EMVision Medical Devices Limited (ASX: EMV) (“EMVision” or the “Company”), a medical device company focused on the development and commercialisation of medical imaging technology, is pleased to advise that the Princess Alexandra’s biomedical engineering department has successfully completed functional and electrical safety testing of the EMV brain scanner unit and key checks (ethics approval, notification to TGA, Electromagnetic compatibility results) essential to commence the Company’s clinical trials. The Company has worked with the lead clinical investigator to complete the necessary training with the device prior to the commencement of clinical trials In parallel to this work in the clinic, the Company has continued to test the newly fabricated clinical units on several healthy volunteers, and demonstrated encouraging progress on the imaging algorithms, establishing a solid imaging “baseline’’ to support the clinical trial. The Company anticipates receiving administrative “green light” for activation and to commence patient scanning shortly. This marks an important phase of the clinical development program for EMVision’s portable brain scanner for stroke and traumatic brain injury diagnosis and monitoring. During the trial, the Company’s primary objective will be to collect imaging data from stroke patients that allows refinement and selection of the optimal imaging algorithms as well as early data on correlation with CT and/or MRI. The single centre study, up to 6 months, will enrol 30 diagnosed stroke patients with confirmatory CT and/or MRI. No intervention or modification to the usual hospital-based treatment of stroke is proposed as part of this trial. The Company expects to provide updates to the market as it reaches relevant milestones throughout the clinical testing. EMVision CEO, Dr Ron Weinberger, commentated “To enter the clinic, on schedule, with a breakthrough technology like ours, is an exciting milestone. The clinical trial will provide us with valuable learnings and enablement to explore the potential of our technology for diagnosing and monitoring time sensitive neurological disorders at the point of care in a manner otherwise not possible today. EMV was recently invited to the Radiological Society of North America’s 105th Scientific Assembly and Annual Meeting in Chicago, the world’s biggest radiology conference with more than 50,000 attendees from around the world as well as the largest exhibition of imaging products and companies. It is clear from the meetings that we had with executives of world leading imaging manufacturers and distributors, that point of care diagnosis and monitoring of stroke is a significant unmet need for which there is no imaging solution in use. This strongly validates our approach of having a small footprint, safe and easy to use device that can be quickly deployed for diagnosis and continuous monitoring.” Lead Investigator Dr David Cook commented “the rapid progress made by EMV in deploying the brain scanner in the hospital for us to initiate our trial with stroke patients is great. Our vision is that timely and widespread access to a portable, point-of-care scanning will improve patient survival, reducing personal disability and the community burden of stroke. While stroke is the first clinical target, Electromagnetic (EM) scanning has a broad potential for diagnosing and monitoring a range of other brain disorders.” The Clinical Trial summary is part of this ASX Announcement as Appendix A.
