EMVision Medical Devices (ASX:EMV) has announced positive results for its neurodiagnostic technology to identify stroke and stroke types.
In total, 307 participants were enrolled in the EMView trial and successfully scanned with the EMVision emu brain scanner across Liverpool Hospital, Royal Melbourne Hospital and Princess Alexandra Hospital. This included 277 suspected stroke patients with 48 haemorrhages and 140 confirmed ischemic strokes.
The company said the study’s primary objective of collecting matched EMVision emu and CT/MRI ground-truth brain scans to advance the device’s AI-based diagnostic ‘blood or not’ and ‘clot or not’ algorithms was achieved.
It said the results of the ‘EMView’ multi-site study with the point-of-care emu brain scanner will be submitted for publication following peer review.
Over 240 participants’ scan data was used to train the AI algorithms. This enabled the algorithm to learn patterns and features associated with a normal versus abnormal brain, including hyperacute, acute, subacute and chronic ischaemic and haemorrhagic stroke. The training set was diverse across demographics, stroke sizes and locations, and time from onset to enhance the model's generalisability.
The neurodiagnostic AI algorithms were then applied to an isolated test dataset not used in the training.
The company said this prevented the model from 'learning' any patterns from the test data, ensuring the assessment provided a real-world evaluation with unseen cases, albeit on a smaller sample size, before definitive sensitivity/specificity confirmation in the upcoming validation trial.
EMVision said the promising study result allows it to proceed with the validation trial, as planned, where the diagnostic performance of the portable brain scanner will be definitively demonstrated to support an FDA De Novo clearance. EMVision has site visits scheduled this month with its prospective US investigational sites.
Co-chairs of the Australian Stroke Alliance Professors Geoffrey Donnan and Stephen Davis, said, "The results are very encouraging, particularly as related to detection capabilities and sensitivity to small haemorrhages. We look forward to confirmation of this impressive neurodiagnostic capability in the validation trial."
EMVision CEO, Scott Kirkland, added, “There is a huge unmet need for stroke and stroke type diagnosis at the point-of-care. We can fill that need. We are very proud of these results which highlight our technology’s unique neurodiagnostic capabilities. We remain focused on progressing and executing our clinical validation and commercialisation strategy as we look to revolutionise stroke diagnosis and make a substantial positive impact on one of the major causes of global disability.”