Brain imaging technology company EMVision Medical Devices has moved to its second phase of human testing of its innovative portable brain scanner.
The company’s first generation scanner, which uses microwave imaging techniques to detect strokes at an early stage, previously successfully completed a stage 1 trial with 30 healthy volunteers.
The scanner is aimed for bedside use in emergency departments and other clinical settings, and is being developed in parallel with a second-generation version being designed for first responders under an $8 million R&D contract with the Australian Stroke Alliance.
The Stage 2 trial will enrol up to 150 acute stroke and ‘stroke mimic’ patients presenting to the emergency departments of major hospitals, including Liverpool, Royal Melbourne and Princess Alexandra hospitals.
The sites were selected because of their stroke patient population and research teams to support the trials.
EMVision CEO Dr Ron Weinberger said: “We have now achieved the critical and noteworthy phase of acquiring data from suspected stroke patients in the acute setting.
“Significant preparation and positive collaboration between the EMVision team and hospital staff has been underway to ensure the next phase of our multi-site clinical trials is set up for success.
“…We have taken the technical and usability information from Stage 1 and refined our device for Stage 2, and although modifications are not major, they will result in significant improvements in performance.”
Once Stage 2 is completed further stages may be required taking six to nine months.
EMVision has a target of achieving regulatory approvals and market entry in FY25.
In October EMVision was awarded $5 million under the Modern Manufacturing Initiative Medical products Manufacturing Translation steam to help establish commercial production of its first generation scanner.
Government grants EMVision funding for brain scanner
Browse @AuManufacturing’s covefrage of EMVision Medical devices here.
Picture: Australian Stroke Alliance/EMVision’s portable scanner and a traditional CT scanner compared