Well, good afternoon everyone in Europe, and good morning to those in the U.S. I'm Dan Schneider, President and CEO of Photocure. Welcome to first quarter 2023 results. Joining me in today's presentation is Eric Dahl, the Chief Financial Officer, and David Moskowitz, Vice President of Investor Relations, who will be translating questions, and at the end of today's session. Next slide please. Slide two. Just a reminder for everyone on call today, disclaimers are in place. Slide three, please. I think the headline is return to growth for both regions. 30% revenue growth, 8% unit growth. Sequentially, revenues were up 12%, and sequentially, and Q4 demonstrated in demonstrating the anomaly that we spoke about in Q4. U.S. volume on unit was up 16%, and Europe was up 6% year-over-year.
Hospital budgets still remain challenging, U.S., Germany, Italy, we continue to grow the business nonetheless. I think excitingly, 30 new Saphira towers were installed during the quarter, 18 new, 12 upgrades. In addition to new account growth, we believe the upgrade equipment is important to keep physicians engaged in Blue Light. It's not only the visualization, but it's also the reliability, which we believe is expected to help increase productivity per tower per account. We'll get more to this as the year progresses. It's too early to measure this with any certainty or prove it out, but we will be coming back later this year to support that hypothesis. Just a reminder, you know, Q4 there were 24 rigid and 7 Flex installs, so a total of 57.
We've had two back-to-back huge quarters of installations, which bodes well for the future, in sales. On citizen petition front for the US in key news and events, the process continues to move forward. The potential FDA comments to KARL STORZ will come at the end of May. This is no statutory requirement. There's no requirements in terms of timing. However, we have put a lot of effort behind this. If anyone has gotten on the public comments, you'll see a lot of comments from various parties, stakeholders, manufacturers, patients, patient advocacy groups, KOLs, et cetera. We believe we have a reasonable opportunity to encourage the FDA to address this issue of the Class III PMA current status of the blue light scopes and moving it to a Class II.
We had great visibility at medical conferences, the largest conferences in the industry, both AUA and EAU over the past 60 days. There were a lot of scientific sessions where blue light was featured. We have a slide for you today to talk about, you know, kind of what we did this year versus prior years. I think it was quite astounding. The reception by KOLs and clinicians was very good. We'll talk about that a little bit later today. We also had two peer-reviewed publications demonstrating the benefits of BLC. All right. Next slide four. Let's go into segment trends. Slide five, please. There's still market challenges.
TRBT procedures appear to be stabilizing from declining trend in Q4. The good news is that Cysview and Hexvix continue to gain penetration adoption, especially with new BLC equipment upgrades by all manufacturers. As you are all aware, Richard Wolf has state-of-the-art equipment. KARL STORZ has upgraded their equipment both in the U.S. and the EAU, we expect Olympus to upgrade their blue light equipment later this year. We'll talk about that a little bit later. Staffing shortages are still an issue globally. Economics are playing into capital budgets, we expect this will resolve over time. The new blue light equipment rollout, there's broader recognition of the benefit of blue light, that is the key driver for continued growth and combat the winds of staffing shortages. Next slide six, please.
Both territories back to growth in the quarter with sequential months of solid growth. US quarter was the best in history. Each month in North America was a record month. Momentum continued to build. In Europe, January started off a little bit soft, momentum build as the quarter progressed. Staffing shortage and strikes are still an issue in parts of Europe, we expect these to resolve. I think the good news from a year ago is we still had limited access in 2022 through May, we now have full access to accounts here in 2023, we're expecting a continued growth in the European market. The growth markets are up 2% over year-over-year in Q1, again, expecting this to continue to accelerate as we move to the back half of the year.
I wanna remind everyone, last year, Q2 in both US and EU were quite strong as we were rebounding from the Omicron on a worldwide basis, and EU had limited access up until May. We are coming up, but we expect a strong second half to this year. Next slide seven, please. Strong quarter for our US business, 38% revenue growth overall. Unit growth is 16%. There was a benefit from the foreign exchange. We had 30 new Saphira installed. That's on the back of 57 in Q4. That makes 87 new towers that are out in the market. Of the 18 new towers, 17 were new accounts. one account took two towers. We also had 12 upgrades.
The overall base, and I think this is something that's quite astounding, 25% of the rigid towers in North America now are Saphira, which I think bodes well for future growth. Demand remains really, really strong. Our pipeline and the interest is very, very high. In fact, under the old system with KARL STORZ, there were only two evaluation towers. Evaluation towers are used prior to purchases, gives the accounts a chance to trial the equipment before they buy. We only had two with the old standard definition. We have had such a demand that KARL STORZ has increased that for this new version, the Saphira system, to a total of eight. That's three-four times the capacity, which bodes well to future installations and purchases.
Enables more accounts to get into the pipeline and trial the new blue equipment and purchase. KARL STORZ continues to assess the demand and the need for maybe more evaluation towers in the future. There are two key activities in North America that I wanna speak about today. One is the reclass process in the U.S., and the second is Flex discontinuation by KARL STORZ, which I'm sure is on everyone's minds. Let's first talk about the reclassification process in the U.S. The systems petition, we've had great support, as I mentioned, KOLs, equipment manufacturers, patients, patient advocacy groups, and actually manufacturers of therapeutics, both now and ones coming onto the market. We are approaching the 210 days from the filing, so that date is around May 25th.
There is a potential for KARL STORZ to get feedback from the FDA. However, there's no statutory requirement. In other words, the FDA does not have to respond. Given all the pressure and effort we put in behind this, we feel that there is a good probability the FDA is gonna respond to this petition. Like anything with the FDA, especially if it's not statutorily required, this could we don't have an exact timeline on when this process might take place. I think it bodes well that the FDA had already identified several years ago that the blue light cystoscope would qualify for potential consideration for a down-classification. That was from them. The fact that KARL STORZ initiated the process and that we have strongly backed it along with all the stakeholders, I think bodes well.
I think in addition, having Flex now being discontinued, is a direct impact on patient care in the United States, especially on the eve of a lot of these second-generation therapeutics coming out that are dependent upon the identification of CIS and patients who are suffering from cancer. There's a lot kinda coming together, and we feel pretty good about, but we do not have. There's no statutory requirement for response from the FDA. We will update everyone as things progress, if there's anything to update on. On the Flex discontinuation by KARL STORZ, as we mentioned in the Q4, they initially said there would be no installations in 2023. We did have a pipeline of accounts, a very healthy pipeline for Flex. It was continuing to grow in interest.
As you know, I think on 2nd January , a paper was published by Neal Shore talking about the economics behind using flexible cystoscopy in the outpatient setting. This is, you know, this is unfortunate situation. They subsequently, after that, have told us that the entire support for Flex will be discontinued by the end of this year. They're actually targeting October. This does not mean that all Flex will go away. We have a couple different initiatives in place to keep the existing base going for as long as we can go, but there is an eventual termination of the current Flex system.
We are working on an alternative opportunity where we could perhaps work with another manufacturer to bring Flex back into North America and Europe. We will update you as that progresses. We estimate the Flex sales impact for the new installations that we anticipate this year to have a 2% impact on revenue. The overall Flex market, which is predominantly US, it represents about 5% of our global sales, and it's approximately 14% of the US sales. We feel that the effort we're putting behind the rigid systems and the interest, we believe we can make up a majority of all that, if not all of it. We will work hard on that this year.
That the, that is the key to this whole situation. Again, it is unfortunate, but it is fortunately, I guess, in a sense, a small percentage of our total business and one that we think we can make up this year in our rigid tower business. Next slide 8. Speaking of towers, we had another good quarter of tower placements despite the unavailability of Flex blue light scopes. There was a pipeline growing interest for Flex, as I mentioned, to detect CIS and BCG unresponsive patients, and reimbursement had improved. It's unfortunate situation. We will continue to exploit Flex. We do not believe there was any loss of business in the first quarter.
We're not anticipating a major loss of Flex business in the second quarter, but as we move through the year and into 2024, there will be a phasing going on. Overall, we grew the installed base of rigid scopes by 20%, and as I mentioned, now Saphira represents 25% of the installed base in the market, bringing better visualization and reliability in the operating room. We think this is important as image quality and system reliability, and the ease of use will support the usage of Blue Light Cystoscopy and increase the productivity of our existing accounts that upgrade. Next slide nine, please. Moving into Europe, Q1 trends in Europe also show recovery from the Q4 anomaly. We had good growth at 6%.
26% sales growth with the benefit of the German price increase in mid-year 2022 and tailwinds of foreign exchange. After taking over the Ipsen territories in Europe during the pandemic, we had to relaunch these countries that were in decline for years. This is extremely difficult in its own right, let alone face COVID and the lack of Carewell support and dated equipment. We believe we have a good handle on this. We've got good traction, and we're expecting strong growth through the second half of this year. The challenges do remain. Europe does have strike issues, staffing issues, et cetera, but we believe we can work through those. We also coming in a second half, there's the German bus tour, which will run in September and October.
There's been tremendous interest, as you see the picture to the lower right. It'll make 20 stops throughout Germany and Austria, and there's even more demand. This is the interest in Blue Light Cystoscopy. They'll be surrounded with scientific programs for patients and marketing activities that will take place. All right, next slide 10. As I mentioned, we regained the rights to EU in the midst of COVID and its aftermath. This is a relaunch into what was all but forgotten regions suffering from the lack of support over the years. When we took over the region of Europe, continental Europe, there were no KOL support, no data, no new data, old equipment, a long sales process, capital equipment manufacturers who had no relationship with Photocure, reimbursements, and guidelines that needed improvement.
I think we made a lot of good progress over the last two years despite the challenges of COVID. We're seeing good signs of growth, especially as we look into second half of this year. EAU, and we'll get into the congress in a moment, had tremendous support and a lot of stage time for Blue Light Cystoscopy. The established businesses of the Nordics and DACH expect to remain steady growth. You know, Denmark and Norway to a lesser degree, although we believe both are tremendous opportunities, for those that are aware, Denmark and Norway are heavy Olympus strongholds. There's tremendous, what's the word I wanna use? Tremendous support by the accounts. They're very loyal to Olympus. Olympus's Blue Light equipment is woefully behind times.
The good news is they are going to launch VISERA ELITE III , the later half of this year and into 2024. It is the latest and greatest in blue light technology. We think this is an exciting development for both Denmark and Norway, and we see them to returning to growth in late 2023 and into 2024. That is the good news. France, UK, Italy will continue to upgrade some of the old KARL STORZ equipment, also installing new Richard Wolf. When Olympus comes into market where it matters, although a lesser degree in continental Europe, they'll also upgrade to that. There's strong interest in new accounts in UK and France. We have a nice pipeline growing behind both of those countries. We've reversed the c-curves in all these countries.
I just, you know, giving you a flavor for this, you know, The CAGR for Italy between 2014 and 2018 was -7%. In 2019, it was -20%. We picked it up in 2020. In 2022, we grew 2%, and so far this year, we're up 12%. The UK, -15% through 2018, CAGR. In 2019, -10%. In 2022, we're at -5%, and this year up 30%. France, the CAGR, -1% through 2019. We've got 6% in 2022 and +17% in 2023. Again, you know, reversing the downward trends is a tremendous amount of effort and time.
It takes an engagement on all levels. I think the European team has done a fantastic job of doing so, and we're expecting good growth as we move through the second half of this year and into 2024. Let's go to slide 11, please. I think this slide is the picture tells a 1,000 words. You see the amount of activity comparative to 2022, 2021. I will tell you in 2020, 2019, particularly in Europe, there was actually nearly zero if not completely zero mentioning of Blue Light Cystoscopy. We're seeing great success. It kind of indicates the level of exposure we've gotten at the recent conferences.
It doesn't account for activity at our booths or at the booths of Richard Wolf, KARL STORZ, or even Olympus, who did have the Visera three there. Plus the discussions with other companies where these collaborations could take place in this space. We expect the activity to translate into Blue Light Cystoscopy growth. It is more powerful now that the blue light equipment has been upgraded and KOLs are activated. Should reclassification occur in the US, we expect this investment to gain even more in traction. A couple details. EAU, we had the new global brand rollout, KOL interviews. There were 52 interviews recorded at the booth. Some of the who's who, Mariappan, Palou, Daneshmand, Babjuk, Gakis, to name a few. Morgan Rouprêt was talking about the PHOTO study.
We'll get to that in a moment, as that was debunked on stage. There's more active interest in PDD and BLC than in any other EAU. The session between Morgan Rouprêt and Rakesh Heer was fantastic. Rouprêt basically debunked the entire PHOTO trial. Subsequent to that, the EAU guidelines have been updated, and for the first time, they actually do list blue light cystoscopy rather than just enhanced visualization. That is a tremendous highlight for the guidelines as it's specific to our technology. We had a fantastic EAU. Since the PHOTO trial was out there have been eight editorials supporting blue light cystoscopy, and the existing evidence for PDD and non-muscle invasive remains valid is basically the conclusion. There was no impact. In fact, it's been quite the opposite.
On the AUA side, the Nordic Registry provided further evidence for Blue Light Cystoscopy in the flexible, in the surveillance setting through our US BLC Registry. We had a real-world evidence concept session where US BLC Registry highlighted us as an example of a successful real-world evidence study. Put up, you know, in terms of real-world evidence, things to study in urology. They used our product, Cysview, and the patient registry in the US as a real-world evidence of a really well-run registry and the data that can be pulled out of it. We had BLC improving white light resections, and it should be used to train residents. That actually came out of the PHOTO trial, presented by Rakesh. We had the CME event reinforcing the benefits of Blue Light Cystoscopy with videos featuring images of Saphira.
I think what was most interesting is at the end of the session on Sunday, there was a BLC debate where two clinical, two current clinical practicing physicians, debated the benefits. One took the white light, why would you use white light, and the importance of the PHOTO trial. The other one took blue light. I will say unequivocally, the person who presented blue light did a fantastic job to the point where the follow-up from the white light was, the white light defender was at the end of it on a follow-up video. Basically said, "I'm glad I lost. I believe in Blue Light Cystoscopy." It was quite an impactful AUA and EAU, and I think all of this will bode well for the future of interest in blue light.
With that, we'll move to slide 12, and I will hand off to Eirik Dahl. Eirik.
Thank you, Dan. Well, we'll go through a financial review now, including the consolidated income statement, segment report for the two main segments, and finally, headlines from the cash flow and the balance sheet. Before we do that, let's talk a little bit about foreign exchange. Norwegian kroner has, as I guess everybody knows, depreciated significantly over the last few weeks. Year-over-year and measured by unweighted quarterly average, the US dollar increased 15.6%, and the euro increased 10.5%. Looking at our financials, the year-over-year foreign exchange impact for Q1 was for revenue positive approximately NOK 11 million, for COGS and operating expenses, negative approximately NOK 10 million, and the remainder, EBITDA, positive approximately NOK 1 million.
Keep in mind as we review the financials that, unless other currency is specified, all amounts mentioned in this presentation are in NOK. Slide 13, please. We're now looking at the consolidated income statement. Total revenue was for the quarter, NOK 106.2 million, which is an increase of NOK 24.6 million or 30% from Q1 2022. Main drivers were foreign exchange impact of NOK 11 million, as well as increased volume and average selling price. Consolidated in-market unit sales increased 8% year-over-year, and average selling price was positively impacted by last year price increase in both Germany and U.S., as well as country mix. Total operating expenses, excluding business development expenses, was NOK 100.5 million, an increase of NOK 13.6 million or 16% from Q1 2022.
The increase was mainly driven by foreign exchange, a total of NOK 9 million, and the remaining increase, which is approximately 5%, reflects the general inflation from Q1 2022 to Q1 this year. Business development expenses were minor in the first quarter this year. Operating expenses within business development are related to the objective to increase our product offering. The expense level obviously may vary from quarter to quarter, given the one-off nature of these expenses. EBITDA in Q1 after business development expenses was negative NOK 1.2 million. This is an improvement of NOK 12.7 million from last year Q1. The improvement is revenue-driven. Currency impact included in EBITDA is approximately NOK 1 million positive for the quarter. Depreciation and amortization, NOK 6.5 million in Q1.
Main cost item is the amortization of the intangible asset related to the return of the European business from Ipsen. The net financial items in Q1, a cost of NOK 2.4 million compared to a net cost of NOK 7.4 million last year. The reduced net cost is driven by gains on foreign exchange and incurred interest income. Tax expenses, NOK 1.6 for the quarter. The net tax expense is mainly driven by intercompany items in the parent company, and a minor amount for taxes paid in European subsidiaries. After net financial items and tax, we have a net loss in the quarter of NOK 11.7 million, compared to a net loss same quarter last year of NOK 22 million. Main single driver to this improvement is improved revenues, combined with flat operating costs adjusted for FX and inflation. Next slide, please. Slide number 14.
We're looking at segments this time. In the segment reporting, we will focus on the two main segments, namely North America and Europe. North America now includes both U.S. and Canada. Revenue for North America increased 38% in Q1. The drivers are an increase of in-market unit sales of 16%, as well as a 3% price increase second half of 2022. FX movements were significant as the value of US dollar appreciated 15.6% year-over-year. Q1 direct costs increased year-over-year with the $5.5 million or 15%. The increase reflects the strengthening of US dollars. The contribution was -$2.8 million in Q1, an improvement of $5.8 million compared to same quarter last year. The improvement is revenue driven.
Finally, EBITDA, excluding allocated business development expenses, was negative NOK 11.6 million in Q1. Our European business experienced year-over-year an increased revenue of 26%. This is driven by volume, by FX, by price increase, finally by country mix. In-market unit sales increased 6% year-over-year and sequentially from Q4 with 9%. The price increase of 6% in Germany middle of 2022 also had a positive impact. Finally, FX movements were significant as the value of EUR appreciated EUR 10.5 million year-over-year or 10.5% year-over-year. Direct costs increased year-over-year with NOK 7.5 million or 35% in the first quarter. This increase is activity based and partly the result of a different phasing of expenses this year.
Finally, foreign exchange and inflation drives expenses above last year. We ended Q1 with a contribution of NOK 29.6 million compared to NOK 24.2 million in 2022. EBITDA, excluding allocated business development expenses for Q1 was NOK 13.7 million, reflecting an EBITDA margin of 22% compared to 16% Q1 last year. Let's look at the cash flow and balance sheet. Next slide, please, and that's slide number 15. Net cash flow from operations, negative NOK 9.1 million in Q1 compared to negative NOK 22.1 million in Q1 last year, and the improvement was mainly EBITDA driven.
Cash flow from investments was in Q1 positive NOK 0.6 million. Cash flow from financing in Q1 was negative NOK 13.5 million, which was driven by the repayment of NOK 6.3 million of the term loan from Nordea, as well as the Ipsen earn out repayment of NOK 8 million. The remaining term loan at the end of Q1 was NOK 6.3 million. This will be paid at the end of Q2. This gives a net cash flow in Q1 negative NOK 22 million compared to negative NOK 37.4 million in Q1 in last year. The year-over-year improvement is mainly driven by improved EBITDA. The net negative cash flow reflects the financial cash flow related to the term loan repayment as well as the Ipsen earn out payment. Also the negative working capital development impacts the quarter.
Working capital development is normally negative for the first quarter and improving later in the year. Final repayment of the term on loan in Q2 and improved working capital will obviously improve the net cash flow second half of the year. With this net cash flow, we end Q1 in 2023 with a cash balance of NOK 260 million. Looking at the balance sheet, we end the quarter with total assets of NOK 706 million. Non-current assets was NOK 357 million at the end of Q1, and this included customer relationship of NOK 125 million. The customer relationship is the intangible assets identified in the purchase price allocation for the Ipsen transaction. Non-current assets also include goodwill from the Ipsen transaction of NOK 144 million and a tax asset of NOK 53.6 million.
Inventory and receivables were NOK 102.9 million at the end of Q1, and the increase from year-end is driven by increased revenue. Long-term liabilities of NOK 165.6 million include the earn-out liability related to the Ipsen transaction of NOK 133 million. Finally, equity at the end of the quarter was NOK 455 million, 64% of total asset. Now this concludes the financial section, and thank you. Dan, it's back to you.
All right. Thank you, Erik. All right. Let's move to slide 17. Final two slides. All right. you know, just a reminder, overcoming some significant headwinds from 2022, you know, KARL STORZ had delayed launch on the new Saphira towers till the end of the year. We installed a tremendous amount of towers in the 4Q, and we continued that pace in the 1Q with 87 Saphira towers now in the market, 80 towers in the Saphira in the market, which is around 25% of the base. There was a COVID resurgence in the 1Q and of course the residual effects through 2022 of staffing, et cetera.
Some of those residual effects are continuing into 2023, but we believe we're on top of things and more control, and we're expecting things to continue to develop in a positive way. We had revenue growth of 6%. The installed base overall grew 19%, and it was all Saphira in the Q4. Despite the delayed launch, demand remains high this year as we move forward. There's improvement in US Medicare reimbursement, which we believe will continue to support growth in 2023. You know, with reimbursement and funding, it's a never-ending battle. We continue to try to improve it, not only in the US, but throughout the European countries as well, including guidelines as well.
There's a lot of new data from our registries, a treasure trove of data that we believe is gonna produce the continued preponderance of data that will, you know, make Blue Light Cystoscopy, you know, the decision that all clinicians should make going forward. KARL STORZ initiated the reclassification process in the U.S. If successful, it'll invite more Blue Light Cystoscopy manufacturers into the U.S. market, creating an opportunity both in improving the technology, but also the competitive pricing of these will certainly have an impact on a positive impact on the U.S. business. Again, there is no statutory requirement. There is no necessarily clearly defined timeline to this.
I will tell you that the organization's put a tremendous amount of effort and time, and will continue to do so to try to push this forward, and with KARL STORZ supporting it as well, of course. We continue to strengthen partnerships, bringing Blue Light Cystoscopy to the rest of the world, looking for opportunities in other countries around the globe. Our cash position remains strong, and we're well-capitalized to fund long-term growth. We have a best-in-class product. The guidelines and reimbursements support us in most countries, and the US market remains the largest untapped market with less than 10% penetration. We believe, especially with the reclassification, that we can really unlock that market as time progresses. Slide 18. Just key milestones. We reiterate our guidance.
You know, as challenging as it's gonna be this year, we still believe the 65-75 Saphira installs is our target, and these are all rigid, of course. The flexible pipeline is no longer valid, so we will make it up with all rigid. Product revenue growth above 20% and generate a positive EBITDA in 2023. We'll continue to grow the base of blue light towers in the U.S. and in Europe. It's a key strategy. We believe that upgrade of image quality and reliability will have a positive impact on the business. We look forward to reporting out that measure later this year. We are proactively supporting that systems petition in the U.S. to reclassify blue light equipment. This is an important step to unlocking the US market.
We'll continue to expand geographically in both and also penetrating the untapped European markets. We'll continue to present a lot of data. There's been a huge investment in the medical side of our business, particularly in the registry work, and there is a lot of data, a lot of interest in pulling out some really interesting data around Blue Light Cystoscopy and supporting it as the product of choice when you're doing your cystoscopies. We'll continue to evaluate product and business opportunities that leverage our organizational strength. We have a global organization, a global footprint in commercial that could be leveraged and we look forward to doing so. With that, I think we can finish on slide 19 and go to Q&A.
Okay. Am I on screen?
You are.
Okay. Very good. Hi, everyone. Yeah, a fair bit of questions. Let me kick it off. First question is: Does the guidance 65-75 towers installed in the U.S. for this year, does that include upgrades, or is that just pure new scopes? For example, the 18 placed in Q1, which were pure new.
New scopes. It's new scopes. I mean, thinking about it, if it was everything, we put in 30 this quarter, I wouldn't claim that we have half of them in. It is new scopes. One of the key things though on these new scopes for everyone is we're gonna start talking more about new accounts. Scopes are great. You know, it's funny, the, if you get on our website, we have the locator map out there. That was intended for patients who were looking and seeking Blue Light Cystoscopy. It was never meant as a direct KPI to the business, although I know it's being used that way. What's missed in that is it's really the number of accounts, and the quality of those accounts is what we're focused on.
We'll continue to report the scopes. Again, 65-75 new scopes this year is our guidance. We also expect a fair amount of upgrades as we move through this year and into next year. The goal is to have an entire Saphira-equipped US market over the next 24 or so months.
Okay, great. Another question is on from an analyst. The medtech peers appear to be more upbeat about their CapEx and what they're hearing from the hospitals. The question is: Is urology being sort of deprioritized or prioritized at a lower level versus other procedures, or is it Blue Light that's being deprioritized or at a lower level versus other procedures?
Honestly, David, that might be better answered by you. I mean, I can start it off with, I could tell you in the world of urology and cystoscopy, it's not a must-have procedure. I mean, it can be postponed. Certainly, you know, you can extend the periods, surveillance periods, et cetera. I don't know. I don't have first-hand knowledge of what you're talking about.
Yep. I will add that we have seen other analyst surveys, in particular some from the U.S., which actually did show at the end of last year that the urology volumes were actually down relative to other procedures. Echoing what Dan had said is that urology has, you know, at the end of last year, was being deprioritized. Our own data that we see, which are based on claims, and there's a delay in those because we have to wait for those claims to get adjudicated, we were seeing a decline in the fourth quarter last year. In fact, that's part of the anomaly that we were seeing and why we didn't finish strong in the fourth quarter. I can tell you in my conversations internally, you know, we are seeing a stabilization of that.
In terms of Blue Light, you know, being singled out in terms of deprioritization, I can tell you we continue, and it's in our earnings report, that we continue to gain share in both sides of the ocean. We continue to beat the market in terms of our penetration. Yes, urology was being deprioritized at the end of the year. It seems to be, stabilized here in the first few months of the year. Another question. Moving on to Flex, which is a we got a fair bit of questions there as well as reclass. How long do you expect for the 69 existing towers to go to zero? You know, what is the company's assumption for that?
Well, we will never know for sure until it happens. We know KARL STORZ is, in their own right, forecasting, by the end of the year they'll have run out of parts to support them, and they're no longer gonna service them. I'm thinking we can keep a lot, you know, some of the key guys running into 2024. Where the end is, your guess is as good as mine. Remind you, it's, you know, it's 5% of the total global business. It'll slowly Phase out. We have an acceleration on the rigid side happening in both the US and Europe and, we think we can offset that.
Okay, great. Question on the Phase 3 trial going on in China for Hexvix run by our partner, Asieris. What are, you know, what are the criteria for a successful trial? Maybe even give us an update on the timeline. What makes this, what are the endpoints essentially that make this trial a success?
Yeah. David, again, this one you should answer because I know you were in the background, getting the specifics around it. I will say, on a timeline basis, we're trying to prove that blue light is better than white light in a Chinese population. This is very typical in life sciences. Both Chinese, Japanese, Asian communities will want a specific Asian trial. We're mimicking past trials, but in the Chinese population. Timeline-wise, they have indicated that they believe they'll finish enrollment this summer. They hope to be able to pool the data by the end of the year and submit in early 2024 with a 2024 approval. That's the latest we know from them. They're running the trial.
Right. Potential Phase 3 data toward the end of the year. In terms of the endpoints, essentially the patients serve as their own control, they'll analyze the patient under white light and then under white light plus Blue Light to see if they're identifying additional lesions. As most of you know, Blue Light typically does catch a number of lesions that white light alone doesn't catch. Secondary endpoint that is key I think is the number of CIS lesions, which also most of you know is the most aggressive form of bladder cancer. Blue Light is really important for catching those cancers. Not only is it aggressive, but it's also sneaky and lays down flat on the bladder wall, so very hard to identify.
That would be a key secondary endpoint for the trial. Of course, safety, which also we have a very good track record of safety, but safety is of course, an important primary endpoint. Okay, I think you've answered this before, but when do you expect a response from FDA on the down classification? Can you give us a little bit more of a timeline? A tail end to that that comes from another question is, can you give an indication of the potential impact on Photocure's business once reclassification happens along with the timeline?
Yeah. Well, as I mentioned, 210 days from filing, that puts us in and around May 25th. There's no statutory requirement by the government, FDA to respond. Down classifications to give you guideposts, eight months to 11 years is what has been the history on these. We don't believe we're anywhere near 11 years. We believe we got an opportunity to be closer to the eight-month mark, which means if they were to respond favorably, it could be by, you know, potentially by the end of this year, we could get a favorable decision. That is, you know. That is completely uncertain, and that would probably be a best-case scenario. The impact on the US business would be significant.
I think in the sense of you would have then competition both on the technology, so all the capital equipment manufacturers would be, you know, competing against each other to outsell each other in the category. Whereas right now we have KARL STORZ by itself, so there's no external pressure on them to make the best blue light equipment in the world. Although I think, you know, this latest version of it is really, a good step forward. You'd have that technological competition, and then you'll have price competition. You know, it's not without saying KARL STORZ realizes it's a monopoly position in the U.S. It prices it like a monopoly position in the U.S., both on the cost of the equipment and also the servicing of the equipment.
I believe that those, that pricing would come down in a competitive marketplace. That would be, you know, in our estimate, what would the impact would be. Obviously, you had the majors coming in, you know, the Richard Wolfs and the Olympuses, et cetera. There was also a host of other manufacturers, secondaries, et cetera. I call them the secondaries. Probably not fair. They probably wouldn't like me calling them that. You know, not the big, big guys, but guys who wanna, who really wanna make a difference in cystoscopy, who would also come in, put additional pressure on the three big manufacturers. That's it. Again, time-wise, we're just only gonna be able to inform you when we get information there. It could go void of any communication from the FDA for some time.
We're hopeful, and we think all the right things are in place for this, from the effort we put into it, you know, to the FDA's pre-submission. If you go back to 2016, 2017, they identified Blue Light Cystoscopy as a potential down-class device. They've already pre-identified it. KARL STORZ has initiated. That's another key step. We started the citizen petition, and we've rounded up all the stakeholders from all categories, not just, you know, just one category, but patients, patient advocacy, KOLs, equipment manufacturers, and therapeutic manufacturers. I mean, that is a tremendous swell of support from a variety of people who care about patients.
Also finally, to underscore this, the termination of Flex in the U.S. is a great podium from which for us to speak from. Talking about now you know, KARL STORZ in a monopoly position, unable to support their own equipment, has withdrawn from the market at a time when patients need the best technology possible to identify CIS and BCG unresponsive patients in the surveillance setting. Now that equipment is no longer gonna be available to them by the end of this year. That's a travesty, to be honest with you, and I'm hoping the FDA sees it the same way the rest of us see it.
Right. Perfect. A question on Cevira, cervical cancer product, Cevira. What is the market potential? Can you also give us an update on the potential timeline for seeing Phase 3 data?
Are you talking about Cevira?
Cevira, yeah.
I wasn't prepared for that question, David. I would say from a Phase 3, I can tell you that they have completed the Phase 3 enrollment. The last patients in I think were towards the end of last year. They're still pulling data together. They're hoping to have a readout later this year.
Right. There's a substantial several months of follow-up to see if the cancer has been eradicated. Yes, toward year-end is what we're hearing. Market potential, as Dan said, it's not our product. We don't have the forecast on that, but potential to be large. You know, Asieris
I'm pretty sure. Yeah, I'm pretty sure. We could go back to a press release a few years ago and probably had it in there if someone wants to reference it. I just don't have it with me today, guys. It's not top of mind. I gotta be honest with you.
Okay. Here's a question. Why have we not seen a massive buyback of own shares at the, at these low prices? The answer is, you know,
Erik
... we're continuing to run the business, right?
I'll take that one. I mean, we are a growing business. We need to invest in our future. It's my target and my wish always for this company and for the other companies I work for that we are able to give dividend or buy back shares, depending on what's best. Right now I think the right thing to do for us is to invest in our future.
Okay. We just covered this one on the reclass, another question there. What is your action plans to address the Flex opportunity in the U.S. and potentially worldwide?
Our action plan right now is try to support the ones that are out there, by finding third parties that hopefully can repair or sustain them, and then find a partner, I think I said it in the presentation, and find a partner out in the market who will produce a Blue Light flexible system. We'll update everyone when we're successful.
Getting down to the bottom here. Currency adjusted growth was 17% in the quarter, despite easy comparables. Are you still comfortable with achieving the 20%+ currency adjusted growth this year?
I don't know if that was for Erik or me. You didn't say who.
Yeah, I put that to Erik first.
Okay.
Okay, that's fine. I mean, what we're looking at here, let's start at Q1. We have a 30% increase of revenue for the company. That's NOK 24.6 million. If you look at FX alone, that's NOK 11 million out of the NOK 24.6 million. That's about 13%-14% of the growth is FX driven, which leaves organic growth to somewhere between 16% and 17%, which is pretty cool as a start for the year, I think. I think that's a good start of the year, and I believe that, you know, forms the basis for us to achieve the 20%+ that we're talking about.
Now, in terms of fixed currencies, I think when we go back to the guidance, we said 20+% as a headline number with no predictions on FX per se. Still, you know, and we were still also at that point in time facing significant market challenges such as, you know, staffing shortages, strikes, loss of Flex. We stand by our guidance here, we do.
Okay, excellent. Here's actually the last question. How locked in are the physicians to the tower manufacturers? Is it possible for them to switch from Saphira? If reclassification happens, how likely are they going to want to switch to new manufacturers?
Well, you know, the physicians are one piece of it. But they're part of hospital systems. Hospital systems have strong relationships with oftentimes what they call prime vendors, key manufacturers that they wanna work with. They'll push it and emphasize it and get tremendous discounts. There's a level of loyalty to it. Also, physicians get used to using certain equipment. They just like you know, the ergonomics on it. Having said that, if you believe in blue light technology in the surveillance setting and what it means to patient care in identifying patients with CIS BCG unresponsive, then you will push as a physician your institution because if it's a one and only, that's not generally a problem for institutions to make that exception.
I think I also wanna underscore, you know, this surveillance setting with Blue Light Cystoscopy, if you think about the fact that Merck's KEYTRUDA is out there now, it's, you know, for BCG unresponsive. FerGene is wanting to come out with its gene therapy bladder cancer product. Immunity Bio is coming up on its PDUFA date here in the next couple weeks. Again, another line. UroGen's out there finishing off its Phase 3. I mean, there are manufacturers who are looking for patients who are CIS or BCG unresponsive, and there is no better technology in the world than Blue Light. That's why it's an imperative, and it's a major initiative for us to find a answer for Blue Light flexible. We aim to do it, you know, whatever it takes.
Quite frankly, ideally, I'd like to have a proprietary system that we sell the razor and the razor blades. That's our aim. I don't have any conclusion or anything to announce today, but that is exactly what we're looking for, is to be, to sort of control our own destiny in the, in the surveillance setting.
Excellent. Okay, well, that's the bottom of the list of questions. Thank you all for the great questions, and thanks Dan and Erik. Turning it back over to you, Dan.
All right. Well, great. Thank you everyone. Look forward to speaking to you at the Q2 in August. Thank you.
Thank you.