Just a reminder, the usual disclaimers are in place for today's presentation. Let's talk about the third quarter 2022 highlights. There has been some recent developments. We'll get into those today. Some exciting, positive things happening to the business. We got positive momentum on the SAPPHIRA launch, which launched late third quarter. As we said in the presentation and in the report, we already placed six of those towers. We've also recently announced through the quarterly the improved Medicare access and reimbursement. This is something the organization's been working on for years, getting access to not only the hospital outpatient, but the ambulatory surgery centers, which are an important growing segment of business in cystoscopy specifically. We see a tremendous opportunity.
Reviewing the quarter, we had a 12% revenue growth, partially driven off of FX and unit growth, 3% unit growth on Hexvix and Cysview. The launch is underway with KARL STORZ after some initial delays throughout the summer. We still are dealing with staffing shortages. I think that's common for all companies in the medtech space, where OR time is being rationed out, due to you know, reduced staff supporting the various operating procedures. We had 7% market growth in unit for Photocure, aided by the German and that's minus the German buy-in that took place in Q2, Q3. We also had a positive EBITDA. Commercial investment continues to support the Cysview, Hexvix growth.
We had a $1 million milestone paid by Asieris that was tied to the Cevira progress. To date, the program continues forward. As everyone knows, the last patient in was back in late August. This is a six-month follow-up, and then they'll package the data and hopefully submit or make the next decisions. Q3 OpEx is relatively in line with Q4 2021. No significant growth there. As I mentioned, CMS improved the Cysview reimbursement, and we are now receiving and will receive on January 1st a higher payment for outpatient procedures in ASC and HOPD settings.
Incidentally, on the ASC, and we'll get into this a little bit more, we were the only company, as far as we can tell out of the 1,800 pages that are in the registry, that was actually given a complexity adjustment or an additional reimbursement in the ambulatory surgery center, which I think is quite an accomplishment after years of working on this, both on the legislative side and the regulatory side. We also had positive results from the Laser III study. It's an outpatient laser-mediated destruction of the bladder tumor. Why this is important, as we know, the operating rooms are continuing to have pressure on them with staffing shortages, and physicians are trying to move more and more of those procedures to the outpatient, to the clinic side, to ambulatory surgery centers, et cetera.
Having the ability to prove that this type of procedure can be done effectively and, you know, essentially, get the same results as a TURBT in the hospital setting without the general anesthesia is actually a very positive development. We see this sort of as a way of blue light continuing to enhance and support the trends in cystoscopy used in bladder cancer. All right. Let's get into some of the segment trends. You know, quick comment on COVID-19 impact and update. Staffing shortages are a remnant of COVID, but the good news is in third quarter, we finally had complete and unadulterated access to clinics throughout Europe and the U.S.
We don't know what the future holds as we head into the winter months here in the northern hemispheres, but we suspect that most hospitals and physician offices have found a way to deal with COVID as a sort of , you know, it's here to stay kind of situation. However, the staffing shortages remain. It remains a challenge. It is causing operating room rationing and disruption in general about any procedures, not just cystoscopies, but all kinds of procedures done in the operating rooms of hospitals. We don't see that resolving until into 2023. All right, so quarterly trends. You know, US highest quarter ever in units. The global trend is continuing to grow. Germany, we've specifically circled to the right that impact.
You have to consider quarter three and quarter two together. You know, if you take out the impact of the inventory build between quarter two and quarter three, there's actually a + 6% growth in the European market sales. We had a 10% growth in North America. We continue to see an upward trend in quarter over prior years' quarters. Trends in the U.S., we hit the highest quarterly unit sales in U.S. Photocure history. We continue to grow the existing base of business. The SAPPHIRA launch is off and running, a very strong pipeline. OPP, which is the obsolescence protection plan, which are accounts that bought the old system but bought into the rights to get the new system as soon as it's available, are currently being swapped out.
In addition, new accounts are already being installed with the SAPPHIRA system. As I mentioned, we were able to get six new accounts, including Moffitt, which is a large, major cancer center in the United States down in Tampa, Florida, outfitted with the new SAPPHIRA system. It's exciting development as the pipeline behind this and the excitement when physicians try the equipment and they see this remarkable difference between the old blue light system and the new blue light system is quite good. We pressure the hospital systems to use the system a lot, especially after installation, to build out that repetitive behavior and familiarity with the new device. It remains very strong. On the Hexvix side, we had four installations.
A lot of KARL STORZ's focus was on getting SAPPHIRA out the door, in all honesty. We had a couple of machines on the flex side. We were very strict in what we consider an installation. It's not that it's just on site, it has to actually have treated a patient. We have a good pipeline of flex also as we move into Q4. We have improved access on Medicare reimbursement. I can't underscore how important this is for the organization. We've been working on this for years. This will go into effect on January 1st. We'll come out with more specifics around what this reimbursement looks like as the federal registry unveils itself.
At first blush, this looks very, very good for Blue Light Cystoscopy in both the HOPD, hospital outpatient setting, and also the ASC, the ambulatory surgery center, as it will become effective on January 1st. Contracting remains an important part of this, and especially with these new reimbursements coming in, there'll be growing interest not only on the clinical side, which we've always had in blue light, but now the economic interest in Blue Light Cystoscopy and what it could mean to a facility who adopts blue light technology. We expect that will also increase the demand for installations and ultimately, you know, with volume-based contracting, we can accelerate the growth rates.
Of course, you know, the staffing shortage in the U.S. does remain a challenge. I don't want to back off of that. It still remains a challenge. We've had multiple situations where procedures have been canceled due to staffing shortages or they've been postponed. We continue to deal with that, but we're dealing with it as effectively as possible. All right. Next slide. On the U.S. blue light cystoscope placements, you know, we're at 28 for the year. We had six rigid, all brand new SAPPHIRA, and then four flex, which I said there were a couple that were, we did not count because they didn't treat patients. The cumulative base looks good. We continue to grow it. There's an important announcement to make for everyone on this call.
We just found out it's public information that KARL STORZ has finally filed a citizen petition to begin the down-classification in Blue Light Cystoscopy. What this means for us is that this will open the door for competitive blue light systems to come into the U.S. under a Class II designation. Now, this process is gonna take time. There's no guaranteed timelines by the FDA. Typically, the Citizen Petition, which is a point in time in the registry, the host company has the right to petition the FDA to ask for a down-classification. This is the quickest way to down-classification.
For those that have been following the organization for quite some time, you do know that the FDA had listed blue light cystoscopes several years ago as a device that they would consider worthy of a down-classification. What expedites that is when that, you know, originating company, like KARL STORZ, begins that process. Now, the citizen petition will be out there for 210 days, possibly less. They will entertain anyone writing in, you know, so this could be facilities, physicians, even competitors as to why blue light cystoscopy, these scopes should be down-classed to a Class II from a Class III. You know, the question comes up, why would KARL STORZ do this?
You know, I think those who have been following for a while can see the challenges they've had under a Class III PMA to get product, new products, upgraded and out into the market. This has been tremendous drag on their organization. It's also been a very tough situation from a reputation standpoint because the old standard definition blue light system had been out there for well over a decade, and they weren't keeping up with the latest technology. This is gonna allow them to do that. In addition, they got some advantages to doing this in terms of future upgrades. For us, most importantly, is an upgrade to the flex system in the future is what we're hoping for. Very, very encouraging news. It's, again, out into the distance.
It's not something that's gonna happen, you know, in the next six or nine months. It's gonna take time, but this is very, very positive news. If the FDA buys into it, this could change the market for us. All right, moving on to Europe. Third quarter sales were +6%. 1%, you know, was reported due to the German hospital inventory sell-through. This is very healthy growth out of Europe that everyone's been waiting for. The price increase in Germany did not impact in-market usage. There was no response out of the market other than business as usual and a continued interest in Blue Light Cystoscopy with Hexvix. We ran the bladder cancer bus to DGU, the National Urologic Congress, and you can see the picture in the lower right corner.
Conjured up a lot of interest. We continue to grow interest throughout all of Europe. There's strong interest in the new SAPPHIRA system throughout Europe. Now, one thing about the European upgrade, it is incrementally better than what they have. They have a good system out there today, but you know, this incremental improvements to the KARL STORZ system is expected mid-first half next year, is the expectation at this point. And it will bring on some additional features that aren't on the current system. The faculty of Europe continue to be very, very supportive of our progress throughout Europe. Speaking of progress in Europe, I thought this would be a very good slide to share with everyone.
We often get asked the question, "How is Europe going?" It's often difficult because Germany is 80-some-odd% of the total business with very high penetration rates. Even though we have it on a positive growth rate of 6% or 7%, it sometimes gets kinda lost as some of these very high priority growth markets like France, U.K., and Italy aren't as visible. I think this slide actually says it all. To the right, we talk about the last two years of Ipsen and the cumulative aggregate growth rate was -8.3% in the first two years that we've had the product. Keep in mind, this is through COVID with limited or no access to cystocenters, us doing whatever we can to regenerate and rejuvenate the blue light cystoscopy with Hexvix marketplace.
We have a positive 8.6% growth rate. That is a 17-point change upward trending. We can see that trend continuing into the future. A lot of positive things in terms of interest in blue light, both in terms of converting old machines, which, if you've been following us for some quite some time, there were well over 700-800 systems throughout all of Europe. A good majority of those are older systems and, you know, the users of those systems and/or the systems themselves were not keeping up to the latest, you know, trends. In this case, we had the opportunity to switch out a lot of the old machines with the newest technology and regenerate sales and rejuvenate the sales throughout Europe. We see positive momentum moving forward through Europe.
With that and positive forward momentum, I'm gonna hand over to Erik. Erik?
Thank you, Dan. Well, as usual, I will start with the financial review of a few main segments, North America and Europe, and we'll then follow on with the consolidated income statement and headlines from the cash flow and balance sheet. Now, before we go into the numbers, foreign exchange has had also this quarter a significant impact on our results. In short, the FX impact for Q3 was for revenue positive approximately NOK 4 million and for EBITDA - NOK 1 million. Year-to-date revenue impact was positive approximately NOK 7 million and for EBITDA - NOK 4 million. I always state this, but it's important to note that, as we review the financials, please keep in mind that unless other currency is specified, all amounts mentioned in this presentation are in Norwegian krone.
Looking at the segments, we'll start with North America. The North America segment includes Canada from the first quarter of 2022. In January this year, we launched our own commercial operations in Canada for the direct sales of Cysview, and this sale was previously partnered to BioSyent. We have not restated 2021 financial segment numbers to include BioSyent in North America, as these were deemed not significant. Total revenue for the year 2021 was less than 1% of U.S. sales the same year. We dropped that. We did, however, restate the in-market unit sales. The in-market unit sales for North America in third quarter increased year-over-year by 10%, and U.S. unit sales alone also increased 10% year-over-year.
Revenue increased 34% in the third quarter, of which U.S. had a growth of 32%. The revenue growth was mainly driven by volume growth, a significantly stronger U.S. dollar, and the price increase. Year- to- date volume in North America increased 6%, and revenue increased 24% year- to- date. The revenue growth was, as for the quarter, driven mainly by volume growth, foreign exchange, and the U.S. price increase.
Direct cost in the third quarter increased year-over-year with NOK 5.9 million or 18%, and this increase reflects first of all the strengthening of U.S. dollars, but also operational items such as the investment in the launch in Canada, the preparation for the launch of the new scope from KARL STORZ, medical programs and initiatives to develop relevant data, and finally, a high activity level in the quarter resulting in the year-over-year volume growth of 10%. The contribution was NOK 2.7 million in Q3 compared to -NOK 2 million in Q3 last year, and year to date contribution was -NOK 8.5 million. EBITDA was -NOK 7.1 million in Q3, an improvement of NOK 2.7 million from Q3 last year.
The improvement was driven by revenue growth, partly offset by higher activity level resulting in cost increases, including the Canada launch. Dan, would you please move the slide back?
Sorry.
I'm still working on the segments.
Sorry.
Takes time, you know? Now it's the European business. Had also a strong development in the quarter. Reported volume growth in Q3 was only 1%. However, if you adjust for the impact of the inventory sell-through in Germany, we estimate that growth of in-market unit sales in the European segment would have been approximately 6% in the third quarter, and year- to- date volume growth was 5%. The inventory sell-through was driven by an announced price increase from the 1st of August, which resulted in customers building inventory in the second quarter. In Q3, we saw a net reduction of inventory at customers. Revenue declined year-over-year 1% in Q3 and were level year-to-date. The difference between volume growth and revenue in Q3 is explained by a 3% negative impact from FX in the quarter.
Direct costs increased year-over-year 10% or 13% in Q3, and the increase is driven by the investments in the local European commercial structure. We ended Q3 with a contribution of NOK 24.3 million compared to NOK 28 million Q3 prior year, and EBITDA for Q3 was NOK 7.2 million or 13% of revenue. Year-to-date contribution NOK 79.5 million and EBITDA of NOK 31.3 million. Now we can move to the consolidated. Next slide, please. Total revenue NOK 106.8 million for the third quarter, an increase of 22% from last year. Main drivers were milestone revenues related to Cevira. It was volume growth as well as foreign exchange impact. We also had a change or an increase of average selling price for the company. Year-to-date revenue increased 9% and was impacted by the same drivers.
In addition, the comparison with prior year was impacted by the upfront payment from Ascletis of NOK 6.4 million in the first quarter of 2021. This payment was for the partnership agreement with Ascletis for Hexvix in China and Taiwan. Operating expenses increased 17% in Q3 compared to Q3 last year, and year-to-date the year-over-year growth was 24%. Contributing to this increase was investment in Photocure's European commercial organization, which is required to support and grow the European sales, as well as commercial investments in the U.S. and the launch of the Canadian business. Furthermore, operating expenses both for the quarter and year-to-date were impacted by the strengthening of the U.S. dollars. Sequentially from the fourth quarter of 2021, the third quarter operating expenses increased 4%, which is driven solely by foreign exchange.
EBITDA in Q3, NOK 4.7 million compared to last year - NOK 0.2 million. The development from last year EBITDA was mainly due to increased revenues, including the milestone revenue from Asieris related to Cevira, which is partly offset by investments in Photocure's commercial organizations, including the launch of the Canadian business. Year-to-date EBITDA was - NOK 7.8 million. Looking at depreciation and amortization, NOK 6.1 million in Q3 and NOK 18.1 million year-to-date. Main cost item is the amortization of the intangible asset related to the return of the European business from Ipsen. Net financial items, net cost of NOK 4.8 million in the quarter and year-to-date a net cost of NOK 16.7 million. Year-to-date net financial items are mainly driven by incurred interest costs totaling NOK 18 million for the deferred consideration to Ipsen.
Year-to-date 2021 net financial items were also driven by a net currency gain, which explains the difference between 2021 and 2022 year-to-date. Tax expenses, NOK 3.7 million in Q3 and year-to-date NOK 7.8 million. Tax income and expenses relate mostly to our tax asset and tax loss carryforward in the parent company. In other words, it's not tax payable. The net tax expense for 2022 is driven by currency fluctuation for intercompany item. After net financial items and tax, we have year-to-date a net loss of NOK 50.4 million compared to net loss last year of NOK 2.7 million. Let's look at the next slide, cash flow and balance sheet. Perfect. Net cash flow from operations, NOK 21.3 million positive in Q3 and -NOK 2.7 million year-to-date.
The improvement from Q3 last year is mainly driven by EBITDA, including the milestone payment from Ascletis, in addition to positive working capital development. Year-to-date working capital is mainly driven by reduced short-term liabilities, meaning changes in working capital. Cash flow from investments only NOK -0.3 million and cash flow from financing in Q3 NOK -10.2 million, which is driven by repayment of the long-term loan to Nordea and also the Ipsen earn out payment. This gives a net cash flow in Q3 NOK 10.8 million and year-to-date NOK -39 million. With this net cash flow, we end the third quarter with a cash balance of NOK 284 million. Looking at the balance sheet, we end the quarter with total assets of NOK 732 million.
Non-current assets was NOK 355 million at quarter end, which include the customer relationship with NOK 133 million. The customer relationship is the intangible asset 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 46 million. Customer relationship is amortized in a straight-line basis over ten years, while the goodwill is subject to impairment testing. Inventory and receivables, NOK 93 million at quarter end, an increase from year-end 2021 of NOK 2.8 million. This is mainly driven by increased revenue. Long-term liabilities of NOK 169 million include the earnout liability of NOK 136 million. The earnout liability represents the capitalized value of estimated future earnout payments to Ipsen.
The liability is subject to a 10-year annuity. Finally, equity at the end of the quarter, NOK 480 million or 65% of total assets. This concludes the financial section. Thank you. Dan, back to you.
Thank you, Erik. Am I fired from my slide job? That's so good. All right, here we go. We'll bring it home here with summary results. 12% growth in Hexvix/Cysview revenue growth despite ongoing staffing shortages and a lack of rigid towers for most of the quarter. Again, SAPPHIRA launched the back end of third quarter last week or two. However, we still had 10 towers placed, six of them in the new SAPPHIRA system. Pipeline still remains extremely strong. OPP swap outs are happening as we speak. And we're looking forward to not only the Q4, but going into 2023 and beyond with the pipeline. We have improved the Medicare reimbursement for Blue Light Cystoscopy in both their surveillance and the hospital HOPD setting and ASC.
I'd mentioned, you know, earlier this is quite an accomplishment given that this is a rarity from a government standpoint to give this sort of complexity adjustment in the ASC setting. In fact, from what I understand, of all the companies that petitioned for it, we were the only one who was able to receive at this time, and we'll verify that. It's a lot of work through many years and effort that went into this. We're excited about what's gonna transpire on January 1st going forward and giving us access to some of the market parts that we did not have access in the past, and complement it with the contracting strategies that we've employed throughout the last year or so.
Europe will get the benefit of the access and the SAPPHIRA system as we move through into 2023. We'll continue to drive initiatives, both commercial regions and through our licensing partners. There'll be more updates on Asieris in future, and we're well positioned for growth. Anticipated milestones. We wanna regain the sales momentum that we had prior to COVID-19. We continue to inch up. Again, largest quarter ever in the history of Photocure for U.S., and we showed the growth underlying in the European markets, and these all on the eve of the launches of the new equipment.
The execution and launch on the upgraded blue system, but the improved Medicare reimbursement for both the ASC and the HOPD is gonna be a significant inflection point for us, we believe, and to continue expanding the blue light cystoscopy in North America. The recent announcement publicly by KARL STORZ that they've begun the citizen petition for the down-class will have a big impact on the U.S. market. You know, if you think about the U.S. market, KARL STORZ has roughly, you know, 35%-40% of the market in terms of access into hospitals. This, having other competitive products out there will obviously have an impact on price and also access to a lot more of the hospitals in a much more easier way. This process is gonna take time. This citizen's petition period is at least 210 days.
There's no guarantee by the FDA at this point, but it's very encouraging that the, you know, the originating organization, KARL STORZ, has started the process on a device that the FDA had already identified as eligible and should someone initiate the down-classification. We'll continue to execute on contracting, especially with the ASCs now that we have access to them through the new Medicare reimbursement scenario starting on January 1st. We'll continue geographic expansion. We didn't talk a whole lot about Canada, but Canada had a very strong third quarter. It gets sort of lost in the North American numbers, but, again, you know, it just shows good growth underlying, you know, these decisions we've made to take back geographies throughout the globe. We'll continue to publish additional data from the patient registries.
EAU, AUA have multiple papers submitted, already getting acceptances, so again, supporting it. A lot of our strategy with the ongoing data and studies is to support the trends that are going on in cystoscopy, whether it's moving patients from, you know, TURBTs under general anesthesia to the physician's offices and/or ASC settings. Is it, you know, for emerging therapies that are coming on that are BCG non-resistant, non-responsive? You know, how can blue light cystoscopy play a part in it? Is it in the biomarker spaces where blue light cystoscopy could complement and augment its purposes as well? More and more data coming out in addition to recurrence and progression data.
We'll continue to talk about the partner companies and license agreements, particularly Asieris, and we are evaluating and will continue to evaluate product or business opportunities that leverage the urooncology organizational commercial footprint and strengths that we have in the global setting. With that, I'm gonna turn it over to David for Q&A.
All right. Thanks, Dan.
Mm-hmm.
Now we'll move into the Q&A portion. If anyone on the call has questions, please enter it into the web browser, and we will get to as many questions as we can today. We appreciate that. We can start right off with the KARL STORZ citizen petition. Since you gave that background, there was a question about background, but you sort of talked about the process and the timeline. What kind of pushback might you expect on the citizen petition from the public or from FDA?
I don't know that you're gonna find a whole lot of pushback, in all honesty. You know, when you think about access to care, and access to care in the U.S. has become a very hot political agenda as well, you talk about parts of the country that don't have access to the latest technologies to help them fight bladder cancer because, you know, of the way this device was originally approved by the FDA limiting access by hospitals who either choose a different vendor as prime vendor, so they might be an Olympus shop or Richard Wolf shop or whoever. You know, they're less switch over to KARL STORZ. Although we've been pretty lucky with that, and you know, we've tried not to make that a barrier, it still becomes another hurdle we fight through.
I think, you know, the momentum and the positioning on this is such that I don't see that there's gonna be any necessary pushback. You know, had this been something done outside of KARL STORZ's purview or their abilities, then it would've been KARL STORZ that might have pushed back, but they're not, they're pushing forward. I don't see any necessary pushback on this. The big thing for them is coming up with, you know, the controls and the engineering measures so that they're set so that anybody coming in as a 510(k) using them as a predicate has the right blueprint and can be measured against the standard that's on the market today.
Okay. As a follow on to that, you know, from the FDA perspective, what sort of parameters do you think, FDA is going to need or be looking at with regard to this citizen petition and perhaps down-classifying the device? Is it patient safety?
It is safety. Safety is number one always. Then is it doing what it's supposed to do? Those controls, those engineering controls, making sure it's equivalent equipment, that it you know looks, smells, and tastes like the KARL STORZ predicate is what it's gonna have to do, patient safety is always number one for these things.
Yeah. I might add, this is an early part of the process, so more to come as we find out more about the process and what the FDA's looking for. We have a series of questions about the KARL STORZ new equipment launch. First question is, what do we think the impact of the new equipment in Europe, what kind of impact will that have?
You know, in the markets where KARL STORZ is dominant, to get another upgrade to the existing will be a positive. Again, this isn't the same as the U.S. It's not going from, you know, Stone Age standard definition to now, you know, state-of-the-art high def. On the other hand, it is an upgrade, and I think anytime you have an upgrade in devices that improve the experience of the physicians doing these procedures and surgeries is always a positive. You know, if you look across the map, in Europe, there are certain countries, regions of certain countries where KARL STORZ is extremely strong, and there's other parts of the countries where Olympus or Richard Wolf are very strong.
I don't know that it's gonna change that dynamic, as much as it's just gonna improve the experience for the KARL STORZ users that are out there.
In the U.S., you know, how is the launch going so far, and can you talk or give a little bit more color about the pipeline for new capital equipment?
Yeah. It's going very, very well. You know, KARL STORZ had its challenges early this year with a recall of a separate type of machinery that was out there. It really distracted the organization. Some challenges with getting, you know, the blue light system up and into the marketplace, but we've crossed that finish line. Now the new finish line is, how do you get to a growth rate for us that places these so we can get Hexvix and Cysview used in the marketplace? I will say that we expect placements of systems to outpace our high mark, our high watermark from 2019, which was 61, I believe, 64. So, we expect to do better than then. The pipeline would tell us that is exactly the case.
In addition to that, on the OPP side, and any, you know, any systems that we put in that are replacing old systems, we expect a better user experience, so better leverage of those machines and more patients being used and treated with Blue Light Cystoscopy. Don't lose sight of the fact that with the CMS change, there is not only the clinical reasons to use Blue Light Cystoscopy, which we've always had, but now you have an economic story that could back it up as well.
Okay. Actually, you walked right into that one, 'cause that's another question in the roster, is, can you give a little bit more detail on the Medicare reimbursement change and what it means to Photocure's business?
Yeah. I think the big thing, we had been in certain settings of care, there the white light cystoscopy has had an advantage in terms of economics. We weren't negative economics, but we weren't as positive economics. What we're seeing now in the change is that we've more than made up that difference. Let us decipher this 1,800-page registry, and we will come back to you with more of the specifics. But at least a first blush on this looks very positive in the HOPD/ASC setting with the complexity adjustments attached that we will have a very good position versus white light and gives them one more reason to use our product.
Yeah. You know, part of the language in the earnings materials do talk about expanding our business into the ASC setting. Can you-
Yeah
View that a little bit more?
Yeah. Well, it's roughly 10%, a growing segment of business, growing more than 10%, you know, it's 10% roughly, 10%-11% currently. We think it'll continue to grow. With the pressure on the hospital systems, there's been more push to get things into the ambulatory surgery centers. The challenge with ambulatory surgery centers is that the reimbursements were approximately 60% of a hospital reimbursement, and when you took that reimbursement down that low, it didn't really cover the Blue Light Cystoscopy. This has changed. We've got the trend of more patients being pushed to ASCs. We got the positive developments of a positive and improved reimbursement on Blue Light Cystoscopy that puts us in the driver's seat when it comes to choosing either white light or blue light. Yeah.
Here's one for Erik. When can we expect steady positive EBIT? You're muted, Erik.
Oop.
Erik, the pandemic's been going on for a while.
Yeah.
Gotta learn the mute button.
Oh, you better be kind then.
Now, you know, I'm not gonna leave behind a guidance or a forecast going forward, but maybe I can leave behind a little bit of hope. Because, you know, if you look at the development on the EBIT during 2022, I mean, the first quarter was very bad. It was -NOK 20 million EBIT. Then it improved, -NOK 4.5 million in the second quarter. Both numbers are negative. The third quarter we have a -NOK 1.4 million. We do have a positive development. I believe that with the current development in U.S., what we're seeing with KARL STORZ, when we finally get the nursing situation or the, you know, the situation with labor shortage in the healthcare system under control, then this will improve gradually.
I believe we have things in place to develop this into being a profitable business, definitely. You will get no guidance, but it's moving in the right direction.
Okay, probably another question for Erik. Can you talk about the status of the inventory in Germany? What proportion has been sold through, and when will this issue be resolved?
Approximately 85%-90% of the inventory has been sold after the third quarter. There is a little bit left going into the fourth quarter. How much that is gonna be as a percentage of the unit sales in the fourth quarter, I'm not sure, but it's definitely not gonna be by far what we saw in the third quarter.
Okay. Another question back to the CMS is, currently what proportion of your U.S. sales comes from Blue Light Cystoscopy in the ASC setting?
Nearly zero today. There is some, and it comes from the hardcore believers in blue light, and they use it sparingly on patients they feel it's gonna make the most dramatic impact in their care. They all would like to use it a lot more, and it's probably been the number one area that you hear from large urology group practices wanting a positive ASC reimbursement scenario for blue light. It's not even the case prior to the CMS decision. It wasn't even a case of white light having a better reimbursement. We actually had, when you did blue light, you actually lost money as a facility. That is not gonna be the case on January 1st 2023.
Yep. I would add that, in the private insurance setting, that's where we've gotten some a little bit of traction in the ASC, but very little. Now with this new reimbursement change, Medicare can become a significant payer in that segment of the market, and that can really help us penetrate. I know the commercial team's very excited for this. Okay, I guess really, seems like the last question. Dan, in your quote you mentioned that the company is at an inflection point. Can you elaborate a little more on that?
Well, I think when you take all the recent developments that have taken place, I think we you know, this is something we've been waiting for and working towards. You know, it's the launch of a new hi-def system by KARL STORZ in the U.S., and on a global stage. It's seeing the inflection in the European markets, getting access to those markets now, and starting to see the growth rates that we expected out of Europe, and returning it to its, you know, to a growth rate that Germany many, many years ago had. It's looking at the CMS reimbursement that we just received late last night, and what we think that's gonna do to impact the business.
It's the now filed citizen petition by KARL STORZ, and what that could mean to the U.S. market in terms of access to blue light cystoscopy with multiple manufacturers in market. Think about, it's not just the equipment coming in, it's their sales forces also selling blue light cystoscopy. It's not just, you know, the 30 or so sales reps of Photocure selling it with, you know, part-time KARL STORZ attention. It is an army of Olympus and Richard Wolf, and anybody else who wants to come out with blue light, which I've said in prior calls, we know of at least 10 others that have shown interest in blue light cystoscopy. It's exciting time, and I think we're right on the precipice of that. It's all coming in time.
I think 2023 is gonna be an exciting year as it develops. Doesn't happen overnight. Everything requires effort, but I think we're heading in the right direction.
Okay. Yeah, we've had a couple more drop in. On the cost for the U.S. business, how many more heads do you need to fully support the SAPPHIRA rollout, higher volumes, and this new CMS reimbursement change?
I'll start it. Erik, you wanna jump in, or you want it, Erik?
No, please.
All right. Well, I'll start it and then I'll let him talk. From a commercial standpoint, we have the right footprint. We did, and we've been honest about this, throughout COVID, and awaiting the SAPPHIRA launch, there were a few vacant territories that we covered from other territories in the U.S. We are now gonna fill those positions, so that's a handful, few people. Minor, to be honest with you. When you look at the overall productivity of the U.S. sales force versus the European sales force in terms of workload and product productivity, we've got room and capacity to handle what we have in front of us.
Now having said that, you know, if this thing explodes and gets to be too much, of course we're gonna invest and we're going to reap the rewards of that investment. Erik, you wanna add more to that?
Yeah. Yeah, what I expect to see is an improved productivity and an improved contribution and EBITDA. That what I expect to see. I also expect us to fill the open positions, but you know, the impact of getting a new equipment in there is gonna be far larger than the number of head count we are looking at.
Excellent. I'll just remind the audience, if there are any more questions, please send them in. We do have one question right now remaining. Do you focus only on bladder cancer for external growth, or also on other indications?
Bladder cancer. For our current product, it's bladder cancer. We do support SAPPHIRA with the series in the background. We're the sponsor of the trial, so there's a lot of work behind the scenes, just to make sure and helping them get through their trial. I should say, I back up. We're not sponsor of that trial, but we do support it. We're the sponsor of the trial for Hexvix in China, and in that case, we do have a lot of work in the background, but that's for this current indication. Outside of that, we do not have any other active programs for blue light technology outside of bladder cancer.
Okay, very good. It looks like that's all the questions we have in the queue, so I'll turn it back over to you, Dan.
All right. Well, I want to thank everyone. Exciting point in time for Photocure. I'm looking forward to fourth quarter 2023 and beyond. Thank you for staying with us, and we'll see you at the Q4 update. Thank you. Bye-bye.