Medical imaging technology specialist EMVision Medical Devices Limited (ASX:EMV) has progressed in-principle agreements with the first two clinical sites for its upcoming clinical trials detailing how the studies will be conducted at these sites, being Royal Melbourne in VIC and Liverpool Hospital in NSW.
Additional trial sites will be announced progressively.
In addition, EMVision has appointed Avania Clinical a global leading medical technology Clinical Research Organisation (CRO) to support EMVision’s upcoming multi-centre study.
The Royal Melbourne Hospital is a comprehensive stroke care centre with a world renowned tertiary academic unit that provides leading care for patients across Victoria. Liverpool Hospital is one of the largest stroke referral centres in NSW, including an active endovascular clot retrieval service.
Both sites have a special interest in providing excellence in the diagnosis and management of acute stroke patients. The sites will be activated progressively, commencing with Liverpool Hospital.
Avania is a leading, global full-service contract research organisation focused on the management of clinical studies for medical devices, IVDs, biologics, and device-drug combination products internationally. Avania supports products from the first-in-human phase through the post-market phase.
EMVision is targeting study commencement this quarter, multi-centre ethics has been submitted to the Human Research Ethics Committee (HREC) and devices are in advance stage of commissioning. The Company will provide further information on the clinical trial plan shortly. Next steps include execution of clinical site contracts, completion of device commissioning, alongside ethics and governance approval to commence patient enrolment.
We are pleased with the progress being made and look forward to collaborating with our study sites as we move into the clinical trials. This is a key milestone in the development of our novel portable brain scanner as we seek to fulfill our mission of improving stroke patient outcomes,” EMVision CEO, Dr Ron Weinberger, said.
