Thank you all investors for joining us this morning on the release of the phase II U.S. Army platelet results. This morning we are joined by Managing Director and CEO, Brent Owens, who will provide a summary of the results and the work streams with the U.S. Military. If you do have any questions throughout the presentation, please use the Q&A function at the bottom of the Zoom platform, and we will answer those questions at the conclusion of the presentation and open it more generally to the floor for any further questions. Brent, what I'll do now is hand over to you to present the results. Thank you.
Thanks, Tim. Thank you everybody for joining. For those who haven't had a chance to have a read, there's the word release that came out, the PDF, sorry, that came out this morning that I encourage you to have a look at. Again, to Tim's point, if you do have any questions, please just put it in the Q&A, which is, I guess that's the main purpose for this call. As many of you know, one of the core programs that we undertook as part of the IPO was the work with the U.S. Army, focused on blood platelet cryopreservation. For various reasons, which I will touch on in a moment. What I can share, which we're really excited by today, is the results. As you can see here, we've achieved 94% post-thaw recovery on cryopreserved platelets.
Importantly, really importantly, this is for a no-wash protocol, which I'll go into in a moment. With that, we had high functionality across all quality measures, which is an important piece to the puzzle. Beyond that, it is fully independent U.S. Army validation. It's our first complete validation test in large volumes, commercial volumes, using Vitrafy's ecosystem across all of the different protocols tested, which I'll go into in a moment. A completely hands-off validation of the technology itself. For us, we see this as a category-defining opportunity, a market first. We believe that this is a critical gap in the workflow and the supply chain that we can address, and these results would indicate that that is the capability as well. Just briefly, I thought it'd be worthwhile just touching on the background and how all this came about.
We did sign a CRADA agreement with the U.S. Army between Vitrafy and the Army a couple of years ago. That's a cooperative research and development agreement, essentially to develop and see to translate different products that you take through. Blood platelets was identified as the priority and need. We needed to validate Vitrafy's cryopreservation ecosystem and its ability or capability to successfully cryopreserve critical response products, which are blood platelets. That was the primary objective, first and foremost. Second to that is it suitable and practical for an operational solution with the objective to have a rapidly deployable cryopreserved platelet product, which is what we're calling the no-wash protocol itself. With that, under the program, again, it's the first full independent validation completed on Vitrafy's cryopreservation ecosystem. This is the largest testing program to date.
We had over 20 donors for this, with over 60 samples tested across three different protocols. I'll touch on that in a moment. It was something that we committed to as part of the IPO, which was a really important piece of the program, and the milestone for the company that we've achieved, we're very proud of. With that, I'll go into a bit more detail at the end. We do have a full report that is there. We are planning to publish that, so it needs to go through its processes before that is to occur as well and released. On the roadmap ahead, this does really help with our next milestone we're expecting from the device perspective, which is the FDA medical device registration in this space. Just expanding on the results.
I did mention that there were three different protocols tested. I'll go into what they are and why, or the context around it. Importantly, the different guidelines and compliance standards that exist today is what the red line is. The two lines across the center. One is the European regulatory guidelines by the EDQM, which is about fit, which is 50% post-thaw recovery for cryopreserved platelets. That's a reference to the 6% DMSO, which I'll touch on. The second is the FDA AABB guidance, which is the U.S. guidance of what platelet quality needs to be to be transfused into humans. That's used in fresh because there isn't an FDA standard for cryopreserved platelets. That was really where we were benchmarking against and comparing to fresh. We broke the protocols into two categories. One is wash, the other is no-wash.
What you can see on the wash is that's what's the guideline with the European regulatory guidance, and is a step in the process where you have to have a lot of technical staff completing multiple processes, which makes it very challenging from a workflow perspective. The second is the no-wash. What's important about the no-wash is it not only has a quality outcome, which we're speaking to right now, but it's also an operational benefit that unlocks what we believe is new market opportunities because it removes some of those complex operational steps that are required throughout the supply chain and workflow. What it means is that if you have a trauma event, and you want to be able to rapidly respond to that, you don't want to have tedious, laborious, complex manual handling steps prior to that.
You want to have that product available, stockpiled, and ready to use. The no-wash protocol is designed for exactly that. Using our cryopreservation ecosystem, what we're demonstrating is we can get the quality outcome, but with the no-wash solution, we're also providing what we believe is a tremendous operational benefit being removal of those manual steps that are required for rapid transfusion, so a rapidly deployable solution. We believe that could unlock the ability to stockpile and be prepared to respond in the event of conflict and trauma as well. That's why there's the wash and the no-wash protocol. You may recall, for those who have been following during the phase I in vitro study, we did also have other protocols.
What we did was try and identify which one performed best using Vitrafy's ecosystem, and that's where we've landed on the no-wash protocol with 3% DMSO, as you can see there. Does our ecosystem keep the quality of the platelets and recover them? Yes, 94.4%. The second part to that is not only do they survive, but do they function? Think about a car example. Does the car turn on is the recovery. Does the car drive is probably more important, actually, and that is what this slide is here, the platelet's functionality versus fresh.
There were key measurements done on different functionality requirements across a very wide width, and we can confirm that there was great functionality across all the measurements that were conducted as well, which include the strength of the clotting and how quickly they respond, which is related to how quickly they help when there's a bleed. We're really excited by that. What's next with all of that? Well, as part of our device and product roadmap, we have the medical device registration coming for the cryopreservation freezing unit called Guardion. We're expecting that still in the first half of this financial year as well. As I mentioned at the beginning, the intent is for these results to be peer reviewed and published across military and civilian publications, and that process has now commenced, and we're expecting that to be released in the first half of the financial year also.
Obviously, in the past we've mentioned that the results of phase I unlocked some conversations in not only the military environments, but also the civilian setting too. We remain proactive, these results are really quite important to progress those conversations towards an adoption goal across military and civilian settings too. A lot to look forward in that space. In closing, I guess very excited by the results. A big achievement for the company. The first full validation across a wide cohort of donors in an area that we believe is a category and market first opportunity for the company. Tim?
Excellent. Thank you, Brent. Just a reminder to all attendees that the Q&A function is located at the bottom of the Zoom platform. If you would like to ask a question of Brent or Simon, please drop your question there. We will kick off with the questions that have been submitted so far. Brent, in terms of the role of DMSO, could you please expand on the role DMSO plays, the purpose of it, and the intention around the obligation to use the washout protocol in the market at 6% DMSO?
With most, if not all products that are cryopreserved, there's an additive that's added to the material, and that additive is called a cryoprotectant. The purpose of that is to help protect the materials when they're frozen and then stored, so that when they're thawed out, it helps with their recovery and their functionality. DMSO is one of those additives that's been widely used for a long period of time across many, many different applications. The problem with high levels of DMSO is it becomes quite toxic to the cells, whether that's platelets, red blood cells, or other. It's commonly used in concentrations of around 6% or 10% in most cases, of which you then need to have pre and post-processing to either remove it or dilute it heavily so it's not toxic.
Lowering that concentration and/or removing it is really quite important to reduce that or remove that toxicity level as well. That's the purpose of it, and it does have utility. It's how it's used and how you benefit from the use of it. By us being able to not only reduce the concentration, but also provide the operational benefit with our cryopreservation ecosystem, we believe that removing that wash step and those complex supply chain processing steps is very advantageous to remove that toxicity and enable a rapidly deployable product in the market.
Brent, just expanding on that last point, in terms of the context of what that means for the market and its current function and how it currently works, how do you see that benefit of having a no-wash deployable transfusible product playing out and benefiting the market?
Well, I think about I'll try and summarize as succinctly as possible, which is not always easy for me. I think about the platelet market as it exists today, and there's various examples of this. There's multiple units of platelets collected and transfused every year in the U.S. alone. I come back to that stat of there's around 20% wastage of the multiple millions of units. Now, that's got a very expensive price tag to it, approximately AUD 280 million, just for the wastage component based on what we've seen. Notwithstanding the constant supply and demand challenges that operate in the supply chain because platelets only have a five to seven-day shelf life.
Being able to enable not only a rapidly deployable product that could unlock stockpiling and preparedness for both military and civilian use cases, there's also the potential to flatline some of that supply chain and provide a scalable and sustainable solution to the platelet needs across both the military and the civilian use cases as well.
Excellent. Thank you. A question from [Kat Wons]. Was there a study using 3% DMSO plus the wash step rather than 6% DMSO plus wash to benchmark against your 3% no-wash results?
Can you repeat that one? Sorry.
Was there a 3% + wash DMSO study?
No.
Why wasn't that undertaken given that you benchmarked?
I think a lot of that comes down If I understand it correctly, sorry, [Kat], if I've misinterpreted this. A lot of it comes down to there's sort of the operational benefit of being able to rapidly deploy it, and then there's the why piece. Part of the why piece beyond the quality outcome is the toxicity. If you don't have high levels of cryoprotectant, such as DMSO, the less is better because the toxicity goes down. With a small percentage and the benefit of the quality outcomes, we believe that we remove that toxicity that doesn't require that to be processed both upstream when it's added, but also downstream before it's used. I hope that answers your question, [Kat].
Thank you, Brent. From [Tom Godfrey]. Noticing the FDA guidance of 75%, did the USAISR have an internal benchmark it was looking to determine a go/no go on the Guardion rollout?
Whilst it is a guidance, it's an important guidance marker, and frankly, whether it's military or civilian or even Vitrafy, if we didn't exceed the guidance number, then I couldn't see us getting adopted, full stop.
In terms of the steps, Brent, just expanding on it, what are the steps are required from here to get approval and the eventual commercial traction?
Yeah. As part of the medical device pathway, there's a step in there, which is essentially what we're commencing and doing now, and that is called verification and validation. It's a series of performance tests on the equipment. The Guardion goes through a heap of different tests to see if it performs as it should. The second part to that is actual biological testing to prove that it does what it says. We're undertaking that program now on the performance testing ahead of that medical device registration. Whilst we do have opportunities to commercialize now, that medical device registration just further unlocks more of those markets in more clinical applications, which we're expecting in the first half of the financial year 2027.
Thank you, Brent. Further follow-up. Given there are two other protocols in the market that already meet the current FDA guidance and European regulatory standard, how does this data force the shift Vitrafy's cryopreservation ecosystem?
Well, whilst there is guidance, the guidance from the FDA and the AABB, which I think is referenced in the PDF version, so I encourage you to have a look through that guidance, is more related to fresh platelets or platelets that It's not specific to cryopreserved platelets. There isn't actually an FDA standard or guidance for cryopreserved platelets specifically. I think part of that was around compared to existing products in market. There aren't existing products in the market for cryopreserved platelets.
Thank you. A further follow-up. Given the length of relationship with the Department of War or U.S. Army in particular, what are the next steps with this relationship, and how do you see that playing out over the coming sort of year?
Yeah. We have a really strong relationship. We've really enjoyed the collaboration between U.S. Army Institute of Surgical Research and Vitrafy. We expect that to continue. Again, there's ongoing conversations across military and civilian applications for the adoption of Vitrafy's technology, which we'll continue to be proactive with, which we are looking forward to progressing that further.
Excellent. Thank you. I'll just give another moment for any further questions from the floor. Just a reminder that this release is available on the ASX platform, and the webinar will also be made available for review as well post the call. All right. If there's no further questions, we might call time on the presentation. Thank you very much for all joining us. If you do have any further questions or want further follow-up, please reach out to Vitrafy directly via the investors@vitrafy.com email address. If you would like to arrange a time, we're more than happy to do that. Thank you very much for joining our call this morning, and have a great day.
Thanks, everyone.