Thilo Hoelscher, BURL Concepts - Portable Battery-Powered Ultrasound System | LSI USA '24

Thilo Hoelscher  0:00  
Jeff, yeah. Thank you very much, Jeff for the introduction. Dear ladies and gentlemen, it's my pleasure to introduce you to Sonas. Sonas, just starting with pure technical information, is a portable, non invasive, battery powered ultrasound device. This is how it works. You have a headset with two transducers, each on one side, they transmit and receive in a ping pong fashion. Once that's done, we inject in the peripheral vein an ultrasound contrast agent, so called micro bubbles. These micro bubbles oscillate. Once they hit B with the ultrasound wave, they start to oscillate. This oscillation creates so called harmonic frequencies, which we specifically filter out based on this response. We then create bolus kinetic curves, like you see in the in the in the middle pictures. And based on this bolus kinetic curves, we then separately. We separate both hemisphere from each other in each hemisphere, we cut in half again to to to display the MCA and the ACA supply area, mainly so a technology which is very much from its basic concept, comparable to perfusion with its CTO and MRI, based on the information we are then able to assess in each of this quarter fears the perfusion we create, We generate an ICP index and the resistance index. The principle is just a razor and the razor blades. So you see here the operating unit, which is connected to the headset I've introduced you to carrying the two transducers. That's a stationary unit. For each test you need a consumable package. We've developed a specific gel pad which you need to improve the coupling between the transducer and in the head. So that's how it's how it's being set up. Once we are gone, approaching the market, we envision, you know, a purchase per purchase model or a leasing model for for all the components. Device carries wireless and Bluetooth and runs currently on eight double A batteries. So the device itself is very easy to use. You read the manual once, and you know how to run the device. The only skill you need is to place an IV line to inject the micro bubbles. It follows the same technology like perfusion with its CT and MRI, but it's not competitive to these technologies, it's actually augmenting the clinical information you have and improve your decision making process, very similar to a 12 fleet EKG. That's how I would like to compare it with. Because of its portability and battery power, it can be used literally everywhere, including the prehospital scenario or very rural areas. These are the applications where device is being used right now for perfusion screening, this mainly in stroke patients to make a decision whether CT or MRI is needed or not. We use it for post treatment monitoring, especially in mechanical thrombectomy patients, to see once a patient improves, gets worse, the patient right now needs to be carried back to the CTO and MRI scan scanner to see if there's a re occlusion or hemorrhage happening. Now, you do a sonar test at the bedside by the nurse to assess whether the perfusion has changed or not, and then you make a decision based upon that. We use it on the NICU neurointensive care unit for vasospace and monitoring here, specifically in patients suffering from subragnal hemorrhage or intracranial hemorrhages, and based on that decision, neumitan being given to counteract the vasospasta, and it's being used for ICP monitoring here, specifically in patients suffering from traumatic brain injury. So what we hope to see on the long term is that this device could become the standard of care for brain monitoring in general. So where are we today? So we have successfully finished our clinical safety trial in human sorry, in health volunteers. We have performed an early phase two trial in stroke patients, showing a sensitivity of 93% to detect strokes. That's all in relation to the standard reference methods perfusion, whether it's CT or MRI, we have clinical data about 350, to 400 datasets today. This is all referring to our post market surveillance clinical trial we run in Germany. We're working with seven highly prestigious centers in Germany, such as a charity in Berlin, and collecting these data. Since this different patient population I've alluded to, we've advanced the technology way beyond stroke, so now, accurately, any brain pathology which might impact the perfusion is actually a target for our device for diagnostic or monitoring. We have, oh, I'm sorry, I just forgot to show mentioned that we have CE mark, minor detail we've transferred very recently to MDR. So it's a class two A device. The consumables are a class one device. But we are now officially MDR certified. We have established a contract manufacturing that's located in Germany right now. Currently, the first device. Being built to promote and to support our, mainly our clinical trial work, which is coming up. We have recently engaged in a clinical strategic partnership with Braco. Braco is a global leader of contrast imaging, the number one manufacturer of contrast agents. So their product will be part of our consumable package, and they will join us in the FDA filing. And we have established very prestigious clinical partnerships with all the key opinion leaders necessary or known in the newer intervention of fields, such as the University in Buffalo Mount Sinai, New York, and the Northwell healthcare group as well as UCSD. So just one application, would just point to you very briefly, stroke. Why are we dealing with stroke? Stroke is the second common cause of death, and there's a lot of work which has not been done in stroke, one of them being early detection. So we have very efficient therapeutic approaches like mechanical thrombectomy, but only three, less than 3% of all patients who are eligible for this kind of treatment. Actually do receive the treatment. Why is that the case? Number one, diagnosis is too late. Symptoms are not being recognized early enough. And the transfer rate from a rural hospital or acute hospital to a comprehensive stroke center where this treatment can be provided is insufficient. The rate in the United States, about 30 or 40% which have to be transferred. And that is comes with costs. So with our device, and I would like you to think about an analogy of the 12 feet EKG, because I think it's a perfect match. You can do the diagnosis much quicker, because now you have a device which confirms, so this confirms your clinical assessment by that they transfer to a comprehensive stroke center. If you are not a comprehensive stroke that's much quicker. And with that, treatment, especially mechanical thrombectomy, which is the gold standard in ischemic stroke, treatment, can be applied way earlier. So with you utilizing sonar, small stroke patients eligible especially for mechanical thrombectomy, will receive optimal treatment. The second major impact we see our device will have is in the bedside monitoring. So assuming you have a patient who received a mechanothrombectomy improves significantly. About symptoms. Next day, patient wakes up, it's not responsive. You don't know what's going on, what you have to do today is to carry the patient again to a CTO MRI scanner do another scan to see if there's a re occlusion of the vessel or bleed. Now you have the sonar system you can be used by the nurse, again, equivalent to an EKG at the bedside to see if the perfusion has changed or not. If it has not changed, the change in symptoms is not due to a re occlusion or bleed, but for example, for due to a medication or urinary infection, whatever that might be. So that's an optimization of the diagnostic usage today, so that alone will save a lot of costs, manpower and risk to the patient. So where are we on the clinical side. Again, as I've mentioned earlier, we have about 400 patients studied today. We have done safety trials. We've done our feasibility trial. We're now doing the efficacy trial in Germany. The big next step for us, and that's why I'm here standing in front of you, is our clinical trial with the FDA. So we have agreed with the FDA on the clinical trial strategy. We submit our IDE application by the end of the month, and if everything works out, as we would like to see it, we can start with the clinical trial by the end of this year. So if this might have caught your interest, what we're looking at is a round of about 15 million to support the clinical work here in the United States and to get prepared for commercialization in the United States, and this brings me to the end of the presentation. Thank you very much for your attention.