EMVision Medical Devices Limited (ASX:EMV) has received Human Research Ethics Committee (HREC) approval for its multi-centre clinical study which will take place at Liverpool Hospital, Royal Melbourne and the Princess Alexandra Hospital, Brisbane.
Ethics approval is confirmation that EMVision has completed the necessary safety testing required to commence its multi-centre clinical trial in Australia.
Activation of the first site, Liverpool Hospital, under the direction of principal investigator, Dr Dennis Cortado, will proceed in the near-term following delivery of commissioned units and governance “green light” letter receipt.
The clinical study follows EMVision’s prior successful pilot study with 50 patients, which demonstrated encouraging capability to accurately classify and localise stroke types. The upcoming clinical trial consists of two phases.
The primary aim of the initial pre-validation phase is to verify hardware and safety and to provide acute stroke/stroke mimic data for AI algorithms. The subsequent validation phase aims to confirm sensitivity and specificity (efficacy).
Completion of both stages is expected to generate the prerequisite data for EMVision’s first regulatory approvals. The “Clinical Investigations Roadmap” diagram below provides a summary of the clinical trial.
In addition, a further $1.2 million in milestone grant payments have been activated pursuant to the partnership with the Australian Stroke Alliance (ASA) to develop mobile diagnostic imaging for road and air ambulances, “Algorithm validation studies – Planning commenced and in progress” and “Ethics clearance received for algorithm validation / multi-site clinical study”.
The company has submitted invoices and supporting documentation as required in relation to these milestones to the ASA for review and payment.
This is a significant milestone for EMVision on the journey to commercialise our first-generation product,” CEO, Dr Ron Weinberger, said.
“Knowing that our device has gone through rigorous assessment and has been given a tick of approval to enter the clinical environment is a meaningful development. This trial will provide us with significant information to learn about the range of capabilities of our technology to inform clinical decision making in stroke care.”
Clinical Investigations Roadmap
The sites will be activated progressively, commencing with Liverpool Hospital. All sites selected are major stroke centres that treat significant volumes of stroke patients each year. The Clinical Research Organisation (CRO) is Avania Medical.
