EMVision Medical Devices, a medical imaging company, has reached tentative agreements with the first two sites for its upcoming clinical trials – detailing how the studies will be conducted.
In addition to Royal Melbourne in Victoria and Liverpool Hospital in New South Wales, additional trial sites will be announced gradually. EMVision has appointed Avania Clinical to support the upcoming multicenter study.
“We are pleased with the progress made and look forward to collaborating with our study sites as we enter clinical trials,” said EMVision CEO Dr. Ron Weinberger.
“This is a key milestone in the development of our new portable brain scanner as we seek to fulfill our mission to improve outcomes for stroke patients.”
The Royal Melbourne Hospital is a comprehensive stroke care center with a world-renowned tertiary academic unit that provides state-of-the-art care to patients in Victoria. Liverpool Hospital is one of the largest stroke referral centers in NSW, including an active endovascular clot retrieval service.
Both sites have a particular interest in providing excellence in the diagnosis and management of acute stroke patients. The sites will be activated gradually, starting with Liverpool Hospital.
Avania is a global, full-service contract research organization that manages clinical studies for medical devices, IVDs, biologics, and combination device-drug products internationally. Avania supports products from the first in-human phase through the post-marketing phase.
EMVision is aiming to start the study this quarter. Multicenter ethics have been submitted to the Human Research Ethics Committee (HREC) and the devices are in an advanced stage of commissioning. The company will provide further information on the clinical trial plan shortly.
Next steps include execution of clinical site contracts and device commissioning, as well as ethics and governance approval to begin patient recruitment.