William Altman, CorInnova - Minimally Invasive Soft Robotic Cardiac Device | LSI USA '24

William Altman  0:04  
I'm CEO of CorInnova, and we're developing a new type of cardiac assist device. As you can see, it's a thin film polyurethane cup that goes around the heart. We inflate Erin in to gently squeeze the heart to increase output. And it's much different than other devices, as many different advantages. In summary, though, we have this new paradigm of cardiac cyst technology for heart failure patients, we address very large $5 billion plus addressable markets. We've demonstrated safety and efficacy in 23 large animal studies, including 14 day studies in a chronic model of heart failure. And our first target market is short term five days use for acute heart failure patients, for bridge to recovery or to bridge them to another device. It's been validated nationally, internationally by heart failure thought leaders, device experts. We've had multiple peer reviewed publications and numerous awards. We're raising 30 million to complete our first human efficacy trials within 36 months, with aim then to either exit for a potential high return with comparables, up to 600 million or after an additional rounds to take us to FDA approval, which could provide a billion dollar plus exit. Our path to first in human now is very clear and technologically straightforward. We're simply manufacturing our device to fit human hearts. We've already begun, and we're manufacturing a miniaturized pneumatic driver of established divine with design, with a very experienced and excellent vendor, CEO of Texas Heart Institute, with deep prior experience in cardiac assist, has chosen personally to lead our clinical trial design. We're very excited about where we are. I want to give you more detail. You all know, heart failure is very large and growing problem. We are addressed addressing acute heart failure, a short term episode in which your heart fails to produce enough blood to support your body. And again, we're aiming for five days, bridge, street cover, bridge to another device. There's about a million people a year hospitalized with acute heart failure syndrome. We estimate about a quarter million of those need short term circulatory support. There are existing devices out there, but they're limited by the fact that they do contact the blood which relates to adverse events. And in addition, 50% of patients or more cannot use existing devices, and those are the patients who we're targeting. As I said, our breakthrough in cardiac assist technology is very gentle, direct cardiac compression. We have no blood contacting surfaces with the device. We help both ventricles. We have biventricular assist. The device can be rapidly implanted, and short term Assist is simply the first in many potential applications. This animation shows how the device can be folded down into a one inch delivery tube. We then make a small incision and minion left thoracotomy between two left side ribs about an inch and a half. We then make an incision in the bottom of the pericardial sac, and it goes smoothly inside the pericardial sac. We have inner chambers that we fill with saline in order to conform it to the heart shape. And then we have outer chambers that we pump air into in order to gently squeeze the heart, just like a surgeon, we'll do an open heart surgery to the patient in cardiac distress. Our device will massage the heart and help recover that patient. Our external pneumatic drive system promises very small, compact and very lightweight, and it could be not only used for in hospital use for our first indication, but also potentially for longer term indications later. Again, the device been rapidly implanted. You can see here a fluoroscopic image of the device being implanted around a sheep heart, typically less than 20 seconds to deploy. It's 100% success, rated deployment with a 55 deployments by six different surgeons and minimal training, no deployment. Accessory tools, very quick to activate within 10 minutes, and a cardiologist can insert this device after surgical access, just like an impeller, five, five. And we believe the ease of use of this device will lead to very low barriers for adoption. This shows the mechanism of action. On the left, the device is off in a model of heart failure in a sheep. And on the right, you can see the device is turned on, and it's just this very gentle, direct cardiac compression that can increase cardiac output by over 50% as shown in our animal studies. Now, not only have we tested this in short term studies, we've actually done it for up to 14 days and shown evidence of heart recovery over that 14 day period, we had animals that had microsphere embolism occlusion, which led to heart failure, reduced ejection fraction down to 20% with the device in place, they all improved with a 50% increase in ejection fraction percentage. And even those after we turned off the device at the end of 14 days, they still showed residual improvement, indicating heart recovery the animals that had sham surgery, but no device. Two out of the three died, so we showed survival benefit as well. Importantly, we also showed very safe operation over 14 days, and we can even turn the device on and off, which you can't do with any other cardiac Assist Device today. So you can have a patient do rehab, get up and get out of their hospital bed. In addition, we observed No. Adverse events among the animals, and we see it's very safe and has been safe in all our animal trials. Anyway, the short term assist market is very large. Abby med Impala, about half of their sales address cardiogenic shock cardiomyopathy, and that's about a $5 billion market, but they can't address half of the patients that we're going to target people that are ineligible because of calcified arteries, smaller arteries, like women, are people who can't take anticoagulants. So go over that in a minute. So we have a half of a big, $5 million market, initially just ourselves, and later we could always address that other market. We currently have a very rapid path to first in human and high value exit in 2425 we'll be designing and manufacturing for human sizes and completing our driver first in human use, finishing a first in human up to 10 patients, which major value inflection point with comparables at 250 to $600 million the revenue model is very favorable in a space with the Driver being sold at 60,000 plus the disposable at 35,000 equal to that device, will provide us 85% gross margin. And again, it's a direct sales force to a select group of cardiac hospitals in the US, and we plan to exit to a partner who can use their existing sales force. We have very strong patent protection. We really own the space, with 18 patents issued in the US, and allowed two pending and 18 international patents as well. So a very strong intellectual property position, and we are differentiated from the competition. You can see here that existing temporary mechanical support devices are all inserted to the femoral artery, which causes bleeding at the access sites. There's also blood contact, which leads to significant adverse events of up to 15% rate of stroke, even within five days, hemolysis, kidney dysfunction, et cetera. But very importantly, half of all patients can use these devices because they have calcified arteries. So you can't get implanted. They can't use any coagulants or aortic insufficiency or stenosis a contraindication, or they need biventricular support, and they're not getting that today. And very importantly, women with smaller arteries can't use a lot of these devices, and only one in five cardiac Assist Devices is implanted in women. So we basically have shown through animal studies that we can size our device down to fit smaller women, so we can address that very important market which is underserved today, we have fantastic team. Boris lashinsky, our VP product development, former VP of technology, datascope, invented the thortek php, which sold for over $300 million in the sale of thortek. Also Bill Abraham, one of the top five people in world and heart failure has been involved with us from the beginning. Susan Alpert, former chief regulatory officer. Medtronic is on our board and investor in the company, people like Dan burkhoff, George letsu, Texas Heart Institute, top people in the field. And we're very happy to say that the CEO of Texas Heart Institute is now engaged fully and is on our Scientific Advisory Board to lead the design of the first in human trial our capital sub date, we've been funded $20 million and we're at an easy inflection point to go forward. So raising $30 million to complete that first human efficacy trial, and leaving plenty of, I guess, extra money for the unknown unknowns. And so we've already begun the work on the first in human device. We already work in a pneumatic driver, and we plan to exit after that. And the exits are very big in this space, up to 575,000,004 50 million in cash for cardiac devices, large market. Abmed, as you know, sold for 16 times sales to j and j because of the huge long term market for short term assist devices. And we've received multiple points of validation as our technology has matured recently, covered by a major investment bank and a private company report, I could talk to you about that later. And overall, clinicians are enthusiastic about this. They're saying this is a real potential game changer in the field of heart failure, and we can revolutionize the market like the pacemaker. So we've got a breakthrough, exciting technology, hi reimbursement with the early exit potential. So I encourage you to come talk to me after this. Contact me however you'd like, but we're very excited about this, and love to have you as part of the team. Thank you. Applause.