William Altman Presents CorInnova at LSI USA ‘23

Transcription

William Altman  0:05  

Thank you. I'm CEO CorInnova and we're developing a breakthrough cardiac assist device for heart failure. As you can see, we have a thin film polyurethane cup with a nitinol wire framework, we inflate gently to squeeze the heart to increase output, and we can treat the 50% of patients that can't use existing devices. In summary, we've created a game changing cardiac assist technology for heart failure. We address large markets that have no competition of 48 billion a year, we've consistently demonstrated safety and efficacy and 23 Large Animal studies. Importantly, including two weak recent studies and a chronic model of heart failure. We anticipate our first target market will be for short term use of five days for breached recovery and British decision patients. And the technology has been validated nationally and internationally by heart failure, clinician leaders, international wards, peer reviewed publications, etc. The technology is now at the point their next step is to raise 20 million to do our first in human study in 10 patients over the next three years at which may we may I did for potential high return of up to 450 million based on comparables or more are two we can take it further forward to FDA approval our path the first team at this point is very clear, technologically straightforward. We simply have to manufacture device to fit human hearts and reduce the size of a pneumatic driver. And we're so pleased that the CEO of the Texas Heart Institute has chosen personally to lead our design of our first in human study. And it's great to be working institution like that to bring a game changing heart failure technology to market. So as I said, we are treating the unmet needs to treat acute heart failure. That's a short term episode in which the heart fails to pumping up blood for the body. We plan to provide a bridge to recovery. For instance, you have a viral infection, you need some support until your heart recovers, or you may already have heart failure, but then you have a kidney complication, you need more cardiac output, do the kidneys healthy again. And after that you may be able to be bridged to a longer term device. So both these are large unmet needs. There's about a million people here with acute heart failure cases, about 300,000 of these needs some type of short term circulatory support, and there are existing solutions but they have extensive blood contact related adverse events which is limitation. And importantly for us, 50% of patients can use existing devices but those 50% can use our devices we'll explain later. So this breakthrough as we said provides general relativity and compression it's five and tricolor it sits around the heart there's no blood contact, we can rapidly implant it. In this next video can show how the insert platform from multiple indications. This animation shows how the device can be folded down into one inch delivery to and then approaches the heart through a mini left thoracotomy between two left side ribs. Minimally invasive surgery we make a one inch incision and the bottom of the pericardial sac slips over the heart neatly and quickly. We have inner chambers that we fill with saline and conform it to the heart shape. And then we have outer chambers that we gently fill with air to gently squeezed the heart to increase output. Just like a surgeon would do with a patient and open heart surgery on the table and do cardiac massage proven safe effective. Our device can do this over 120,000 times a day where their external pneumatic driver has proven how rapidly This is implanted. This is the X-ray sheep study. We've done it goes in typically less than 20 seconds. We've had proven 100% success rate and 55 deployments and 23 Large Animal studies six different surgeons super easy to learn estimated 10 minute surgery time to device activation. And a cardiologists would insert this after surgical access is given by cardiothoracic surgeon just like impella 5.0 or 5.5 is implanted. And the mechanism of action is simple and clear. It certainly squeezes the heart. Here's a heart failure heart with a device off on the left and then turned on in the right. And you can see that gentle squeezing and increases cardiac output by 50%, which is the difference between life or death for these patients. Very exciting news. Going over this chart we did 14 a large animal studies in chronic heart failure. No one has ever done this type of study before. And we showed that after 14 days of treatment of the three animals that had the device improve their ejection fraction over the period of this study demonstrating heart recovery, and animals without the device two out of three expired. So we've demonstrated an enhanced survival as well. In addition, we showed safe operation over 14 days you can even turn the device off but the animal walk around. And that implies that we could be able to do physical rehab for patients which currently cannot do with existing devices. And importantly, we observed no adverse events during the period. We found it's very safe overall and takes us to the point now for previous institution around and as I said before, we can double the size of the market. abeam estimates is markets about 4 billion in size. existing devices sell for 25,000 each. But we can address the half of the patients that can use existing devices doubling the size of the market 8 billion we have a rapid pathway to a first inhuman try All and then a high value, exit, and 2023. And we'll be finishing our human heart design manufacturing the device, doing final FDA work and then starting our first inhuman and 2020 for six to 10 patients finish that by the end of 2025. Or we've seen exits for PMA devices and cardiac area as high as 575 million at that point, revenue is here's highly compensated reasonable driver be sold as 60,000 or more, the disposable sell for about 25,000 comparable the impella estimated cost of goods colon or estimated gross margin is very high 85%. And this is sold to the direct sales force again, we seek to exit someone who has that sales force we needed to attend people, we could cover all the major heart centers in Europe in the US, we have strong patent protection really own this space with 18 patents issued and three pending in the US and 16 internationally. And to show you how different we are the competition, all these devices are inserted into the femoral artery, and there goes up into your bloodstream. So these devices are blade bathed in blood, there's bleeding at the access sites which problem to manage. And also you get up to 15% rate of stroke and only five days 13% rate of ribs blood cell disruption requiring transfusions, and up to 47% rate of kidney dysfunction. But importantly for us, half of patients can use existing devices. So there's no competition for patients that have peripheral arterial disease and calcified arteries, for those that can't use anticoagulants, for those that have aortic insufficiency, and stenosis, or the need by ventricular support, which is 20% of the patients. In addition, women have smaller arteries. So many women cannot use existing devices, they only get 25% of the of the devices, whereas they have 50% of heart failure patients. So we can address the issue of health equity and help those patients. And we have a great team, including Boris Liz Schinsky, our VP product development who developed another percutaneous LVAD called Thoratec PHP, which at the time of Thoratec sale brought in between three and 500 million in revenue over that sale price. People like Susan Alpert, who served chuff investor in the company on the board former chief regulatory Officer of Medtronic Dan Burke off and the bill Abraham tops in the field and again to Texas hearts CEO Joe Rogers has recently signed on to design our first in human trial, and we're delighted to have support at Texas Heart Institute. In terms of capital requirements, we spent 18 point 7 million in funding to date with a 6 million lead investment from Wellcome Trust in their translation fund and fund for breakthrough applications like ours. We've also had support from Texas Medical Center venture fund the Texas merging technology fund, and other angels and super angel investors and 2 million in grants. As I said, we reached a critical inflection point the path to first inhuman is clear and easy. We were raising a 20 million institutional round to do the final human heart size devices and our final pneumatic driver to reduce the size. Begin our first in human study within 18 months and finish in 36 and exit to major med tech. For comparables you can see in the current and mitral valve space, for instance, 2018. All these companies had only 10 patients of data, but good data and type of data we'll see in our studies. And they sell for between 250 and 450 million in cash plus milestone payments. And we would expect especially given the validation we've seen for the value of Abiomed, which j&j bought, which is the only short term assist device maker publicly traded had a billion in sales sold for 16 times sales, when j&j was selling for seven times sales. So obviously, there's perceived a huge growth potential in this market. And our device can address is half of the patients that cannot use the abdomen impeller other devices. So we'd be a great complement to a company like that or a great base to build a cardiac Assist Device business for other companies. We've had strong validation and support as our technology has matured. And we've been called a potential game changer for heart failure by many of the top clinicians in the world in heart failure, or the ability to revolutionize the market by like a pacemaker. Overall, we've got a breakthrough exciting technology is high reimbursement great data, there's early exit potential and high premium with first inhuman data. And we'd love to talk to any of you that would like to help us in this journey and join in a way to to create a heart failure treatment for people that have no alternatives today and save many lives. Thank you