Michal Jaworek Presents Approxima at LSI Europe '23

Approxima is an early-stage medtech startup developing a minimally invasive solution for tricuspid valve repair.
Michal Jaworek
Michal Jaworek
CEO & Co-Founder, Approxima



Michal Jaworek  0:05  
Hello everybody, my name is Michal Jaworek. I'm CEO, Co Founder of Approxima. Approxima is an early stage med tech company developing right ventricle reshaping device to treat patients with tricuspid regurgitation. We are at the preclinical stage in fundraising for series A to reach first man clinical trial. tricuspid regurgitation affects mostly elderly population in particular women. This pathology is associated with 46% One year mortality rate and the majority of those patients remain untreated. In over 80% of the cases tricuspid regurgitation is due to right ventricular dilation. This displaces the papillary muscle enlarges the tricuspid valve annulus that leads to the lack of cooperation between tricuspid valve leaflets and results in check blood regurgitation. If we take into account only the patients with right ventricle dilation with at least severe tricuspid regurgitation, at that are at high surgical risk, we arrive at a patient population of over 250,000 in Europe, and in the US every year. Considering a min price of a benchmark device of 20,000 euros, we get the market opportunity of over $5 billion this market today is almost unexplored. The open open heart surgery is the state of the art today for treatment of tricuspid valve regurgitation. Unfortunately, majority of these patients are not eligible for this kind of treatment due to the advanced age comorbidities and high surgical risk and if performed overnight surgery has quite suboptimal clinical outcomes. If we look at the state of the art surgical techniques that are used to treat tricuspid valve regurgitation, we can see that all of them are applied at Valve level treating the effect of the pathology. The valve which does not close, the right ventricle dilation is not addressed, it can progress over time, causing the failure of surgical techniques that are contributing to very high recurrence rates. There is a clear need for specific treatment for this disease that can be offered to patients with high surgical risks. And that's why in approxima, we are developing minimally invasive tricuspid valve repair system, which is based on the right ventricle reshaping approach. This technology targets directly the root cause of this pathology right ventricle dilation. It has a simple and rapid implantation procedure on a beating heart that could be offered to all those frail patients, we expect double therapeutic effect. The first one tricuspid valve regurgitation reduction thanks to the ventricle reshaping an annual reshaping the second one improvement of right ventricle functions. The repair system is composed of implantable device that has two anchors that are connected by a tighter the anchors are placed outside the right ventricle one or the scepter wall inside the left ventricle, the other one or the epicardial. Now, the approximation of the anchors allow us to reshape the right ventricle and restore proper sealing between tricuspid valve leaflets. The delivery system allows for minimally invasive transthoracic delivery of this device and for adjustment the distance between two anchors. This is possible during the procedure and also after the procedure. This technology has extremely low footprint, there is only a debtor in one ankle that remain implanted inside the heart. And we believe that our minimally invasive transthoracic device has a great market potential is today there is nothing on horizon in tricuspid valve space that addresses venture dilation. Nonetheless, we are working on totally percutaneous version of this device to further expand its market opportunity. We protected this technology with an IP portfolio that we are continuously growing. And our US patent has been just granted. We also tested this device in a preclinical setting and today I would like to share with you the results of two in vivo trials that we carried out recently. Just the first time we are showing this results in public. So I'm very happy to do it here and it LSI in the first study, where we were assessing the feasibility of the implantation procedure in in vivo a cute animal model and we obtain 100% technical success, no adverse event and the implantation time which was below 10 minutes and also very short learning curve. In the second study, we assessed the efficacy of this technology in treatment of TriCaster regurgitation. For that, we use a pathological invivo model of tricuspid regurgitation, where we implanted our device and assessed using steady state of the art echography based parameters the effects of this treatment we obtain, besides the ventricle reshaping and reduction of the ventricle dimensions, we saw that our device also has a strong impact on the reduction of the tricuspid valve annulus. And both those geometrical changes contribute to the reduction of tricuspid valve regurgitation. If translated to clinic, this will be considered more than success. And also our EVO chronic pilot study is already ongoing. The tricuspid valve space is quite new. What our competitors are doing is translation of surgical techniques that we saw in some of the slides before into minimally invasive implantable devices, often exploiting technologies, which are already developed for other hardware treatments like mitral and aortic making the solution nonspecific for future costs without treatment. Approximate is the unique solution in short, kasuba space that addresses right ventricle direction and has very competitive participant implantation procedure time. We are young, a young team, first time founders with previous experiences in cardiac devices testing and development coming from Politecnico di Milano, and also coming from our previous industrial experiences. Our CMO Dr. Pawlenty, he is a cardiac surgeon at Sarafa Hospital in Milan. He's an expert in tricuspid mitral valve treatments. And he has this unique expertise in supporting preclinical level technologies, and bringing those technologists to the first in many clinical trial. His expertise is track record proven. Our board has over 20 years experience in cardiovascular field, in particular on hardware therapies, development, and panic as partners is already with us. We are quite early stage, but we already got attention from internationally recognized key opinion leaders. I think we have a nice balance between different specialties in medicine, and especially in the instructional heart field. We have cardiac surgeons experiencing minimally invasive procedures, interventional cardiologists, and imaging experts that know how to guide the implantation of this of these devices. At this moment, we are concluding feasibility phase preclinical phase with very strong preclinical data that we got, thanks to the our seed round that we received last year. And I'm very happy to announce to you that we are starting fundraising for the next round series A thanks to which we will conclude our preclinical work and will carry out the first Imen clinical trial. We are looking for seven millions, an elite investor to support us in this journey. Our current investors are interested to follow on. To conclude, were talking about huge unmet clinical need. Very interesting market opportunity. And approxima has a tailored solution, very promising preclinical data. So if you're interested in this technology or in the current round, please reach out. I'm happy to talk to you. Thank you for your attention.

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