Video Transcription
Michal Jaworek 00:02
Hi, Michal Jaworek, CEO and co-founder of Approxima, and it's my pleasure to present today Approxima, a med tech company developing transformative technology to treat tricuspid regurgitation. Tricuspid regurgitation is a huge unmet clinical need with over 36% one-year mortality rates, and today, the majority of those patients remain untreated. This also creates a very interesting market opportunity of over $5 billion, with over 250,000 new cases per year in Europe and the US only. In this pathology, the valve itself is healthy, and the real cause of this disease is the dilation of the right ventricle. So the right ventricle enlarges and does not allow tricuspid valve leaflets to close properly, and this leads to blood leakage from the ventricle towards the atrium. Today, the standard of care is quite poor with open heart surgery, which is not an option for this frail patient population, while the emerging percutaneous solutions are quite limited. First of all, they target the effect, the symptoms of this pathology, the valve which fails to close, while they fail to address the underlying cause, the ventricular dilation. Also, we are talking about very complex procedures which are long, and the devices, once implanted, do not allow for any future alternative treatments.
So taking into account the mechanism of this pathology and the standard of care today, at Approxima, we are developing a tricuspid valve repair system which is based on a ventricular reshaping approach. This device targets directly the root cause of this disease, right ventricular dilation, and has a relatively simple design with two anchors connected by a tether. The approximation of the anchors allows us to reshape the right ventricle and restore proper closure of the tricuspid valve. This device is implanted via a totally percutaneous, very straightforward implantation procedure, and this is how we do it. We cross the skin in the ventricular walls with a needle, then we position a small nine French delivery filter across the ventricular walls that allows us to position the components of the device inside the heart: the septal anchor, tether, and the epicardial anchor outside the heart. Now the operator can adjust the distance between the two anchors, reducing the distance between the two anchors, and decides the optimal distance based on echocardiography Color Doppler.
So Approxima creates a totally new category in the tricuspid valve therapies. It is a unique solution that addresses tricuspid valve regurgitation at the ventricular level. It leaves all bailout options feasible as we do not touch the valve, and this has a very straightforward and simple implantation procedure. Today, we have already collected very promising preclinical data, and I would like to share it with you. First of all, the percutaneous delivery procedure is reproducible, repeatable, and it takes only 10 minutes to deliver the device. This procedure can be performed by interventional cardiologists, as it doesn't require any surgical cut. Secondly, in our very elegant preclinical study on the efficacy of this technology in pathological animals in which we induce tricuspid regurgitation, we were able to demonstrate that this device is efficient in systematic reduction of tricuspid regurgitation. Here you can see examples from echocardiography Color Doppler, from two from the same animal before and after the treatment. You can see that the regurgitation jet in red is reduced. We can also appreciate the reduction of the right ventricular size and also the reduction of the tricuspid annulus size. These two geometrical changes of the right heart contribute directly to the reduction of tricuspid valve regurgitation.
Last but not least, this device and this technology is extremely low footprint technology that translates to a very nice safety profile. We demonstrated this already in our pilot chronic study on four sheep in a study with a follow-up of up to 90 days. And you might be wondering what the future users of this device say, and we actually already asked them about that. As we are moving towards first-in-human clinical trials, we talked to over 20 key opinion leaders from this sector, experts in tricuspid valve treatment, and what they say is that they really appreciate the therapeutic concept. They see the reshaping of the right ventricle as a physiologically like treatment to tricuspid valve regurgitation. They also see potential indications of this therapy to treat right ventricular dysfunction as it often coexists with tricuspid valve regurgitation. They like the bailout options that are feasible, and they see it as a long-term, safe, and durable treatment with no anticoagulation and no need for pacing during implantation.
The second strong aspect of this technology they emphasize is the percutaneous procedure. They see it, and they recognize that this is a straightforward, simple procedure which doesn't require any complex imaging. And that's why all of them told us that they would be confident in performing this procedure. This only confirms the last year's recognition of Approxima from the medical community as a top innovation at PCR London Valve. Our team is a group of biomedical engineers experienced in cardiac device development. We are supported by Dr. Denti, who is an internationally recognized expert in tricuspid and mitral treatments. He is an innovator who has already supported other companies in going from the preclinical to clinical phase with successful outcomes and very promising clinical data and successful acquisitions. Our scientific board is an international team with multidisciplinary backgrounds. They are the rising stars of tricuspid valve treatment. We have international cardiologists and cardiac surgeons experienced in minimally invasive procedures and percutaneous treatments, as well as clinical cardiologists.
Our board of directors is a team of experienced entrepreneurs in med tech and partners who have already invested in our company in our seed round, with a ticket of 1.6 million euros, thanks to which we collected all the technical evidence that I shared with you today. And I'm also very happy to share with you that we are in fundraising to reach the first-in-human clinical study and to perform an early feasibility study in the US that would lead us to potentially exit triggering milestones with clinical data on patients in Europe and in the US that would demonstrate preliminary safety and efficacy of this technology. We're looking for 10 million euros. We have already commitments from two colleague investors that are willing to participate in this round, and we're looking for other potential co-investors to join us. So if you are interested in this opportunity, if you would like to learn more about Approxima and our team, please reach out. Let's connect and have a discussion. Thank you very much for your attention.
