Sonna Patel-Raman Presents NuPulseCV at LSI USA '23

Transcription

Sonna Patel-Raman  0:05  

Thank you. So I have made calls from this phone. And looking at the audience, maybe a few of you have made calls from this phone. But like any technology, it's time for an evolution counterpulsation for heart failure has been around for more than 70 years. And it is the most commonly used device in the United States to support patients with heart failure. But it's only used 50,000 times a year in the US 50,000 times, we can do better. New pulses developed a device that can expand the market from 50,000 to 430,000. The NuPulse device is an implantable percutaneous counterpulsation device that is implanted through the shoulder. The device rests in the descending aorta, and is connected to a drive unit that inflates and deflates the pump, which is wirelessly connected to a tablet that allows you to remotely control and monitor the system. The NuPulse device is specifically designed for axillary implant or placed in the shoulder. It allows patients to get up and walk around or ambulate and it is for short and long term use and therefore allows patients to get discharged from the hospital. This device solves a global problem. In the US alone, we spend $9.3 billion on heart failure 50% of patients who receive a diagnosis five years from that diagnosis will that 50% will die. Our device allows the pump to be off at times, which means you avoid issues associated with device thrombosis device migration, and it eliminates the need for nuisance alarms. We also preserve the hearts natural pulse utility. The system overcomes the current limitations of products that are currently on the market including balloon pumps, and current drug therapies. Balloon pumps right now which offer counterpulsation are only available in the hospital. These pumps cannot be paused because you're worried about device thrombosis. Patients can't walk around because the pump is implanted in the leg, which means patients have to stay in the hospital. And current drug therapy has known side effects. So what does Nu mean? Nu is being able to carry the device the size of a lunchbox on your shoulder. It means getting up and walking around. It eliminates this large console that's used in the hospital. And the need for a very specialized staff to be able to use it. Nu is being able to leave the hospital to go home and play your guitar. It's seeing the sunshine for the first time in three months. And it's being able to go home and mow your own lawn. Even though for some of you that may not be that fun ambulation and discharge from the hospital for heart failure heart failure patients we know improves outcomes. NuPulse is a derisk company in a number of ways with a proven ability to execute. We've executed a successful regulatory, clinical and reimbursement strategy. We've received AFS approval or early feasibility trial approval from the FDA. We also have pivotal trial approval, and we've executed a reimbursement strategy that has resulted in 2 million in pre commercial revenue as a result of the trial. Based on our 430 patient TAM, we have access to revenue potential of $15 billion. We've designed a device that fulfills a gap right now. And it is intended for short and long term use. We can implant this device in the cath lab or in a hybrid OR operating room. It can be used by an interventional cardiologist or a CT surgeon which allows us to have a footprint in both the cath lab and the OR. We've completed an 81 patient trial across 17 sites, demonstrating an ability for clinicians to adopt this technology. Our patients were walking immediately after the procedure. Across our 81 patients, we had almost 20 years of patient support. 34 of our patients were discharged from the hospital. And we demonstrated a positive benefit risk profile with zero device thrombosis, zero thromboembolic events no major complications such as bleeding, infection, and limb ischemia. As a result of conducting this clinical trial, we actually learned something really important. Beyond the patient population we studied for this trial, we could expand the indication to a second patient population. So the first trial was focused on long term use patients had the device for months to years we had a range of four to 504 days, making NuPulse, a company with the largest experience of long term counterpulsation. Our device was used to bridge patients to transplant, bridge them to a decision to recovery and in fact, keep it longer if that's what they needed. Because it's a long term system that is a class three PMA device. Our second system, which allows us to expand the market is the device that's implanted in the cath lab. This is the percutaneous device that can be used for days to weeks. It is specifically for an acute on chronic heart failure patient population, also known as acute decompensated, heart failure. This is not the acute myocardial infarction patient, or crash and burn or sudden heart attack. And the reason that's important is because there is no device that's indicated for acute on chronic heart failure patients. With FDA agreement, which was a long and lengthy process, we were able to get FDA to agree that this device will be a class to de novo. So in order to focus on the fastest path to commercialization for our class II de novo device, we're going to execute a small clinical trial in 2024. And we will commercialize your device in 2025. Our second system, which is the long term system will follow with a clinical trial in 2025. And then we'll commercialize that device in 2026. If we assume only 10% of our revenue potential, our TAM, we have access to 1.5 billion in revenue. And that is a calculation that results from an existing pricing strategy that we already executed in our clinical trial. So we've already proven that sites will pay for our device, they can get reimbursed based on a pricing strategy. We're currently looking for a lead investor we're raising 40 million which will take us through to commercialization. We're very grateful for the support of our current investors. We have a management team with almost 100 years of combined cardiovascular Circulatory Support experience with expertise in product development, Clinical Affairs, r&d, and my own experience at the FDA having eight years in Circulatory Support and structural heart. We're also grateful for the support of our key opinion leaders across leading institutions. Beth Israel Deaconess and Harvard, University of Minnesota and Duke University. NuPulse is a de risk company with a proven ability to execute on several fronts. Like the untethered wall phone, also known as a cell phone that some of you are probably looking at right now. We have greatly expanded the market for our patients to have access to a device that lets them get out of the hospital, untethered, walk around, go to a ball game, mow their own lawn, and get the clinical support that they need for their heart, wherever they choose to get it. We have significantly de risked this company and the team is located in Raleigh, North Carolina. We have 26 full time employees. We're excited to be on this journey, and proud of our success. But perhaps our visit biggest success lies in the outcomes of the patients who have actually received our device. Tom here who plays the guitar at home was ultimately transplanted. Rob also ultimately transplanted and went on to write a best selling book about his experience. And John was one of our patients who recovered. I'm really looking forward to talking to potential investors about our journey. Thank you