Brain imaging company EMVision Medical Devices has revealed what it called ‘exceptional’ results for its world-first emu scanner to identify stroke and stroke type.
In total 307 participants were enrolled in the EMView trial and scanned with the EMVision emu brain scanner (pictured) at Liverpool Hospital, Royal Melbourne Hospital and the Princess Alexandra Hospital, including 277 suspected stroke patients with 48 haemorrhages and 140 ischemic confirmed strokes.
The study matched EMVision emu brain scans and patient CT/MRI brain scans, utilising ‘blood or not’ and ‘clot or not’ algorithms, with full results to be submitted for publication following peer review.
The study correctly identified Haemorrhage/not Haemorrhage in 85 percent of cases and Ischaemic/not Ischaemic events in 78 percent of cases.
The company’s shares were up 9.24 percent in early trade on the ASX to $1.95.
EMVision’s device utilises microwaves to scan the brain.
EMVision CEO, Scott Kirkland said: “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.”
EMVision is set to move forward with a validation trial, where the company will test the diagnostic capabilities of the portable brain scanner to support FDA De Novo clearance and product commercialisation.
EMVision plans to recruit up to 300 suspected stroke patients across a minimum of three US based centres and two domestic stroke centres.
The validation trial duration is estimated between six and 12 months
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.”
The ASA funded EMVision to develop the brain scanner, along with a separate minaturised CT technology being developed by Micro-X.
Further reading:
EMVision reveals first responder stroke scanner
Micro-X miniature CT scanner to enter clinical trials
Picture: EMVision Medical Devices