Video Transcription
Shieak Tzeng 00:02
Thank you all for coming. My name is Shieak Tzeng. I'm the co-founder and CEO of Wellumio. It gives me great pleasure to introduce you to the work that we are doing to help physicians better manage neurological emergencies by bringing imaging to the bedside. So neurological emergencies are very common in the US. Around 8% of all ED presentations involve a primary neurological complaint, and of that category, 10% are for serious conditions, of which a suspected stroke is the most common. Now, what makes the management of this patient group challenging for the front-line physician is that the symptoms overlap a number of different conditions, and it can be very challenging differentiating what is causing what purely on the basis of a history or physical exam alone. There are no simple blood tests as yet, and so what we have is neuroimaging. Now, when it comes to neuroimaging, the best modality is an MRI because of its exquisite soft tissue contrast, but most patients will not be offered an urgent MRI because of resource constraints, but also partly because of time constraints. So I'm sure we have all heard of the term "time is brain." This refers to the fact that the benefits of reperfusion therapy diminish rapidly with time. It's why we talk about the stroke golden hour and why clinical guidelines call for urgent imaging and treatment upon arrival at the hospital. Now, over the last 20 years, we have seen significant advancements in stroke systems of care, but despite those innovations, the rate of golden hour therapy is still under 5%, and outside of comprehensive stroke centers, the rate of golden hour therapy can be as low as 1.5%. So yes, we've come a long way, but there's definitely room for improvement. Now, where can we help advance the situation? One place is to look at the diagnostic paradigm. So currently we have a centralized imaging paradigm whereby patients need to be transported physically to radiology. I think it's fair to argue that no matter how close your radiology is to your emergency department, the minute you are having to physically transport a patient, you are wasting valuable time. Once a patient arrives in radiology, they will most commonly receive a non-contrast CT exam because it's accessible, and you can get one done pretty quickly, typically within four minutes. The drawback of a non-contrast CT exam is it doesn't give you the same information that you get with an MRI unless you tag on additional CT sequences. Now, these additional sequences will buy you more information, but at the cost of a longer imaging exam, not a shorter one. In addition, these additional sequences need to be analyzed. They need to be interpreted and read, and each of these steps can introduce delays in the treatment pathway. Now, these delays can be significant if you are in a smaller hospital without the resourcing, and you might be reliant, for example, on a telehealth service. It's not always the case that the person at the end of the phone call knows how to interpret the advanced imaging because it's not currently part of clinical guidelines. So what you have is a situation where even in top-tier centers, the door-to-treatment times are somewhere between 45 to 70 minutes, which is twice as long as if you have a heart attack; the door-to-treatment time for a heart attack is half that time. So our mission at Wellumio is to flip that script: instead of bringing patients to imaging, bring the imaging to the patient and then empower those at the bedside with the tools they need to triage and diagnose patients efficiently. By eliminating unnecessary patient transfers and streamlining the imaging process, we can save 20 minutes off the acute care pathway and increase the rate of golden hour therapy by five to six-fold. Now, at the heart of our solution is a portable imaging system. It weighs 50 kilograms. We've designed it to be used plugged into the wall or powered by batteries. It is self-shielded. There is no liquid helium involved. It is completely silent. So it's a system that's been designed to be used outside conventional imaging radiology suites. Now, portability is very important, but by itself, means absolutely nothing if the imaging takes a long time, and that's the main challenge that we have in low-field imaging; stroke protocols currently can take anywhere from 20 up to 30 minutes to complete. That's far too long if you're interested in acute stroke triage, and that's why we have been very focused on designing high-efficiency pulse sequences that can deliver a stroke panel in four minutes. So AI is an important part of our technology strategy; we use it in adaptive scanning to minimize the scan time, and also in post-processing with tissue classification to help identify lesions. When we talk to physicians, what excites them about our technology solution is that it gives them optionality. There are many time points along the stroke pathway when a physician just wishes they had access to an MRI because of the information it provides, and a classic scenario is an acute DWI scan to positively confirm the presence of an ischemic stroke. The other major advantage is in sick patients; it's logistically very challenging transporting unwell patients on various life support systems around the hospital, so having a simple solution that can be brought to the patient is very attractive. We're targeting the acute, serious neurological presentations market. So these are patients with serious symptoms, suspected of a stroke. It's a 1.1 million per annum caseload. It's a $1.7 billion market in the US alone that can be targeted through emergency rooms, stroke centers, and smaller hospitals in the near term, and in the long term in emergency response vehicles. So we have completed our pre-clinical animal trials showing that our technology can detect hyper-acute stroke within the golden hour with 100% concordance. So that means that the MRI showed a stroke; our system detected the stroke. We are currently completing our human feasibility trials in Australia and planning for our US pivotal trials next year, ahead of regulatory submissions in 2026. Our plan is to do a soft launch in 2027, so future customers will be able to access our technology through traditional capital equipment contracts or through subscription bundles with the option to upgrade those bundles to include teleradiology services and other diagnostic and decision support modules at price points that customers have indicated, or potential customers have indicated, they're willing to pay for such a solution. We estimate that the break-even point is between 10 and 25 scans per week. These are feasible imaging volumes when you consider that clinics are performing in excess of 100 neuroimaging scans per week. Our solution is differentiated in that it is built on a familiar technology platform. So MRI is familiar to clinicians, the contrast mechanisms are very well defined, and this gives us an edge over less familiar platforms as to how we are different from other low-field imaging solutions out in the marketplace. We are not trying to be everything to everyone, so we're not designing a general-purpose imaging system because you have conventional imaging that will do that just fine. What we're trying to do is to be a solution to a problem, and we believe it's a problem where we're going to achieve more by focusing on being less, so having the least amount of footprint complexity and the time you need to spend imaging to get your initial triage results. So the team, this is the team where a group of serial entrepreneurs; we have all built previous companies, some of us have had previous exits. We bring a combination of deep technical as well as commercial experience, and we're supported by industry advisors who are very experienced in the imaging industry. So we have raised our seed round last year and used those resources to build our prototype, complete our conduct our feasibility trial. We've set up a QMS system. We have a regulatory strategy that's been communicated with the US FDA. Currently, we're preparing for our upcoming Series A financing round where we're going to focus on completing product development, our pivotal trials, and our regulatory submissions and approval. So on that note, I want to thank LSI for this opportunity, and to this audience for your time and attention. Thank you. Applause.
