CorInnova | William Altman, President & CEO

CorInnova is developing a minimally invasive, soft robotic cardiac device for the short-term treatment of acute heart failure.
Speakers
William Altman
William Altman
CEO, CorInnova

William Altman  0:00  
Thank you very much. I'm William Altman. I'm CEO of CorInnova and we are developing a breakthrough cardiac assist device. It is the first minimally invasive thin film device that can go around the heart and gently squeeze the heart to increase cardiac output. Surge cardiac surgeons have been doing this for years with patients in distress and open heart surgery. And it's extremely beneficial to get the heart moving and provide therapy to increase output. We're the only company that's ever been able to develop a minimally invasive device that can do this, over periods of days to provide relief for short term support and later on, it can be developed for longer term support. So we're again we're developing the device first to meet the unmet need to treat acute heart failure. That's for patients that don't have enough cardiac output to support their body during a period in which time they need a device to bridge them to recovery, or bridge them to a longer term device such as a chronic LVAD device. This is a large unmet needs about a million people a year hospitalized with acute heart failure syndrome. About a quarter million people need some type of short term circulatory support during this period. And there are existing devices but they have extensive blood contact, and as a result significant adverse events associated with them. And up to 40% of patients can't even use existing devices, which gives us a great market entry to be able to address basically a $2 billion market that no one else can touch.

Our solutions we talked about is a thin film polyurethane device that goes around the heart of the collapsible nitinol framework. It provides very gentle direct cardiac compression. The big breakthrough is we don't touch the blood. Secondly, we revive and tricolor and treat both ventricles, we can rapidly implant this device and it is a platform for multiple other indications including longer term support and diastolic heart failure. This animation shows how the device can be folded down into one inch delivery tube. We then make an incision between two left side ribs and many left thoracotomy make about a one inch incision in the pericardial sac. Introduce the device inside the pericardial sac. It goes in and seconds, we have inner chambers that conform the device to the heart shape. And then we have outer chambers that we pump air into in synchrony with the heartbeat to gently squeeze the heart to increase output by 50%, which can mean the difference between life or death for these patients. Again, just like a cardiac surgeon provide massage, we can do this 144,000 times a day with our external pneumatic driver. The device is rapidly implanted you can see here and a large animal and a sheep how quickly the device goes around the heart. We've had over there's no direct attachment you don't have to suture it. We've had 100% success rate with over 55 deployments by six different surgeons and 26 large animals to date and acute and chronic heart failure with an estimated 10 minutes to device activation and 30 minutes surgery time comparable to other devices. And the device works mechanism of action is simple that enhances motion the device is off here on the left side of the chart, it's turned on in the right and that gentle squeezing evenly around the heart increases cardiac output by up to 70%. Again difference between life or death for these patients and comparable to other short term assist devices. The market for this type of device is quite large AbioMed, the market leader with over 14 billion market cap estimates in the market for bridge decision bridge to recovery is about $4 billion. The device is selling about 25,000 apiece, which is what we would seek to sell the device for but since we can expand this to patients that can use existing devices we can create another $2 billion market that only we can access to expand the total market for short term cardiac assist devices.

The pathway for this device for approval list with the FDA, it is a PMA device. We've just finished a series of 14 day animal safety and efficacy studies with excellent results. We'll be sharing those later as we started intuitional fundraise in about a month. We are now working on a breakthrough device application human sizing studies and within 24 months should be starting first in human studies and complete that within 36, which will be major valuation inflection point. In other cardiac device companies with large markets have exited for over $400 million in cash with only 10 patients of data in the first in human study. We need to go further we do 20 patients safety study which can be a major valuation inflection point. The revenue model for this type of device is simple. There's a reusable automatic driver to be sold estimated 50,000, but the money again is made in the implantable selling at the same as competition be 25,000. Each estimated cost of goods will be about 15% We have strong patent protection with the prior art 15 US patents issued three pending, also international patents issued and pending. We really own this space, having been one of the few people working in this area the last several years, but very effective technology and very different from the competition. You can see here the existing short term assist devices are inserted to the femoral artery and they have extensive blood contacts which is a balloon come the actual flow pumps like the AbioMed Impella and VA ECMO, which is only biventricular device, all connected to the femoral artery with significant rates of bleeding at the access points. But more importantly and worse, his blood contacts continually use those devices pump blood through those pumps, causes up to 15% rate of stroke and only five days, 5 to 13% rate of blood cell destruction causing a need for transfusions and a 20 to 47% rate of kidney dysfunction and even 12% out right kidney failure via ECMO and up to 40% of patients can use existing devices because they have calcified arteries. Or they're intolerant to the anticoagulants that are necessary stopped stroke, or they need biventricular Assist and all the existing devices except the most dangerous device via ECMO are single ventricle devices. We have a great team to bring this forward Boris Leschinsky, our VP product development as former VP of technology DataScope 400 million revenue company,

He invented another percutaneous LVAD called the Thoratec PHP, which Datascope sold the Thoratech, Thortech took its CE mark approval. And when they sold the St. Jude that single device was valued at between three and $500 million by two different investment banking advisors. He brings also Jonathan Williams from DataScope with us consulting we have top heart failure advisors such as Bill Abraham, arguably one of the top five cardiologists in the world for heart failure is our advisor with Wellcome Trust. Susan Albert, former chief regulatory officer for Medtronic is on our board of directors also an investor in the company and works on the regulatory side. Dr. Dan Burkhoff, one of the top people in the cardiac physiology field, again, our Senior Scientific Adviser, Dr. George Letsou, at Texas Heart Institute, our Senior surgical advisors, so we have a fantastic team, we found great reception among clinicians for this technology, they're really waiting for it. We've had this history is ZF financing with about 18 million in prior funding, with a 6 million lead investment from the Wellcome Trust with a highly competitive translation fund award, they are like the Gates Foundation of England, and highly competitive there. We've also raised 10 million from our founders high net worth individuals, family offices, and 1.7 million in grants. We've just recently received another million dollar grant for diastolic heart failure not even featured here. But we are basically kicking off an institutional fundraise about the end of April, to advance this technology to begin first in human study. And we're seeking to raise 15 to $20 million, then. So the proof of concept we've achieved we've got a great computer simulation model, we've shown the durability we need and we have excellent 14 Day chronic heart failure study results, which I haven't shared here, but we'll be sharing as we bring this out to market for institutional fundraising again, first human indication, like AbioMed to just be four to five days use. So we've really accomplished a lot with this technology and there's huge market out there. Again, the large potential exit after first inhuman these other cardiac companies in the mitral valve space, for instance, exited between 250 and 450 million in cash because they had 10 patients a day in a huge market. We believe we will get similar treatment because we are addressing a huge cardiac assist market and not just short term cardiac assists, but we can expand that to longer term indications as well. We've received very strong validation and support as their technologies have ensured winning numerous awards. As we've taken our results out to the to the marketplace and to clinicians. We've been invited to all the major clinical conferences, including TCT devices and heart failure in Europe, and receive really outstanding feedback from physicians who really want to see this technology out there and in use. People have called this a potential game changer in the field of heart failure. I've named major Northeastern Medical Center, TMC, the Texas Medical Center venture funded calls, it could revolutionize the market, like the pacemaker and a top 20 Heart Hospital for instance, said this has a terrific technology with tons of clinical applications. So please come and talk to me. I'm happy to talk to people about our upcoming institutional round we'll be doing we've got a breakthrough technology that was excellent actually reimbursement in place as well and early exit potential at first in human so be happy to talk to you and we appreciate your time today. Thank you



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