Video Transcription
Sheldon Goldstein 00:00
Sheldon, good morning, everyone. I'm Sheldon Goldstein, CEO of Coagulation Sciences, and we will bring to market better and faster control of major bleeding during surgery. So blood transfusions are risky and costly. On the top of the slide, you see a list of the complications that are known to be related to blood transfusions. They are severe. They are serious. On the bottom of the slide, I quote one of thousands of studies that looked at the complications of transfusion. I quote the study by Morton, because they have over 4 million subjects in the study, and this is a very carefully done case-control study. What they showed is that patients who received transfusions had a longer hospital stay, which was more expensive, $17,000 on average. The risk of developing an infection was 90% greater in the patients who were transfused, and the risk of death was 70% greater. I consider death a very bad outcome. What's on the left of the slide is a test-guided algorithm, and literature suggests that physicians perform this particular algorithm, which requires three separate devices, manual pipetting, as many as 15 decisions. When a patient with a gunshot wound is bleeding on the operating table, there is no one in the operating room who has time to run this algorithm. So there is an unmet need for a test platform that supports transfusion decisions in real-time at the point of care. Over half the nation's blood supply is used just for cardiac trauma, liver surgery, and postpartum hemorrhage. 40 to 60% of transfusions are known to be unnecessary, needlessly harming patients and increasing unnecessary hospital costs. Hospitals in the US are mostly for major surgery, reimbursed on a DRG or a fixed dollar amount, so each unit of transfusion that they give costs them money. Better tests to support transfusion decisions would both improve patient outcomes and decrease costs. Our solution is the multiple coagulation test system (MCTs), which is truly personalized medicine. As compared to an AI system, where data from millions of patients makes a best guess, our system compares the ability of multiple treatments to correct bleeding in the blood of the specific patient with their specific bleeding disorder. It provides far more useful information than existing tests, which say something's wrong. I'm an anesthesiologist. When there's 10 units of blood on the floor, I know something's wrong, so a prolonged PTT or an abnormal TAG-our time doesn't help me. Our system indicates which treatments will restore clotting to normal. Results are generated fully automated in about 10 minutes. It's a razor blade business model. Over 90% of revenue will be from disposable cartridges at scale. They will have a profit margin of 73%. Anyone who sees me after gives me a card; I can send you a deck, and this link will play an animation of the system used at the Mayo Clinic in heart surgery, where we studied 98 patients. This was an 18-channel cartridge. Two channels were controls, and 16 were filled with hemo therapeutic agents. This is a schematic of the cartridge. The blue top tube on the side is inserted into the cartridge. Blood is vacuumed into the cartridge and then drops down through the therapies. The 16 channels in the middle contain eight different chemotherapeutic agents in low dose and high dose. This includes blood products, drugs, and factor concentrates. This figure in blue and green on the bottom right is a screenshot of an actual test result. This was run in an abnormal plasma sample that was developed as an abnormal control substance. This is a factor II or prothrombin deficient sample. If you look at rows one and 18, those are the control channels. The blue bar at the right means that no blood clot has formed, which is what you expect in the absence of prothrombin. Now look at rows two and nine through 17. These are all substances, hemo therapeutic agents, substances that improve blood clotting, and yet none of them did anything. Still, no blood clot formed. Fibrinogen is the most important protein in the coagulation cascade. Factor VII is the most potent procoagulant we have, and still no clot is formed because in the absence of factor II, they can't. So basically, the system has rejected all those therapies as ineffective. Now look at the green column, rows 8, 7, 6, 5, 4, and 3, which indicate results ending here. So the system, fully automated, indicates these therapies will bring clotting into the normal range. Furthermore, it displays dose-response curves within each therapy and between therapies. This is what physicians need: one tube of blood into a cartridge. Fully automated testing. The anesthesiologist and the surgeon can focus on the patient. The screen results are generated live, so you don't have to wait 10 minutes to see the result. Once you're in the green column, you already see which therapies restore clotting to normal. So what we want to do, our goal is to replace these algorithms on the left, which, frankly, during major hemorrhage, are not even performed with our fully automated system on the right, which is easy to use and easy to interpret. We have testimonials from key opinion leaders. Dr. Shander is arguably the number one expert in the world. Time Magazine labeled him a hero in medicine for his work in Bloodless Medicine, and he wrote, "The benefit of our system is that by testing multiple therapies in advance of treatment, only the therapies proven to correct clotting would be administered." Dr. Spice wrote that what is deficient in any given patient would be identified and how to treat that patient. Dr. Ness, Senior Director of transfusion at Johns Hopkins, said, "I believe we'd have great interest in using this device at Johns Hopkins and that other transfusion directors at other hospitals would share my enthusiasm." Julie Dillon is our Senior Vice President of Engineering. She was an engineer at Humanetics for 10 years, the largest publicly traded company in the space. Our chairman, Lee Golden, is SVP Chief Medical Officer of PTC Therapeutics, a publicly traded company. Another advisor is Mike Webb, who's a serial entrepreneur. He's CEO of EpiOn Therapeutics, and he has had six successful exits. As for our Scientific Advisory Board, these are truly world-class experts. Maureen Hoffman is one of the three physicians who figured out how blood actually clots. She described the cell-based model of hemostasis. Bruce Peace oversaw $11 million in funding to study injury and transfusion. Candice Marchant, recently retired, served as chair of Laboratory Medicine and Pathology and the section head of Hemostasis and Thrombosis at the Cleveland Clinic. Marc Lipsitz directs the cancer laboratories at NYU. To date, we have raised $6.1 million, and this has funded the development of three generations of devices and cartridges. Our reagents are already GMP quality. We have validation research in five in vitro bleeding disorders. We have a feasibility study of what would be the actual clinical trial that was performed at the Mayo Clinic. It identified the problem the MCTs will solve based on factor levels and their relationship to bleeding. The data does suggest the mixing in the system needs to be improved, and we're raising capital now to build the GMP system, which will solve that. We've met with the FDA in three pre-submission meetings. It will be a de novo 510(k), and seven unique patents have issued. So we're seeking $6 million now to fund GMP system build and validation of that system. We're offering equity and warrant coverage, and we have started some discussions with strategics, but the impression we have is they want to see data from a GMP system. Still, overall for an acquirer, an extra $30 million—these are all the costs—gives them a new platform, new revenue stream. We are projecting revenue over $60 million in year three. But note that's based only on cardiac surgery in the US and the EU, and our cartridge is therapy agnostic, meaning we can individualize therapies in the cartridge for specific coagulopathies. So for example, for postpartum hemorrhage, we would have more of the channels filled with fibrinogen to give a better assessment of whether it's a moderate or severe fibrinogen deficiency. Although an IPO is always possible, acquisition is the most common exit in this space. This is a list of potential acquirers. In summary, our system compares the ability of treatments to stop bleeding. No other system does that—truly automated personalized medicine. And you can see here different indications, different types of surgery, and bleeding disorders for which cartridges could be put on the same device. A second-generation system for platelets and live function is foreseeable, though I expect we will exit before then. Thank you for your time.
