Video Transcription
Nadav Agian 00:02
Hello and good afternoon, everyone. My name is Nadav. I'm the CEO of Append Medical, so let's start. I'm here to speak about Append Medical's solution for LAA elimination. So why do we need to eliminate the LAA? Atrial fibrillation, which is a heart rhythm disease, can potentially create clots inside the left atrial appendage, which is an organ on the left side of the heart. Those clots can potentially flow into the brain, causing a stroke, and by that, atrial fibrillation patients have a risk of five-fold increase in the likelihood of having a stroke. The current main solutions for a transcatheter approach to eliminating or reducing the risk of stroke for those patients are metal occluders, which are actually metal implants designed to be implanted inside the left atrial appendage cavity in order to seal it and avoid the creation of blood clots. This is a huge and fast-growing market expected to reach up to $4.5 billion by the end of 10 years from today, but this solution has significant inherent risks due to the nature of the solution. Two of the main risks are peri-device leakage, which is actual leakage that still exists after the procedure. Twenty-five percent of the procedures end with some kind of leakage behind, or even through those devices, which can potentially create clots over time. The second risk is device-related thromboembolism (DRT) due to the fact that there are metal-based materials inside the heart, creating clots on top of them over time. So, over the years, leading industry players have been in pursuit of suitable candidates to disrupt this market, with no success until now, leaving Boston Scientific to dominate the U.S. market with over 90% market share. So we think differently, actually. Why do we need to use metal implants and put additional metal inside the heart to seal this cavity when we can actually manipulate and use the natural tissue to do that? And this is the way it's done.
Nadav Agian 03:05
Append Medical introduces an innovative left atrial appendage (LAA) exclusion system. The system is inserted via a standard transseptal access procedure into the left atrium. The tissue grabber is advanced into the LAA and captures the LAA tissue by vacuum. The tissue grabber pulls and invaginates the LAA into the ligation device that is attached to the LAA ostium. The ligation device releases and tightens the suture around the invaginated LAA tissue. The system is retrieved, and the suture cutter is inserted over the suture, cutting the excess suture material above the knot. Then the entire system is retrieved. A few months after the procedure, the invaginated LAA native tissue volume is significantly reduced.
Nadav Agian 04:13
So this is an example of how it looks via fluoroscopy. On the left side, you can see how it looks before the procedure. This is the left atrial appendage volume, and this is a post-procedure fluoroscopy. You can see a total elimination of the left atrial appendage and a clear absence of blood flow inside this cavity. We already kicked off our first-in-human clinical study earlier this year. We are targeting to complete up to 20 patients in three different sites. Until now, we have had excellent results. First of all, safety: the device and the procedure are completely safe with no adverse events at all, and excellent acute and three- and six-month follow-ups, showing the results of total elimination of the left atrial appendage. This is one example from one of our patients that we treated in Prague. On the top side, you can see pre-procedural CT and TEE showing the left atrial appendage cavity, which in this patient is pretty complex. And on the bottom, you can see the results. This is the TEE immediately after the procedure; you can see no cavity at all, but still a bulged tissue of the inverted tissue inside the left atrium. The middle image is from day 30, and the last is from day 90 follow-up, showing a significant reduction of the inverted tissue volume and good heart functioning. Our clinical advisory team includes top-level KOLs within the space, electrophysiologists, as well as international cardiologists from the U.S. and Europe. Our roadmap includes completion of this first-in-human study by the end of the year and kicking off the U.S. EFS study of up to 50 patients earlier in the beginning of Q2 in 2025. Our B round is targeting $18 million, which will enable the company to complete the EFS study and prepare for a pivotal IDE study in the U.S. by the end of 2026, for which the company has already secured $5 million out of the $18 million. So finally, Append Medical presents a complete LAA elimination solution, natural-based, without any device in the heart at all. And this is the future of structural heart. So actually, we are structuring the heart without any metal structure, eliminating the risk of DRT and leakage by the nature of the concept. We have one system that can fit various morphologies and shapes of the left atrial appendage. Thank you very much. Applause.
