Video Transcription
Tjeerd Homsma 00:02
Good morning, everyone. My name is Tjeerd Homsma. I'm the CEO of TripleMed, and TripleMed is focusing on solving the issues with abdominal aortic aneurysm treatments. The issue is really nicely displayed here by Professor Jacobs. Endovascular aortic repair, or EVAR in short, is not a final solution. It does not really address the bulging of the vessel wall from the aortic sac. So over a time period of 10 years after surgery, more than one in three patients require additional surgeries to stop the continued sac growth, and with that, the potential for rupture. AnaFix is the solution, as is nicely displayed from the statement from Professor Dr. Hochberg, the principal investigator of our study. AnaFix is an elegant solution to treat endoleaks and prevent aneurysm sac growth. It is safe, simple, and cost-effective, and exactly the type of product that we're looking for. In my presentation, I want to explain to you why AnaFix is that solution.
So first, to start off, what is an abdominal aortic aneurysm? It's an enlargement of the lower part of your aorta. It's the most common type of aortic aneurysm. More than 400,000 patients are diagnosed every year with the disease. If not treated, 85% of the patients die. The estimated cost of diagnosis plus treatment over the year is going to be up to 3.8 billion in 2030. Current solutions are open aortic repair, which is the long-stay product, or since two decades, endovascular aortic repair, or EVAR, by using stent grafts coming in from the groin of the patient to circumvent the aneurysm sac. So EVAR has been the mainstay of products. Now, 75% of all patients are treated by EVAR, and the main reasons for that are the lower cost of the procedure and the lower mortality and complications. However, these benefits diminish over a period of time of something like six years, after which open surgical repair is preferred. The main reasons are the high rate of reinterventions, five years down 18%, and 10 years down more than one in three. The main causes are endoleaks, like you see here on the right side, leakages into the sac from all kinds of reasons: allowance of the stent graft, migration of the stent graft, occlusion of the stent graft, and with that, a lot of cost.
So the main unmet need is that we're looking for the solution to combine the short-term benefits of EVAR with the longer-term benefits of open surgery, and that solution is AnaFix. Here on the right side, you see what we do is immediately at the implantation of the stent graft, we have a filling catheter placed alongside it, and with this filling catheter, the green one here in the picture, we can fill a polymer around the sac, completely surrounding the endograft and filling the complete sac. The polymer that we're using is a two-component PDMS polymer, which is easy to inject, has a high viscosity at rest, is very controlled in this delivery, and has low viscosity during injection, such that we can inject it via smaller catheters or needles. There's a balanced radio opacity, meaning that it is very easily detectable during injection, and it forms an elastic implant after curing. It is safe, and obviously, it's been patent protected.
If you compare AnaFix to what's out there now for treating the same disease, from this picture, it's obviously clear that AnaFix is the only product which is providing both compatibility with existing systems. It is a fast procedure, it is a very effective procedure, and it's the only really cost-effective procedure because if you look here at the pricing from the main direct competitor, $30,000, we can get that to a fraction of that price. In our clinical approach, we're now in clinical phase with the product. We used a two-step regulatory approach, first treating endoleak repair, so existing EVARs with an endoleak. So far, we have treated 40 patients with almost 100% technical success and clinical success close to 90% at six months follow-up, no endoleaks, and no continued sac growth. The dossier for CE submission has been submitted and is now under review.
Second to that, we started with the prophylactic sac filling, which is by far the biggest market that we're looking for to have it in comparison to something like four to five patients. With prophylactic sac filling, we can basically address 100% of all of the patients. We've now started a feasibility study with five patients so far, very successfully, with 100% technical success and 100% clinical success, meaning all of these sacs regress, so there is no further growth of the sac. We are now in discussion to expand this feasibility study with 10 more patients and in discussion with the FDA to start a pivotal study next year in the EU and US for regulatory approval of this product.
If you look at the market opportunity, the total addressable market is estimated to be around 1.2 billion, on top of the EVAR market, just for the sac filling. The majority of that, close to 80%, is in Europe and the US. So that's our focus, which is over 900 million, and being only one or few competitors in the field, we estimate to have a serviceable obtainable market of over 300 million, with high profit margins. The product is relatively cheap to manufacture, easy to scale, and with a very good and interesting average sales price. Reimbursement discussions are ongoing, and our go-to-market strategy is a mix of direct in the Benelux and part of Germany and via distributors in the rest of the countries for the prophylactic sac filling.
What are our timelines for the endoleak repair? We're closing off the pivotal study for CE and hoping to achieve CE mark by the beginning of 2025, and thereafter, we can start up a limited launch in Europe for the polymer sac filling. We expect to complete our feasibility study also by halfway through 2025 and in parallel, have discussions with the FDA completed for the pre-submission and obtain a de novo. Our current funding covers that period till mid-2025, so we can achieve CE mark in that important period of time.
For the period thereafter, we're looking for a Series B investment of up to 30 million in two tranches: a first tranche of 6 million to have all of the patient inclusions in Europe and the US for this randomized control trial and start up the part of the limited launch in Europe for the endoleak repair application. Then after that, a second tranche of 7 million for the regulatory phases in Europe and the US, and then continuing to expand our limited launch for the product in Europe and building the reference centers for the next phase, which is then end of 2027 when we have the regulatory approval in Europe and the US to expand worldwide with sales. For that, we envision that we would need another 10 to 50 million in a Series C, or by the time we would have an exit because we have an excellent opportunity in time from 2025 to the end of 2027 to obtain an exit.
Looking to the exit, these are the typical partners that we are in continuous discussion with, like Medtronic or Cook Medical. If you look at the field, then typically an exit will take place with earlier revenue stage and an average value of 175 million. So early revenue stage would be, in our case, end of 2027, we should be at that point in time. The team that brings us there is an experienced team with a lot of experience in regulatory work, clinical work, sales, and general management. We're supported by a strong medical advisory board with a lot of expertise in vascular surgery, as well as a supervisory board with a lot of experience in creating value and exiting a company.
With that, I hope you want to join us in our journey. Please contact me if you have any questions and approach me. Thank you very much for your attention.
