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Thilo Hoelscher, BURL Concepts - Portable Ultrasound System | LSI Europe '22

Speakers

Thilo Hoelscher

Thilo Hoelscher

CEO, BURL Concepts
Read Biography
BURL Concepts' SONAS is a portable, battery-powered ultrasound system that enables non-invasive brain perfusion assessment at the point-of-care. SONAS is used in combination with microbubble contrast agents to evaluate unilateral and bi-lateral cerebral perfusion

Transcription

Thilo Hoelscher  0:06  

Thank you very much for the introduction. Ladies and gentlemen, it's my pleasure to introduce you to Sonas as the future EKG or ECG for the brain. Sonas actually say an acronym stands for stroke or not a stroke. Stroke, it's what I would like to talk about for a while is the second common cause of death world. Worldwide, more than 85% of all strokes are so called ischemic strokes caused by a blood clot occluding, an artery providing oxygen to the brain. If that happens, neurons die very fast at a rate of about 1 million brain cells every minute. So once that's taken place, there's no better number supporting the fact that stroke is the most time sensitive disease in medicine we know. So meaning time is brain couldn't be more appropriate. In this case, we have very efficient treatment options such as mechanical thrombectomy. To move up the blood clot from the artery, the only restriction there is that these technologies are only available in specialized centers, and so called Comprehensive Stroke Centers. So the challenges then coming along with stroke care, the early stages, how to recognize stroke symptoms fast enough how to get the patient to a specialist stroke center fast enough, and how to treatment to how to monitor treatment success fast enough, preferably at the bedside. So the four challenges are late diagnosis, stroke is a clinical diagnosis being done in the pre hospital environment. There is no diagnostic tool like an ECG or EKG to to screen patients appropriately, late diagnosis or wrong diagnosis leads often to the admission of the patient to the next Hospital, which might not be a stroke specialized hospital, that actually then leads to the fact that patient might have to be transferred to a comprehensive stroke center, causing treatment delays. And once a treatment is established, there is no bedside monitoring tool available other than the eye of the experienced clinician to say whether this treatment was really successful or not. If not, it's a suspicion is that the patient has to undergo another CT or MRI, to see what the problem of the of the symptom Lalji is so and monitoring tool, like an EKG for my cardio infarction, it's not available for the brain, but it's highly wanted. So what changes with Sonas, so Sonas can be used in the pre hospital environment for early diagnosis as a screening tool. If we use it this way, then we can detect stroke at the earliest time when possible and directly admit this patient to a specialized stroke center where now treatment can be provided. It's in at the proper time and the in time treatment. And we have a device the same device which can be used for early detection now to monitor any kind of changes of the therapy, success at the bedside which is currently not available. So Sonas is a portable battery powered ultrasound device for non invasive, early stock detection and treatment monitoring. The device is easy to use this is very safe, it actually runs on currently on eight double A batteries. And this is currently CE certified as a class A device. The vision we have with Sonas is to provide a point of care medical device for any brain disease not only for stroke, a device it can be used for early diagnostics, treatment, monitoring and prevention. To provide a device that can be used wherever the patient is located, as as mentioned earlier, for example, in the patient's home and on the pre hospital environment, and to provide an affordable easy to use solution to improve Medicare for brain diseases worldwide. Global market for stroke is huge. We've heard that already from my from my colleague earlier, it's a gigantic market which is increasing so the predictions are just for the acute treatment, not the after effects after treatment and not recognition of the symptoms is about $67 billion by 2030. Upon my apologies. So looking at the data the from the World Health Organization, so about 15 million people per year suffer from a stroke 5 million of those die as a consequence of the stroke and about 5 million remain with long term disabilities in Europe. The numbers are increasing 2000 We've had 1.1 victims suffering from a stroke the predictions are 1.5 million for the year 2025, about 650,000 people die of a stroke in Europe and it's a second common cause of disability. In Europe in the United States, the numbers are very comparable. We have about 800,000 people suffering from a first stroke in the United States about 140,000 die. But interestingly enough, about 300,000 additional patients are being diagnosed wrongly because of the false interpretation of the symptoms, because of the lack of a screening tool in the pre hospital environment. Sonas just to introduce the device itself, you see here the prototype version, which is currently in use in eight centers in Germany, the technology it's a non imaging device. It uses ultrasound contrast agents, a signal traces, contrast agents are very well established in the diagnostic world of ultrasound for other purposes. The analytic algorithm is based on kinetic bolus kinetic modeling, which is very similar to perfusion weighted CT or MRI technologies used today. There's stillness test includes obviously the device itself, which and the test kits which have to be used for each and every single individual case very similar to the EKG and the ECG EKG patches. So the razor razor blade principle from a commercial perspective is what we follow the status where we are so the device right now is certified for CE as the class A device we are in the process of the FDA pre submission, which is being scheduled. We are currently in post market surveillance clinical trials. In Germany, in a very well recognized internationally well established centers such as the surety in Berlin, we have IP protection in all for us relevant markets around the globe. The total market traction based on the business model we have created is significant and as you can see as we go along, just here as an example, for the United States, the business model is mainly based on the the the revenue gained through the sell orders the sales of the test kits. The competition, two examples I've mentioned here one is Novartis as a US based company uses blood flow data very similar to transcranial Doppler to assess the blood perfusion. It's FDA cleared and CE certified. The main differences to our device is that this is not battery powered. It does not measure intracranial pressure, which our device provides. It's a much higher cost available and the business model is not based on consumable consumable sales devices system uses impedance phase shift to assess perfusion changes in the brain. It's as well FDA cleared and see certified, battery powered but does not measure ICP as well. So just to reference, one of the quotes of one of the key opinion leaders we're working with Sonas is the first and only non CT MRI stock screening assessment tool to instantly evaluate both perfusion imbalances of the brain and intracranial pressure. With a single test the tests can be run in virtually any location and requires no patient transfer, thereby minimizing exposure risk. The milestones are we on the pre launch phase by the end of 2023, we see our need to launch the device in Europe. We then move on with the FDA approval to the US market and then from the global market. But the ultimate goal is to provide an affordable easy to use solution to improve Medicare for brain diseases worldwide. Our management team is is sophisticated in various phases, such as private equity or key opinion leaders in ultrasound advisory board is established as well, pretty eloquently on the medical side as well as on the as well as on the technical side. What we're looking for as a strategic partnership, to help us to accelerate the current efforts towards product launch and successful commercialize the Sonas device. The product launch will be in Europe, first in the United States and globally and we are looking for a partnership to make this happen in a successful fashion. So thank you very much for your attention and happy to take questions for the outside. Thank you very much.

 

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