Good morning. Thank you for joining us. I'm Dan Schneider, CEO of Photocure, and joining me on this call today is Chris Thibodeau, CEO of Vesica Health, and Priyam Shah, Vice President of Investor Relations here at Photocure. Today, we are announcing a transformational step for Photocure as we expand beyond visualization and treatment support into a further up-steering precision diagnostics for bladder cancer. We are very excited to announce the acquisition of Vesica Health and its lead asset, AssureMDx, a highly differentiated, non-invasive, urine-based molecular diagnostic designed for early bladder cancer detection in hematuria patients. Strategically, this transaction broadens Photocure's reach across the bladder cancer care continuum and strengthens our long-term position as a leading uro-oncology platform company. I'm going to click through the next three pages to remind you with the usual disclaimers and legal information are in effect for today's presentation.
You can find them on the website, the entire presentation today, but I will take a second to go through it. All right. Let me begin with the structure and the rationale of this transaction. Photocure is acquiring 100% of Vesica Health for a total potential consideration of approximately $30.5 million in cash and equity, consisting of an upfront and milestone payments tied primarily to reimbursement achievements. Net consideration of this deal is $28.5 million, accounting for the $2 million in cash Vesica Health has held at the time of transaction. We believe the transaction was completed at an attractive valuation and at the right stage of development to leverage Photocure's existing commercial infrastructure and accelerate long-term growth while creating the potential for meaningful operating leverage over time. The transaction structure is designed to align value creation and execution milestones while preserving balance sheet flexibility.
The acquisition immediately advances several strategic priorities for Photocure. First, it expands upstream into hematuria evaluation market, a significantly larger patient funnel than the currently diagnosed bladder cancer market. Second, it complements our existing blue light cystoscopy platform by helping identify and triage the appropriate patients earlier in the pathway who could receive blue light cystoscopy. Third, there's a substantial commercial synergy. We already possess deep relationships with urology practices and KOLs across the United States and Europe, which creates a highly efficient go-to-market opportunity for AssureMDx. Governance-wise, Photocure's leadership and operating structure remain intact, and Vesica's team of Chris Thibodeau, Laura Caba, and Manuel Krispin will join us in bringing their important molecular diagnostic and biomarker expertise into the organization. Let me quickly frame up where Photocure stands today.
Photocure has built a lean but highly differentiated commercial platform centered around blue light cystoscopy with our product Hexvix, as it's known globally, or Cysview as it's known in North America. It plays a critical role in bladder cancer detection and treatment, leveraging OEM partners, including KARL STORZ, Olympus, Richard Wolf, and now most recently, Stryker entering both Europe and into Canada. The business continues to demonstrate strong operational momentum. Our revenue growth in FY 2025 was double-digit 11%. We have strong gross margins at 92% for FY 2025. We have an expanding EBITDA margin to now double-digits, 13% in 2025. Most recently in Q1, we reported 11% reported adjusted EBITDA margins, which measures the core business, in Q1 2026. We have growing utilization trends, seeing 29% rigid growth in the U.S.
market and double-digit growth in Europe, as reported in our Q1 last month. We see also several meaningful catalysts ahead that will further accelerate our base BLC, our blue light cystoscopy business. Broader BLC rigid equipment adoption through an expected U.S. FDA reclassification to begin in the second half of this year of blue light systems and additional geographic expansions. We also see access to three times larger surveillance market with the global launch of the Richard Wolf Photocure flexible blue light cystoscopy system in 2027. Meanwhile, the interim solution by Richard Wolf is already available in Europe and receiving extremely positive feedback. At the same time, we have made considerable effort to diligence opportunities that diversify and expand our portfolio to access meaningful markets.
Vesica Health fits directly within the strategy of a large upstream adjacent market directly tied to funneling patients downstream to our higher yield blue light cystoscopy business. The environment for blue light cystoscopy is stronger than ever. Guidelines from AUA, EAU, and various others now recommend BLC, and the new guidelines coming out are only getting stronger. The science itself from over 300 publications and multiple well-powered randomized studies provides a wealth of clinical evidence. Over 40 independent studies confirmed improved detection and reduced recurrence, and we have the world's largest bladder cancer registry with over 4,000 patients in the U.S. Our OEM partners are investing more on the anticipated volume growth and rising tides in bladder cancer diagnostics by upgrading their systems with rollouts of 4K and hi-def capabilities. New OEMs like Stryker are increasingly wanting to enter the market to offer BLC.
BLC is increasingly viewed as an emerging standard of care technology because it improves the detection and long-term outcomes for patients. This matters because it establishes a strong scientific and clinical credibility foundation from which we can now expand into molecular precision diagnostics. There are several investments to enhance BLC, and the acquisition of Vesica Health directly supports our strategic priorities which we have consistently highlighted in our corporate presentations and earnings presentations for several years. Photocure's corporate strategy is built on three priorities guiding execution and capital allocation. First, strengthening the core Hexvix and Cysview business. Driving disciplined revenue and EBITDA growth while expanding our operating leverage. Scaling BLC mobile, along with tower installations and upgrades in the U.S. and Europe for increasing the accounts, and increased penetration in EU markets through expansion, image upgrades, and broader and deeper distribution reach. The second, lead the standard.
Establish BLC as a primary precision diagnostic across detection, surveillance, and treatment monitoring in non-muscle invasive bladder cancer. Support next generation hi-def BLC adoption via the recent OEM upgrades and the new OEM entrants such as Stryker who are entering into these markets. Partnering with Richard Wolf to grow flexible BLC in Europe while advancing 4K global flex system development. Where we are today, expanding the platform. Build a broader uro-oncology and precision diagnostic platform, biomarkers, artificial intelligence, flex, new technologies. Leverage the partnerships to scale mobile and 4K hi-def solutions and advance innovation and pursue M&A to accelerate growth and cash flow. Results, near-term growth and strengthen long-term competitive positioning. The addition of AssureMDx allows us to expand upstream in the patient journey through exciting and fast-growing biomarker and molecular precision diagnostic products.
Its ability to leverage our current commercial and medical infrastructure to more efficiently now and into the future. I'd like to hand off to Chris, CEO of Vesica Health, to discuss this best-in-class urine-based biomarker that he and his team have developed over these last many years. Over to you, Chris.
Thank you, Dan. AssureMDx is a patented urine-based multiomic assay designed to help stratify patients presenting with hematuria, the primary symptom associated with bladder cancer. The assay combines DNA methylation and somatic mutation biomarkers to identify patients at elevated risk who should proceed to more targeted cystoscopy and imaging evaluation. Across prospective multicenter validation cohorts, AssureMDx has proven itself to be a best-in-class assay. Sensitivity has ranged from 93%-97%. Specificity from 73%-92%. A negative predictive value has consistently exceeded 99%. Particularly impressive has been the performance of the assay within the microhematuria population, where it has demonstrated negative predictive value of 99.7%. The test has also achieved several important validation milestones. Inclusion in the American Urological Association guidelines, FDA Breakthrough Device Designation, and strong support among the urology community.
From a clinical workflow perspective, AssureMDx can help improve referral quality, reduce unnecessary invasive procedures, and optimize downstream cystoscopy utilization. We believe this creates value for patients, physicians, and the healthcare system.
Great. Thank you, Chris. Let's talk about the investment thesis. The strategic logic behind this transaction can really be summarized in five simple points. First, we now participate across a broader portion of the bladder cancer continuum. Secondly, we gain access to a much larger $6 billion hematuria evaluation market. Third, we are acquiring a clinically validated, and I argue, best in class and guideline-recognized product. Fourth, the commercial overlap is substantial, 100%. We already call on the same physicians and institutions. Finally, fifth, there is a clear path forward to near-term reimbursement and long-term value creation. This is exactly the type of adjacent synergistic expansion opportunity that unlocks significant market value. Let me go through each of these points in detail. Historically, Photocure has operated primarily at the confirmed diagnosis and treatment stage, the green box to the right.
Majority of Hexvix and Cysview is used today with rigid BLC scopes in the operating room setting, and in the clinical setting for regular bladder cancer surveillance once BLC Flex is back on the market. With AssureMDx, the blue box to the left outlined, we now move upstream to the first point of clinical suspicion when patients present with signs and symptoms, primarily hematuria, blood in the urine, that require further workup to confirm the diagnosis. Being upstream expands our relevance throughout the patient journey, from initial hematuria evaluation all the way through resection, surveillance, and treatment. We believe this creates a more integrated bladder cancer platform and strengthens our long-term competitive positioning in uro-oncology and precision diagnostics. Truly the bladder cancer company. The market opportunity is substantial.
Today, the U.S. bladder cancer market already represents a significant TURBT and surveillance cystoscopy opportunity where Hexvix, Cysview, play a critical role given the 400,000 TURBTs in the U.S. done every year and over 800,000 surveillance cystoscopies. Upstream, hematuria evaluation is a much larger market, with more than 7 million potential hematuria tests per year. 2 million in the urology practices, 5 million in general practice primary care. It is here where AssureMDx may be used to rule out early indications of bladder cancer. We estimate the U.S. hematuria diagnostic opportunity alone exceeds $6 billion, and the market where biomarker adoption is already occurring at a rapid pace. Reminder, Photocure is a global commercial company, which will further support our ambition to expand throughout Europe and beyond.
Next, Chris will talk about how AssureMDx market leading product profile and performance, along with the growing market acceptance, will speed up the adoption curve, leveraging the tenured and well-established Photocure sales and marketing team, supported by also the established medical team. Chris, over to you.
Yes. Thank you, Dan. When comparing AssureMDx against competing technologies, we believe the product is exceptionally differentiated. It combines two independent biological mechanisms, DNA methylation and somatic mutation analysis, whereas many competitors rely on a single modality or even suboptimal analytes. The supporting evidence base is also remarkably robust, including multiple prospective validation studies. Across the key metrics that matter most for a cancer triage assay, including sensitivity, specificity, negative predictive value, and overall accuracy, AssureMDx performs at best-in-class levels.
That's it. Well, thank you, Chris. Appreciate that, and I'm super excited. You can see clearly on this slide where the AssureMDx asset stacks up against all others. One of the most compelling aspects of the transaction is a commercial leverage for Photocure. We already possess a dedicated urology sales organization, strong community and academic relationships, and a proven commercialization infrastructure in both the U.S. and Europe. AssureMDx can be deployed through the existing platform with limited incremental SG&A. We believe this creates a meaningful competitive advantage. The reimbursement pathway is another critical component of the story, and it is fast developing in favor of a faster reimbursement for AssureMDx. There has been a recent unexpected and encouraging positive news from CMS in the last 30 days, where expected reimbursement could come as soon as mid-2027.
The takeaway from the CMS public meeting was biomarkers are and will be an important tool to urologists in the diagnosis and treatment of bladder cancer patients. Look no further than prostate, colon, or breast cancer. Biomarkers are now ingrained into their clinical workups. We are early in bladder cancer but believe the adoption curve is going to accelerate with CMS support. The company expects important milestones over the next several years, including potential Medicare reimbursement, continued health economics and data generation, and randomized controlled trial evidence through the SEARCH study, which will aim to provide level A clinical evidence. Importantly, the recently proposed Medicare policy development may accelerate the reimbursement timeline. Assuming successful execution, we expect initial U.S. revenue contribution beginning as early as 2027. One of the reasons we're excited about the Vesica Health deal is the attractive risk-reward profile it brings Photocure.
With a downside protection, the transaction is structured thoughtfully. Of the $28.5 million purchase price, only $14.75 million is paid in cash and equity upfront. The remainder is tied to the all-important reimbursement-related milestones, which we discussed earlier look to be extremely positive coming in the future. In addition, the business is relatively low reoccurring cost structure, and we've seen several important de-risking events already happening. The Novitas proposed LCD just weeks ago, AUA guideline inclusion last fall, FDA Breakthrough Device Designation earlier this spring. In addition, we also see multiple potential pathways to reimbursement. On the upside, our assumptions remain deliberately conservative. Our base numbers assume less than 5% penetration of the U.S. hematuria market, even though other biomarker categories have achieved significantly higher adoption rates over time.
We also assume pricing of roughly $900 per test, which well below the recent benchmarks in the category of being over greater than $1,300. Final pricing is expected in the coming months, given similar multi-omic tests, it is very conceivable the price point will be above $1,100. Strategically, Vesica expands Photocure's upstream into a large hematuria market, while adding precision diagnostics platform that can support future growth opportunities across diagnostics, artificial intelligence, and bladder cancer management. The key takeaway is that we believe we've acquired a highly strategic asset at the right time and at an attractive valuation. Even under the relatively modest assumptions, the opportunity is meaningful. In a 10% category penetration with the current pricing benchmarks, which we've already stated are lower than we believe they will be, the revenue potential exceeds over $500 million in the U.S. alone.
Overall, we see limited downside, multiple value creation catalysts, and a substantial long-term upside for shareholders. Let me close with outlook for the business and how we see Photocure evolving over the next several years. Starting with the core business, we remain with our outlook for 2026 unchanged. We continue to expect product revenue growth of 7%-11% on a constant currency basis, alongside continued expansion of the adjusted EBITDA margins, the core business. Importantly, this guidance reflects the strength of the existing business and does not depend upon any of the contributions from Vesica. Looking beyond 2026, we believe Vesica adds in a compelling second growth engine. Assuming Medicare reimbursement by mid-2028, which we believe could come sooner, and continued positive clinical data supporting commercialization, we expect the initial AssureMDx revenues in 2027 and positive EBITDA contribution from the business by 2030.
We also expect commercialization and market access investments to be funded through Photocure's existing cash generation. In the near term, Vesica is expected to generate only modest operating losses as we invest in market access and commercialization activities. As volumes scale, however, we believe the business has the potential to achieve EBITDA margins north or greater than 30%, consistent with the attractive economics typically seen in successful molecular diagnostic businesses. The most important key takeaway is the impact on our long-term growth profile. On a standalone basis, Photocure was expected to grow at a mid-teens CAGR through 2030. With Vesica Health, we now expect the consolidated company to deliver revenue growth above 25% annually from 2026 through 2030, while maintaining strong profitability and targeting adjusted EBITDA margins above 25% by 2030. Importantly, we continue to see upside beyond these assumptions.
Potential FDA reclassification and entrance of other OEMs will have a significant impact on the U.S. market by 3x. The reintroduction of flexible scopes again triples the size of the opportunities, further strengthening the growth outlook for Photocure's core business. Overall, we believe this transaction positions Photocure to accelerate growth meaningfully, expand into a larger adjacent market, create a larger, more diversified, and increasingly profitable bladder cancer company over the coming years. With that, I thank you for your time, and I believe we left plenty of time for questions, so I'll open it up.
Great. Thanks, Dan. Thanks, Chris. We do have quite a few questions here. Let me start with the first one. Dan, this is for you, I guess. How do you think about the total price paid for Vesica, given that it does not yet have revenues?
Well, the total consideration of $30.5 million, of which increments of $11 million paid in cash and $2.7 million in stock is appropriate in our view, given the size of the market opportunity it opens up, and the strong clinical validation of AssureMDx. An incremental $2.75 million in stock is due by the end of 2026 if Vesica achieves ADLT status, and the balance of $13.75 million in cash in stock is due when CMS reimbursement is achieved, which we believe will be prior to 2029. As we discussed earlier, we believe it could come much, much earlier based on the current actions of Novitas and CMS. Both of these milestones are significant drivers of our ability to generate not only a coverage for AssureMDx, but attractive pricing.
This is why we've tied future payments to these milestones, because they are important catalysts to our ability to generate revenues from Assure MDx.
Thanks. The next question is, given all the catalysts for Photocure, China entry, FDA reclass, quite a few others that you talked about, why is now the right time for an M&A deal?
Yeah, we've been consistently communicating this. It should be no surprise. We have been a single product company. For those that have been on this ride for quite some time, you have seen the impact of various things that can hit a single product company. BLC Flex leading the market took 15%-20% of our business out. If there's ever an issue, we're completely exposed. This has always been in our plan. We did it very thoughtfully. We went through hundreds of assets and products over the last several years, looking at products, seeing what synergistically fitted and what didn't. We felt like Vesica Health was an important product portfolio addition because it was right on the uro-oncology bladder cancer continuum. It provides us with a best-in-class, that's very important to us. We believe blue light cystoscopy is a best-in-class enhanced cystoscopy.
We want to hang with other products that are best in class and Vesica, with its AssureMDx, certainly is that. The scale of our U.S. commercial footprint and European footprints are extremely important, and we knew that with reclassification and addition of BLC-compatible scopes in the U.S. market, and flex opportunity meant that we're going to increase the sales force to meet that opportunity, and AssureMDx is a second addition. Now instead of going to an account and calling on a doctor and only offering one product at $1,300 in the U.S., you now may have two products at close to $1,300 each. That's a $2,600 call point for every time you're calling.
That's an important thing to keep in mind, and probably most importantly, both of these products can make a dramatic impact on a patient's care, and that's probably at the heart of who we are at Photocure, patients first.
Great. Another one here is, how can AssureMDx generate revenues in 2027 if Medicare reimbursement is not expected until 2028?
I'll start it, and maybe Chris might want to jump in here too. We continue to invest in generating the clinical evidence and the health economics to support CMS coverage for AssureMDx. Our belief, and other diagnostic companies have demonstrated this, is that a robust clinical evidence and health economics data ultimately will drive reimbursement and coverage. That's why we'll continue to invest in randomized controlled trials like SEARCH, and readout expected in mid-2027. That said, there's been really specific proposed LCD coverage, and maybe Chris, you might want to go into that a little bit.
Happily. Yes. Thank you, Dan. The recent Local Coverage Determination from Novitas really is intended to cover urine-based biomarkers in patients with microhematuria, and that would provide Medicare coverage for the use of our test, potentially, in selected microhematuria patients. This determination that will be finalized in the coming months could provide that quicker path for reimbursement for AssureMDx in the Medicare population.
Yeah. This
Perfect. Great.
I think the other thing to look at, some of the competitive products like Cxbladder has not had reimbursement. There is an opportunity in the private pay sector.
Absolutely
where our patients will pay for it. We do believe there is a revenue that'll start. I think the real acceleration always comes with CMS reimbursement. We think that has a real potential. Just in the last six months we've been in heavy diligence, there's been so many positive signs along the way that Chris and his team have delivered on. We're super excited about it.
Next one here is, Cysview and Hexvix are currently sold primarily in the OR as part of a procedure, much like a traditional medical device, even if the product is regulated as a drug. How do you anticipate your commercial organization being able to sell a diagnostic test?
Well, it's the same doctors, number one. Also important in these launches are getting the key academic centers, key physicians that are looked upon by other physicians as sort of the leaders in the space. Our sales force and medical teams combined. On Chris's team, we got Laura Caba, on our team, we have a whole full-out organization, both U.S. and Europe, are well ingrained with physicians. I will tell you, upon this approval, there has been an outpouring of U.S. KOLs, both to our side, and also I think Chris has received a ton as well, saying what a great deal between the two companies. You're bringing great products and great people together. We do recognize over time the opportunity for Flex and AssureMDx will expand. We've always had the intention with Flex because it goes out to the LUGPA.
There's 145 of those in the U.S. Plus physician offices, there are 14,000 urologists, plus or minus, in the U.S. alone. The sales force was going to need to expand, now its expansion is predicated now on two-product call instead of a single-product call, which makes every call more valuable for Photocure. That's an important component of it. Then I think we also bring a European sales and marketing team, and we're going to work diligently to get this launched in Europe. Different in Europe. In the U.S., they use centralized labs, and also IVDs, which are sort of decentralized versions. In Europe, it's a decentralized lab where the local hospitals or institutions will conduct a test. I don't know, Chris, you want to add to that a little bit?
Certainly, happy to help. In Europe, what we would focus on is delivering an IVD kit. Making the test available for that decentralized model where most institutions prefer to run the test in-house. That could be applicable in the U.S. market as well with certain institutions.
Certainly, the LUGPA are interested, and there's an economic incentive for them to do so as well. It aligns the clinical and the economics.
Absolutely.
It's an interesting opportunity for us. I believe we have all the right things, the right footprints commercially for this.
Okay. Next one is, what evidence do you have that owning Vesica materially accelerates Photocure's core growth and profitability versus remaining focused on BLC alone? How does AssureMDx funnel patients into BLC?
I'll take the first part and I'll let the funnel go to Chris, if that's all right. I think we've hit on this. We have a sales rep or account manager going into an account currently with only one product in hand and sitting in a procedural sale. It's already a technical sale for them. Adding AssureMDx is adding an additional technical sale to the same physician, the same group of physicians. We're leveraging our current footprint. We believe those relationships, I think we often take for granted. The sales force, in particular for us in Europe and U.S., are procedural sales reps in the ORs. They're sitting there with physicians, surgeons, more than a second. It's not like a typical pharmaceutical cell where you go in, spend a minute and a half, and out the door you go.
These reps, these account managers go into these accounts and spend an hour, two hours, three hours with a surgeon. They really get to know them. Their relationships are extremely strong, and that trust is built. I think for Chris and AssureMDx, what was attractive to them was putting this product in the hands of a sales force that had the same reputation and respect that they have with their product and its profile. I think it's just a great opportunity to leverage. Chris, I probably have some more to add about, I guess, the connection between AssureMDx and BLC.
Absolutely. Yeah. I 100% agree with that view. We just found that this was a perfect alignment in terms of the teams, but also in terms of the products. With AssureMDx, we're going to really help improve the stratification of patients presenting with hematuria, solve a clinical dilemma to say who's at risk for bladder cancer versus who are those that are at sufficiently low risk that they might be able to avoid an unnecessary invasive procedure. When we look at the use of the assay in the clinical setting, we can identify those patients who are at elevated risk, and that really will benefit from earlier intervention using blue light cystoscopy for really targeted detection, and then ultimately get those patients treated early when there's the greatest opportunity for cure.
Perfect.
Next one here is why was the full ownership of Vesica Health necessary?
Yeah. I guess it's kind of like dating, and then you realize you really want to marry the person because it's going to be a stronger partnership and relationship for a long time. A partnership creates in a commercial alignment. A full ownership is a complete strategic alignment across clinical development, reimbursement settings and strategies, data generation, commercial prioritization, integration of the products and how they complement each other, long-term platform expansion. As we invested back in the first quarter, we really quickly came to realize there was a genius and a deal here to really form this in a permanent way. Yeah, I think that kind of underscores it. Chris, maybe from your perspective, why sell out?
Yeah, no, great question. For us, we always envisioned having a strategic partner to commercialize the assay. Then through dialogue and the engagement with the Photocure team, we just realized that this was just a perfect fit. We'd always envisioned our test as complementary to blue light cystoscopy, both best-in-class products. This just really brought us both together. I think the strength of the combined technologies and teams really will help us deliver on significant growth in the years to come.
Yeah, 100%. Yeah. I think owning the asset allows us to allocate the capital, prioritize indications, integrate data assets, and optimize commercial model. It just makes so much sense to do this and do it now.
Great. Chris, maybe one for you. What will make physicians choose AssureMDx over other competing products like Cxbladder, UroVysion? How do we think about the competitive landscape?
There are several other products that have been on the market, some for quite some time, upwards of 20 years. What we bring is a next generation assay. We're utilizing, as we mentioned earlier, two different modalities, DNA methylation, otherwise known as epigenetics, and DNA somatic mutations. The approach that we bring delivers the greatest performance in terms of sensitivity, specificity, and negative predictive value. I think that makes a distinct difference. When we approach clinicians in the field and we start talking about the benefits for their patients, it's important to recognize that these biomarkers really will deliver, as Dan mentioned earlier, in other cancer and other oncology settings, biomarkers are the standard of care. They are utilized routinely and are absolutely important for the diagnosis and treatment of patients.
We envision here, just like with prostate cancer biomarkers that evolved over the last decade, that really there's this next generation, such as AssureMDx, which is really going to deliver improved patient care. Relative to the other competitors, again, we've been able to demonstrate consistently and reproducibly in clinical validation studies, best-in-class performance. I'll leave you with two notes on this. One, I think it's an important distinction that across the landscape, when we look in oncology, people are talking about early detection, the importance of early detection. That is so true in the area of bladder cancer, where patients that have early-stage disease can be treated and cured, whereas patients who have later-stage disease suffer greater mortality. We deliver on that promise of early detection. In fact, a combined sensitivity for Stage 0 and Stage 1 disease, really important data points.
We're delivering 96% sensitivity for those populations. That outstrips and outperforms every other modality and every other assay that's on the market today.
That's good. I think, when we look also, I can add some commercial element to this as well. Some of the competitors have gone through fits and starts as organizations. I think they're, without slighting them too much, they've had some difficulty and relationships have been fractured. Meanwhile, Photocure's relationships and Vesica Health's relationships with both the academic, the KOLs, and the surgeons out in the field has always been a strong element of the company. From a commercial standpoint, relationship-wise and respect and in that market, I think that really gives us a leg up. I thought, Chris, maybe if I can ask a question that I learned about our product, and it's specific to IVD kits, and specifically why an IVD kit is important economically and clinically, and why it can be done with ours but maybe not with the others. This is a competitive advantage.
Absolutely. It's a great question. In fact, it is part of our plan, as we discussed earlier, to develop a kit for the European markets, but also very strategically in the United States, what we envision is the opportunity to work with large institutions. I won't name them, but just consider large integrated distribution networks, large hospital systems, even as you mentioned earlier, some of the large groups where these are Large Urology Group Practice Association, where they have their own laboratories where they could envision having this test and be able to run it within their own lab and deliver, as we said, that decentralized offering, but really provide results to their patients even faster. Then also sharing the economics of the program. Now, why we can do this is because we're looking at DNA methylations with very stable sample.
That we can take it from the clinic, we can ship it to our centralized laboratory over three to five days, and the sample is very viable. Other assays that are on the market, some of them use RNA, and RNA can be very labile, meaning that it's dynamic, and it can degrade rapidly. Now, there are preservatives out there, but to then convert that into a kit makes it very challenging. Whereas what we have is a very easily combined assay that can be performed in remote laboratories.
Yeah. There you go. Thank you.
Dan, you presented this, but just for further clarification, how many new employees will be involved in this transaction?
A total of three so far. Over time, of course, as we get closer to commercialization and some of the other elements, I'm sure we'll have to add a few more folks. Currently, Chris come on as Chief Operating Officer of biomarkers. Laura Caba is coming on as Vice President of Medical and Biomarkers. Manuel Krispin, maybe I'll let Chris even talk about Manuel because I think he has a unique background, he'll come on as leading the biomarker scientific Vice President. Chris, maybe just a little background on Manuel and the tests themselves and his background maybe would give people some.
Absolutely. Manuel brings a great area of expertise. He did his PhD in epigenetics. In fact, if we look back when we started working on the development of the AssureMDx assay, Manuel was instrumental in actually building the assay, the final configuration of the biomarkers, establishing the analytical validation, and really was key. Now, Manuel's career, he's developed a lot of different molecular assays. He worked with MDxHealth. He worked at Foundation Medicine. He's worked at some great companies that were developing molecular diagnostic assays. That is his area of strength and expertise, and we're just very fortunate that we were able to have him join us at Vesica Health, and then subsequently, of course, coming together with Photocure.
Yeah, I should mention Chris and Laura both have over 20 years of biomarker experience. They had worked together long ago. Chris brought her with him. She also has a very extremely broad and deep network of relationships with urologists across the globe, which is extremely beneficial in this space. We're super thrilled to have Laura with us. Of course, Chris came out MDxHealth, that's the prostate side of biomarkers, which is really interesting. As Chief Operating Officer, so he knows how this works, this is not his first rodeo going to the stage, right, Chris, or?
Absolutely.
Yeah.
Just exciting to be working with a team with such a great reputation and great product technology that we can complement each other.
Yeah.
Great. I think we have time for maybe one or two more questions. How should we think about the risks associated with the two key milestones, ADLT designation and CMS reimbursement? Chris, maybe you can take that one.
Absolutely. Well, I think that what we can say is that we've got multiple pathways to gaining Medicare coverage. As Dan mentioned, of course, there's also commercial reimbursement, which we'll pursue in parallel with the private payers. When we look at the Medicare reimbursement, obviously this recent news with the LCD, the draft LCD at Novitas is very promising. Just all the dialogue, the CAC meeting that was discussing the need for these biomarkers, the LCD as is drafted is just really well drafted. We think that presents us with a near-term opportunity to gain coverage and really drive commercialization of the assay. As you mentioned, ADLT, that's advanced diagnostic laboratory test, which is specifically designed for assays like AssureMDx.
Last fall, we successfully secured a proprietary laboratory analysis code, a PLA code, it's a billing code for our assay. That positions us well for the ADLT program through CMS proper. We provide unique and different clinical information as compared to anything that's currently available for these patients. We think that that's a near-term opportunity as well to pursue coverage under that pathway. We were, as we all know, there's the MolDX program in California where our core laboratory is located presently. Beyond that, we do envision taking the FDA pathway for the longer term to gain FDA approval of an IVD kit. As I mentioned, there's three different pathways to coverage. We're very excited about the recent news coming out of Novitas. We think that that's going to be the nearest term opportunity.
Great. Chris, I think you talked about this when you were talking about the IVD kits, the question is, are there plans for launching Assure MDx to Europe? We can tie the two together.
Absolutely. In fact, Dan mentioned earlier that we're participating in a large randomized control trial called the SEARCH study, and that's with our longtime collaborators at Erasmus University. That study is about 50% enrolled. We expect it to read out in mid 2027 or thereabouts. Part of that was that study was funded by a Dutch Cancer Society grant. Really great program, really great opportunity to generate real world evidence, level A evidence, that will provide not only meaningful incremental validation of the assay, but will allow us to demonstrate how the assay works in a real world setting with intervention in terms of the case arm of the population. That'll also generate some health economic data in that setting. That's really going to build the foundation for us to pursue EAU, the European Association guideline inclusion.
Ultimately, as we mentioned, the development of a kit was always a contingency plan there that we would want to make sure that the test was then therefore available in the Dutch market, more broadly across European markets and other parts of the globe.
Great. I believe we're roughly at time. We will end the Q&A here. Thank you both very much.
Thank you.
Yep. Thank you everyone for joining us. Exciting times ahead. Have a great day. Bye-bye.