Martin Cook, Venstra Medical - Temporary Cardiac Assist Device | LSI USA '24

Martin Cook  0:04  
Venstra Medical is a company that's developing a next generation of cardiac support technology for critically ill cardiac patients. In particular, the technology is designed to provide these patients with the full cardiac support that they need. It's backed by an IP portfolio of multiple granted patents. And we're looking to raise our series B at the moment to get us through our first in human study. So there's a real problem with cardiac patients, many of whom have suffered a myocardial infarct, and if they go into cardiogenic shock, it's a life threatening situation. cardiogenic shock is when there's a critically low cardiac output, the patient's heading towards multi organ failure, they need cardiac assistance, they need it promptly, and they need a high degree of cardiac assistance as well. Unfortunately, this category of patients have have a stubbornly high mortality risk of about 50%. That stayed that way for quite some decades. There are other cardiac patients that require cardiac assist, such as very high risk patients that need to undergo a coronary intervention. So P VADs. are becoming the standard of care for these patients. What's the P that a percutaneous ventricular assist device, it's a, it's a tiny pump on the tip of a catheter implanted by a cardiologist to provide temporary cardiac support. These technologies exist, but there's an issue with them. The physician can either choose a low profile, very small catheter device that can be implanted on an emergent basis in a cath lab. However, because of its size, because it's low profile, it can only provide partial support to these patients. Alternatively, the clinician can pick pick the larger device, because it's larger, it can provide something closer to full support. But now it requires a surgical cut down requires an hour to be prepped can't be done on an emergent basis, Adventure Medical, we're obviating the need for this Choice. We're getting the best of both worlds if you like, based on a collapsible, expandable technology, our device collapses into a very small profile catheter. And when it's in situ across the aortic valve, as you'll see in a minute, it's now larger and can and can pump the full support that the patient needs. In this animation, you'll see our system being deployed through the femoral artery, the device has collapsed into that low profile catheter. It's introduced over the wire. When that delivery sheath is across the aortic arch, the delivery sheath is retracted, the device naturally expands. And you'll see in in a few moments, the device starts pumping. And when it starts pumping, once that delivery sheath has been retracted, it draws blood from the left ventricle injects it into the ascending aorta essentially takes over the function of the left ventricle. And importantly, it reduces the myocardial oxygen consumption. For these critically ill patients who have suffered a myocardial infarct of the cessation of therapy, maybe a few hours, maybe a few days, it's retracted back into the low profile catheter. So we've completed our engineering development of the device all the way through our preclinical animals, multiple animals, using a non French delivery system, definitely produce full cardiac support. In fact, in a recent animal, we produced up to nine liters per minute, very successful, implantation retraction into a nine French sheath. And the real, I guess, differentiating factor of our technology, as I alluded to before, is the ability to provide full support. Now, when we talk about cardiac support, we talk often talk about the flow that a device generates. But we also have to talk about the pressure that it generates to the blood, you're in my left ventricle is pumping flow across the aortic valve, but it's also generating an increase in pressure. Our device, which we believe is the most powerful PVC that we're aware of, can generate five liter per minute output while generating an increase in pressure of 18 millimeters of mercury, or alternatively, say seven liters per minute at 60 millimeters of mercury. And it's important, the there is a dose dependent reduction in infarct size for the level level of support that is provided. So partial support you see there, the bar in the center, produces a relatively small reduction in infarct size, total support, much greater reduction in infarct size, and that's really important, because the smaller the infarct size, the less chance that that patient's going to subsequently go into heart failure. So how much support is required? Well, we have data from LVAD patients over many years and you can see the blue circle there is the typical pressure and flow required from these critically ill cardiac patients. You can see some patients require for up to six and a half liters per minute of output, some require up to 80 millimetres of pressure generated. And overlaid on that circle is our performance curve, showing that we can generate the pressures and flows required of the vast majority of these patients. And we do so in a very small profile system, it's nine French, which is three millimeters, it's actually really incredible to see a device pop out of such a small catheter, expand and then be able to pump the flows and pressures that we get from this device. So we've largely directed the project from a technical perspective, we generate full support and a very low profile system, successful preclinical animals and all done at clinically acceptable low levels of hemolysis, which is blood damage. And I'm proud to say that we've done all of that having spent less than $7 million over the life of the company. And we've been able to do that because of a great team, a team that have done it before we're not reinventing the wheel. You'll see here multiple people that have developed P VADs. Before I've been in the circulatory support space for about 25 years. And my co founder cardiologist Dr. suku. Samba is a P vatting. planter himself. The same can be said for our great medical advisory board all of which have had P VAT experience. And in fact, some have written P VAT guidelines in the past. And it's great and convenient to have to Mayo Clinic doctors, not far from our operational Center in Minneapolis, Minnesota. I alluded to before our IP, we have a portfolio of seven granted patents. Three in the US three in Japan, one in Germany, priority dates go back quite a few years. So we're very happy with our powerful IP position. Let me talk about the market for a minute. Many of you may know this market because of the acquisition by j&j of Abu Ahmed for 17 billion. I think last year, the revenues in the industry were estimated at about $1.5 billion. It's growing at double digit figures. The current addressable market is estimated at up to $8 billion. The average selling price for one of these disposable catheter pumps is north of $25,000. So very exciting, but that's not the end of the story. There's more blue sky potential yet there's new indications coming along for P VADs. STEMI is a particular type of heart attack, if you like and that a lot of preclinical data has suggested that rather than wheeling the patient into a cath lab and putting in a stent straightaway, if you put in a P that first for a while before you unblock the coronary artery reperfusion injury is minimized. And infarct size is reduced. Now, if that indication is approved for P VADs. It about doubles the existing large market for this this technology. And key opinion leaders are already opining that P beds will become the standard of care for these STEMI patients. It seems that rarely does a month go pass without some good news for the PV adspace. News about the efficacy with cardiogenic shock patients updates the clinical guidelines reimbursements in place at about $72,000 for for the implant of of a P van. In terms of our schedule, we're planning to get to first inhuman by the end of 2025 and then move on to our pivotal studies. The first one being for the indication of high risk PCI. And finally a bit on our funding history. We started the company in 2018 Got some non dilutive funding and our seed round in 2021 raised our Series A at the end of 22. And we're now looking to raise $25 million to get us through and complete our first in human study. So thank you very much. It's we very much look forward to getting through our first in human study and getting this great technology into the hands of clinicians and more importantly, benefiting patients. Thank you very much.