Morning everyone, or good afternoon, depending on where you're visiting us from. My name is Philip Renaud, Chairman of Kane Biotech, and thank you for your time and interest in Kane. On behalf of the board of directors, I would like to thank our shareholders for their continued support of the company through a challenging period of transition. Over the past year, Kane has transformed itself from a company with multiple business activities into a focused wound care company built around a unique capability. The ability to address biofilms, reduce healing time, and improve a patient's life through our FDA and Health Canada-approved revyve product platform. The team and I believe that this focus has fundamentally improved the quality and the strategic value of the company.
I want to speak briefly about three areas: my commitment to Kane, my confidence in the team, and the encouraging feedback that we are getting from both doctors and patients alike, with reordering continuing. First of all, my commitment to Kane. My commitment has never been stronger. Robert Huizinga and his team never stop amazing me with their dedication and hard work, and we are finally seeing the results. As both a Chairman and a significant shareholder, my interests are aligned with every shareholder. I understand that my responsibility is to create long-term value through disciplined decision-making, responsible stewardship of capital, and an unwavering focus on education. We remain actively engaged in evaluating opportunities that may enhance shareholder value while maintaining our commitment to transparency and sound corporate governance. Since assuming leadership, Robert Huizinga and his team have brought focus, urgency, and discipline to the organization.
They have worked to rebuild credibility, strengthen relationships, advance commercial activities, deepen clinical engagement, and position Kane for sustainable growth. No early-stage healthcare company is without challenges. However, what gives me confidence is not the absence of challenges, it is the quality of the people addressing them. This is not Rob's first time in bringing an innovative, game-changing product to the market. He has the scars to prove it. Robert understands what it takes to win. The board has observed a management team that is prepared to make difficult decisions, operate with transparency, and remain focused on the fundamentals of building a successful wound care company. They have our support, and they continue to earn our confidence through their actions and executions. Finally, and perhaps most importantly, I would like to discuss revyve. Over many years, Kane has developed a differentiated technology platform grounded in biofilm science.
What excites me today is that we have moved beyond a purely development stage story. We now have products that have achieved important regulatory milestones and are being introduced into the marketplace. The wound care market is searching for solutions that are clinically relevant, practical for healthcare providers, and capable of addressing the significant burden associated with chronic wounds. Based on the work completed by the company, the feedback received from clinicians, and the growing body of clinical experience, I believe revyve has the potential to become an important tool in wound care management. As Chairman, I am encouraged by the quality of the science, the growing clinical interest, and the commercial opportunities that management is pursuing. While there's still important work ahead, I remain highly optimistic about the opportunity before us. In closing, I want shareholders to know that the board is actively engaged.
Management is executing on a clear strategy, and we remain focused on building long-term value. We believe Kane is better positioned today than it was a year ago. We have a clearer strategic focus, stronger commercial leadership, increasing clinical engagement, and a product platform that addresses a significant unmet need in wound care. Thank you again for your support, your patience, and your belief in the company. I would like to turn over the presentation to Dr. Robert Huizinga . Thank you.
Well, thanks for your kind words, Philip. We really appreciate it. It really is a teams-based approach, not only within Kane, but with clinicians and patients, so that we can make a difference for people that have chronic wounds. Before I give the presentation, we welcome your questions throughout today's webcast. To submit a question, please click the Q&A icon located in the meeting controls and just type your question in the Q&A panel. Questions may be submitted any time during the presentation. To help us manage the session efficiently, all questions will be reviewed by the moderator, Ray Dupuis, before being published and addressed. Due to time constraints, we may not be able to answer every question live. However, we will make every effort to address the most relevant questions during the Q&A portion of the webcast.
We encourage you to submit your questions as they arise rather than waiting until the end of the presentation. In addition to a Q&A session, we have our forward-looking statements as well, too. This may look a little bit longer than what you've seen in past presentations. That's because we're going to talk about the revenue model that we've put together and what that means for the company, for the patients, and for investors. There can be no assurance that the expectations reflected in the forward-looking information will prove correct, and so readers and webcast participants should not place undue reliance on forward-looking information. The intent of today's call is really to have a presentation from myself talking about the commercial access and turning that into repeatable adoption by clinicians and, of course, revenue to the company.
Then, of course, Dr. John Lantis will be talking about a clinician's view of biofilm, chronic wounds, and revyve in his practice. He's running a busy clinic, and he's in clinic right now, and he'll be able to join us, hopefully, during this presentation. Internally, we talk about this as Kane 2.0, and we have a lot of new elements to the company, and that's really building the foundation of a sustainable commercial enterprise. The first is we have a new board. As you know, we brought on new board directors last year, and you elected them onto the board of Kane. They have expertise across various arenas of bioscience, including medical devices, drugs, financial expertise, and so we are glad to have them there. We, of course, have Philip, the new chair of the board as well, too.
As a significant shareholder, to ensure good governance, we additionally have a lead independent director to ensure that your wishes are being well represented. On top of my new role within the company, we have new commercial leadership as well. A person for Canada and for the U.S. have great expertise in not only dealing with wound care medical devices, but launching new devices in the wound care space. Kane as a whole has a new vision, wholly focused on human wound care since the divestment of the animal healthcare division. Of course, we have a family of products, three cleared products in the U.S., the gel, the spray, and the cleanser, which are all FDA 510(k) cleared. Of course, the gel and the spray are approved by Health Canada as well.
Our plan through 2027 is to move into Europe through a CE Mark that will allow us to continue our commercial efforts there. That is built on the back of a clinical evidence program. You know about the clinical data that we have built to date. We are continuing to build clinical data along the way in new patient arenas, like burns. As these clinical trials start, we will be announcing them to you. In addition, we have a scientific advisory board that is being formed with the first meeting towards the latter half of this year. We are excited because they also have expertise across the clinical space and the pre-clinical space. Lastly, all of this has value, but really it relies on an important distribution network across the U.S. and Canada. I will be talking about that in a few minutes. You have seen this slide before.
We amputate a limb in the U.S. about every four minutes for a diabetic-related complication. There are about 10.5 million people that have a chronic wound that are covered by Medicare alone. In addition, there are about 700,000 people annually in the U.S. who have a burn-related insurance claim, meaning they have a significant burn that requires some sort of acute care. That care is expensive. It is not a lot cheaper in Canada either. It is about CAD 47,000 for a diabetic amputation. Overall, that results in about CAD 750 million spend for Canadian taxpayers in diabetes alone. If you are a First Nations population, your rate of diabetes and, of course, your subsequent rate of amputation is even higher than that. That is the patient population we are trying to address. Ray, I am not sure if John Lantis has joined us yet.
Yes, Dr. Lantis is on the call now.
John, if it is okay, I will just introduce you for a second. You are the Site- Chief of Surgery at Mount Sinai West Hospital , and you are a Professor of Surgery at the Icahn School of Medicine. You are the Director of Advanced Care, but in addition to all of that, you are the Editor-in-Chief of the prestigious journal, WOUNDS. You have been involved in a lot of clinical trials as a principal investigator over your time, and you had the chance to use revyve over the last year in your patient population, in addition to co-authoring a publication for us. I would like to turn the presentation over to you and just have you share with us your experience of using revyve in your patient population.
Thank you so much for the kind introduction. Thanks for having me today. Sorry, I am in the middle of my office and clinic day, but yeah. Again, thanks for making time. With that in mind, the product is incredibly there is a real realization. The other thing that is not here is I train a wound fellow every year, and I also have significant number of trainees. We have 26 vascular surgery trainees in our program, which is actually the largest in the country. All that being said, we have a lot of folks who are clinically doing actually the work in the trenches, so it is top-down. In our outpatient center, revyve, especially in its spray-on formulation, but in all formulations, but really on the spray-on formulation, has done some amazing things. It is one of those issues that probably addresses biofilm in a very unique fashion.
The weird portion, or the unique portion maybe here, is without contact or without debridement, which is painful to patients, and there are certain populations. I guess the amazing component is I have had a gentleman who has sickle cell anemia, which is, of course, an environmental, learned trait of our bodies to deal with malaria. Folks from a Nigerian heritage, which for obvious historical, inappropriate reasons have ended up in the U.S., South America, and the Caribbean and have these ulcers. They develop ulcers in their lower extremities due to poor oxygen delivery to tissue, and they get chronic infection primarily with Pseudomonas. A very difficult bacteria to remove. I have had one gentleman specifically who had his ulcer open at his ankle for 36 years. Right. 36 years. Like older than most of our kids.
His ulcer has been open for that long, and he used revyve spray and he healed. There is a 62-year-old gentleman who gives you a hug because you have healed his ulcer. I have done other things. Plenty, plenty more. I have debrided him. I have done this. I put on super agent X, Y, and Z, but revyve healed him. I mean, that is anecdotal, but we have seen this in sickle cell anemia. We think we see it in other people. There is no magic bullet for everybody, and nothing is right for everybody. But from our perspective, we have shown in using biofluorescence, that we reduce bacterial burden in patients with a topical antimicrobial therapy. There are other ones out there at the moment, but I think that this is a very viable option.
And I think for the folks who are not medical who are on this call, one thing to keep in mind, although clinical staff and medical folks are swayed by evidence, a lot of us, it is very hard not to be swayed by experience. And those are two differences. And revyve has, for two fellows, so these are people with full medical school training, two or three years of surgical training, and for several residents who are, again, four years of medical training and two or three years of surgical training. Revyve has given them numerous anecdotal improvements or closures of wounds that have been problematic to them. So I think if you personally think about this, anything that solves a problem for you is usually a benefit to you. That can be something that makes your car run better or makes your doors not squeak.
And I mean, it sounds silly, but when you take care of patients and you see 120 patients a week like I do, and you operate two days a week on eight different patients, things that solve a problem for you more often than not are attractive. Revyve has interestingly entered that realm. So for us, it is something we like to have available. We're going to be doing a prospective trial furthering the data around this. But to date, this is something that in cases I can say, "Have we tried this yet?" And it's not always a one and done, and that's one thing I will say about it. Obviously, treating using a spray-on or applicable hydrogel with an antimicrobial property doesn't do everything for everybody. But it does something for almost everybody. So the issue is there, you move people in the right direction.
It may be a portion of an algorithm of care, but the sickle cell guy who gave me the huge hug, which was not expected, it was just spraying it on 3 x a week, dressing his wound. He'd done the same thing for 36 years, like I said, and he added his spray, and his wounds closed, and he has no pain. And sickle cell wounds are very painful. So, from my personal experience, it's almost like I like to say to the Kane group, "Thank you," because this is a person I care about. He's a patient I saw weekly. I saw him weekly for two years. So, he had fundamentally, I don't see him every week. My fellow sees him, blah. But fundamentally, he had 104 visits. Now I see him once every three months to make sure he's okay.
Huge improvement.
Yeah.
So that's what I have to say. Thank you very much for your attention. But that's that, and we have other data. Our data says that we reduce bacterial burden. Patients get better. They feel better. They like the therapy. One of the patients with sickle cell anemia, quite frankly, is actually a physician, young man who's a physician and has this problem. He's closed one wound. His other wound is closing. He goes to work every day. He couldn't without this. So I think that really covers it. There's a clinical, emotional benefit to this that we're very happy to further elucidate whether it is, who else it's helpful to. So this isn't just your diabetic foot ulcer or your this or your that. I think there's a wide spectrum and obviously there are other products out there that are antimicrobial.
This has been very beneficial and a lot of the patients we've had have experienced some of the other therapies that are theoretically competitive and have done very well with this. We look forward to doing further research work in regards to.
Awesome. Well, thanks very much. I appreciate it, especially the anecdotal story about that one patient. One of our key values is patient centricity, so I get really excited when I hear patient stories. I really appreciate you sharing that with us. We're looking forward to the continued work and investigation of revyve with your patient population. Thanks, I appreciate that. I'm going to continue on, if it's okay, John, with my part of the presentation. I know you have a tight clinic window, but I'll continue on. One of the things that we've learned over the last several decades is biofilm is a real issue for all of us. As Dr. Lantis mentioned, it may not be in every patient's wound, but it looks like somewhere between 70% to 80% of wounds have a biofilm component to them.
Very simply put, bacteria's response to being potentially killed is to glue themselves to the base of the wound as quickly as they can, and to form this thing we call a biofilm. They form that biofilm within 72 hours. In 72 hours, you have this mature biofilm that now makes these bacteria more resistant to antibiotics than they would be normally. The picture there is in the bottom right of your screen, it's typically not one bacteria, but it's multiple bacteria forming this invisible shield that they have. As Dr. Lantis mentioned, your only way around that is to physically disrupt it, so to debride the patient's wound, which is painful, or to chemically disrupt it. That's what revyve does very clearly. We have a biofilm disruption component, which works in 30 minutes.
We see the difference in biofilm disruption and reducing the inflammatory cascade, it's a thing we call the elevated protease activity. In addition to that, we have PHMB as the antimicrobial, which works in the preclinical models for up to seven days. When you think about a patient in the outpatient setting who may not be able to see a physician every three days, or a surgeon every three days, they have the ability to have that combined activity over that seven-day period across multi-species and resistant strains. Lastly, as Dr. Lantis mentioned, there is this no-touch approach with the spray. Regardless for both products, it's a thermal reversible gel that support this thing we call autolytic debridement, which basically means it's cleaning the wound underneath as the gel is sitting there.
To put it on, it immediately turns into a thick, viscous gel on the patient's skin. But then to remove it, cool water, cool saline, it comes right off. There are three cleared products within the revyve family, and a fourth of which I will talk about in just a moment. We of course have the wound gel, which you are well aware of, which is intended for chronic ulcers like diabetic foot ulcers, venous leg ulcers, pressure ulcers. We have the Antimicrobial Wound Gel Spray, which is intended for burns or large areas, or those painful lesions that Dr. Lantis mentioned, or irregular wounds where a non-contact application really matters to patients.
We had already announced that we have a skin and wound cleanser that has been 510(k) cleared by the FDA, and we are presently working with negative pressure wound care companies to find a way to work with them so that their device and our cleanser work well together. And then lastly, the surgical environment is important for us because right now the products we have, the wound gel is not sterile, which means it can only be used after the incision has been closed and they are ready to put a final dressing on the incision. The s urgical gel, we have heard from clinicians, would be very valuable to them because as implants are put into patients, when you think about hips and knees, there is a chance for them to have a biofilm and an infection there.
The opportunity to use a surgical gel in the OR with a sterile product is important to us, and that development program and regulatory pathway is being defined, and we hope to see that run through 2027. You have already heard about the clinical research that we have done with revyve, both in Canada and in the U.S. And as you see on this picture here, we have expanded that across multiple centers. So we now have data coming in on burns, we have data coming in in different patient populations. And when we did the initial clinical series, it really said the same thing. Regardless of how a patient came to a chronic wound, whether that was through sickle cell disease, a radiation-induced ulcer, hidradenitis suppurativa, a diabetic foot ulcer, a venous leg ulcer, they ended up with the same problem due to the bacteria and the biofilm.
And we showed in that case series that we had a high rate of conversion from a non-healing wound to a healing wound. And in addition, as mentioned by Dr. Lantis, a meaningful reduction in pain, which is very important to patients. Over the life of Kane, we have had 11 peer-reviewed publications. But in the last year alone, we have had a tremendous number of conference presentations, both in the chronic wound setting, the burn setting, but now of course in the military setting, which I will talk about in just a few minutes. And we are working with a number of partners that you can see down below with us to make a difference in the lives of patients. And you may have seen these pictures before.
This on the left is a standard 52-year-old male with a diabetic foot ulcer who had failed multiple therapies prior to coming to revyve. If you look at that crevice in the heel, that is something that is concerning from a clinical point of view, because that may end up in osteomyelitis. Over the 90 days, approximately, we saw near closure of that wound. By month five, a fully healed wound by the clinician. So a very good outcome in a patient that had failed prior therapies. On the right is a patient of Dr. Lantis, a 62-year-old female with a chronic venous leg ulcer, CVLU, who had recurrent issues since 2013. Not quite that patient that he talked about, 36 years of chronic wounds, but again, a very serious story since 2013.
Pain score 10 out of 10 with these CVLUs, which are quite painful. The pain was eliminated by week six. We can see the healing by week eight, and by week 33, had sustained healing. Those are the reasons we do what we do. We want to see a difference in the lives of these patient populations. In order to get revyve to those patients, we needed to build a distribution infrastructure. As you know, prior, we had exclusive agreements with the distributor in the U.S., and we have changed that approach. As of today, we have seven agreements signed with distributors and sales agent companies who will make sure that revyve gets out to clinicians and to the patient populations. On top of that, we have seven commissioned U.S. sales representatives, what are called 1099 representatives, who have direct relationships with different forms of wound care treatment.
That is important in the U.S. that we have these different touch points, both in-hospital, out-of-hospital, mobile wound clinics, and geographic wound clinics. In Canada, we have three distributors and GPOs that we have signed. We have mentioned those already, including Ontario Medical Supply, who has just signed recently, and we have 11 further agreements in discussion, including a new GPO that we have signed into the U.S. who are very important to us, and they would like to wait for the press release until they have signed their first order. But revyve is a dual use technology in every sense of the word, and we are working with the military as well too. So we have a Department of Veterans Affairs distribution agreement signed through Marathon Medical, and that will allow us to use the 1099s to get into those centers and use revyve in the chronic wounds that are there.
In addition, we recently presented data at the MHSRS Symposium in August, and that resulted in a conversation with some military researchers who want to engage on a clinical research plan, excuse me, across several patient populations. Finally, again, in Canada, we have had ongoing conversations with CFHS, Canadian Forces Health Services, and we are looking forward to continuing those conversations and seeing that turn into orders, initial orders, and hopefully repeat orders. So what about the military? We have identified very distinct treatment areas for revyve within the military. The first is delayed access. I was a medic many, many years ago, and we used to believe in this thing called the golden hour, that we could take an injured soldier and get them off the battlefield and into a sustained treatment area within an hour. Ukraine has taught us that is no longer true. It is taking nine hours or longer.
We are looking at longer evacuation times, which means they need treatment in the field to prevent the inevitable infections that may happen if the wound is not properly treated. In addition to that, the trauma has become more complex, so they are looking at the spray delivery and in situ gel formation within this three-dimensional wound that we have within the battlefield. On top of that, some of the bacteria being seen in the combat spaces are different than what we have seen in the civilian spaces. We will engage on a plan to look at those new bacteria and look at bacterial attachment and biofilm development in the combat setting.
Of course, frequent dressing changes are important in the military, just as they are in the civilian space, as Dr. Lantis has mentioned, and we are looking to help the soldiers so they can reenter back to their units as quickly as possible. Lastly, we are looking at battlefield treatments in austere environments, very, very cold environments, which Canadians are well used to, and very warm environments. Revyve needs to perform in the same deliverable manner in all those different environments in a low technology manner, meaning that a soldier can use it right at the battlefield at time of injury. Those are the plans that we are looking at along the military. I told you at the beginning of the call we were going to talk about a model that we have built and put together to look at how revyve would be used across various spaces.
That includes the revyve Antimicrobial Wound Gel, the revyve Antimicrobial Wound Gel Spray, the revyve Antimicrobial Skin and Wound Cleanser, and the Antimicrobial Surgical Gel. The first question is: how do we build that model? We looked at the different U.S. addressable market sources that we would normally have, and then we were able to look at the launches of predicate products, so for example, hydrogels. We looked at the five-year launch run of similar companies of a similar size with a similar, and I would argue, less efficacious product, and looked at their five-year launch ramp and then modeled it from there. If you look at the revyve Antimicrobial Wound Gel on the left side of your screen, you can see that we are predicting a market share of 0.5% moving up to 2.5% in the hydrogel space. That is a very conservative prediction.
The same applies for the revyve Antimicrobial Wound Gel Spray, a little bit higher for the revyve Antimicrobial Skin and Wound Cleanser, and that is because by this point, we will be working with negative pressure wound care companies, hopefully, to ensure that their products and our products are used together. The Antimicrobial Surgical Gel had to be modeled differently because we looked at active surgical accounts in the jurisdictions where we know we will have a presence, multiplied by the procedures and the protocol penetration rather than a share, excuse me, of the total addressable market. Looking at the first revenue of that product in 2028. Across the model, we also did some assumptions for Canada and international sales and of course, held an exchange rate.
Now this is a model, and a model is only as good as the inputs that are put into it, but we believe we've put together a predictive model that is still conservative. That means that we are targeting sales of 400,000 through the year 2026. Now, those are modest sales, and you might want to say, "Why would I believe in the Kane story? Why is this important to us?" Because you can see that model shows a ramp through 2027 through 2031, which in a very predictable manner and consistent with the five-year launch ramps of other similar companies. Now, there is upside not built into this model. We have not done anything in terms of dual use technology, in other words, any military orders, because it is very hard to get our arms around that at this point.
We have not talked about DispersinB or any of the aspects of DispersinB either. This is primarily revyve, the wound gel, the spray, the wound cleanser, and the surgical gel in the civilian market. Now, to do that, we need to make sure that we have supply chain ready, and we are working on that now. Our partners, Halo Pharma in Quebec, are actually fill finishing right now a batch of three-ounce gel that we can get to the Canadian and U.S. markets to make sure we fulfill that demand. Then early next year, we will be working with our partners, Renapharma AB in Sweden, to do spray fill and the bag-on-valve packaging of the five-ounce spray. As you know, we have a 3PL system set up both in Canada and the U.S. to deal with the logistics of shipping in each individual country.
But as you also know, that means that we are going to have to embark on a capital raise of one kind or another, to which we have engaged DNA Advisors to help us. We are targeting between a CAD 3 million and CAD 10 million raise. To make the answer very simple to when people ask us, what does it fund? It is going to primarily go towards the commercial expansion of revyve in the U.S. and Canada. We need to help our commercial colleagues, who are experts in their field, have the tools that they need to make sure that revyve is being adopted and well used across the clinical space and across different hospitals and different touchpoints. Now what happens if we had a smaller raise? We can either look at this in tranches. We have looked at non-dilutive funding. We have looked at interim funding.
We will do what is necessary to ensure that we have the right tools necessary for our commercial colleagues to do their job. As I have mentioned, we have engaged DNA Advisors who are on this call, who are going to help us look at strategic partnerships, commercial collaborations, financing initiatives, and any other strategic opportunity that is going to be beneficial to both shareholders, patients, and clinicians. We are excited to work with them over the course of this transaction to make sure we are carrying out successfully. I am going to end my presentation there. Ray Dupuis, our CFO, has been on this call. He has been taking questions in the background while this has been going on. I want to thank you for your time and attention listening to this presentation. Ray, I will stop here and turn it over to you.
Thank you, Robert. Just a reminder, if you have any questions, please press the Q&A icon on your meeting control panel. We do have some questions, so we will start with the first one. One moment, please. The first question is, "Have sales improved since Q2?
Yes. Sales improved both in two areas which are important. The typical initial sales are small sales and initial order, and they see how revyve is working within their patient population. Then we are seeing repeat orders. We are seeing not only the time to first order shortening, but the time between repeat orders shortening as well.
Okay. The next question is, "Is revyve manufactured in the U.S. or Canada?
Great question. revyve is manufactured in Canada right now through Halo Pharma. The reason for that is because it is a thermal reversible gel, meaning normally in plants, you would heat things up to make it move through pipes quickly. In this case, we need to do the exact opposite. We need to cool it down so it stays in its liquid form. We are looking at a secondary supplier in the U.S. who can accomplish those goals as well, and that may be something that we bring online through 2027 as we have the capital to move into a technology transfer.
Thank you. The next question is, "What is the shelf life of the gel and the spray?
Also, a really good question. Thanks. The shelf life for the gel and the spray are the same. It is three years, and we have that shelf life approval.
Thank you. "Is manufacturing the spray in Sweden still viable on cost and logistics?
Yes. The margins we have for the spray are good, and we are able to deal with the fill finishing of the spray in Sweden right now. We would really like to find a landed manufacturer within North America. That would be obviously the best alternative, and we are doing that work trying to find that right manufacturer. But as of today, the answer to your question is yes.
Thank you. Another question has just come in. "What is the temperature effect, if any, on the shelf life of the product?
There does not appear to be any impact of temperature on the shelf life of the product. We will have to continue to find that data, and the militaries have asked us for that data, so we will continue to look at that along with the performance of it as an antimicrobial in those austere environments, specifically very cold environments. I do not have that data as well too, but our R&D team are working with the militaries to get that data. Again, great question. Thank you.
Thank you. Next question is, "Why was distributor sell-through still limited at the end of Q2 despite partnership and its ramping?
I think Dr. Lantis said it best. Part of this is adoption by clinicians and showing them that we are solving a practical problem that they have today, and that practical problem is that dressing changes either involve extensive debridement or using products that do not work well. This is in essence like a push-pull approach. We are going to continue to exhibit at medical conferences, continue with new data, continue with practical presentations, and continue with booth presentations so that clinicians are aware of this while we work with finding new distributors in those therapeutic touch areas, so that we can bring those two needs together at the same time. It is really about getting our name out there as often as possible, as many times as possible, and as many different venues as possible.
Thank you. We've also received some questions in advance of this webcast. I will start reading those. "When will sales increase materially?
Well, we are targeting for CAD 400,000 through the tail end of this year. We are expecting that to happen through this last quarter.
Thank you. "What needs to happen for commercial access to translate into repeatable product adoption?
Great question. Again, it is going to require two things. Potentially maybe three, but two things for sure. We need to make sure clinicians understand that there is a new way to treat wounds. What is remarkable when you look at the actual data for percent area reduction for revyve versus what has been reported for the competitor products, and remember, we do not have head-to-head data, but we do have their data. We are showing a much faster time to healing rate with revyve than has been seen with other products. We just need to remind clinicians that there is a product out there that works well. We need to also remind distributors that this is a product that is going to make sense for them to want to carry, because there is a financial advantage for them as well. I said maybe three.
The third one may be actually getting more patients involved in this. When you look at these smaller diseases like HS, hidradenitis suppurativa, an adult skin disorder, or when you look at sickle cell disorder, for example. These are areas where we are now talking to patient advocacy groups and letting patients know that their physician should know that there is a new treatment alternative for them. I said two, maybe three. The third one may be getting the patients involved in this directly so they understand that there is a way for them to be empowered with their care by using a product like revyve.
Thank you. Another question that has just come up on the Q&A panel is, when are you planning to start the CE Mark process, and do you currently have any partners in Europe?
Great question. Thanks. The CE process takes about a year to accomplish, so we are starting that plans in 2027. We have already had conversations with groups that can help us through that regulatory pathway, whether that is through Ukraine directly or through the rest of Europe. Of course, remember, this does not include the U.K., and so we will have a separate plan, excuse me, for the U.K. We do not have partners in the U.K. now. However, at conferences like SAWC, which I will be attending shortly, we will be having conversations with potential partners and distributors in the EU.
Thank you. Any details on the CAD 10 million raise, equity or other?
No, I would turn to my colleagues at DNA Capital to provide any other comment, but we've not defined that at this point. We're looking at any and all alternatives. Daniel, I'm not sure if you have thoughts.
Sure. Well, good morning, everyone. Daniel Labrecque, founder and CEO of DNA Capital. The objective of this strategic alternative mandate is to look at all the potential alternatives, one of which is to raise between CAD 3 million to CAD 10 million of treasury stock and this is something that we are currently working on. Of course, we were waiting for this presentation to be able to divulge our guidance on our business plan. That is now done, and we're going to be working with this with a number of potential investors, some of whom are currently on this call. That will be also a parallel path with the possibility of selling the business. We haven't had those discussions yet, but this is something we're going to have as well. Or even potential partnerships, mergers.
All the options are on the table, and we are working with management and the business plan, which is now well in place. That's quite exciting. We're very excited about the discussions we're going to have in the coming weeks and months.
Thank you, Daniel. Next question is around, have there been any impact on the company due to tariffs? Or the impact on a company of the status of the Canada-U.S. relationship, has that impacted the company at all? Sorry, you're on mute, Rob.
Sorry. Thanks, Ray. I apologize. We're obviously constantly watching what's happening south of the border with the U.S. At present, it's covered under CUSMA, so there's no tariff applied to the product that's manufactured in Canada and shipped to the U.S. So that means the 3 ounce gel and, of course, the 1 ounce samples that we give. We're part of Medtech Canada, so we have weekly calls with them, sort of monitoring that situation. It's one of the reasons we're looking at a secondary manufacturer within the U.S. that will provide some comfort around not only supply chain management, but ensuring that we would have a manufacturer that would then not have to worry about the tariff situation.
Thank you. Another question is it a lack of manufacturing or a lack of demand that has been the reason for the relatively poor sales so far?
Yeah, I appreciate that question. I think it's a lack of awareness. Kane is a very small company in a large wound care arena. You can imagine we're competing against the companies like Smith+Nephew and Urgo Medical, who have a tremendous number of employees. The one thing I've learned from my old life, where we had the same issues of being a small company in a large company space, is that I won't be able to out-market those companies. We can't do that. But we can out-relationship them, and that's an important part of what we do, that we form these relationships with partners like Dr. Lantis and his institution and other institutions across the U.S. and Canada, and have those relationships we know that we are a trusted provider to them for the problems they experience with their patients, and that we will do in spades.
It's really lack of awareness. We're forming those relationships. We will continue to do that, and I think that will be the route to success if past history shows true.
Thank you. Can you speak at all to the development and clinical plan for DispersinB, and is it dependent on raising capital?
DispersinB is dependent on raising capital. As you know, the initial plan was to look at that in an acne application, and we're still evaluating that as well too. There may be opportunity because it's an enzyme and works very quickly, even faster than revyve. There may be opportunity for a differentiated market approach. We always want to make sure that we're protecting the revyve because that is our primary franchise, so we want to make sure we're doing that. But we should also be aware that it's under what's called the PMA approach, right? Where we have medical devices like revyve, drugs, which are different, and PMA sort of fits somewhere in between. So it will be a longer development cycle. So it is dependent on the amount of money we can bring to the company, and it will be a longer development cycle.
Thank you. Another question that we received prior to this call is, what are the measurable commercial milestones for the next two quarters?
Fair question. The target of sales for 2026, I think, is a fair, measurable target for us and a good KPI. In addition to that, we should see a national distributor for Canada signed as well too. That would be important for us. In addition to that, an order starting from the militaries, whether that's the U.S. military or the Canadian military, but an order starting from them, because that will show adoption through the military system and really validating the dual-use technology.
Thank you. How much of the potential revenue that you showed in your five-year numbers, how much of that is backed by current customers or signed relationships?
I am trying to think of a way to answer that question well. We have in our model that we need to continue to build distributors throughout the U.S., and I am just going to focus on the U.S. just for a moment. We know that we have to continue to build distributors throughout the U.S., and so part of that will come from the existing distributors and part of it will come from the new distributors. I do not have that detailed out for a slide on the model, and certainly for those that are under NDA, we do have that detailed here.
Thank you. What gives management confidence that 2027 revenues will be substantially higher than 2026 revenues?
Yeah, again, a very fair question. When we looked at the launch ramp, we did not take the launch ramp of products run by companies like Coloplast or Smith+Nephew or Mölnlycke. These are large companies that have large commercial machines behind them. We looked at companies that had similar style of products and a similar size of company, and then we took the average of those five-year launches. There are tailwinds that are moving in our favor for a company like Kane Biotech in the wound care space overall. So the change in skin substitute reimbursement has helped us out. So I feel a sense of confidence within those models that we have put together that they are realistic. In addition, if you look at the percent penetration into the markets, these are sub 10% penetrations. These are not large penetrations.
Our hope is as we do our job well, we will be able to underpromise and overdeliver. But I think the models hold true based on the work that we have done.
Thank you. What are the principal obstacles that have prevented revyve from achieving broader commercial adoption to date?
Yeah, I think it is a similar question to what we had previously, and it is really going to be about getting our name out there. Importantly, when we did the first case series, we looked at real key opinion leaders in the wound care space, whether they were in the diabetic space, whether they were in the venous ulceration space, or whether they were in the burn space. And those are clinicians that when they stand on a podium and talk about the use of revyve in their patient populations, they command a lot of respect because they are known to be speaking fairly for products or their experience for products. We just need to continue to do that, find those key opinion leaders, work well with them in relationship, and that is going to provide the multiples.
We always want to see these early contracts with big numbers, but the concern has always been if we sell to a distributor and they cannot move the product, that is really not helpful to Kane. On our end, we are going to continue to build those relationships. That is going to result in the meaningful difference. It just takes time for us to do that. That is the reality of the business we are in and very similar to my old life. We will continue to do that, and hopefully, we will be able to move those numbers from what we have seen in the first couple of quarters to what we have predicted into the model.
Thank you. Have initial orders predominantly been paid commercial orders, evaluation orders, or free samples?
Yeah. To be very clear, we do not count the free samples. This is a heavy sampling arena, so the samples we do not count at all in our projections that we have here. They have been small evaluation orders in some cases, and in other cases, they have actually been true commercial orders. It sort of depends on the partner they are working with in terms of whether it is a GPO, whether it is a sales agent partner, it is dependent. But to be very clear, the sampling, while important to us, we have not counted into those models.
Thank you. One last question I have that was submitted prior to the call. At what point would management conclude that the current commercialization strategy is not progressing quickly enough?
This is something I worry about every day. Are we doing all the right things necessary to make a difference for the commercial strategy? I do not think I have a very good answer for you at this moment, other than we continue to monitor it on a daily basis in terms of where the orders are coming from or where they should be coming from, and are we able to fill those orders well. That is probably the best that I can answer that question at this point. Hopefully, as we continue to gain traction with revyve in the clinical arena, we can build more of those KPIs that are really important for us to know that we are on the right track for revyve, it is a commercially viable entity, and will make a difference in the patients.
Okay. Rob, I do not know if not everyone on the call knows you and knows your background and what you have achieved in your previous life. Could you just give us a sense of what you have lived in similar situation, and you have created quite a lot of value.
Yeah. Again, it is really in a team environment. Thanks, Daniel, I appreciate that. For those who are unaware, I am one of the co-founders of a company called Aurinia Pharmaceuticals, which is still up and functioning well. I was responsible development for voclosporin and lupus nephritis. That is a rare disease, and you are competing against large companies that had ineffective products, and we had the exact same issue. We were an unknown Canadian company competing against large companies with a third-in-class drug, and we found a way to out-relationship those companies.
First year sales of voclosporin, LUPKYNIS, in lupus nephritis was CAD 100 million. So a different arena, but the same principles apply, where we just have to find those relationships with the key opinion leaders, make sure that we are seen as a trusted provider of information, and that they were going to make a difference for those patients. Those are things that we hold very important to us.
Thank you. I just received one further question through the chat feature. What are the major pushback issues from federal authorities for either military or first responder widespread use?
I'll tackle the first responder use first. Ray, just make sure you hold me honest to answering the full question. For first responders, the spray, which is extremely attractive to them, is in a 5-ounce can right now. It's single patient multi-use. What that basically means is the can travels with the patient. We're trying to determine whether we can make a smaller can size so that it, quite frankly, is easier to transport, but it's easier for the medics to use in the case of MVAs or road rashes and that sort of thing. That was the first responder question. Barriers to adoption by the federal use?
Federal authorities.
Yeah.
What are the major pushback issues from the federal authorities' perspective?
For on the Canadian side of the border, they've been underfunded for a long period of time, and so this is a new environment which they're living in, and they're having to evaluate it. I'm sure they're flooded with a lot of different products that show potential, and so they're having to evaluate those. We're looking forward to the potential of early orders that will make a difference. On the U.S. side, we have to remember it's split into two separate venues, and both we have to handle differently. The first is the VA. The agreement with Marathon Medical gives us, in essence, the license to hunt. The 1099s that we have in place there are the ones that are going to go out and build those relationships with different VA centers.
Site evaluations need to happen, and it is a bit of a long cycle time, but those have to happen. That is the VA setting. The active military setting right now, the majority of our work with the active military has been on the R&D side and answering their questions so that they have comfort that whether they use this in a hot environment, a cold environment, like I described earlier, whether this is in a long transportation time, whether it is with a new bacteria that they are seeing, that we have a product that will cover all those needs. We are heavily involved on the research side of things with them, and hopefully that will then translate to the clinical adoption. But they are really looking for those answers first.
Thank you. We have received a few more questions. How would raising money in multiple tranches impact sales projections made?
That is a fair question to which I actually do not have a good answer for you because it is going to really depend on the size of the tranches. We have really devoted the vast bulk of our enterprise towards those commercial activities. We are going to continue to do that. I think where it is really going to see any delay if possible is going to be on the R&D development. DispersinB, surgical gel, CE Mark, those are things that we can hold or slow down while we focus primarily on the commercial activity, and that is probably the fairest answer I can give to you at that point.
Also if I may add, Rob, at the moment where the stock is trading at would create a great deal of dilution. To the extent we can have a book of subscription that is scaled over a certain time at better values, it is going to be for the benefit of the current shareholders. The company will be managing these questions in the best interest of all the shareholders.
Okay. I believe we have a couple more questions. Is there a plan to collate all the real-world data from the registry into a peer-reviewed publication or dissemination at conferences and congress? Secondly, do you feel this type of scientific communication plan will help with the awareness and product uptake?
Yes and yes is a simple answer. Now I'll give you the long answer. That real-world registry is extremely important, and we even know that from my prior life at another company. The problem with case series and clinical data, the concern is always is how generalizable is that to my patient population? So a real-world evidence trial irrespective of how often your dressing changes, irrespective of the type of dressing you choose, irrespective of the type of wound that a patient may have or the cause of the wound, those real-world evidence registries are key for us. So the answer is yes, we will collate that because we're collecting it in a very rigorous fashion, and that will allow us to present that data at the subsequent meetings. There were two parts to that question, Ray. What's the second part?
One moment. Sorry, the second part is, do you feel this type of scientific communication plan will help with awareness and product uptake?
Yeah, the answer to that one, I said the short answer was yes, and the long answer is yes. When physicians see the real-world data, it reminds them of the patients they see. As Dr. Lantis said, he's struck by one patient. That was an anecdotal patient who had a disease for a long period of time who we finally see healing with. Those anecdotes stick with you, and you're looking for those in the real-world evidence. As these get presented at the large meetings, whether it's SAWC or some of the burns meetings, they're looking for their patients in that real-world dataset because it confirms to them that this can be used by their patients. So, the question's really good. I appreciate it. You got both the short and the long answer.
Thank you. We're getting close to the end of our hour, but we do have a few really good questions remaining. One of them which is, given the interest from MHSRS meetings, is there an opportunity for an R&D cash infusion from U.S. or other military sources?
Yeah, the short answer is yes. We're working with different military research groups, and our preference always is to find mechanisms to have the research funded. I'm very grateful to the funds that the U.S. DoD has already put into Kane over the years, and these are unrestricted funds, other than we have to stick to the plan that's laid out, but they're non-dilutive money. We're looking for the same sort of approach post MHSRS.
What is your maximum production potential in dollars and how is it funded?
We have to pay, obviously, in advance for the manufacturing runs that are done. Without getting into the specifics, our margins are fairly good, and so manufacturing capacity is, I think, the question. Halo Pharma-
Yeah, I think the manufacturing, the potentials. Sorry.
Halo Pharma has the manufacturing capacity to cover the needs irrespective of what the need volume is, and we are carefully monitoring that as well, too, even with the model that we built, knowing that we can do that. Having said that, I have mentioned this earlier, we are looking for a secondary supplier because supply chain resiliency is a key part of having a successful commercial enterprise, and so we will work through that through 2027.
Thank you. I think there is one last question on the chat. The final question that we have time for is, can you speak to your interaction with indigenous communities in Canada and in the U.S.?
It is a really good question. Thank you for that. We have had the start of dialogue with different indigenous communities, both on the West Coast and in Manitoba, remembering, of course, that Kane Biotech is headquartered in Winnipeg. What we have learned about diabetes and the amputation rate, it is actually the highest in Manitoba. We are having conversations there, and we are having conversations in two lights. One is how do we get clinical use adopted by different First Nations groups, and that may look like a case series, that may look like something that they want to do a larger clinical trial. We are there to backstop their academic efforts to make sure that what they are seeing is valuable and reproducible, and that will, of course, allow them to present that data on the stage.
The second light is we are also talking to First Nations funding potential partners who might want to partner with us in terms of getting that data out there and working with Kane as a commercial entity. The second part of your question is really important. The data that we see in Canada is very similar to the data we see in the First Nations populations in the U.S., for example, the Pima Indian, and it is very similar to data we see with the indigenous population, the Aboriginal populations in, for example, Australia. They have their own series of conferences talking about these issues there. We are really interested in partnering with First Nations communities in Canada and in the U.S. to make sure we have a great clinical plan that makes sense for them, and then allowing for it to be used commercially.
Well, that concludes our question and answer session. Thank you everyone for your great questions. I now turn it over back to you, Rob.
Well, thanks everyone for your questions. That was a lot of questions. I really appreciate that. Hopefully this has been helpful for you if you are an investor in Kane. If you are an interested person in what Kane is doing, whether you are a patient or a physician, we hope we have answered your questions as well, too. We really want to be transparent with you, so you are always welcome to email us questions, and we will do our best to answer them in a timely fashion. We are grateful for the work that DNA is doing with us. We are thankful for the support of the board. We look forward to seeing revyve being used across different patient segments, including the military, in the near future. Thank you very much for your time. I think, Ray, we can close the webcast.
Thank you.
Goodbye. Goodbye, everyone.
Bye, everyone.