This announcement definitely shows the potential of our tech to...

This announcement definitely shows the potential of our tech to redefine stroke diagnosis at the point of care. With sensitivity of 92% and specificity of 85% for haemorrhage detection, and 85% sensitivity and 78% specificity for ischemia detection, EMView’s performance is highly competitive, especially considering it’s a portable, non-invasive device.

These numbers are impressive when compared to traditional stroke diagnostics. Non-contrast CT, often the first step in acute stroke evaluation, has a sensitivity range of 39-70% for ischemic stroke detection, which can be particularly limited in the critical early hours post-symptom onset. In contrast, EMView’s “clot or not" algorithm achieved 85% sensitivity and 78% specificity in identifying ischemic strokes—numbers that place it well within, and sometimes above, the performance range of CT perfusion scans, which generally show 80-90% sensitivity for acute ischemia. For haemorrhage detection, non-contrast CT sensitivity ranges from 90-100%, while EMView achieved 92% sensitivity, demonstrating a robust ability to detect bleeds in a portable format.

One of the standout achievements in this study is EMView’s ability to detect extremely small haemorrhages that even gold-standard imaging can struggle with. For instance, the device successfully identified a 0.7mL thalamic haemorrhage and a 1.7mL subarachnoid haemorrhage. Such precise detection of micro-bleeds showcases EMView's advanced sensing capabilities and highlights its potential utility in situations where rapid, on-the-spot diagnosis could impact treatment outcomes.

The study involved 307 participants, including 277 acute suspected stroke cases, across multiple major stroke centres. Notably, EMView’s AI-driven algorithms demonstrated steady improvement as more training data was introduced, as shown in the sensitivity and specificity learning curves. This scalability suggests the device’s diagnostic accuracy could continue to enhance as it accumulates more diverse data.

These results set a strong foundation as EMVision heads toward the validation trial, a crucial step toward FDA De Novo clearance and commercialisation. The validation trial is projected to cost around $4 million, funded from cash reserves, and will likely take 6 to 12 months. Given the strong preliminary results, EMVision is well-positioned to make a significant impact in stroke care, where timely and accurate diagnosis is critical. The device’s ability to approach and even rival gold-standard imaging in certain aspects, combined with its portability, could make it a valuable tool in both hospital and remote settings, addressing an urgent global need in stroke diagnostics.