Perfect. Thanks, Simon. Thank you all for joining. As Simon mentioned, I'm Brent Owens, one of the co-founders and Chief Executive Officer of Vitrafy Life Sciences, which is a cryopreservation technology company. Cryopreservation itself, it is not widely known, I guess, that for decades, almost half a century, many parts of the healthcare system globally has been underpinned by cryopreservation. Even further, it's not widely known what the step of cryopreservation is. Well, cryopreservation is the process of freezing biological materials down to very low temperatures to be used in the future. Entire healthcare systems and industries would not exist without it. As an example, IVF. You know, to create a family in the future, the woman often freezes her eggs, and the man often freezes his sperm. That is the process of cryopreservation. Global blood supply chains wouldn't exist without cryopreservation.
If you think about the plasma industry, global plasma supply chains freeze that plasma to be used at a future state. You do this because the materials, whether it be the eggs or the blood or anything else, it deteriorates and dies once it's collected from the body. It's a very broad category, cryopreservation, with many parts of the global supply chains it touches, which is why Vitrafy is prioritizing a few key areas, primarily in the North American market being cell and gene therapies, blood products, and the animal reproductive market. Next, Simon. Cryopreservation itself was built in the 1960s. Long time ago. Unfortunately, later, many of the technologies in cryopreservation still remain in the 1960s. The problems then are very much the problems now. It's dumb technology, simply put, isolated. It's expensive. There's no intelligence.
Very simply put, it damages the biological material, which makes it expensive, and there are plenty of hidden costs and outcomes that are a result of that damage occurring. Simon. I guess with the advancement of technology and systems as a whole, the world has moved on from this technology from the '60s. Cryopreservation workflows as a whole remain broken. Users expect more sophistication, and frankly, the global markets are now demanding them to increase their sophistication. An example of that would be if you look at U.S. blood supply as an isolated use case, there's constant shortages, whether that's because of war, which is obviously very current, or hurricanes and natural disasters, whether U.S. would stockpile many of these critical response components like blood or even for general trauma use.
There are constant shortages that remain globally, and particularly in the U.S., which is where we're focusing our efforts. Advancements in personalized medicine, such as cell and gene therapy, these are very innovative forms of immunotherapies, primarily cancer therapy, that is expensive, it's costly, and it needs scalability and advancement. Cryopreservation underpins this industry, and it needs to be improved to work at scale. Fundamentally, the loss of quality of these life-saving materials is the result, which is extremely costly to not only the material itself, but the impact of care. This is exactly what Vitrafy is addressing directly. Next, Simon. It's why we were created. Vitrafy is building a cryopreservation ecosystem that digitizes, optimizes, decentralizes the preservation of these critically sensitive biological materials. We are on a mission at Vitrafy to improve the quality of healthcare treatments by providing effective cryopreservation solutions.
We were listed on the ASX at the end of 2024 as we commenced our transition from into commercialization. We were founded in regional Victoria, and we still remain there as an R&D facility, but our focus now is the U.S. market, and we've been building towards having a full U.S. operation since listing. Next, Simon. Our technology is an ecosystem. That's what we're building. Simply put, we're trying to deliver outcomes and value by deploying an ecosystem. We believe that more cells we can keep alive, the more value we create for our customers. While we do have a combination of hardware and software that delivers our ecosystem, we are selling solutions. We can do this because our technology is smart, it's connected, and importantly, it generates value from our customers from both time, cost, and a quality perspective.
The way that we're commercializing and the revenue model is targeted to match that. Rather than just selling a box. We're selling solutions under a managed service model, so it's a recurring revenue model as well. Simon. Within that ecosystem itself, the core technology that is the lead is our hardware innovation, our cryopreservation freezing device. This is the device that completes the process of freezing the biological material. Once it's collected, whether that's blood or whether that's reproductive material, it is then frozen using this piece of equipment. It's a mobile unit that can be located anywhere with a good power outlet, which you can't currently do. It doesn't use liquid nitrogen, so it doesn't need infrastructure to be able to be deployed, which is really differentiated with what the current market standard is.
This device is bringing cryopreservation processes into the twenty-first century with intelligence. It's safer, it's smarter, and simply put, it's just much better. Simon. Supporting our hardware solution is the brain of this, and this is our software which we call LifeChain. It's a platform that controls our technology. It also connects with others. That's how we create an ecosystem. It provides intelligence and data. This is the system that can show the traceability of that sample across the whole workflow to show those quality outcomes that we get. This software, it digitizes, it connects, and it creates that closed-loop ecosystem in the cryopreservation workflow. Simon. It's the combination of Vitrafy's technology, our hardware and our software, that creates a new generation of cryopreservation processes and intelligence.
It preserves the biological material with quality and consistency that importantly, our ecosystem unlocks better products and better care when it matters most. Simon. The best part for us as a company is we have one solution with multiple opportunities. These are global opportunities and global markets that are growing. As a small early-stage company, we have to prioritize, and we have, and there've been very deliberate prioritization efforts to be focused. First is animal reproduction. Partly why we decided to focus in on this area is it's an unregulated market, so it gives us early revenue and data and learnings to transition into the human health market. 100% of all bull semen that is collected is cryopreserved. That in a, is what starts the dairy process and the beef process.
We now have a commercial agreement in place with a global leader in that space that represents approximately 50% of that animal reproduction market. We have significantly de-risked that part of our commercial strategy. There's over 2,000 collection sites just in this space alone. In the blood and blood product space, we've prioritized blood platelets in particular because there's a growing need. There's end-of-life technologies, and there's constant shortages in platelets, which results in over 20% wastage per annum across the military and civilian applications, which costs the healthcare systems well over $250 million per annum alone. It's a very critical need, and we do have some milestones in that space as well. Thirdly, cell and gene therapy. This is a very rapidly emerging sector that's young, but it depends on global cryopreservation supply chains to function.
It needs standardization and consistency, and the earlier we get into this market, the more sticky we will be long term. Across that blood and cell and gene therapy market in the USA alone, there's over 8,000 points of collection, which is where our technology ecosystem can be placed, and this is where we've been focusing our efforts on pipeline and customer growth. Simon? In those three categories, again, we've made great progress in all areas. Animal, as I mentioned, was our first cab off the ranks, securing a global strategic partner that is revenue generating, where we'll see up to almost $1 million this year while we prepare for our broader global go-to-market strategy together. We have completed a phase I non-clinical study with the U.S. Army Institute of Surgical Research in Texas in the United States in the blood program.
That's a product that's needed for critical trauma response, and we achieved outstanding results in that area, which we are very excited by. We've built our U.S. operation from the ground up in very recent times, which is now established with leadership across the sales sector and commercial operations, which is for customer success. We're building that now into our manufacturing capability as well. We've built our second generation technology since the IPO, and we're scaling up our U.S. manufacturing capability in anticipation for our commercial demand in not only the animal space, but also the human health space in North America too. Simon. Tightly coupled to that progress is what's coming up, and in particular, the very near-term catalysts that we are expecting at Vitrafy. We are being quite deliberate and purposeful to keep absolutely focused on what we're trying to achieve.
We are still well-funded into calendar year 2027, which is really exciting, and we'll be focusing our efforts on securing new opportunities in the human health market in the United States that remains ongoing, and the pipeline is quite exciting in that area. In the very near term, within weeks, we are expecting the next results readouts of our phase II non-clinical study with the U.S. Army in the blood platelets space, something to watch out for. We have commenced our work with our global animal health partner, who are based in France, to determine our global market offering in that space. Our technology has been heading over to Europe to kick that off. The devices.
We have unlocked a large portion of the human health market recently by completing the first phase of that device development, and we do have an FDA approval expected during the second half of this calendar year as well, which only broadens our market opportunity in the United States. Now we're building out our U.S. manufacturing capacity and building more equipment in anticipation of our demand that's coming. A very transformational time for the company in a very short period, and we're really excited by what's coming in the very near term as well. If you would like to follow along on the next slide, you can track us through LinkedIn website or through the ASX platform, obviously. Thank you very much. Simon, I'll hand it over to you for Q&A.
Perfect. Thanks for that, Brent. Just a reminder, if you did wanna submit a question, the Q&A button at the top of your screen. If we just talk through IMV, Brent, maybe just sort of explain to us, yeah, just the reason why IMV, why an exclusive license? Is it so you can focus more so on CGT and blood? If it's a smaller sort of market, what's the sort of strategy there?
The global animal reproduction market, particularly in bull semen, is quite consolidated. There are only really a small handful of players. Rather than spending time, effort, resources, and cash in trying to crack that market and compete with the global leaders, we thought a better strategy would be to partner with a global leader in the space so we can keep our efforts, priorities, and focus resources in the human health market, primarily in North America. IMV Technologies is a global company headquartered in France. That's who we have partnered with. For sizing, they represent about 50% approximately of the global animal reproductive market across a lot of the different species that use reproductive material.
In terms of throughput, by sizing, they sell close to 0.5 billion Sperm straw units per annum, so very, very high volume throughputs. They see Vitrafy's ecosystem technology as potentially being the next phase of how that market could work, and we are working together during this exclusive period of 12 months to work out a go-to-market strategy where we have a joint offering of both Vitrafy's technology and IMV's to take that animal reproductive market to its next phase.
Great. That market sounds massive just in terms of when you're talking about the straws and the billions, and whatnot. What does that sort of compare to if we look at human health, in terms of our market opportunity there? Is it now sort of five-10 times or more?
I would say the value per unit is actually quite different. If you think about the human health market, there's much more points of collection versus animal, so many more places that we can deploy our technology. While the throughput units is not as high as, say, the 0.5 billion in the animal space, the value of each unit is much higher. Blood platelets as an example, there's multiple millions of units currently processed in the USA alone per annum, where they sort of wholesale at approximately $600-$700 per bag. Quite high value products that only have a few day shelf life until they're thrown in the bin effectively because they deteriorate.
The human health market is quite different, but it's much higher value and there's many more points that our technology can be deployed into that market from collection centers across the entire country.
In terms of the sort of pipeline, without asking specifically what that looks like, I'm assuming the Guardian development and completion has, you know, voluntarily helped move that along. If we look sort of six to nine months ago in terms of conversations, yeah, particularly on, you know, human health and CGT, cell and gene therapy. How has that changed, and why has it changed?
Yeah. It's a good question. I would say from when we started our, let's say, marketing efforts, outbound conference attendance, those types of things, the first phase of it was just verbal because we actually didn't have any devices or technology to show. When we had our sort of first Guardian, which is the freezing device, built and manufactured early this year, we could actually take that to the United States, which we did, and present that at a conference in person for the very first time, which we did a couple of months ago. The conversations have evolved quite significantly since they had something to touch and feel and see in person. That is really important for these blood centers and cell and gene therapy manufacturers in particular.
How the conversations and the interest has evolved, I would say has gone from, "Yes, we like what you're telling us. Now we wanna see it. Now we've seen it," it's a very different conversation. Across those two primary human health areas that I mentioned, human health, blood and cell and gene therapy, the conversations are quite deep in the pipeline on both, across the U.S. market. I mean, it's coming in broader, but we're focused on the United States.
In terms of those sort of discussions and pipeline, how are you prioritizing them? Is it validation with, you know, a key party that is then gonna flow, you know, throughout the rest of the industry? Or is it, you know, who wants it more? Who's gonna be able to move the fastest?
Yeah. It's again, another good question. I would say the animal market is sort of consolidated, focused on the top-down type approach. Cell and gene therapy is a bit more of a bottom-up, where we sort of go, we'll go more ones and twos and be more active in securing individual customer wins. That being said, we will be looking to secure more of a beachhead in that space, so a big name, because that's quite important in the U.S. market to make sure that you do have credibility, and building that would come through something like that. Then in the blood space, that's sort of broken into civilian and military are the two categories. We are working with the military again. The civilian market we thought would come much later of our evolution.
Because of the results that we got through our phase I work with blood platelets, that civilian opportunity has actually been brought forward and there's a lot of interest in that space much earlier than we had anticipated as well.
Brent, on who your competitors are in the human health market, and what are the key bottlenecks to be overcome?
I'll answer the second question first. I would say the bottleneck is more the legacy process and thought process with a lot of the users of the technology. Cryopreservation historically has been a back room operation, just a step in a process. There's a lot of the sort of scientific community more so are understanding that it's actually a workflow. It's a, it's an entire process end to end. That's very exciting for us. There's still a, it's still a back room operation in some areas, which it's a more of a psychological barrier of change management in some areas. That's one of the barriers from a competitive landscape. From a device perspective, there's, you know, the main device by Thermo Fisher has been the same device that's been in the industry for decades.
Now that's pretty much the full stop. There's not a whole lot of others that have really cracked the market nor have tried to. That's because that one size fits all approach which they've had has very much been the same for, and wasn't required to be much different for, many years. Now that's evolving because of the requirements in the market itself.
Last question, maybe a bit of a cheeky one. You've been at it quite some time now, and it feels like you're on the cusp of delivering, particularly on human health, which is the key rerating milestone as far as the market sees. Where does it, you know, in two to three years' time, where does the business sit in terms of contribution across animal, human health and CGT?
I have very high expectations and very confident in what we're trying to achieve. two to three years' time, Vitrafy's goal and high confidence of delivery is focused in the human health market in the United States with a large presence across the cell and gene therapy sector in CDMOs, which are the manufacturing facilities. Importantly, that will be led by Vitrafy's technology in blood collection centers. That's our focus, and that's where I think we will capture most of the market in that space, and that the interest that we're getting at the moment would support that hypothesis too.
Thanks very much, Brent. If there's any other questions or interest in the company, please reach out to NWR or the bottom of the announcements on Vitrafy. Thanks all for attending.
Thank you.
Great. Thank you.