Ondine Biomedical Inc. ($OBI)

Good afternoon, and welcome to the Ondine Biomedical Investor Presentation. [Operator Instructions] Before we begin, I would like to submit the following poll. Today's presenters are Nicolas Loebel, President and Chief Technology Officer; and Alan Thomas, CFO. I would now like to hand you over to Nicolas Loebel. Good afternoon to you.

Thank you, Alex. Hello, and welcome to Ondine's Financial Year 2025 Results Presentation. Thank you for joining. My name is Nick Loebel, Ondine's CTO and President. We will go through the presentation, which will be made available on our website, and we'll take questions after the presentation. This presentation provides general information. It's not intended to be a comprehensive analysis. Please review the company's annual report available today to investors. As a reminder, Ondine is focused on blocking hospital-acquired infections before they start prior to and increasingly now after surgery. Remember, 8,000 surgeries are performed every day in the U.K., 130,000 daily in the U.S. To address this challenge, Ondine has developed a novel light-activated antimicrobial called photodisinfection. This is a painless and broad spectrum approach. It's designed to rapidly eliminate microbes from various areas of the human body to prevent or even treat potentially devastating infections. For investors new to Ondine, we're not an early-stage research company. We have a proprietary technology platform. It's an active commercialization in Canada, the U.K. and elsewhere. It's a growing hospital customer base, and we're at a pivotal U.S. Phase 3 study readout, placing the company at an important value inflection point as we advance along the U.S. regulatory pathway. So where do these pathogens HAIs, generating about a GBP 2 billion annual cost to the NHS and requiring 5.6 million additional bed days at a time when NHS is suffering from the worst backlog in history, some 6 million patients waiting for surgery. Well, they often hide in the nose and they ride into operating theaters, ICUs, CCU step-down units, long-term care facilities in patients who are otherwise completely unaware that they're transmitting these microbes. Today, only a few agents, primarily antibiotics are used to treat the nose before surgery. These agents are becoming increasingly ineffective as bacteria evolve resistance to them and no antibiotic kills bacteria, virus and fungi in the nose as we do with Steriwave. Treatment takes only minutes. It's painless. It doesn't cause harm to patients, and it doesn't generate resistance like antibiotics do. Crucially, this takes the patient out of the compliance loop and transfers infection control where it belongs to the nurse, infection control specialists in the hospitals themselves at the point of care. Please visit our website if you'd like a more detailed look at how this fast, painless, effective technology actually works. And now I'd like to hand over to Alan Thomas, our CFO, for a discussion of the results. Thank you, Alan.

Thanks, Nick. Before we get into the financial results, I just want to frame how we allocated our resources in 2025. As a small company approaching a major clinical and regulatory inflection point, we made a deliberate decision to prioritize clinical evidence generation while maintaining targeted commercial activity. That meant focusing both financial and management resources on 3 areas: our large Phase 3 clinical trial, which is central to the U.S. regulatory pathway, the ICU pilot study to open the door to this high-need critical care setting and hospital and clinician pilots designed to build real-world evidence, deepen clinical engagement and support future expansion into new geographies and use cases. You can see that focus reflected in the chart. R&D investment increased significantly year-over-year and represented the majority of 2025 operating spend. This allocation reflects our strategic investment in key clinical evidence to support future commercial growth. The year was marked by advancement of the Phase 3 clinical study and regulatory pathway, completion of the ICU pilot study, expansion of our real-world evidence and commercial footprint and continued preparation for scale-up. The headline growth metrics are shown on the bottom right. Revenue increased 29%, gross profit increased 22% and hospitals increased 28%. I'll speak to the financial results on the next slide, while Nick will cover the clinical, commercial and operational progress in more detail later on in the presentation. Turning to the financial results. Revenue increased by 29% to $2.6 million, reflecting new hospital deployments and increased utilization within existing accounts. Gross profit increased 22% to $1.6 million with a gross margin of 61%. This modest change year-over-year primarily stems from the company's hardware segment, where strategic subsidized light source replacements continue to support customer adoption and market penetration. Consumable margins improved during the year following the rollout of the company's next-generation nasal illuminator in Canada. The key year-over-year change was the planned increase in R&D investment, which rose to $21.2 million from $9.2 million in 2024. This was driven primarily by our Phase 3 clinical study, which accounted for approximately 3 quaters of R&D spend during the year. It's worth highlighting that Phase 3 clinical studies in the pharma sector typically involve per patient costs in the tens of thousands of dollars. Our ability to conduct a larger scale clinical trial at this level of expenditure demonstrates disciplined execution at costs significantly below industry norms. In addition, our ICU hospital study costs were funded through an equity-based arrangement, allowing Ondine to advance clinical evidence generation while preserving cash resources. With regards to other expenditures, sales and marketing expense remained stable at $1.1 million, reflecting a targeted commercial approach that supported customer growth, partner development, clinical engagement and evidence generation initiatives. G&A expenses decreased to $8.7 million, reflecting continued cost discipline and operational efficiencies while maintaining the capabilities needed to support the business. Overall, the financial results reflected a planned investment year with total operating expenses increasing to $31.6 million, driven primarily by the Phase 3 trial and a net loss of $29.5 million. The company raised approximately $24 million during 2025 and subsequent to year-end completed a further financing of over $9 million in April to support our continued execution of our clinical, regulatory and scale-up priorities. I'll now pass it back to Nick, who will take us through the clinical progress behind these results in more detail.

Thank you, Alan. I'd like to cover the Phase 3 study at a glance. We're talking about the first randomized controlled study of nasal disinfection ever. It was conducted across 2 countries, involved 2 clinical research organizations, 18 hospitals enrolled almost 5,200 patients. Over 350,000 pieces of data were generated that gives you a sense of the scope and scale of this study. You see here a generalized graphic of the study design. This is a classic crossover in over 5,000 patients. Initially, we split the hospitals into 2 groups. The first half is the treatment arm and the second half is the control arm. After all hospitals have completed recruitment in that phase of the study, crossover occurs and the treatment arm hospitals become the control arm and vice versa. This is a really effective way to hone in on the treatment effect because each hospital serves as its own control. We'd like to take this opportunity to thank our clinical partner, HCA Healthcare, for all of their tremendous work and focus over the past year, runny the LANTERN study in 14 of their hospitals, with Dr. Ken Sands, HCA's Chief Epidemiologist and Patient Safety Officer as the lead principal investigator. Ken and the entire team did an incredible job ensuring good clinical practice across the study. Note, we deployed in multiple surgical specialties on the top right, cardiac, vascular, breast, neurosurgery, all of the places we'd expect to be used in hospitals and surgical suites throughout the U.S. upon approval. Where are we? Well, we're nearing database lock. We're in excess of 95% complete in the data cleaning and the endpoint adjudication. Most of the hard work and the expense of clinical operations, monitoring, patient follow-up, query resolution is now behind us. We're talking about this massive database with a great deal of information, and we're being very careful about ensuring that all data is in appropriate form for FDA review. Remember, at the database lock, nothing further can be added to the data, and we proceed with a prespecified statistical analysis. We're pleased to say we're on track for top line readout before the end of spring, which is imminent. Top line results are an early high-level summary of the data. We remind investors, this is a first look, detailed scientific data, clinical study reports, et cetera, are available towards the fall when we expect to be meeting with FDA prior to the NDA submission. Success means that we met the primary clinical endpoint, the primary efficacy endpoint, defined as a statistically significant reduction in the number of surgical site infections within 30 days after surgery. And this is compared to a standard of care control. It also means that we met the primary safety endpoint with only common nonserious adverse events like a running nose being experienced by patients versus more serious adverse events. A positive readout does not automatically guarantee FDA approval, but it brings us a major step forward towards the full NDA submission where FDA will review the totality of the data from the company. The Phase 3 study, LANTERN, was not the only study we engaged in over 2025. We also supported the first-ever study of Steriwave in the intensive care unit at Royal Columbian Hospital under Dr. Steve Reynolds and Elizabeth Rohrs. The aim of the study was to see whether the technology could be deployed in patients who might be intubated with nasal and oral hardware in place and are much sicker than the average presurgical patient. We looked at nasal pathogen control between treatment and control groups and whether we could see a trend towards reduction of one of the most dangerous events in the ICU, which is pneumonia. Pneumonia is a leading cause of death in the ICU. It drives severe complications like sepsis and shock and acute respiratory distress syndrome. And this sort of systemic stress on the body drastically increases the risk of cardiac arrest shock, kidney and liver failure. So it's a very, very dangerous outcome in the ICU. Very pleased to have reported excellent results from the study. Steriwave implementation in instrumented patients was found to be feasible and safe with no device-related serious adverse events. We found a highly significant reduction in nasal pathogen burden and most importantly, a nearly 40% reduction in ICU-acquired pneumonia with results published in the peer-reviewed journal of Critical Care. The next step is a larger study designed to generalize these results to multiple endpoints across more varied multicenter patient populations with the goal of both clinical and statistical significance across all endpoints. While our clinical programs in 2025 were our primary focus, we continue to make good commercial progress. We've expanded our deployments, pilot programs, clinical collaborations with a number of facilities increasing by 28% on a year-over-year basis now to 37 hospitals and surgical clinics. In Canada, we expanded adoption across major health care institutions, including the University of Ottawa Heart Institute, adopting Steriwave as standard of care in all cardiac surgeries, Interior Health becoming the second health authority in British Columbia to standardize Steriwave for hip and knee replacement surgeries and continued deployment across Fraser Health Hospitals and leading cardiac and surgical centres in Canada. In the U.K., we initiated a Steriwave pilot at Royal Papworth Hospital. Royal Papworth is one of the world's leading cardiothoracic centres, and we expanded the NHS supply chain access across England and Wales. In Europe, we expanded clinical collaborations and pilot programs in Switzerland, Germany and Spain. including studies evaluating Steriwave in preoperative nasal decolonization and ENT surgery, ear nose and throat surgery pathways. And we launched the first Steriwave pilot in Mexico at ABC Medical Center while continuing to advance other international opportunities, including in Australia, where we're testing the impact of Steriwave in cancer patients. Real-world impact is increasingly important in regulatory outcomes. We reported significant real-world infection control data from leading orthopedic and spine surgery centers over the year. At Sherbrooke University Hospital in Quebec in a 1-year retrospective quality of care, Steriwave was associated with a 78% reduction in spine surgical site infections, a 30% reduction in average hospital length of stay. These results were presented at the 25th Annual Scientific Conference of the Canadian Spine Society. Mid-Yorkshire Teaching NHS Trust, Steriwave implementation is associated with a 71% reduction in knee and hip arthroplasty surgical infections compared with another topical nasal antimicrobial agent, and this was presented at ICPIC 2025. And interestingly, the York Health Economic analysis adds an important dimension demonstrating the pharmacoeconomic return on the investment in Steriwave with an estimated savings net of GBP 1.49 to GBP 2.38 per every pound spent across major surgeries. It's a major, major finding. This was also presented at ICPIC 2025. Well, the increases in the number of hospitals, clinics and surgery centers using Steriwave means an increased demand on our manufacturing and our supply chains. During ' 25, we decided to bring manufacturing of our Popule line in-house. This is a new high-margin twist-top device, which delivers the photosensitizer. I'd like to show you what this looks like in a short video. I'm just going to click over here. You see the units being oriented using a pick-and-place robot. Those get placed into the production line on the left and the swabs are inserted along with the fill of photosensitizer formulation. Here, you see the swabs being ultrasonically sealed and then trimmed and the red laser is being used to write the lot codes and the other date codes, variable information, as you can see. After trimming, the unit produces finished sealed Popule every few seconds -- and this should be in production within the next few months after our facility is audited by our notified body. Zooming out, this slide shows the broader scope and scale of the opportunity. Our current focus is targeted hospital use, beginning with presurgical nasal decolonization in Canada, the U.K. and selected pilot markets. Over the medium term, we see the opportunity to expand into broader hospital use across surgery, in ICU, in other high-risk patient populations, obviously increasing our exposure in the U.S. should FDA approval be gained. We will continue to build our presence across Europe and North America as well. Longer term, our broad vision is to apply this photodisinfection platform across multiple indications, areas such as wound care, sinus disease, intrathoracic applications and other targets, all of which have multibillion-dollar global markets. As we progress through 2026, you'll see us advancing towards the NDA submission in the U.S. with engagement with FDA towards the fall as expected. We'll be continuing to focus on evidence generation. These are the peer-reviewed presentations, publications, abstracts, particularly supporting the independent real-world generation that is an increasing focus of regulators worldwide. You'll see us continuing to build commercial momentum with an expanded pilot program and expansion within existing placements into new surgical specialties as well as entirely new opportunities. And finally, as we discussed, we will continue to focus on the potential U.S. launch, which would require us to scale our business in readiness for the largest and most concentrated health care market in the world. So in closing, 2025 was about laying the foundations for what we expect to be a pivotal year ahead with the U.S. Phase 3 study nearing readout, our next steps coming in the U.S. regulatory pathway and expanding our real-world evidence and customer adoption. We're making key investments in manufacturing readiness and scale up, including in-house production of the key components necessary to insulate us from global events and to maximize our gross margin. We're focusing on priority markets, including the new markets of the EU and EMEA with our OUS partner, distribution partner, Mölnlycke Health care, and we'll be planning an exciting expansion into the ICU after the promising results of the first ever study of Steriwave in critical care at Royal Columbian Hospital. As always, I'd like to thank our investors and our stakeholders all over the world, your partners in delivering this groundbreaking technology to patients, families and one day potentially even yourselves. Thank you again, and I look forward to answering any questions you may have.

[Operator Instructions] I would like to remind you recording of this presentation along with a copy of the slides and the published Q&A can be accessed by our investor dashboard. Nicolas, Alan we have received a number of questions from attendees today. And I wanted to start off the Q&A session with the first one here from [indiscernible] . Are the GBP 1.49 and GBP 2.38 savings for hospital networks for every pound spent on Steriwave realized inside the first year? Or is it even faster?

I'll take that question. Thank you. This is, of course, the New York Health economic analysis we discussed earlier. And those are immediate savings. we're not trying to move some other larger initiative in a hospital. We're blocking patients from their staphylococcal and other microbial contamination of wounds. And so therefore, you would expect to see an immediate response as you decrease the microbiome so you decrease the surgical site infection rate and you generate these return on investments. So yes, very quickly.

Perfect. And another question from Myles here is, in the LANTERN trial and in the control arm for the crossover study, was the same standard of care used at each site? Or did it vary?

Very excellent question. HCA Healthcare, in particular, is an extremely carefully run organization with respect to things like data standardization, standard of care standardization. Hospitals are required to all operate within a particular set of metrics. So we can say with confidence that these hospitals all operated with similar infection control criteria and priorities. So standard of care could have ranged from additional antibiotic use to prophylaxis to intrasurgical operative prophylaxis and all of that was relatively similar between sites. It was a very important element of standardizing the control.

Thank you, Nicolas. And the next question we've got here is revenue growth of circa 29% is materially lower than the 70% growth reported last year. Should investors be concerned that commercial momentum is slowing?

I'll just jump in there, if you don't mind, Alan, in front of you there and then hand it over to you. No, we do not review and view the 2025 revenue growth as slowing the important context is that 2025 was a deliberate investment year and the primary focus being conduct and execution of the pivotal study, the LANTERN Phase 3 study. Of course, we maintained a focus on broader consumer relationships. We continued double-digit revenue growth and of course, maintaining a focus on evidence generation, the broader generation work that we need to support our next phase of growth. So when you have as significant a study as we've just discussed, requiring almost all of the leadership focus and targeted support from across the organization, clinical operations, engineering, et cetera, commercial team. Even with that focus, our revenue continued to grow through new hospital deployments, increased utilization within existing accounts, the land and expand strategy. So with strong customer retention, I feel that we were very, very good to maintain the growth we did.

Yes. Maybe I'll add, Nick, I think it's worthwhile noting like our revenue growth in absolute dollars was consistent year-over-year. So even though, as you indicated, our key investment was in the R&D and not the sales team. So yes, the percentage was lower, no doubt. But we're still -- the commercial team is still able to expand our product adoption across the global market, even though we did prioritize the spending on R&D. So that was a very positive accomplishment.

Perfect. And the next question we've got here is, you currently have cash runway into early Q4 2026. Are you actively fundraising?

I guess I'll take that, Nick. We're a growth stage health care company. So we're always looking at options. But as you know, subsequent to year-end, we had an April fundraise, and that should extend our cash runway into Q4. And that will give us time to support our current priorities, our top line Phase 3 results, the FDA engagement activities and our continued commercial readiness. So beyond that, any future fundraising is going to be informed by the LANTERN study. So I think at that time, we'll assess our options and how best to generate the best value for our shareholders.

And moving back on to the LANTERN study. What happens if the LANTERN study does not meet its primary endpoint? What are the realistic next steps available for the company operationally and strategically?

Great question. Thank you. We're obviously very confident based upon a very large existing evidence base that the LANTERN study will be a success. With any pivotal clinical study of this magnitude, there are a range of potential outcomes that are possible. It's, of course, prudent for us as a leadership team to actively consider a range of scenarios. plan for them. We're not going to speculate at this point on what happens when it's not a success because we believe it will be a success. And if it had concerns, we would take those next steps dependent on the totality of the evidence as the regulators do, subsequent regulatory discussions to determine what the agency would like us to do or would have us do with further focus. And so we just evaluate the most appropriate operational strategic options based upon the full data set.

Thank you very much. And the next question we've got here is, what could we expect the ongoing expenses for the FDA approval during the next period be?

I can take that, Alan, or would you like to take that?

Well, I mean, we can't really speculate on the U.S. Go ahead, Nick, and then I can answer after you.

Yes, sure. The FDA approval process is accelerated for us. We're a fast track and QIDP company. We'll be requesting priority review. So the overall G&A expense should be well controlled. In terms of what the FDA asks us with respect to the data, any further discussions with FDA about label claims to the actual deployment that they expect after the PDUFA date, all of that will remain for evaluation with the agency. So we will be providing some of those expense-related items in due course.

Thank you. Sorry Alan, you just on mute there.

Sorry. I was just going to say, Nick, yes, it's hard to speculate now until we know exactly what the requirements and expenditures will be. So we don't really want to provide a firm figure at this point.

Thank you very much. Next question we've got here is, what are the expectations in terms of time lines for the FDA approvals and subsequent rollout of the product, assuming positive LANTERN outcome?

If we go through one of the slides that I provided earlier, you'll see that we estimate that we are now imminent after database lock, we are imminent to top line results. And the subsequent approval time line, assuming good top line results should be that in the fall, we establish what's called a pre-NDA meeting with the FDA. That requires 60-day advance notice to FDA, provide a full dossier briefing package to the FDA, all of the questions that the company would like to ask for guidance going forward. Thereafter, should the FDA provide us with a package of responses that we consider to be actionable, we will do that action. That may take some months. It can take a bit longer depending on the scope and scale of what the FDA would like to see. And then thereafter, you submit your NDA. So at some point in the fall, we will have that pre-NDA meeting. And then depending on what the FDA says, we will then submit for NDA approval. NDA approval with priority review can be as short as 6 months. It does depend on what the FDA would like to see in terms of any other reinforcing evidence, the full complete totality of evidence is reviewed by FDA in an NDA. Given that this is a combination product, they will be reviewing both the drug element and the device element, so CDER versus CDRH. There will also be a complete review of preclinical work, et cetera. So it's a really extensive and expansive review. And so at the point that, that then becomes clear to FDA when they believe that will be done, they will issue something called a prescription drug user fee access date, a PDUFA date, which is when you can expect to receive approval. And so that's about as close a guidance as we can provide within the coming year.

And another question here from [Myles Dixon]. He says, my usual question, how rapid might the adoption be in HCA post any FDA approval? Why might such a large network, i.e., HCA rapidly deploy the product? And how is manufacturing capacity readiness?

Thank you. Multiple questions there. So the first one, how rapid the adoption might be in HCA? Well, HCA reviewed this product extensively prior to joining forces as a clinical partner. And they provided us with prior evidence of their antibiotic deployments, which are throughout every single major hospital and ICU because there are no other standards of care that HCA does recognize. Of course, antibiotics, as we discussed in the presentation, have significant limitations that we and recognize, including the generation of resistance. And so there's a really compelling use case for Steriwave should it be approved. Now HCA does not like to have some standard of care in some hospitals and different standard of care in other hospitals. So we would expect relatively rapid rollout across the hospital suite. That said, it's a very large organization with hundreds of thousands of people working. And so there will be logistical questions, but we would not expect this to be significant in terms of years long type deployments. This happens relatively quickly. Again, HA is a company that works within the U.S. statutes, guidelines, cannot provide any revenue forecast or provide any sort of prior purchasing agreement prior to approval. But this large network of hospitals, some 200 hospitals, some 2,000 sites of care, 5% of U.S. health care, 15% within the construct of their group purchasing organization, Health Trust, would be very well positioned using their enormous data gathering and data deployment and workforce assets to rapidly deploy the product. And the question, as I recall, that Myles asked at the terminal end was are you ready? Is your manufacturing capacity at readiness? Well, we can tell you that we have been rapidly scaling manufacturing. And most recently, as I indicated in the presentation, we've actually deployed an in-house production line now. And that's not just to permit us to expand our manufacturing capacity. It's also to insulate us from manufacturing capacity concerns globally, which may occur. We've seen some supply chain disruption, but it's been minimal so far. Nonetheless, we'd like to focus investors on the fact that we do understand that scaling to the large demand of U.S. health care in general, not just HCA is of primary importance, and we're putting investments in today to start that being addressed well before approval.

The next question we've got here is, when do you expect U.S.A. commercial rollout will start after FDA final approval?

Well, I'd like to say within 24 hours, which maximizes one's intellectual property position and of course, the extraordinary commercial opportunity that you're facing. With that as a goal, we will attempt to do that as fast as possible. There are so many moving parts that will be required. It will clearly be dependent upon the implementation practices of any potential distribution or strategic partner that we maintain at that time. We will certainly have had extensive discussions within HCA Healthcare and potentially other health care services institutions in terms of logistics of deployment down to small details of how particularly the components are prescribed and delivered at the point of care to inventory control, et cetera. So we do expect this to be very soon after FDA approval.

Thank you, Nicolas. And the next question here is, when could we expect the LANTERN results given there aren't many days left in the late spring? Are you allowed to provide a specific date?

We're not allowed to provide a specific date, but you're completely correct. There are very few days left in spring. And we committed that we would do this in spring. And at the moment, we are maintaining that commitment because while there is database lock yet to go and there are queries being resolved as we speak and final cleanup of study reports and also of patient reports, i.e., the clinical reports, -- there's a very large system called the electronic data capture system, which is being reviewed in detail. We're cleaning every single query so that this database is ready for database lock. Subsequent database lock, there's a prespecified statistical analysis, which we've worked on extensively. So we would anticipate that to go quite quickly. We think we will be on time.

Moving on to Europe. What initiatives has your European partner undertaken to drive sales this year?

Mölnlycke Healthcare is a large organization, and they have recently advised us of their intention to expand deployment out of the U.K. as well and into Europe and other countries. And so that's requiring strategic implementation of their sales force in terms of training, in terms of asset access, ensuring that they have adequate access to product, warranty and service depots. There's a pretty extensive rollout strategy for those countries that Mölnlycke Healthcare is engaging in. Just for investors' interest, we provided support to an amazing webinar that we gave a couple of days ago actually, and over 100 people attending that. that was sponsored by Mölnlycke, and there was just a great deal of interest in terms of what we're doing and in terms of the evolving data set. And you can tell that traction is now really beginning to evolve with Mölnlycke and our customers.

Thank you. Another question here is about the potential expansion into the very high-value treatment markets. From personal experience, this is from the investor himself. From personal experience, I'm talking about acne and common facial fungal conditions, both are massive treatment markets with mostly limited effectiveness treatments offering a great opportunity for Ondine's approach with maybe full face or larger area treating Steriwave type devices.

Thanks for the question. That's near and dear to my heart. My roots are research and development. The question goes to our global strategy beyond LANTERN beyond the U.S. NDA submission, et cetera. We have a pipeline of products that involve both, you might say, prescription-only products that will be deployed only within the hospital. You may see that in clinics as well, such as nose and throat products, intraoral products. You may see other products in the ICU such as ventilator-associated pneumonia reduction that goes directly inside an incubated patient. But these are all things that relate to really significant hospital-based concerns with results on -- expected on mortality index, et cetera. What this question relates to is more of an over-the-counter application where maybe by prescription, maybe just directly accessible, you might have something that could treat a fungal infection. You might have something non-steroidally, of course. You might have something that could treat a bacterial infection, non-antimicrobial or non-antibiotic, of course. And this is something that we truly have looked at for many years. We're talking about modifying the technology to consumer type product form factors, so handheld devices, delivering less than the high levels of light that you're seeing in these very carefully prescribed in-hospital environments where nursing staff, professional infection control specialists are involved. When you go over the counter, there are a lot of folks various walks of life, different ages, et cetera, different capacities, and you have to be very careful how you design such a product. But we're super keen on doing it because there is such a large market, especially in facial acne and even in areas that relate beyond that. It does require the regulators to agree on the pathway. You do require extensive studies to ensure that the device and its subsequent impact on the patient is safe. But again, with such a large database that we have at the moment and the succeeding databases with LANTERN and post LANTERN, we think we will have those databases in place. And expanding into consumer type applications is again another multibillion-dollar market. So we're very bullish about that. Thank you for the question.

Another question here is, how do you expect the cost of R&D to commercialization is? How many years do you think this will take to pay back?

Scalability. When you have done this for a decade, when you have designed pieces of equipment through 3 generations, first-generation lasers had glass panels, those could break. Third-generation lasers are practically bulletproof. When you understand how you deliver light fiber optically to small, medium and large areas, all the way ranging from subgingival environments all the way to large skin surfaces, there is an extremely good background in the company. And so we have expended a great deal of the R&D cost and a great deal of the time that will be required to effectuate our pipeline. It's one of the most important things we'd like investors to understand, and thank you to the question, the questioner. We are not merely delivering a nasal decolonization system. We're delivering a platform which truly means a platform. We can go in so many different directions. Each one may be of interest to a different strategic partner, maybe go-to-market pathway. But in general, we feel that this will maximize shareholder value is to exploit each vertical independently and to do so rapidly because of our existing investment.

Thank you. Another investor here says, apologies if I have missed this, but where is your production line based in the U.S. or Canada?

Our production line at the moment is a global supply chain with the majority of final assembly being done right here in Bothell, Washington, where I'm talking to at the moment. So that's in the U.S. We are just launching a major initiative in Canada in the suburb of Toronto, where our contract drug manufacturing organization will be located. And that is designed to evaluate and then finally adapt to the much larger demand coming out of the United States that we expect post approval. So it will be, again, elements of the supply chain coming from multiple countries, but final assembly being done in the U.S. as well as Canada at the moment.

And another question here from Myles who wants to go back to the FDA costs and ask it in a different way. Considering all of the development costs to take Steriwave to approval, both clinical and regulatory, what quantum approximately of the costs is already behind us? Is it 70%, 80%, 90%?

Thank you for the question, Myles. We appreciate your probing with many years of experience behind you. Look, the company has spent nearly CAD 0.25 billion to get here, okay? We're nowhere near that quantum left to take us over the finish line, nowhere near. The majority of the costs are behind us. I don't want to overcommit because we have an FDA approval track. And with all due respect to the regulator, we need to make sure that the agency feels that they can guide in any way they see fit, and it may be short, medium or longer. We expect medium. We feel that we have successfully addressed manufacturing issues. We have enormous database, very, very large database of patients coming into the study, real-world evidence component at this point. It is integrated into the submission to the FDA as well as the statistical plan. So we believe the majority of the costs are already behind us. If I were to say that it's in the high double digits, as you've indicated, you'd be correct.

That's great. And perhaps the last question here as we are getting for every question you answer, we seem to be getting 3 more. So I'll just make this the last question here. Please profile the total addressable market in the U.S. at your most likely wholesale selling price.

I won't directly mention selling prices for obvious reasons, including the fact that they haven't really been set yet. But within the context of analyses that we have done and seen conduit and otherwise, within the construct of the overall infection control market, we can tell you that the total addressable market is in the multibillion range. I've seen expectations as high as 6 -- now having said that, the total addressable market is something that provides investors with a sense of scope and scale. Of course, the market that you can access is smaller than that, but we still believe this to be a really large market. Remember, one, we are a first-in-class product. Should we be approved by FDA, we will be the first formally approved nasal decolonizing agent in the U.S. history. All other agents are used off-label for their intended purpose. And I'm talking for general universal nasal decolonization prior to surgery. Given that position and given intellectual property position and given NDA exclusivity terms, which are provided to a company upon first approval, there is an expectation that we will be able to access a preferred and rather exclusive market for quite some time. And so we're very bullish about the component of TAM that we will be able to access. Suffice it to say, we think it is in the multibillion range.

Fantastic. Well, look guys, thank you for addressing those questions from investors today. And of course, the company can review all questions submitted today, and we'll publish those responses on the Investor Meet Company platform. But Nicolas, before we direct investors to provide you with a feedback, which is particularly important to yourself and the company, could I just please ask you for a few closing comments?

Well, we'd like to thank our investors, our stakeholders worldwide, as I said earlier, for their strong support of Ondine over many years. We believe your moment is coming. We believe that we will be changing infection control as it exists today. It takes time, it takes focus, it takes energy and it takes a village of an entire group such as yourselves to be able to change the face of health care, much less change it in one of the most concentrated and largest markets of all in the U.S. And we would like to ensure that investors understand that our focus, our intent has never been greater. We're extremely excited to be at this place where post database lock, we will be able to have our first look at what we think will be a tremendous study. We do think that the LANTERN study will become a landmark in its scope and its scale and its impact generation in presurgical decolonization and provide that road map through to the ICU, supported by the researchers at Royal Columbian -- and of course, thereafter into the other platform products that we discussed. So thank you for all of your focus, your attention. You will be helping humanity because of antibiotic stewardship. You will be helping yourselves potentially because there will be a hospital near you where you will be decolonized before surgery, and that will help you reduce your risk of infection. I'd also like to thank you, Alex, and Investor Meet for your help with this presentation. And also, as always, Angelika Vance, our Head of Corporate Communications, for her sterling assistance with presentations and logistics. And thank you all again.

Fantastic, Nicolas. Alan, thank you once again for updating investors today. Could I please ask investors not to close this session as you will now be automatically redirected to provide your feedback, which will help the company better understand your views and expectations. On behalf of the management team, we would like to thank you for attending today's presentation, and good afternoon to you all.