John Simmons, CoolSpine - Cerebral Spinal Fluid Cooling System | LSI Europe '22

Transcription

John Simmons  0:02  

Hi, how are you? Thank you for showing up here. I'm here to talk to you about two products we've developed induce localized hyperthermia to provide neuro protection against spinal and cerebral ischemic injury. Our background is we were spun out of Yale University. And through three NSF grants and a collaboration with a public medical device company, we've developed two catheters and intrathecal cooling catheter for the spine, and a ventricular cooling catheter for the brain. What we do uniquely is we cool the cerebral spinal fluid, which in turn, reduces the temperature of the adjacent tissues and organs to levels known to be neuro protective. The the significant clinical benefit is that we're cooling locally into the targeted areas that are injured, and we're maintaining systemic normothermia. And this benefit will hopefully reduce the complications that systemic hypothermia causes such as shivering, chronic shivering, tachycardia and the other aspects that have challenged the adoption of systemic hypothermia. We have two issued IP and we have two or three others in the pipeline. Taking a note from Antoine point last night, one of his presentations, we'll talk about our team. I started way back I think before after, Manny and probably not as successful as Manny, but I'm trying hard, and I started with Procter and Gamble in their surgical drape and gown division. I then went on to grad school and then went to Becton Dickinson for many years in diabetes care, and both here in Europe and in the United States. Then went to a early stage startup in J&J. And then I've done two startups one being Dex calm the implantable glucose sensor, which was in series A and B, and Medic, a small company called medical instil, in which we sold to Glaxo. My partner from Yale John Elif Curiosities, is the former chief of cardiac thoracic surgery and a world thought leader in cardiac surgery. He's also probably got has the most clinical experience in deep hypothermic arrest using hypothermia for aortic arch surgery. So he's a real he knows quite a lot about hypothermia. My other partner is Dr. Rohit Khanna, he's down in Florida, in Daytona Beach, and he's a significant serial inventor and a big help on mutant helping us move this project forward. Neural protection is a significant unmet need. If you think about it, what you wonder why, why hasn't there been more success in neuro protection TPA seems to be about it. Well, not much is done because as you know, the brain is complex and so is the spine. Our first target is aortic aneurysm repair for spinal surgery, which in the thoracic area has a para Palooza rate of 12. Pretend to 12% in open repair, and four to six in endovascular. It's still significant and it's one of the most devastating complications not only that a patient can have, but also the surgical team and the hospital. It's a nightmare. I think most of you understand the brain injury area probably stroke, TBI subarachnoid hemorrhage, and what we do is we place the lat well, I'll get into that in a second. Then the last opportunity is spinal trauma for spinal cord injury. I mentioned this a little bit. It's devastating to the patient. It's devastating to the physician and the costs of societies to these cerebral and spinal cord injuries are significant. Neuro protection in the United States alone represents a 250,000 procedure volume a year so you could double that for worldwide representing over a billion dollar opportunity. These are our products. We've developed them and prototype and use them in 24 animal studies. The top is the brain cooling catheter. And what it's very simple. We have three lumens in the catheter through which cold saline is circulated in a closed loop. This reduces the temperature of the CSF to neuroprotective levels. The third lumen acts as a ventricular or spinal drain. So this means which if you think about a spinal drain or a cerebral brain is used in every procedure, when you're talking about spine injury, or neuro or brain injury, so it's a common Practice, they're placed for an example in brain at the bedside table. So our products have the opportunity to provide additional protective modalities to a doctor without an incremental procedure, because they would be putting in the drainage cache of the catheters anyway. So the top is the brain, it goes into the lateral ventricle. The bottom is intrathecal, which goes just like an epidural in obstetrics, and then we have a pump and controller which controls the flow rate and the monitoring of the temperature. So how do I know this will be exciting. So my partner took this to the society of thoracic surgeons, and showed it in a mock Shark Tank. And the five thought leaders who were running the Shark Tank gave it the highest rating, and equally as important of the 500 attending thoracic surgeons 73% gave it a thumbs up and they all wanted to go in just like AOC said the other day in the previous presentation, it was a wow, wow. Wow. So I think the clinical need is recognized by the clinicians, they don't have the tools to provide neuro protection. This is an old school, perhaps type of product, but it's addressing a significant unmet need. As I said, we're placed in an abnormally wet in a normal way, the intrathecal catheter is placed like an abstract obstetrics catheter in the spinal cord area. And the brain catheter is placed through a burr hole in the into the lateral ventricle. This is some of our data from and I'll show you a little bit more from our animal trials on the left you see our spinal cooling catheter performing in this is one of our early experiments, we were able to drop the temperature of the targeted area of the spine down to as low as 29 degrees C. If you think about it, there's a flow dynamics here we have a circulating fluid, and we can kind of tweak the process. By increasing the flow rate and drop temperatures even lower. The top line represents the normal thermia that basically during these procedures normothermia was maintained. The one on the right is our brain cooling catheter, these are five sheep, again, we were able to drop the temperature very rapidly to the targeted tissues around the lateral ventricle, and then bring it back fairly rapidly to normal normal levels. So we've done 26 sheep studies for both spine and forebrain. And all of them we achieved efficacy and our ability to cool the temperatures down to the neuroprotective levels. And we did survival studies with the animals to 30 days in some cases, and then 48 hours in the other to demonstrate that there was no neurological damage caused by the procedure. This is our brain cooling. And when we first did this, I had the assumption that you can see the whole areas of the brain that's a thermal map, and seeing how we're reaching levels of significant cooling. When we first did this, I thought perhaps we would only be cooling certain areas of the brain circuit to targeted areas of the brain. But when we did when we did the mapping, we showed that we were able to get virtually all of the brain by the placement of one catheter on one side of the brain. So it was beyond our expectations. So we're looking to raise $2.5 million. We've had three sub q pre sub q meetings with FDA and what we will be doing is a last GMP study and then taking that data and giving it to putting it in the IDE for first inpatient study, attend patient safety study. So thank you very much.