Firas Al-Ali, Cygnus Medical - Fully Integrated Manifold/Hemostatic Valve | LSI USA '24

Firas Al-Ali  0:04  
First of all I like to say thank you LSI for organizing such a wonderful meeting. And for us already the founder of Cygnus, I've been a exclusively neuro interventional as for the last 24 years, that many cases in early 2020 to a closets 10,000 patient mark in my small sub niche special sub specialty, this is a significant number published many papers including books, and I have six patents. Five of them is centered on sickness sickness is a product of the last quarter century of my life working in endovascular of space. So what is zero interventionist is very much similar to cardiac interventional is where they work inside the coronary arteries. Neuro interventional is work in a sort of spinal, cervical and intracranial circulation, not dissimilar from the body interventional is working in the pulmonary abdominal and lower extremity arteries. What all the subspecialty have in common is the need for arterial access to be able to perform the endovascular work. And usually we obtain it from a peripheral artery such as a femoral artery in the groin and the radial artery in the wrist. Invariably, the operator will introduce a large port catheter, it will act like a platform to send the micro wire micro catheter, and they will hook it to a hemostatic valve. You see example in the left side of the slide to stop back lead and flush the guiding catheter. If the operator deems blood pressure is needed measurement, they will add a pressure sensor in the side of the table hooked to a separate pour with a saline flush. Here where they divert a neuro and a peripheral, we start to arterial line one to perform the procedure and the other one is to attach to this pole to this pressure sensor in the pole. So the patient ended up was to arterial access and coronary they use only one arterial axis but they hooked that pressure sensor the hemostatic valve to a manifold, as you see in the diagram in the middle of the guiding catheter hook to many to hemostatic valve. And then to manifold, there's multiple ports, one of them will be attached to this pressure sensor in the right side of the slide and allow only intermitted blood pressure measurement not continuous here. So what are the challenges here? There are actually two significant challenges one, these hemostatic valves did not turn out to be as good as we thought once the recent literature in the last 10 years show that 1/3 of this patient to undergo coronary intervention will lose 10 to eight around 8% of their blood while 1.3 of people who undergo coronary intervention and 4% of the patients who undergo body intervention lose a quarter of their blood. During intervention. There's a big elephant in the room. Nobody talks about as you imagine when you lose one quarter of your blood on one procedure and lasting an hour or two significant clinical complications occur increase that mortality rate increase complication rate and increase readmission rate. So each readmission will cost anything between 10 to 17,000. Depends a paper you read if you know there's 8.2 million cases. In United States in 2023 alone, you can see the astronomical number of the cost just by readmission. The other shortcoming is actually the arterial blood pressure is there you have to have two arterial access and that's increased risk to the patient and increased cost to the hospital. And there is most most importantly increase time there's almost 10 to 12 minutes time lapse to insert as our as our catheter in many circumstances especially in emergency time, this is prohibitive. So he comes to sickness sickness is the word first very compacted, divides that allow the father decrease blood pressure to almost zero thanks to a well developed, recently developed and patented signals valve at the proximal end of the device and allow continuous blood pressure measurement throughout the procedure. Thanks to integrating a pressure sensor Cygnus is even more than that it has a air leak valve that allow to have a system which is air free at all time and a three way stopcock that allows the injection of our materials to replace that cumbersome Hemus manifold I just showed you. So we think flying this device is a sickness device into the industry it will be easy in the in the neuro and peripheral group. I call him the early adopter, there is no alternative but to start arterial line with the cost with the rest of the patient cost to the hospital, etc. Within this group, there is an immediate there is a smaller group I call the immediate group those are the physician who are dealing with emergencies that there is no substitute to it. We cannot even have time to put activity line like thrombectomy for ischemic strokes something I do every night and they call there and nobody will give you 1015 minutes just to start theory line time is brain. I just came from the International Stroke Conference four weeks ago we had half day about the importance of arterial blood pressure measurement immediately before during and after thrombectomy and we all agree that it is a problem. And I think sickness is a solution. After Josephy calculate this immediately then we presume 15% penetration rate it will mount almost $40 million gross sale in a year and a 95% gross margin. We aim pricing between 750 to $1,000 per average average sale price since it it will still be extremely cost efficient for the system. So this slideshow our plan the timeline for planning execution, we are trying to adopt a very capital and time. Efficient and staged system our aiming is to first get this device market ready by having the FDA in the second quarter of 2024 would like to rise raise 1.5 million to make it FDA submission at the third quarter of 2025. We expect to have the FDA since we think is going to be straightforward. First quarter 2025 We like to raise a Series A for 5 million to have the commercial loss and then 20 the second q 2026. We would like to have the global loss since the starting in for fourth quarter 2025 the regional law launch in the United States. The device is very well protected has a five total pattern to the regulatory adviser. Thing is going to be straightforward path through the FDA was a 510 K pathway has multiple predicate devices and proven equivalency. Also we have a very strong and illustrious advisory board Mr. Cullen and Dr. Fishel both are serial MiTek founders, Mr. Christian been a medical engineer for the last 40 years have 46 patents under his name. Dr. Hedrick is a renowned interventional cardiologist and Cleveland Clinic and Mr. Bound is our marketing advisor. In closing, we think the time is now to launch the Cygnus there are multiple procedure with unmet clinical needs that now start to get into the medical literature that we need these informations. Sickness does reduce blood loss to almost zero, increase safety to the patient and is very well protected. The total market is 6 billion in the United States more than 12 million in the world we have at least for this immediate need and immediate sales we think for 14 million. We are looking for a investor to join us as a lead investor. Going to be very exciting journey to change the angel suites flow, make the procedure safer to the patients simpler to the operating team and more cost efficient to the hospital. Thank you very much