HALF YEARLY REPORT & CEO UPDATE
EMVision Medical Devices Limited (ASX: EMV) (“EMVision” or the “Company”), a medical device company focused on the development and commercialisation of medical imaging technology, today released its Appendix 4D and Interim Report for the half-year ended 31 December 2019 and is pleased to provide the following CEO Update to shareholders.
Dear Shareholders, There have been many achievements in the period since we listed on the ASX in December 2018, and we have been able to meet our milestones as planned. Taking a prototype of our complexity from the lab to a device that is designed for and meets the primary clinical needs in 12 months, is a significant feat in our industry.
We are pleased with the early progress of our clinical trial and the acquisition of stroke patient data to date. Our clinical prototype has been well tolerated by both the clinicians operating it and the stroke patients participating in our study. We have been pleased with the rate of suitable patient participation into the study and do not foresee any challenges meeting our patient enrolment targets within our desired study timeframe. Our imaging algorithm team eagerly look forward to processing and analysing the datasets acquired. We have worked to ensure that we are as well prepared as possible for our future clinical and commercial needs. To this end we brought on Ruth Cremin as Head of Regulatory and Quality Management with extensive experience in prosecuting international medical device regulatory applications. Ruth has already initiated discussions with the FDA and as our device is further developed, she will start discussions with other regulatory bodies. We have also begun recruiting for key in-house engineering roles for commercial product development, including a Senior Systems Engineer and Test Engineers. As advised in our “Entry Into Clinic” ASX release in December 2019, EMVision held meetings with senior executives of the world’s largest medical imaging manufacturers at the Radiological Society of North America’s 105th Scientific Assembly and Annual Meeting in Chicago. These meetings supported that we are addressing a problem of significant need for which there is no solution in the market today. We anticipate continuing these discussions. Receiving validation from these companies and clinical partners, such as the
Australian Stroke Alliance, indicate that we have the potential to build a significant business with a unique value proposition.
Our commercial partnerships are world class and Keysight is critical to developing a customised and best in class Vector Network Analysis (VNA) unit that meets our needs at the right price and footprint. The relationship we have with them is outstanding and communication has been excellent. 2020 will be a watershed year as we generate data from stroke patients, and we look forward to continuing this exciting journey with you.
Chief Executive Officer
LINK TO THE REPORT HERE https://www.asx.com.au/asxpdf/20200227/pdf/44fk0cg5tprs3n.pdf