Video Transcription
Eugenio Passanante 00:00
Good morning, everybody. It's a pleasure to be here. I'm presenting to you StarTric. We are developing a transcatheter solution to treat tricuspid valve regurgitation, which is by far the most significant clinical need in the entire structural heart landscape. Tricuspid valve regurgitation is the most common pathology that actually afflicts the tricuspid valve, and it occurs when the valve doesn't close properly, causing blood to backflow and reducing the flow to the lungs. It has a huge impact on mortality; a patient with severe tricuspid valve regurgitation has an 80-85% chance of dying within 10 years. It also has a significant impact on the quality of life, which is very typical of cardiovascular diseases. But despite this fact, it is really and hugely undertreated. It affects 0.4% of the entire population, and only 3% of severe tricuspid regurgitation patients are treated with surgery.
Today at StarTric, we are developing a new technology to safely and effectively treat tricuspid regurgitation. This is a healthy valve; you see it functioning properly. Now the valve is regurgitant, so you see backflow coming back to the atrium. We will have a transfemoral approach, approaching the right atrium through the inferior vena cava with a steerable catheter. We are deploying a stabilizing system that enables us during the procedure to stabilize the leaflets and bring them together on the valvular plane to create a surface that can actually be easily seen under echo guidance, allowing us to puncture with three needle cannulas, deploying on the ventricular side three self-expandable anchors, one for each leaflet in the desired position.
So you will see on this leaflet, very far from the center of the valve, we are able to grasp it very far and deploy a needle. We then completely retrieve the stabilization system, leaving only the three anchors implanted, and we deploy a central blocker, fastening the three pledgets that act like suture pledgets. We basically achieve a clover repair of the tricuspid valve by restoring coaptation and proper functioning of the valve, abolishing TR and leaving implanted a very tiny device. Now you'll see both atrial and ventricular sides in these two pictures. Mind that our technology is actually based on a very strong clinical and surgical evidence of the clover surgical technique, which is the gold standard in surgical treatment of tricuspid regurgitation, and we are the only company that is treating and developing a transcatheter technology to actually replicate the end result.
It has been developed at Cereal Hospital. It consists of stitching together the central leaflets' free edges, creating a triple orifice valve, as you just saw. It has been proven to be very effective on very severe patients over the course of 15 years of follow-up; over 100 patients are free from TR after nine years, which is almost 80%. We have also recently encountered the recent experience of Dr. Zanotti in Greece, who performs an endoscopic Clover procedure by basically using not sutures, but pledgets and tightening them up with a titanium fastener, similar to what we do in our transcatheter approach. He has published results on 20 patients with over three years of follow-up with great results. It's a cross-validation of what we are doing, of course.
But if we see what's happening right now in the market, until two years ago, open-heart surgery was the only solution for these patients, being highly invasive, with only a few patients having access to care. Right now, we see a first generation of technologies that can reduce surgical risk but are really falling behind in terms of efficacy because they have been migrated from mitral applications and adapted to the tricuspid valve. We see that in the near future, there will be a need for effective transcatheter solutions that are both safe and effective for tricuspid regurgitation. That's what we do, actually. Our procedure is simple; it is a single implant, easy, repeatable, reproducible, adaptable to different anatomies and pathological conditions, and based on proven surgical experience.
This is why we really believe we can become the gold standard for tricuspid regurgitation treatment, addressing different stages of TR and different types of anatomies. I want to show you now on the left side of the screen; this is a big heart valve on an ex vivo model, a very pathological valve with huge coaptation gaps, highly treatable with current devices. On the right side of the screen, you will see the valve coaptation being completely restored, TR abolished, and the functioning being completely restored. We also recently performed an in vivo case with a follow-up at 30 days on a sheep model, cross-validating what we actually experience in many ex vivo cases. The implant is stable; we didn't experience any major or minor complications, cardiovascular-wise, and no significant TR was experienced, so it was a very positive test that we recently conducted.
We have built an IP portfolio of over five patents covering alternative designs to replicate the surgical Clover technique. We have raised 2 million to date, successfully tested the technology in ex vivo and in vivo campaigns, and proven the comparability of TR reduction with the Clover technique. We are receiving a warm welcome from the scientific community. We will attend TCT this year in Washington, and also the Shark Tank innovation. We have been at EuroPCR with the Scientific Session, and also in the NAMI today, in 2022, at the SEI innovation finalist. We are raising 5 million euros to complete the design phase of the implant and the preclinical validation, with the first in human to be achieved in 2028. The 5 million round is structured with a 1 million SAFE to be closed by the end of this year, with commitments already made, and a 4 million equity closing next year.
If we look at current exit opportunities, we see a market that is far behind, actually having in their portfolio either effective or at all transcatheter solutions for tricuspid regurgitation treatment. So there's a huge potential here with strategics to address this problem. Conjointly, we are very honored to have on board of our team Professor Alfieri and Professor Debonis, who are the inventors of the device, as well as the pioneers of the surgical technique behind our technology. Professor Alfieri himself is also the inventor of a surgical technique, which is the basis of current tier technologies like MitraClip and Pascal. They are replicating their technique on the mitral side. We are also surrounding Professor Debonis and Professor Alfieri with a scientific advisory board with worldwide recognition, and we have put together a management team with a lot of experience in cardiovascular innovations and commercialization, as well as the development of technological devices in the market.
Thank you very much, and if you want to reach out, I'm here for you.
