All right. Good afternoon, good morning. I'm Dan Schneider, President and CEO of Photocure ASA. Welcome to the fourth quarter, full year, and 2024 results. Next slide. Disclaimers are in place for today's presentation. Next slide. Q4, just to kind of review our strategic priorities and initiatives. In the first block, our intention was to deliver on our financial guidance for growth in revenue and EBITDA this year and to continue generating operating leverage. We want to drive the mobile strategy for ForTec in the US, increasing penetration in our priority growth markets in Europe, plus additional image quality upgrades throughout the continent of Europe, and expand our geographic footprint and leverage our distribution partnerships. We believe we've done and moved the needle on all three of those.
In the second block, we talk about positioning and access, positioning BLC as a primary diagnostic tool to facilitate early and appropriate use of non-muscle-invasive bladder cancer therapeutics. It is really heating up in this space, and I'm very pleased with the way things are developing. Blue light cystoscopy is becoming more of the center of gravity for a lot of these new therapeutics coming out. We're getting more and more greater awareness and interest in incorporating blue light cystoscopy. We want to remain relevant in this space, and we need to play. We want to support the high-depth BLC technologies entering the market, both current and new capital equipment manufacturers. We've moved the needle on reclassification.
Again, it is not something that we can predict per se, but I will say that I'm very pleased with the organization's push with the FDA, and we'll see how this plays out this year. Just as a side note, I mentioned in the last presentation, this is one way of getting additional technologies, blue light technologies, into the market. We are also pursuing, with our partnerships, other alternative ways. The key is getting more devices into the market, more manufacturers into the market. More to come on that. With the announcement earlier this week, we're focused on the Richard Wolf flexible system, building adoption in Europe. As you recall, this is the largest segment in cystoscopy in Europe. In the US, it's about a $1.3 billion opportunity for us.
We had said that we were working on the development of an LED high-depth blue light system with Richard Wolf, and that development continues on time. In the meantime, we were able to co-develop and co-investigate and discover a way to combine existing technologies that are already in the market into a flexible blue light cystoscopy. This opens up the opportunity in Europe and for us to make sure that Flex is continuing to be relevant in the surveillance market, collecting the data, and making sure that we can properly prepare the market for the full launch of the new high-depth system in the next couple of years. The third part is acquiring and transform, actively access opportunities in non-muscle-invasive bladder cancer and uro-oncology indications, things such as biomarkers, artificial intelligence, and new technologies.
Real-time examples of that are some of the work we've been doing with Richard Wolf with the interim solution as well as the long-term solution, and then also ForTec in the mobile systems. We continue to look for other opportunities to expand our influence in the uro-oncology space. Next slide. Some of the highlights on Q4. We had strong growth in the quarter with 13% revenue growth, 11% unit sales growth in Q4. We generated 10% product revenue growth for the full year, plus we received NOK 37.5 million milestone revenue from Asiris. We delivered 20% product revenue growth in the US and 9% growth in our European business in the fourth quarter. The installed base of flexible blue light equipment continued to increase with six placements in Q4.
I want to make a note here because some might not think that is great, but one of the things you got to keep in mind is we count towers when they are active in the market servicing patients. I will tell you that there are many, I guess, POs, and we expect this is more of a phasing issue, and you'll be happy with the first quarter of 2025. Again, don't get too caught up on six towers. The Karl Storz program for the rigid Saphira upgrades is still in effect till the 31st of March of this year. We continue to execute in the EU with strong growth from Germany and contributions from the priority markets of the U.K. and France in the fourth quarter. Italy had a major center that has been down due to equipment failure.
We expect that to be up and running, and we'll return strong growth to Italy as well. This priority market space continues to build, and we're very pleased with the developments there. In addition, Germany had a very strong fourth quarter as well. I think it's worth noting the Nordic region is now stable and starting to show signs of a turnaround. With Olympus, which is roughly 80% of that market, now upgraded to the Visera Elite III, we expect that to fuel growth for the Nordics beginning in 2025 and carrying forward into the future. We also generated positive EBITDA. It's our seventh quarter in a row and added cash to the balance sheet in the period. We ended 2024 with NOK 294 million in cash, and we have no term debt. On the news flow side, earlier this week, we announced Richard Wolf interim solution.
Europe and the rest of the world where the System Blue and FLEX components are approved. This puts a control in our hands to relaunch into the largest market segment in the world for cystoscopy. You can see that also, as you can see in our growth initiative slides later in the deck. The ForTec mobile strategy answers the challenge of access and capital costs. We are very pleased with the progress so far. With 44 accounts, they have tried it by the end of 2024. We continue to see that building momentum, and it is following the analogs of prior devices and products that ForTec has launched in the past. We are very pleased that we are on track with that. Our partnership with Asiris continues to advance. They presented Saphira data at IPVC with the clearance rates for different HPV types. The product currently is under Chinese review.
It's going, from what we understand, pretty well. We think the approval could come as early as third quarter this year, but we'll have to see. The PDUFA for that is actually late fourth quarter. We will see how this develops, but we're very excited about the possibilities. Of course, Hexvix already approved in Q4, and it's awaiting the Richard Wolf capital equipment approval through the NMPA in mid-year this year, and then they'll launch. Next slide. All right, let's get into segment trends. Slide six, please. Okay, Q4, each of our direct sales territories had solid unit sales growth in the quarter. In the US, we estimate that our unit volume growth of rigid towers continues to grow into the mid-teens year over year. This has more than offset the ongoing decline of FLEX throughout 2024. As you recall, we have about 25 FLEX towers left.
I will tell you that they are aggregated. Most of the units are coming from a couple of accounts. They're very key. They're managed by world KOLs in the US. There is that we continue to manage through that. I know that Karl Storz is doing everything they can to keep these customers up and running with FLEX. One of the key things about FLEX as well is because it's near the end of life for these devices, they're being very selective in the patients they use it. We will continue to see downward pressure with FLEX declining throughout 2025. In Europe, strong growth in the quarter came from Germany. Our priority growth markets had a strong performance, up 9% for the year compared to 2.7% in 2023.
The U.K. has been especially strong, working off a low base, and France has been responding well to our work with the KOLs and image quality upgrades in the country. We continue to expect good growth in Germany and other European territories, given the initiatives we have undertaken, effectively relaunching blue light cystoscopy throughout the continent, with over 200 upgrades and 34 installations in Europe alone for blue light cystoscopies since we took the territory over post-COVID. Next slide. Trends in North America, Q4 revenue was up 20%, in-market units up 12%, driven by 17% rigid growth in Q4, offsetting the continued FLEX discontinuation, estimated to be down 16% in Q4. In the installed base of plus six, three new, three upgrades for a total of 55 new and upgraded Saphira installations. This met the low end of a revised increase in guidance in the range.
Recall, we had original range, and we upped it, and we just came in on the low end of the revised range, so well within the original guidance. Again, a lot of the Karl Storz piece of this is in POs that should deliver in the first quarter of 2025. The Karl Storz promotion program does remain in effect until the end of Q1. We also have rolled out a new metric for you to track our business, one that we believe is a better indicator of our performance in the US, and this is called active accounts, which are defined as accounts that have ordered at least once in the past 12 months. Based on this metric, we're up 11.3% year over year through the fourth quarter, and we'll share that slide in a coming slide here in a moment. Access to blue light equipment remains our top priority.
Reclass efforts will continue, and more pressure has mounted. We've invested significantly in working with U.S. congressional folks and through our consultants in trying to move the needle on this. Meanwhile, ForTec is a powerful alternative strategy to expanding access to otherwise inaccessible accounts and patients. While we believe it will take some time for the awareness to get out there, you got to get the champions, the operations budget, approval, P&T committee review, evaluation, and a committed customer. It does take time to go through that phase, and we believe ForTec can become a significant portion of our business. We think in excess of 15%-20%, could be higher. We'll see where it lands.
I think what's also interesting with ForTec, while I'm on the subject, is some of the accounts that started with ForTec have decided that blue light is more important to them than they originally thought, and they've already started committing to acquiring their own equipment directly from Karl Storz. This is kind of what the hypothesis was, that there will be accounts that will want it on the operating budget, want to use blue light, want access for their patients. There will be some accounts that want to try it, and if it goes well, they will see a greater usage for it, and they'll end up buying the equipment. That is exactly what is beginning to play out over time. We think this will continue through 2024.
One note on this slide, you'll see on the picture there, there are about 16 different companies now involved with Beacon. Beacon is a patient advocacy group for bladder cancer patients. I will tell you that about four or five years ago, there was far less of these accounts. There was about five or six. It goes to show you the amount of interest, investment, and overall companies that are involved in this space now. It is a very exciting time to be in bladder cancer therapeutics, diagnostics, devices. Next slide, please. Fifty-five Saphira systems were installed in 2024, consisting of 20 new, 17 upgrades, and 18 ForTec towers. The high-definition blue light equipment in the US is now roughly 50% of the market, and Karl Storz is highly dedicated to bringing this as close to 100% as it can, as quickly as it can.
It's focused on pre-2022 installs. Anything in 2022 or before are standard definition. That's the old systems. They are focused on upgrading them to the high-def Saphira system. Keep in mind, Karl Storz shares the equipment market with two other competitors holding roughly a 35% share. We actually believe we have a relatively good penetration in Karl Storz-dominated accounts. Karl Storz has indicated that their focus this year will be on upgrading its base of existing accounts pre-2022 to Saphira, although we do anticipate placement of many new towers as well. In fact, there are instances, as I mentioned, where ForTec has started the account, and the account has now committed to purchasing a Karl Storz tower. That's actually good news. On average, I've been asked this question: high-def tower upgrades from standard def, what does that mean?
We know that it means an excess of 10% growth for those accounts, and there's a range. Some of them go much higher, maybe a few a little bit lower, but we do know it has a positive impact on the business. Going forward, we're going to retire the slide for future earnings reports. You can see that we have worked for Karl Storz to significantly grow the installed base of blue light capital equipment in the US since we repositioned our US commercial organization in 2018. We've had 355 installations, 69 FLEX in the recent seven years versus 104 in the prior seven years. We are very proud of the activity in the rigid segment. In addition to the 69 flexible towers, we've held place during the same period with Karl Storz decided to cease the manufacturing of flexible equipment.
Nevertheless, tower count is a real metric for Karl Storz, but it's not a direct proxy of our performance. We look more at account penetrations. Additionally, ForTec mobile towers now in the market and other equipment manufacturers potentially entering the US market will make this metric incredibly difficult to track reliably. The slide we want to share today is the growth in accounts actively using SISU. We will begin now to exhibit the slide of each quarter, which shows our active accounts in the US are those that have ordered on a rolling 12 basis through the current quarter. Importantly, this is a blend of all accounts with all types of towers.
On the bottom of the slide, you can see our active accounts include those with rigid towers only, FLEX only, dual tower accounts, accounts with multiple rigid towers, mobile towers, rigid and mobile towers, and those that are evaluating equipment, whether for installation or ongoing mobile use. We believe this is a more accurate and reliable metric for tracking our performance. As you can see on the slide, we grew the number of active accounts through Q4 2024 on a rolling 12 basis from 294 to 316, which is an increase of 11.3%. Keep in mind, there have been FLEX declines, etc. This is a moving number, but we believe this is a more accurate way to look at the business of what's really active out in the space. These data serve as an internal operating tool as we use to monitor our productivity and keep our accounts active.
If they're not active, reactivate or move to a different type of platform like ForTec. Next slide. Taking a look at trends in Europe, we had a 9% increase in revenue, which was primarily driven by strong performance in Germany and Austria, and good growth in the U.K. and France with continued stabilization in the Nordic region. As I mentioned earlier, Italy had a major center that was down due to equipment failures, but we believe that will return here in the first quarter going forward through 2025. We had 79 image quality upgrades in 2024, which gives us over 220 since 2023, and 34 new accounts were added in just the past 20 months. Key initiatives throughout continental Europe are having impact, and we continue to execute on these initiatives. We also sponsored the most successful EAU Euro webinar.
There were over 296 live attendees and even more on the replay, and there were over 61 questions asked in the session. We were told it was the most successful they've ever had. That was quite an achievement for the marketing and medical teams. Late quarter four developments. Olympus officially launched the new Visera 3 Elite system with a 4K blue light capability. We are closely working with the Olympus team to expand Visera 3 installs with this upgrade. We believe Visera 3 is currently in about 10-15% of the Olympus accounts of installed base of endoscopy equipment in Europe. Adoption will take time to build that momentum. As I mentioned earlier, it's extremely important, and particularly in the Nordic region where Olympus has a very strong penetration rate.
There's several new systems that have already been placed along with new blue light capability in the Nordics and Germany since late Q4. Both sales organizations are working very, very closely together. Finally, as of January 1, 2024, the German healthcare reform went into effect. Photocure continues to see growth in unit sales in German hospitals through mid-February 2024. We will continue to monitor the healthcare reform situation in Germany as it evolves and manage to it appropriately. Next slide. This is the slide that you generally will see on the annual report. It's our annual sales revenue. You can see a nice growth trajectory over the years. Each year we generate this slide and display it in our annual report. We continually show growth in Hexvix and SISU, and despite several headwinds along the way, particularly with blue light equipment challenges in both markets.
However, we have tailwinds, Olympus being the last of the three major blue light equipment manufacturers to upgrade to high-def blue light system. ForTec mobile solution now building momentum in the US to combat capital budget and preferred equipment manufacturer constraints and the potential for additional manufacturers to enter the US and EU markets in the future. We believe the growth of this curve will continue to accelerate going forward. Next slide. We're going to get into some growth initiatives. First, I want to mention the potential reclassification of blue light equipment in the US, which is subject of Karl Storz' citizen petition, as I mentioned before. There are several capital equipment manufacturers that are willing, wanting to get into the US market under a 510K, under the market, under a 510K application process, which takes three to six months for approval.
Expanding the base of capital equipment is key in terms of blue light availability, quality equipment and service, and potentially more competitive pricing. Importantly, in this scenario, more investment in the segment, more salespeople selling blue light in the blue light cystoscopy in the market, and account access would be expected to open up dramatically, fueling growth in procedures for SISU. With Karl Storz's petition now officially closed for public comment, we expect our expert consultants have informed us that the next activity expected would be that the FDA would publish a notice for the next steps in the U.S. Federal Register, which is a compendium of activities undertaken by U.S. government agencies. I do not have to tell everyone on this call, the U.S. government is a little bit chaotic right now, so we will have to see how that transpires, but that is the next step.
We are hopeful that the FDA addresses the SISU petition very soon. We are very well aware that the FDA is very aware of this particular citizen's petition. It has been a tremendous amount of pressure on the FDA that we've mounted on them. They have acknowledged that, and we'll see where this goes. Let's go to the next slide. Just the key growth initiatives, I think two just real key updates on this. We now have 44 ForTec using accounts out there. The announcement on Monday evening of Richard Wolf Interim Solution for FLEX is a System Blue light source, blue light cystoscopy light source. This is a matter of connecting it to an already approved flexible scope to perform procedures. System Blue is already deployed in many accounts throughout Europe. We don't have the exact number, but our sales forces work on their sales force.
We believe it to be in several hundred or less. We want blue light cystoscopy in surveillance to remain relevant, so it's important that we got this out to the market. I'm very, very pleased with how the organizations work with each other. We'll be able to build the data and experience behind the launch of the LED HD system in a couple of years when we launch the full system, and it'll meet the demands of our customers right now in this evolving bladder cancer care landscape. We believe there will be increasing outpatient procedures. We see this in particular in the U.K. where lasers are being used in the outpatient setting, and blue light cystoscopy is under customer demand. We are very excited about the potential opportunity there.
Final comment, the momentum and pressure continues to be built behind the notion of accurate diagnosis and complete resections in line with the precision pathway for bladder cancer patient care. We believe blue light cystoscopy can play a central part in determining the precision pathway. The precision diagnostic leading precision therapeutics is equivalent to the precision pathway that everyone's wanting to put these bladder cancer patients on. We are excited about it. Next slide, please. Just a couple of comments. We talked about this earlier. This is our Asiris programs. One is the partnership in China for Hexvix. They are awaiting Richard Wolf equipment approval. They expect it to come mid-year this year and they will launch late this year into 2026.
On the out-licensed program of SAVIRA that's been submitted last March, March or May, it has an 18-month to two-year approval process, but we believe that they potentially could get, based on the recent feedback, an earlier approval this year. We'll wait on that. That comes with a significant milestone, $11 million. We're really excited about how that program's developing. Regarding EU and US, they are continuing to work for our pathways into both those markets, and we'll update or they will update the market when they find a pathway forward. All right. I will turn it over to Erik. Next slide, 15, Erik. Yeah, thank you, Dan. Yeah, in this section, we will review the consolidated income statement. We will review the segments report for the two main segments and finally headlines from the cash flow and the balance sheet.
We won't talk much about the impact of foreign exchange this time. For the quarter, the impact was approximately 1%, and for the full year, approximately 2%. Just a final comment before we get started. Please keep in mind that all amounts mentioned in this presentation are in NOK unless I specify another currency. Next slide, please. We're now looking at the consolidated income statement, and I'll start with the separate lines. Consolidated Hexvix SISU product revenue was NOK 128.6 million in the first quarter, which is 13% above 2023 and the highest ever. Full year Hexvix SISU revenue was NOK 487.9 million, growing 10% year over year and within the guidance for the year. Hexvix SISU in market unit sales increased 12% in North America and 11% in Europe in Q4, and consolidated for the full year, the increase in volume was 6%.
Obviously, the sales have been negatively impacted by the phase-down of the SISU usage in the flexible BLC setting in the US. On the positive side, however, we have seen strong development in the sale and distribution by our partner ForTec. Total revenue was NOK 141 million in the quarter, and the decline from 2023 is due to the lower milestone revenue in 2024. Full year total revenue was NOK 525 million, which is an increase of 5%. Going to expenses, total operating expenses excluding business development expenses was NOK 120 million in Q4. Year-over-year increase was NOK 13.5 million or 12.6%. The increase included investments in medical programs. It included indirect inventory cost adjustments and obviously also merit inflation and foreign exchange. The increase was also driven by an accrual adjustment, which was reducing the expenses in Q4 2023.
In total, one-off accounting entries amounted to approximately NOK 5 million of the Q4 year-over-year expense increase. Adjusted for one-offs, the year-over-year expense increase in Q4 was 8%. Excluding merit, inflation, and foreign exchange, the increase was approximately 3%. If you look at the detail of the P&L, you will see that other expenses, it's increasing, and this includes mostly G&A. It includes within G&A a reclass from sales and marketing costs. If I adjust for this movement or this reclass, you will see that G&A is mostly in line with previous quarters. Business development expenses were NOK 5.2 million in fourth quarter. Operating expenses within business development are related to life cycle management for Hexvix SISU, our cooperation with Richard Wolf on the flexible BLC system, as well as business development efforts that can diversify our business and significantly increase our growth rate.
The expense level within business development obviously may vary from quarter to quarter given the one-off nature of these expenses. EBITDA in Q4 after business development expenses was NOK 8.5 million, and for the full year, NOK 49.2 million. Excluding milestones and business development, our core business had a full year EBITDA of NOK 20 million, which compares to NOK 8 million in 2023. A 10% revenue increase drove more than a 100% EBITDA increase. Depreciation and amortization was NOK 7.3 million in Q4. Main cost items is the amortization of the intangible assets related to the return of the European business from Ipsen in 2020. Net financial items was zero in Q4 compared to a net cost of NOK 6 million in 2023. Tax expenses, net cost of NOK 7 million for the quarter compared to a net income of NOK 3.4 million in fourth quarter 2023.
After tax, we have for Q4 a net loss of NOK 5.8 million, and for the full year, a net loss of NOK 4.8 million. Next slide, please. We will look at the segment performance. For the segment reporting, I will, as always, focus on the two main segments, which are North America and Europe. The North America segment includes US and Canada. Revenue for North America increased 20% in the fourth quarter. The main drivers are volume increase on 12%. We had increased average prices of about 5% and about 2% foreign exchange. Revenue was also impacted by the phase-down of SISU usage in the flexible BLC setting. As I said earlier, on the positive side, we have seen strong development in the sale and distribution from our partner ForTec.
Q4 direct cost increased year-over-year with NOK 5.2 million or 13%, and the increase is driven by project expenses, inflation, and foreign exchange. Full year direct cost comparison is impacted by a NOK 5.2 million one-off accounting adjustment in third quarter 2023. This was for the capitalization of registry expenses in the US. Q4 contribution was NOK 7.8 million compared to Q4 2023 of NOK 4.0 million. Full year contribution was NOK 21 million, an improvement of NOK 11.9 million from last year from 2023. Looking at the European business, they had year-over-year revenue increase of 9% in the fourth quarter, mainly driven by 11% in market volume growth, but negatively impacted by reduction of inventory at wholesalers. Direct cost decreased 2% in the fourth quarter. We ended Q4 with a contribution of NOK 31.7 million compared to NOK 25.2 million in 2023.
As a conclusion on the segments report and on the business in the two segments, we see significant growth and improved profitability in both of these regions. Now let us move to the cash flow and balance sheet. Next slide, please. Cash flow from operations in Q4 was NOK 15.4 million, and for the year, cash flow from operations was NOK 76.8 million compared to 2023, NOK 48.3 million. It was highly driven by improved working capital. Cash flow from investments in Q4 includes interest received and paid as well as investments in tangible and intangible assets. Cash flow from financing Q4 and full year was negatively driven by earnout payments to Ipsen. The term loan from Nordea was fully repaid at the end of the second quarter 2023. This gives us a net cash flow in Q4 of NOK 2.8 million compared to NOK 4.4 million in Q4 2023.
With this net cash flow, we ended 2024 with a cash balance of NOK 294 million. The balance sheet, total assets NOK 733 million. Non-current asset was NOK 313 million at the end of the year, and this included customer relationship with NOK 95.9 million. Customer relationship in the intangible assets 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 37 million. Inventory and receivables were NOK 125.9 million at the end of 2024. The increase from 2023 is NOK 13 million and is driven by increased revenue. Long-term liabilities, NOK 397 million, include the earnout liability related to the Ipsen transaction totaling NOK 117 million at the end of the year. Finally, equity at the end of the year was NOK 500 million, which is 68% of total assets.
This concludes the financial section. Thank you, Dan. Back to you. Thanks, Erik. All right, next slide. Summary. Let's just go to the summary of the 2024 Q4 results. Overall, I believe it was a solid quarter with a 13% top-line growth, positive EBITDA, which was our seventh quarter in a row of positive EBITDA. In addition to positive EBITDA that we generated, we continue to invest in key initiatives that we believe will generate future revenue growth and increase our operating leverage while remaining relevant in bladder cancer care. We grew rigid tower growth an estimated 17% in Q4 as we continue to outperform the phase-down of SISU usage in the flexible BLC setting. ForTec is coming on and helping with the strong growth. We expect that to continue to accelerate.
Richard Wolf and Photocure joint development program is now bringing FLEX back to the market in the interim solution. It's great news. We'll continue with more updates on this as we continue to launch it throughout Europe and the rest of the world, including some of our partnerships. We also look for opportunities to bring it to the US. In the meantime, we'll continue the development of the high-def system LED with them. We also grew our active accounts ordering SISU in the US by over 11% in Q4, and we believe that this metric is a good indicator of our overall performance. We continue to work with Karl Storz on the growth and the installed base of blue light equipment in the US. The high-definition systems now represent about half of all blue light equipment, and we expect this to continue to expand.
As I mentioned, their promotional program is extended till March 31. There are many POs that we expect to come to fruition in the first quarter. We will report on that in our first quarter results. ForTec National Mobile rollout continues to gain traction and contribute to our growth. Through Q4, there are 44 accounts. Keep in mind, it really officially launched mid-late third quarter. Already, 44 accounts have used the service. Some have ordered SISU kits more than once. We have some instances where accounts have liked it so much that they are going to purchase their own equipment, which is a really good bellwether for the business and the interest in blue light cystoscopy. The number continues to grow.
In Europe, we continue to facilitate image quality upgrades in our nearly 600 target accounts, and we believe that Olympus blue light upgrade will help us strengthen that initiative as that launches here in the first quarter of 2025. Additionally, our priority growth markets grew significantly compared to the prior year, and we anticipate the growth to return to the Nordic region with the Olympus upgrades in 2025. Gearing up for this year's AUA and EAU, just interesting statistic. In general, the submissions that go into these organizations, roughly 20-25% of those submissions for presentations, posters, etc., about 20-25% are approved. We can tell you in quite proud effect, we've had a 50% acceptance rate of our submissions, so we look forward to reporting on AUA and EAU at the Q1.
Our cash balance remains strong at NOK 294 million, up from the NOK 260 million at the year-end in 2023. As Erik said earlier, the commercial business continued to contribute positive Q4 and prior five quarters, adding operating leverage. Finally, last slide, the anticipated milestones that you should look forward to. I think one, the guidance. We expect 7%-11% product revenue growth with year-over-year EBITDA improvement in 2025, minus BD spend in milestones. We expect continued operating leverage flow-through in the commercial businesses and the significant milestones this year, in particular, Asiris and the SAVIRA approval in China. We continue increasing Hexvix and SISU kit throughput and tower upgrades, both in the US and in Europe. The collaboration with ForTec will continue to accelerate as we continue the rollout of mobile throughout the US. They are prepared and will invest more as this continues to increase in adoption.
We're focused on the growth markets and the Olympus equipment launch in Europe. We're advancing the partnership with Richard Wolf. We have the launch of the interim solution that we'll work on for Europe. In addition, we'll continue the development of the LED high-def blue light system, flexible system that we expect to come out with in the next 18-24 months. We'll continue to present and publish additional data from the real-world evidence patient registries and other studies supporting the use of BLC with Hexvix and SISU, leveraging our registries with non-muscle-invasive bladder therapeutic companies. The systems petition, while it is unknown and there's no statutory requirement on response, as I said earlier, the FDA is more than aware of the pressure we've mounted on them. They're feeling it. We're excited about this, but this isn't, as I mentioned, not the only way to market.
We're looking at alternative ways to market. The key here is whether it's the systems petition, the reclassification of blue light scopes, or other ways to market. The main thing we're working on is getting additional equipment into the US, and we're working with everyone on that. Finally, Asiris progress. We'll continue to monitor that. Hopefully, the NDA for SAVIRA will be approved this year, as well as Richard Wolf equipment, so they can launch Hexvix in China. With that, I think we'll land on the last slide for Q&A and turn it over to David to ask any questions there in the queue. All right. Thank you, Dan. Hello, everyone. Really nice Q&A queue. Thank you, guys, for your interest and all your hard work on these questions. The first question really has to do with expenses.
What were the drivers of the higher operating expense in Q4, and should we expect this to continue? Yeah, it's Erik. I think I explained the drivers for the higher expenses in Q4 and also the variance between Q4 this year and Q4 2024 and 2023. Let me focus on whether this will be the standard going forward. It would be wrong to use the fourth quarter and establish a forecast for 2025 based on the fourth quarter. We're scrutinizing expenses all the time. Discretionary spending is kept on a very low level. On the other hand, we need to invest. I want you to watch. I want you to check or look at the slide where we present the segments, and you will see that Europe has an expense reduction, while the US has a significant expense increase. Why?
Because we need to invest in the opportunities in the US. We're also investing in Europe, definitely. It is a different market, different scenario. As a company, we have to do that. We have to utilize the opportunities we have. We have to stay relevant. That was my comment. Okay. Excellent. It's a related question, but given those higher expenses in Q4, what are you doing to reduce costs? I think you may have answered that, but let's just ask the question. It's really the same answer. We are scrutinizing. We are keeping the spending as low as possible, but I can't stop investing. I might add, the investments, as Erik said, are about relevance. All these therapeutics coming on the market doesn't automatically happen that blue light's going to be the center of attention. You have to work at that. You have to invest in it.
We were asked to be part of a patient registry in the US hosted by the patient advocacy group Beacon, and that is in conjunction with the major therapeutic guys we're being asked. Why that's important? If you think about it, these guys have to find the patients that are BCG unresponsive, or deserve a different type of treatment or have CIS. The best way to define or detect those patients is blue light cystoscopy. That data is going to be extremely important and rich into the future of treating bladder cancer. To be able to go back and say, "I used XYZ therapeutic because I used blue light cystoscopy, and here's all the data of why blue light cystoscopy got me there" is so vitally important. If you don't play in these places, you will be forgotten.
We are at this unique point in time where this landscape of bladder cancer care has heated up at such a rate that we've got to stay relevant here, and we've got to invest in ourselves. Same goes with reclass and reimbursement. I mean, it doesn't happen on its own. You've got to mount the pressure on Congressmen, Capitol Hill, CMS, FDA, and we're going after it as hard as we can because it's not even if when we turn the page on that and things change, it opens up a whole opportunity of growth for us that we need to get. The Richard Wolf interim solution, a $1.3 billion segment of market that we currently cannot access. You got to invest in it. You got to go after it. Otherwise, you're relegated to the $300 million market. And that's great, but I want more.
I think everyone deserves more, and these patients deserve more. The Olympus launch, having these partnerships with Olympus, Wolf, Karl Storz being agnostic, but being partners with them and driving the uptake of blue light scopes that we're relying on is extremely important. ForTec, mobile units, this doesn't just happen. You have to work with these guys in helping expand the usage of blue light cystoscopy throughout the US. As we kind of one of our theories early on was, as they use the ForTec equipment, the interest and the usage will go up to a point where the accounts will decide, "You know what? Mobile's great. It's not cheap. It's on my operating expense, but I think I will find room in my capital budget to buy my own blue light machine." That is happening, but it doesn't happen without the investments.
We're investing for the intermediate long-term future of the organization. I think it's beginning to pay off. As we said in the growth initiatives, already two had broke out of that slide. I forget what slide that was, slide 13, I think. Yeah. Excellent. Thanks for that. Maybe related to your answer, what are the potential opportunities that could increase the 7-11% revenue outlook for 2025? I think it's all the things I just mentioned. I think the other thing is, should things change in the reimbursement landscape, particularly in the outpatient setting in the U.S., the—gosh, why is my mind blank? I just got over a cold, so I apologize. In the—David, help me with it. Not the hospitals, but the step down from the hospitals. Yeah, the ASCs. Yeah, the ASCs in the ambulatory surgery centers. Sorry. Yeah.
As we get access to those things, that may also be a time when we look at, do we have the right effort there? Is it more centers, more locations? Do we have the right-sized salesforce? Should we add two people, three people? I mean, for every opportunity, we're going to meet it with the proper investment at the right time to drive usage and utilization. Congrats on the early entry of the Richard Wolf flexible equipment. Can you discuss that opportunity further and whether you expect to get that equipment into the US? Yeah. I will give credit to one of our country managers in Germany who, along with a key physician and I believe also with the Richard Wolf folks, found this opportunity organically on-site. They just tried something. It worked. They took it back. Richard Wolf took it back to the engineering team.
They determined it not only did it work, it's actually a good interim solution to carry forward on it. We now have the availability for Europe and the rest of the world. We have a list of a bunch of countries, includes many of our partners where this opportunity could be utilized: Australia, Chile, Israel, China. We will actually lay this out for our partners as well. Yeah, it's an exciting opportunity to get this into the market a year and a half to two years earlier than we thought. One of the things about any therapeutic or any device or anything you use is you don't want the market to go cold. This is an opportunity to keep this market hot, engaged, generating revenue or generating data, I mean, not revenue.
It does generate revenue, but really, it's about the data, the relevance, collecting, seeing how it's used, positioning it, market research around it. It really sets us up for a very good launch in a year and a half. Reminding everybody, we are developing the world's only, with Richard Wolf, high-def LED flexible blue light scope. It'll have a little more—have more bells and whistles, be a little bit more user-friendly than the interim solution. For the doctors who really want access to surveillance with blue light, they have a nice alternative. It exists right now in two different components that need to be basically connected to work if they own them. Excellent. I'm going to ask a related question to that.
Based on the statement that the FLEX market is $1.3 billion and the interim solution is now available, does this mean the surveillance market is open in Europe? Yeah. I mean, it's open in the sense that it's accessible. Now, you got to also look at country-to-country reimbursement scenarios, to reimbursement scenarios, trending, etc. The short answer is yes. We have something that we can sell in Europe. I think where it's been adopted so far has been the Nordics. We know there's strong interest in the U.K. There are other parts of Europe where we think there'll be some opportunity as well. I'm not claiming this to be the be-all and end-all right now. I think we're working on all the other components of a proper launch. In the meantime, this serves a definite customer demand and customer need, patient need. Yeah.
I'll just add to that. Where Richard Wolf System Blue is available, there is now an option to buy another piece of equipment that you can use with the System Blue to turn it from rigid to flexible. There is a capital equipment purchase. It's really not a big number, but it still is a number, and still a decision has to be made, has to be sold. Also in Europe, the infrastructure for flexible blue light or flexible, yeah, blue light cystoscopy is not quite there. This gives us that opportunity to start to build that infrastructure. That's what's going to be needed when the optimized solution comes out in a year or so. I think the other one other comment too, the therapeutics that are in the US, they still got to make their way to Europe. They're expensive.
As the US sort of sets the tone and tenor on using blue light cystoscopy to surveillance patients after they get TURBTs, determine if therapeutics work or not work, it will lead into a European acceptance and adoption over time as well. That is important. The other question you had is on the US. Yes, we are looking at ways into the US as well. Stay tuned there. Great. There are several exciting upcoming triggers with FDA, reclass, Hexvix launch in China, potential approval of SAVIRA, and others. If some or all of these come through, what impact does management believe this will have on EBITDA? It is going to blow EBITDA through the roof, frankly, because we are talking milestones, particularly from Asiris. I mean, it will obviously have a very positive impact, but I cannot quantify it.
Just look at the development over the last couple of years with the milestones and what happens to EBITDA. Yeah. The Asiris, along with the milestone, any money they generate and whatever they owe us goes straight to the bottom line. It is 100% leveraged in. I am going to take this next question, which seems to pivot off of that. That is, Photocure stock is trading at the lower end of the range last five years. Does Photocure management view the current share price as fairly priced? I will answer that after if you guys want to take it or you can take it. You can. Sure. I mean, I think our view is no. We are trading from an EV to revenue basis of less than two times. There is no value for SAVIRA.
Eric just talked about that, what that could do for our EBITDA. And reclass is not in there. The new therapeutic trend, not in there. Any reimbursement upside. Olympus really kicking in and growing the Nordics and the rest of Europe. And the upside from ForTec. I think, yeah, maybe I think we're below the operating business as it is in terms of fair value. All these upsides, which would be complete leverage because we're already generating a positive EBITDA with the base business and without all these upsides coming through. That's the way I would think about that. All right. When you guide for higher EBITDA in 2024, does this include any milestones in 2025? No. Okay. Great. This is a reclass question. From your experience, how long from public comment closure until a proposed order is published in the Federal Register? No.
No statutory requirement. No statutory determination. It could be any day. It could be days. It could be months. All I can say is that the FDA has made us aware that they are fully aware about blue light cystoscopy and the OAY class of device. That is half the battle right there because there's many citizen petitions that go in. This has been a blitz of stuff hitting them from all angles, from manufacturers, from patients, from physicians, from other organizations, patient advocacy groups, all demanding access to blue light cystoscopy. We're mounting a tremendous amount of pressure. We're not leaving it just with the FDA. We're working with Congress as well. We just had a change in administration. Fortunately for us, everybody we're working with retained their seats in Congress. We let the dust settle, and we're pushing as hard as we can. Yeah.
That's all I can say about it. It's just one of those government things. I do, again, I know everyone gets really caught up on reclass and that being the be-all and end-all. The ultimate goal here is more equipment manufacturers and more blue light accessibility in the US. Reclass is one way to get there. We are pursuing other ways to find a way to help all manufacturers get into this market space. Stay tuned on that as we progress through 2025. Okay. We'll stick with the government for a minute, the US government. How would a potential import tariff to the US affect Photocure? The same question, if a similar tariff would be introduced in the EU. That's kind of topical today. Yeah. Take US. We have a cost of goods sold in the US, which is around 3%.
If you take 25%, if that is the alternative, 25% on 3%, it's a very small amount. Okay. Thanks, Erik. When will the next-generation flexible BLC from Richard Wolf be available to customers? Next gen. The next gen? Yeah. When we announced it back in July, we said it would take approximately two years for development through to approval. Somewhere in 2027 is where we think that would potentially launch. Okay. When do you expect to start seeing meaningful sales contribution from the Olympus Visera 3 Elite upgrade from accounts in Europe? It's already started. They've already started to implement a handful of accounts here early in the first quarter. I think it'll continue to build throughout the year. We'll report on it as we gain more momentum. Okay. We have very little time. Let me go back real quick on Richard Wolf, by the way.
I said 2027. It could be late 2026 too. It's just when I think about a full-on launch, everything working right, in my head, I'm thinking '27. If we can get approval before that, we'll launch before it. On Asiris question, assuming approval of SAVIRA in China this year, when do you expect the product to be on the market? That's a question for Asiris. I would expect them to get to market within 6-12 months, but I can't speak for them. You'll have to go to their website and their investor call. Yeah. I mean, I could say the IPO of Asiris, really, SAVIRA was one of the centerpieces, if not the centerpiece. They created a whole new women's health division around it. It's an important product. I think they want to get it to market as soon as possible. Okay.
We're getting to the bottom here. What was the share of ForTec of US sales in Q4? And what are the assumptions for ForTec growth in 2025? The share of ForTec in the fourth quarter is around 5-6%. We expect that to continue to grow throughout 2025. Excellent. Sorry to end abruptly, but after a long list of questions, I think that's all we have. I appreciate the questions for everyone out there. Dan, I'll turn it back to you. All right. Good. Thank you, everyone, for joining us. I think we have a lot of exciting things going on. I'm particularly excited about a lot of the investments we've made. Already, a couple have come through, such as the interim solution for blue light flexible cystoscopy, as well as ForTec towers being deployed throughout the US and generating revenue and usage.
Already, kind of the hypothesis was that some accounts will convert, and they already started converting. Good news there. I hope to report even better news as we move forward through 2025. Thank you for joining. Have a great day.