Good afternoon. Thank you so much to everyone at Investor Meet, and to 5654, and the help we have received from [Ondine] Events and our company. Thank you to all participants in this webcast. I will be talking today about our LANTERN Phase 3 positive top-line results, and questions thereto. I will move the slides forward there. I am going to start by making it clear that this is an investigational product in the U.S., and therefore it is not approved in the U.S. It is not commercially available for sale in the U.S. It is limited by federal law to investigational use only. Outside of the United States, we are a commercial for-profit company, and we sell this product. I will be referring very carefully within the United States to the results of the LANTERN study as being an investigational product.
Just a quick primer again on who we are and what the case is for what we are doing. We have developed a brand-new approach to disinfection. It is fast. It does not produce resistance. It is designed to remove microbes without using antibiotics, which then, of course, removes the burden of antibiotic resistance development. It is in clinical use today in multiple countries. In the United States, we have received QIDP designation and Fast Track status for surgical site infection prevention.
Just a reminder that there are over 300 million surgical procedures performed globally each year, 35 million major surgeries in the United States, and this product is being driven by the evolving antibiotic resistance profile that you see across the globe. What is it? We apply a photosensitive compound into the nose. The formulation binds to microbes. It is cold. It does not produce any scent or smell. It is not painful.
Then we activate it with red light that goes into the nose for a total of four minutes. It is produced by a laser, and what you see in the graphic is the disposable component, which is used a single time. That red light produces a cascade of photoreactions with immediate broad-spectrum effect. You can see we take care of MRSA, Aspergillus, which is a dangerous fungus, and even Candida auris, which is one of the new, most dangerous microorganisms in hospitals, which has borrowed genes from multiple of its cohort to try to avoid the use of common antifungals. That is a really dangerous one.
This technology is simple to speak about, complex in its development, and it has taken us a number of years to get to our crowning achievement to date, which is the conclusion of LANTERN, a large-scale pivotal Phase 3 study, which we disclosed a short while ago. This Phase 3 study was conducted in 18 hospitals, 14 of which belong to HCA Healthcare in the United States, and four of which were located in Canada. Just over 5,000 patients were recruited, and this design was a cluster-randomized standard of care controlled crossover, and this was discussed with FDA prior to our launching of the study. As you see in the graphic, Period 1, we split the patients between the standard of care and the nasal photodisinfection plus standard of care. This was a classic superiority study.
Nasal photodisinfection was required to achieve better outcomes on top of standard of care alone. After a crossover period, we switched the two groups. Nasal photodisinfection plus standard of care became the original group, and standard of care now switched into what was the treatment group. Please note that standard of care did not restrict the clinicians from doing whatever they wanted, whatever the normal process was in a hospital. That included adding nasal mupirocin, which is the largest product in use today in many clinics, emergency rooms, in operating theaters, and in pre-surgical environments. An antibiotic called mupirocin, pseudomonic acid, which is in an emollient base similar to Vaseline, has to be placed in the nose twice a day for five days prior to surgery. That process has low compliance, and indeed is not immune from resistance.
The mupirocin component was a component of standard of care that was permitted within a particular regimen, so that we did not have any impact on the ethics of how you treat a patient before surgery. There on the right, you see the hospitals as they were deployed. We developed an approach to ensure that large procedures were covered in the study, because procedures that are minor, let's say, are not commonly involved with surgical site infections, do not need a product like this. But in our case, the large procedures such as cardiac healthcare, spine procedures, vascular, neuro procedures, these are procedures with commonly long procedure lengths. They involve some blood loss.
Patients coming into the procedure were ensured to come across a large variety of American Society of Anesthesiology preoperative scores, which are the difficulty, if you will, the risk of the procedure. You will see that ASA I and ASA V are fewer because those are either pre-oriented to an infection or do not develop an infection at all. So we made sure that the majority of the study was focused within components that are likely to respond to photodisinfection, as you might expect. The procedure categories were also selected in such a way to cover the large, high-risk surgery categories. The distribution of procedure lengths, you can see they centered around an hour and a half in our study. Some of them went three or more hours. That matters because your risk of an infection increases with procedure length.
There are numerous other covariates that we tracked, which are still undergoing evaluation and correlation. These include your BMI, the age of the patient, certainly the gender of the patient, all the baseline covariates that you might expect in a large randomized study like this. Primary outcomes were efficacy on a primary efficacy endpoint, the obvious one that you might expect. This was the rate of surgical infections compared to standard of care alone within 30 days post-surgery. Those are when most infections will commonly show after a surgery like this. Then, of course, a requirement to carefully monitor the safety profile, and this is the percentage of participants with treatment-related adverse events or serious adverse events, again, within 30 days after surgery. We used a pre-specified Bayesian analysis method, which combines prior evidence with current trial data, as is the appropriate framework within Bayesian analysis.
Bayesian analysis provides a posterior probability, looking back at the study as to whether a real treatment benefit exists. You can compare this to a frequentist analysis, which is a more complex statistical question of whether the treatment could have produced an outcome that it did should the hypothesis have been it didn't, which is a rather complex statistical question. This question, whether or not a likelihood is a real treatment benefit exists, is an appropriate one for a study like ours. It is ideal for sparse outcomes.
The infection rates are in the few percent range within a heterogeneous background population. There are hospitals that are small, medium, large. There are hospitals with fewer beds in one surgical category than another. There are hospitals that take patients from certain populations within the community and not others. So, not a homogeneous income population and sparse outcomes ideal for Bayesian analysis.
Bayesian analysis also permits us to incorporate prior data from a substantial evidence base. This is the so-called real-world evidence. This is the subject of a recent guidance document from the FDA earlier this year, permitting Bayesian analysis within primary drug study inference. This data that we have used, we have incorporated a large meta-analysis of over a quarter of a million prior patient treatments outside the U.S., and we are in a rare position to permit such a large database of outcomes to be brought to the future regulatory life of this product. Consistent with this evolving FDA guidance, we developed a fully pre-specified approach to include Bayesian methods, including all the operating characteristics per the FDA guidance documents. That includes things like interval coverage, the linearity, the power, certainly the alpha, the false positive rate, and of course, the posterior probability of benefits.
Fully pre-specified and appropriate statistical assessment. Primary endpoint was met, very happy to say that, with a 98.2% probability of benefit. That is nasal photodisinfection reduced 30-day SSI risk versus standard of care alone. You can see that that is correlated with a 40.5% lower risk of 30-day surgical site infections.
Let us reiterate, if we could, that that is on top of standard of care. That is not against standard of care with Steriwave used as a monotherapy. This product, named Steriwave outside the United States, not branded within the U.S. yet, was able to produce, in this particular study, a 40.5% lower risk of 30-day surgical site infection over standard of care alone. That probability of benefit exceeds 98%. We also conducted exploratory frequentist analyses. These are what you might be more familiar with, p- values, confidence intervals, effect sizes. We used multiple different frequentist models.
They are listed on the left. I will not go through them. We can tell you that the frequentist outcomes mirrored the Bayesian outcome very closely. Around a 46%, 47% benefit ratio. The confidence intervals are shown to the left and right of those numbers. To the right, you see the p- values, the frequentist p- values, which hovered around 0.02 or approximately 0.02. That was a very good outcome for us. Again, these are exploratory analyses. Once we have the Bayesian analysis meeting its primary endpoint, the statistical plan requires us to stop there. We did these frequentist analyses strictly for exploratory purpose. The safety profile, now that we have spent even more time with the data since our last press release, is fully consistent with prior clinical experience. Mild transient treatment-related adverse events. This might be blue coloration around the anterior portion of the nose.
No treatment-related serious safety concerns identified. Those are the ones that are important, that must be listed, that are tracked by the federal government. This is consistent with more than a decade and a quarter million patient treatments of prior clinical experience. The product doesn't produce heat. It doesn't produce downstream issues within the nose or within the patient. It is a very short, small intervention prior to surgery. I want to remind folks on the call that our statements relating to outcomes of this clinical study relate to an investigational product and are not consistent with FDA approval at the moment. That is to come with future downstream regulatory discussions, and presentations, and evaluations by FDA. What comes next? Well, from the top-line data, we are going to be having a very close and complete analysis, which will involve all the covariates.
We will look at the secondary endpoints. We will look at the exploratory endpoints. We will determine procedure category responses, all of the things that you might expect that we would want to share with FDA about how the technology worked within this particular study. We will publish in a peer-reviewed journal or two, and we will present at appropriate major conferences in terms of the outcomes of the LANTERN Study. This is one of the larger studies in nasal decolonization worldwide, and it's certainly the largest within photodisinfection ever produced. We will then conduct a pre-NDA meeting, which is an opportunity that we have as a company to talk to the FDA on a wide variety of subjects, ensuring that our NDA submission is well-founded.
Pre-NDA meeting might include chemistry, manufacturing, and controls, our scale-up methodologies, details about the LANTERN Study, aspects related to the labeling claims, and how the product will be positioned within the U.S. market, what the appropriate co-labeling restrictions, if any, will be. Those are all established at the pre-NDA meeting so that the NDA is well-founded. The NDA submission is, of course, the complete modules one through five of a drug submission, which includes the preclinical work, certainly the real-world evidence work that we've done, and all of the LANTERN results, as well as the phase II and other studies that we have conducted.
Within Ondine and beyond the LANTERN study now, we are preparing for the next phase of development. We're strengthening our supply chains to allow continued growth within our approved markets. We've brought manufacturing capacity in-house so that we're fully in control of the technology.
We know how to build this product because we've done so for a decade. As demand increases, so we're increasingly responding with readiness for those markets and indeed for potential future U.S. requirements should the FDA approve this product. Advancing these operational capabilities is critical for us. We do not want to be sensitive to worldwide political and other constraints, and so we've focused on ensuring that we can maintain margins, grow our gross margins, and ensure access to our product, both in terms of the photosensitizer component, which in the United States will be a drug, and certainly in terms of the disposable hardware which go into the nose. I'd like to close with a quote from our CEO, Carolyn Cross. This study represents the culmination of years of hard work.
Certainly assistance by numerous clinicians, numerous hospital systems, numerous advisors and consultants, not least HCA Healthcare, who have been an extraordinary partner to us all through. It also represents a successful conclusion to a great deal of preclinical science and dedicated clinical execution over the last 24 months. Our trial findings mirror our clinical observations over a decade of real-world use. This reinforces our confidence in the product, in the approach as we prepare for our upcoming discussions with the FDA. Thank you for joining us. I will open it up for questions.
That is great. Thank you very much for your presentation this afternoon. Ladies and gentlemen, please do continue to submit your questions just by using the Q&A tab situated on the top right-hand corner of your screen. As you can see, we have received a number of questions throughout today's presentation. If I may just start off with the first question here, which reads as follows. Could you tell us about the absolute SSI rate across the entirety of the LANTERN phase 3 study, and what was the highest and lowest absolute rate according to indication? Does this inform the commercial prospects of the treatment? Is the 40% reduction likely to still be commercially attractive for hospitals to Steriwave in indications with low absolute SSI rates?
Thank you for the questions. I will start with the last component first. We believe that a 40% reduction over standard of care is highly material, both statistically and clinically relevant. What this means is that clinicians who are currently relying on new therapy or other standards of care can look forward to a substantially reduced infection rate after using the technology, should it achieve regulatory approval within the United States. We believe that 40% over standard of care represents a significant enhancement over any other product that we are aware of today.
We do believe that Chasing Zero as the technology approach is commonly called by many large companies involved in surgical site infection and hospital-acquired infection reduction in general, Chasing Zero is an extremely important goal. You will never get there, but whether you are at 3% or 2% or 1% infection rate, it is really important to reduce it.
Every single person who gets a surgical site infection is going home loaded with antibiotics, looking at potentially years of therapeutic rehabilitation, and unfortunately, especially for MRSA carriers, a fourfold increase in the potential of dying from the infection. So we are dealing with human beings. It is not merely a number. Every single patient who gets an infection is a stain on that hospital and that clinician and that environment and that healthcare system's reputation on the hospital environment in terms of the capacity.
There are multiple downstream impacts in terms of the workload on clinicians who have to readmit that patient and block other patients from entering. It is a really significant problem. So yes, to answer part of that question, we do believe that it is very important that we reduce both the medium, the high, and the low hospital infection rates. Just one more thing.
While we do not publish beginning and ending rates in order to ensure confidentiality for hospitals involved, we certainly are in United States and Canadian average surgical site infection rates, and those are available in the literature.
That is great. The next question we have here reads: Your results are all for SSIs. Can you comment on the results of Staphylococcus aureus?
The results are for all SSIs, so surgical site infections that may occur from Staphylococcus aureus, which is the largest causative microorganism, or correlated to causative microorganism, are included. But there may be Enterococci, there may be Pseudomonas-related infections. There may be infections from microorganisms that we cannot even type yet as a scientific community. We do not care. Photodisinfection is an extremely broad-spectrum approach to disinfection. It kills everything. The one thing it does not harm is human cells. So we are very clear in our assertion over many years within the field and in preclinical work that fungus, virus, and bacteria can be killed effectively this way. The deployment is something that is fast enough and sufficient to cover the anterior nares that we believe that this produces an extremely useful approach to removing microorganisms without knowing what they are.
The idea of zeroing in on Staphylococcus aureus is not required.
Perfect. Just turning to the next question. Assuming a constructive FDA meeting, what is the realistic pathway and timeline from here to submission?
We have not published guidance to that. We do believe that we will be within the normal antimicrobial timeline submissions. We have discussions with FDA that are upcoming, we must not preempt what the regulators may find or say. We, however, believe we have a very strong submission. We believe that we have a great deal of real-world evidence to support the current LANTERN results. We are very proud of the LANTERN results, and we are able to position those results as a consistent outcome with prior real-world evidence. We are happy to say that within normal NDA timelines, assuming the regulators agree with our approaches, our statistical analyses, our study outcomes, our real-world evidence, and certainly our development plans, we are very comfortable with appropriately matching industry standards.
That's great. Just turning to the next question. Are you able to tell us more about the preparations you're making across supply chains and manufacturing? How do you meet potential demand?
Yes. We have outsourced in the past more than we are now. We are bringing technology in-house. I am talking to you from Seattle, Washington, and if you were to go behind me a few hundred feet into our large manufacturing facility, you will see our online manufacturing technologies, equipment that is producing drug ampoules, stain ampoules. You would see the normal production lines in clean environments that are producing the hardware that enters into the nose. We are making sure that we scale appropriately with the technology demand that is coming to us.
We have hired experts in operations, we have hired experts in manufacturing, and we have started to review additional facility sites, which will come online, should we decide to move forward with them, towards the middle of this coming year. Those require regulatory submissions as well, since this is a medical device outside the United States. We are also minimizing our exposure to worldwide supply chains, which may otherwise cause problems either with supply availability or costs due to tariffs. This is merely good business practice to make sure that we are in control of what we believe will be a very large product.
That is great. Just moving on here. Are you able to tell us more about the potential size of markets you are targeting, both in the U.S. and/or more broadly in Europe and the rest of the world?
The first few slides showed the 300+ million procedure size. The total addressable market ranges into the many billions, many tens of billions. We believe as a unique product and a first-in-class product, and certainly one which we hope will achieve a first-in-class regulatory approval in the United States. We are looking at markets that are consistent with many hundreds of millions dollars of potential market size across the world.
That is great. Just turning to the next question. What is your agreement with HCA Healthcare beyond the clinical trial? Will they automatically become a customer?
Well, of course, I'm unable to speak to HCA Healthcare's intent. Furthermore, without the product being approved, we're not allowed to engage in any commercial interactions whatsoever in the United States. I can tell you that HCA Healthcare have been an extraordinary positive force for this product and its development. It was their hospitals in which we fine-tuned design methodologies for how the product will be distributed. There are particular machines which products like this are distributed through that dispense the product into nursing stations. We understand how these dispensers will work. The product has been designed from a size, space constraint, nursing work schedule, hospital workflow, usability constraint set that come out, in many cases, from interaction with HCA Healthcare.
HCA Healthcare maintain a research institute, the Health Research Institute, an extraordinary group of clinicians and hospitals designed for this particular purpose of looking at products like this in order to determine their suitability for clinical use downstream. We can tell you that they are extremely keen on what we're doing, in part because it seems to be so broad spectrum, it seems not to induce resistance, and it seems to be so fast in deployment that it increases and enhances hospital workflow. Should we become approved in the United States, I believe that those serious advantages will become available to HCA Healthcare, but also to other healthcare systems. It's not exclusive to HCA Healthcare.
We obviously will intend to treat HCA Healthcare as our closest and best partner, but we will be available, hopefully, to other healthcare systems, including federal systems such as the VA, in due course.
That's great. Just turning to the next question. Operating expenses are notoriously high. What is the cash runway in months, and what are available funding options going forward to keep operations running?
Thank you. I obviously have to be careful how I answer that question within the constraints of the AIM and MAR rules. We do not publish our current rates because these are available in prior releases. You can imagine that we're very carefully focused on cash runway. We have numerous options open to us. We are in discussion with folks representing numerous opportunities, both in terms of equity participation, perhaps strategic partnerships, perhaps private equity. We understand that post a phase III top-line result, companies are drawing closer to a regulatory process, which is meritorious. Certainly, there are a lot of people interested in a first-in-class product like this. We will leave this question for future press releases. Thank you.
That's great. Just turning to the next question. When do you expect the company to achieve a breakeven position, and how does this study bring this forward?
I can answer the second component. This study is an absolute prerequisite to bringing a breakeven point forward, because it brings us closer to our regulatory discussions with FDA and ultimately, and hopefully, to approval. Should the product be approved in the United States, you're opening up the largest, most concentrated healthcare market in the world, a market which clearly needs a product like this, and a market which is available to us both through our friends at HCA Healthcare and through direct distribution into the United States. Certainly within the U.S. a very strong catalyst. Outside the U.S., we believe that we can grow this business sufficient as well.
That's great. Just moving on. How easily does the Steriwave procedure fit into existing clinical workflows, and is there a willingness from clinicians to incorporate it into practice?
That's an extremely good question. Again, the second part of that question is the crux of the matter. You can produce the best product in the world, but it needs to be delivered appropriately. It needs not to impact clinical workflows in particular. It needs to be priced correctly. Most importantly, the clinician themselves must be a willing participant in the distribution to a patient. If you take a product like this to a clinical environment and you don't provide appropriate clinical evidence, you don't provide appropriate statistical basis for your work, you don't provide a simple workflow, the product will never survive that introduction.
We've really focused on ensuring that the merits of the product, both in terms of the speed and the broad-spectrum nature, the differentiators to this complex five-day, twice-a-day workflow that is required with mupirocin, for example, which I can assure you does not result in compliance by the majority of patients. Well over half the patients don't complete a course of mupirocin. They may claim they do, but they don't complete it when that is really evaluated under clinical practice terms. There are holes in infection control that simply exist today because of the exigencies, the challenges of appropriate delivery, appropriate delivery of products which are now, in our view, legacy products. Furthermore, use of an antibiotic indiscriminately in so many tens of thousands of patients is a bad idea.
It simply is a bad idea to provide antibiotics to people prophylactically without understanding whether they need it and ensuring that you're going to be elevating resistance. We believe that within the constraints of current hospital workflow, this will be a standout win.
That's great. Just moving on here. As you think about commercialization, what capabilities do you expect to build internally versus access through partnerships, and what will determine that decision?
I think that the potential for strategic partnerships in a product of this scope and scale is really, really important. We are not going to say that we're the best at everything, and it's important that we realize our limitations. We believe we have a tiger by the tail, and we don't want to harm the development of this product by restricting its manufacturing and production, for example, by restricting its distribution. We may make those decisions at the appropriate time and subject to the FDA regulatory process. At this point, we believe that partnerships represent the best way to utilize the best of the various sectors into which we will partner.
Rather than necessarily duplicating a large sales force, rather than duplicating extensive manufacturing beyond the stable base that we have, rather than directly manufacturing drug or device components, we believe that partnership is most probably the best approach to maximizing revenue.
Perfect. Just turning to the next question. Which surgical specialties or hospital customer segments will you prioritize first?
Obviously, as a surgical site infection reduction product, hospital systems which specialize in surgeries, in particular high-risk surgeries, but we think this product is a universal product, and it should be deployed across the spectrum of patients. One shouldn't restrict a patient from a potentially life-saving prophylaxis like this, just because the surgery is not commonly associated with surgical site infections. Should there be a surgical site infection, the downstream results are the same, whether it comes from a high-risk or a low-risk surgery. Having said that, hospital systems that specialize in surgical procedures like HCA Healthcare that are surgery-driven would obviously be an appropriate target. There are other sectors that we're interested in. First of all, the intensive care unit is a post-surgical surgical theater. Intensive care units suffer from much higher infection rates than the average pre-surgical population.
In the intensive care unit, the risk of dying is far higher. The risk of a complex infection is far higher. Within the intensive care unit that involves neonates, it's a crying shame to see a neonate come into an ICU free of MRSA and unfortunately develop an MRSA infection or downstream sequela from MRSA colonization, because unfortunately, there may have been transmission from surrounding environments. We believe there are numerous places in the hospital, opportunities within clinics, long-term care facilities, any environment where there are surgical or pre-surgical or post-surgical, post-acute care facilities. That includes burns, that includes wounds, and certainly downstream. As we develop this product further beyond pre-surgery, you'll see us in diseases that have nothing to do with surgery, but do involve indolent, recurring antibiotic-resistant infections. Sinus disease comes into firm focus there.
There are numerous places in the hospital care spectrum where patients can develop infections very difficult to treat. One of them, for example, is a post-surgical complication involving abscess formation. Another relates to downstream implantation of devices, talking orthopedic devices primarily, but other devices as well. There are certainly developments within our company involving fungus, and fungus is an extremely difficult-to-treat microorganism because it doesn't actually share as many attributes of bacteria. The so-called prokaryote or early-stage life form shares more with the eukaryote, the human-type cell, and they're very difficult to kill. We do a very good job with fungus. We do a very good job with fungus and yeasts, and we want to see the technology appropriately deployed there, too.
That's great. Just turning to the next question. How quickly can you scale to meet manufacturing demand if approved?
This relates to recent investments that we've made, both in terms of people and in manufacturing capability. We can scale the company internally rapidly. I'm talking months, not quarters, and I'm talking factors of 2- 10, not merely a few percent. We've positioned ourselves with appropriate, careful investments to allow for that kind of expansion. The folks that we have recently hired and now are bringing up through the development ranks into manufacturing and operations have scaled companies that are not billions but tens of billions in size. We are very proud of our workforce and of the stability of that workforce. Realize that we've been doing this for over a decade, and we understand exactly how to manufacture. Scaling is a different technique, it's a different skill set, but we're very well positioned to do so.
Beyond those numbers, we will go to strategic partnerships and potentially offshore manufacturing as well.
That's great. What is the timeline of events for the next 12 months?
Well, within the next 12 months, we would hope to be able to conclude downstream LANTERN evaluations, publish, of course, all the results, engage with the FDA in the pre-NDA and potentially the NDA track, and ensure that future studies are launched, or at least planned, which would involve the intensive care unit and other environments as well. Along with growing the company, focusing on revenue both in Canada and in the rest of the world outside the United States, ensuring that we support our partners both inside the U.S. in clinical development as well as outside the U.S. in marketing and sales, are going to be the focus for the next year.
That's great. The next question we have here reads: Did the standard of care arm of the study ensure a much higher level of compliance with the use of mupirocin that you might expect in real-world use?
From the data that I have been able to review to date, I would say that it was consistent with to slightly better than real-world use to mupirocin. We went to great lengths to ensure that the standard of care, whatever it might be in a hospital, was not impacted by the study. It's one of the factors in why we selected a crossover design study, which was group randomized, hospital by hospital randomized, rather than patient by patient within a hospital. It was just to ensure that we did not impact hospital workflows or standard of care to any significant degree, and the same is true with mupirocin use.
That's great. Just turning to the next question. Can you talk to the costs for hospitals of Steriwave and what savings can be made versus standard of care? What would make this more challenging?
Pricing is not set within the U.S., for obvious reasons. We're not approved in the U.S., and outside the U.S., it does depend on the particular distribution route. There is, within Canada, a stable access to the product through purchasing organizations, all of whom may purchase in larger or smaller volumes, and that makes the price dependent on volume. From the perspective of payback, the system at 40%-50% effect size, let's say, should we enjoy that on a continued basis, which you very often see in hospital systems that have deployed the system, payback is extremely fast. We have just had the immense pleasure of deploying in the first few hospitals in Mexico, where we expect to see significant benefits to infection rates.
That's Coapa Hospital Ángeles, a tremendous healthcare system run by people who are absolute experts at what they do, with beautiful hospitals, and catering to a great number of within Mexico, but as well as external to Mexico, medical tourists, folks who come in looking for superb quality of care at lower pricing. We believe the product has a great opportunity there, and we've discussed with the hospital system how we believe payback can be just a matter of months, because each infection can range up to $100,000 worth of downstream costs, much of which has to be borne by the hospital within today's litigious environment and within today's reimbursement environment. So we believe it's a very, very good value for money proposition.
That's great. The last question we've got here reads: What average dosing is required in an ICU environment compared to general surgery?
I'm presuming dosing means utilization of the product. That's a good point. Within general surgery, we're anticipating being used one time before surgery. There are a number of institutions which have asked us for the potential for post-acute care, but our clinical study has only focused on, in LANTERN, on a single deployment before surgery, so that's all we can speak about.
However, within the ICU, we do expect there to be an administration more than one time. We do know from preclinical work that the suppression effect lasts multiple days, so we may not have to deploy every day. But the risk of infection is so high in the ICU. Remember, most patients in an ICU are intubated. They are carrying an airway catheter, either through the nose or into the mouth, down the trachea, which inhibits that patient's cough reflex. It inhibits clearance of mucus.
With mucociliary clearance impeded, you get a lot more infections. You get a flow of microorganisms from the oral cavity, from the sinus tracts, down the trachea, around the catheter, and those enter the lung and cause ventilator-associated pneumonia. It's really important to keep the upper airway and the oral cavity clean, and there are ways to do that today in an ICU, but not really effectively because it's so difficult to deploy mupirocin. So we believe an every other day approach would be a great opportunity to keep the patient clean. Maybe a regimen that's every day. We don't know because we haven't yet deployed in a widespread way. We have looked at the clinical study, which was, in our view, spectacularly successful. Dr. Steve Reynolds, Royal Columbian Hospital inside Canada. Great outcomes microbiologically.
Nice suppression that we could see in terms of the factors we believe contribute to the infection rates in an ICU. So we do have a strong, both preclinical and now clinical indication that the ICU will be a significant opportunity for us. Remembering that while there are far fewer ICU patients than presurgical patients, that increase in the number of deployments makes the two markets roughly equivalent. We've not included ICU in any of our forecasts to date, but we certainly intend to in the future.
That is great. Thank you for answering all those questions you have from investors. The company can review all questions submitted today and will publish those responses on the Investor Meet Company platform. Just before redirecting investors to provide their feedback, which I know is particularly important to the company, Nicolas, could I please just ask you for a few closing comments?
Well, first of all, thank you to Investor Meet for the opportunity to deploy this forum, and thank you to 5654 for assisting us with the setup. I certainly want to thank all investors, all stakeholders, both our clinical partners in the U.S. and in Canada for their inestimable work, their great assistance in what was, by necessity, a large multi-center, multi-geography, now multi-year study.
I would like to thank the clinicians as well as the administrators, the care coordinators, and of course, ultimately, the patients for all that they did to ensure that the LANTERN study was able to deliver a positive top line. We really look forward to updating investors further as we develop the regulatory track to the pre-NDA and NDA submissions, and then ultimately look forward to a deployment within the U.S. market, which would, of course, be a crowning glory.
Thank you very much for everyone's attention and look forward to speaking again soon.
That is great. Thank you for updating investors today. Can I please ask investors not to close this session as you will now be automatically redirected to provide your feedback in order that the management team can better understand your views and expectations. This will only take a few moments to complete and I am sure will be greatly valued by the company. On behalf of the management team, we would like to thank you for attending today's presentation and good afternoon to you all.