EMVision Medical Devices (EMV) Investor presentation summary

Device and technology

• Investigational, portable in-hospital brain scanner weighing ~220 lbs; uses non-ionizing radio waves at 500–2000 MHz.

• Measures dielectric-property contrasts in tissue; AI analyzes scan characteristics to classify hemorrhage, ischemia, or healthy tissue.

Preliminary performance testing

• Earlier Australian EMView study enrolled 307 participants, including 277 suspected strokes; ~75% of data was used for training and ~25% for unseen testing.

• Hemorrhage detection: 92% sensitivity (95% CI 66.1%–98.2%) and 85% specificity (95% CI 73.8%–92.4%); test set included 13 hemorrhage and 55 non-hemorrhage cases.

• Ischemia detection: 95% sensitivity (95% CI 75.1%–99.9%) and 80% specificity (95% CI 66.3%–90.0%); test set included 20 ischemic and 50 non-ischemic cases.

• Case examples included successful detection of a 0.7 mL left thalamic hemorrhage and a 0.10 mL left M2 ischemic lesion.

Prospective study and workflow

• Multicenter, prospective, consecutive, paired-diagnosis study targets ~300 acute suspected stroke patients scanned within 24 hours of symptom onset and before treatment.

• Study objective is to demonstrate sensitivity and specificity >80%; workflow integrates the scanner into emergency code stroke assessment and imaging.

• Sites include academic centers in the US and Australia, with additional academic centers onboarding.

• Scan opportunities include during stroke-team assessment or while awaiting CT; each scan takes <10 minutes.