Ofer Halbreich Presents CardiaCare at LSI Europe '23

Transcription

Ofer Halbreich  0:05  
Hello everyone. At CardiaCare, our mission is to disrupt the standard of care for atrial fibrillation by introducing a new therapeutic alternative, a wearable that can non invasively. Treat and monitor adults ablation. Some high level data on natural fibrillation. Atrial fibrillation is the most common cardiac arrhythmia, with 10s of millions of patients globally, and with 1.5 newly diagnosed patients every year in the US and the US alone. It is a progressive disorder that leads to significantly higher risk for morbidity and mortality, including fivefold risk for stroke. It also creates a huge economic burden, estimated and $10 billion in the US alone in terms of standard of care style of clinics, limited use of medications that have limited efficacy, and lead to significant adverse events. And you have procedures that include cardioversion, that restores your heart rhythm to sinus but has 80% failure rates after one year of ablation that has 50% failure rates after five years. On top of that, patient's quality of life is jeopardized and the school due to additional hospitalizations, visits to the clinics, and various symptoms that they experience including palpitations, dizziness, chest pains. At CardiaCare, we developed the device that you see here, I worked on my hand, that's the world's first wearable for all in one treat and monitoring capabilities for other atrial fibrillation. That device has a non invasive drug free, non invasive stimulation based treatment capabilities. It also has monitoring capabilities with AI based algorithms to identify precursors of arrhythmia. And the therapeutic approach is a closed loop approach, whereby we leverage monitoring data in order to personalize and optimize treatment. In addition to that, as a digital therapeutic, it allows real full remote management of atrial fibrillation patients, including monitoring compliance of patients to treatment regimen. In terms of treatment burden, it is light. Patients are expected to treat themselves between two to three times a week for between 20 to 40 minute sessions. The mechanism of action is well established, we stimulate the media nerve, which is which is an equivalent of the vagus nerve stimulation. We have completed the first in human study targeting post cardioversion patients that received our device for eight weeks of at home treatment. We have successfully reached the primary endpoints of the study demonstrating safety, there were no significant adverse events and demonstrating usability. We had more than 90% compliance for both treatment and monitoring. In addition to that, we demonstrated initial clinical efficacy, demonstrating 50% reduction in AF recurrence, 60% reduction in atrial fibrillation precursors PHCS, premature atrial complexes, and in addition to that, we were able to demonstrate the acute and cumulative effect of our treatments. Our clinical plan moving forward is based on a 510K de novo pathway, we have two initial indications that we will target. The first indication targets the earlier atrial fibrillation patients Dipolog SysML patients, where we will demonstrate the ability to reduce AF burden for these patients. We have two currently ongoing recruiting studies. Both of them are multicenter, double blind, Sham controlled studies for a total of 120 patients. It is important to know that these studies already incorporate the ability to adjust treatment based on the monitoring capabilities. We have an algorithm that indicates to the PI or the EP Well, potential arrhythmia is detected. The PI or the electrophysiologist gets a message with an ECG report and can then decide whether the risk requirements for treatment adjustment in the future Our vision is to have an auto detect or treat device at full closed loop. We have an additional indication that we will pursue we are currently finalizing the protocol for the study that is expected to be US based led by one of the world's renowned electrophysiologist Dr. Vivek Reddy from Mount Sinai. CardiaCare he has a strong IP portfolio that encompasses various aspects of the device that allow eventually having a device that is expected to be worn 24/7 and provide both treatments and monitoring. This IP includes unique stimulation location Unique stimulation parameters, unique engineering aspects and additional aspects that relate to the closed loop approach to the integration between monitoring and treatment. We have three patent families two of them are already granted in the US and other territories. And we have undergone external FTO analysis that provided very positive feedback. Our commercial model is based on two revenue streams. One revenue stream assumes or is based on device sales that is based on a DME benefit category reimbursement pathway in the US. And we expect ASP of $3,800 in light of recent CMS decisions that will require unique CPT codes. The second revenue stream is a monthly recurring revenue stream based on remote patient monitoring and get that can rely on existing CPT codes. It is important to note that less than a year ago, we engage with Dr. Reddys laboratories and multinational pharmaceutical company traded in New York Stock Exchange headquartered in India. And as part of this agreement, we expect first commercial revenue by the end of 2024. In terms of TAM and SAM, obviously, we are targeting the most common cardiac arrhythmia, so the potential market is huge. For the first indication, AF burden reduction in folks in with patients, we already target 40% of the AF patient population. With the expectation that population for the initial indication, we reach 12 million patients by 2030. Our value proposition for payers is cost reduction, or cost savings of more than $5,000 per patient, per year, on average. And for electrophysiologist or cardiologist, the value proposition is based on generating revenue stream from remote patient monitoring. We have a strong experienced leadership team with 10s of years of experience, including leading commercial and clinical cables from the US from Europe and from Israel. And finally, we've recently completed an oversubscribed seed seed extension round that was led by USBC, and including investment from leaders from both the commercial and clinical domain. We are currently initiating the a round fundraising, targeting $15 million, one five, we can live with key deliverables that include completion of pivotal studies for the two indications that I mentioned, filing for FDA clearance for these indications, cleaning our ECG module based on a 510 K pathway, having a first generation commercial product ready for manufacturing and for scalability. And in addition to that having infrastructure for us commercialization that's CardiaCare unique novel non invasive therapeutic and monitoring device. We'll be happy if any of you would like to join our journey. Please feel free to reach out to me either during the conference or afterwards. Thank you