early 2000s, we have taken back, and most recently, Europe. Ipsen was selling this product. If you haven't picked up at this point yet, this is a drug device combination. The product itself, even though it's a pharmaceutical, with a very high margin, and it is, you know, it's a recurring revenue stream, it is also sold like a device.
It requires the sales service and support that any device would need. But since getting back the product in Europe, we've kind of divided Europe into three kinds, I would call, categories. The established markets of the Nordics and Germany, DACH region, the priority growth markets of U.K., France, and Italy, where we expect high growth as we've now entered into those countries, and then the untapped EU markets, some of the smaller, Spain, Poland, et cetera, which we continue to assess. But we expect Europe to, you know, since taking over in the midst of COVID, we're seeing an inflection point now in Europe as well. The overall addressable market is about $2 billion. The whole key to this slide, we have everything in place on the right. The whole idea now is to move those bubbles, those market sizes, up that adoption curve.
We use the word penetration and not market share, because there is no competition for our product. We are selling against white light cystoscopy. It's just been the standard of care forever. We're bringing a product in. There is no competition for it. No one's selling against us. We just have to sell it in, and we believe we're in a great position right now. A couple other things. As I mentioned, we are an R&D-based company. Originally, we had the product partnered out. Cevira, at the bottom, is a product used for precervical cancer. Again, another product produced or created by Photocure, but we partnered to a company called Asieris. They just had a phase III readout. This had significant milestones for Photocure in a long-term revenue stream for us.
On the top is a phase III trial for Hexvix for approval in China for our product. So this is exciting. They will commercialize in China, Taiwan, and then Cevira will commercialize on a worldwide basis. But in both cases, we have significant milestones and revenue streams into the future. A little bit about our mission. We're focused right now on the accelerate and expand stage. We're focused on bladder cancer. We're focused in on how do we accelerate our own product, but over time, and we have been looking for acquisitions to transform the company. We are the bladder cancer company. All things in bladder cancer begin with a good TURBT, and we believe we are in a great position with a commercial footprint on a global scale. Some anticipated milestones of corporate objectives. We talk a lot about our guidance.
65-75 new Saphira blue light tower installations in the U.S. is a significant growth. We expect to hit that. We also expect a positive EBITDA and revenue growth in the 17%-20% growth range. In North America, or U.S. specifically, our penetration has been fairly low. I took over about five years ago. We have done a transformation on the organization. Of course, we got hit with COVID in year two and three for me, so we're back in here now post-COVID. We're starting to get the traction again, but we expect blue light to really pick up. The Citizens Petition will be a key inflection point for this business because right now it is a monopoly owned by KARL STORZ.
They have not been the easiest for us to work with, but we believe with the Citizens Petition to move the product from a Class III to a Class II, opening up the 510(k) pathway, this will, and we know for a fact, the other manufacturers, specifically Wolf and Olympus, are intending to file into the U.S. That will bring their sales forces and their firepower, plus the competitive economics of competing for price back into the U.S. market, and we want to grow and get the penetration rates similar to what you see in Germany at 45%. The other thing is there's a lot of data. We're publishing a lot of data. We have the world's largest, or U.S. largest, patient registry on bladder cancer.
It is now, well, we're kind of monetizing it. All the other major manufacturers, companies, therapeutics, are coming to see us. They want access to that data set. That data set has got rich with data on the impact of Blue Light Cystoscopy and what it means for patients' overall survival over time. We intend to continue publishing from that. And as I said, the phase III trial on Cevira read out positive. They'll file for that in China and hopefully EU, and that again comes with significant milestones in the future. And finally, I'll land on this final slide. You know, I think when you think about Photocure, I think you think about a company that has started out as an R&D-based company. My predecessor was an R&D CEO.
The company made a decision to become a commercial organization and kind of leave the R&D piece behind. We're focused heavily on that, on the commercialization and bladder cancer, specifically. The bladder cancer space has gained a lot of attention in the last seven-10 years now. If you went back to AUA, EAU back in 2015, there was barely a thing said. Everything was about prostates. Now, the big topic is bladder cancer, because why are these patients still dying? Why are we misdiagnosing them? And our hypothesis is that they don't diagnose them properly because they're not using blue light cystoscopy with our product. If you see all the cancer, you're able to get a better staging and treat it completely. And the guidelines throughout the world are supporting that.
And we believe the U.S., where it is right now with a penetration rate under 10%, has significant growth opportunities for us, in the U.S. specifically. So I got two minutes left. I'm supposed to leave time for questions. Any questions? Yes.
KARL STORZ is already in the U.S., the FDA.
It's been a challenge. So in the device world, the key to devices is you've got to continue to iterate and upgrade and improve your technology. Under Class III, which is what they currently were approved on, with, you know, from the FDA, you know, something that they thought they wanted until they found out how difficult it is for them to even upgrade.
This recent upgrade to the Saphira system, which is not even the latest technology, it's not, not the 5K or 4K stuff, it's just high def. Even that took them about six or seven years. It's a lot of time, money, and effort, and the hit on their reputation has offset any benefit they thought they'd get as a monopoly. So that's part of it. The other part is the technology right now as a blue light scope is sold as an independent device, and they want to have a universal machine so they can plug in all kinds of different instruments, you know, whether it's blue light, green light, red light, or other uses for it. So it's, for them, they see it as a opportunity to grow and improve the product. Any other questions? All right.
Well, thank you. Appreciate it.