The Company is an Australian public company, incorporated on 11 July 2017 founded by Messrs Scott Kirkland and Ryan Laws.
The Company executed a Licence Agreement (Licence Agreement) with UniQuest Pty Ltd (UniQuest), a commercialising entity that manages the Intellectual Property of UQ, granting the Company an exclusive, worldwide and perpetual licence to commercialise The EMvision Technology(EMVT), including the Brain Scanner. Under an IP assignment deed (IP Assignment Deed) and subject to the satisfaction of the conditions precedent, the Company will be assigned the Intellectual Property rights held by UniQuest to the EMVT.
The Company was successful in winning a Cooperative Research Centres (CRC) grant from the Government of the Commonwealth of Australia (Commonwealth), presented by the Department of Industry, Innovation and Science, under which the Company will receive approximately $3,500,000 in cash funding (plus GST), comprising $2,600,000 from the Commonwealth and $910,000 from the Project Participants. In addition, the Company will receive approximately $3,515,759 by way of in-kind contributions including consumables, practical expertise and guidance from the Project Participants.
In March 2018, UQ was awarded a Queensland State Government Biomedical Assistance Fund (QBAF Agreement) grant of $160,000 to assist with the funding of the NAFLD Project. The grant is subject to UQ contributing $80,000 and the Company entering into a collaboration agreement with UQ and agreeing to provide support to the project in the form of a cash contribution of $80,000 and an in-kind contribution equal to $10,000 including practical expertise and guidance.
The Company has also contracted with UQ, principally through the CRC Project Funding Agreement to carry out further research and development of microwave imaging techniques for biomedical applications. These include advancements in iterative beamography, local area tomography, global tomography, classification (deep learning neural networks) and initial brain template construction.
To further the ongoing product development of the EMVT, the Company has engaged Tiller Design, an industrial design company in Australia to provide industrial design and feasibility studies, mechanical and electronic engineering, production tooling, product assembly and certification as well as project and risk management, supply and sourcing.
In July 2018, TUV Rheinland completed a successful second stage audit on the Company, which is a significant milestone in the process to obtaining ISO 13485 certification. ISO 13485 is a harmonised standard for quality management systems for medical devices and a number of countries require ISO 13485 certification to support regulatory clearance.
The Company has also engaged third parties for regulatory advice and strategy for the intended design and development of medical devices, as well as to assist the Company with strategic advice for the development of its clinical investigational plans, including those for initial healthy human trials with a clinical prototype and the Company’s envisioned pilot hospital trial.
Typical Device Development Pathway
The development of clinical medical devices is tightly regulated and involves the sequential demonstration of both safety and efficacy of the devices, comparable to the development pathway for other medical technologies such as drug development.
The Company’s Proposed Development Pathway
The Company intends to develop the EMVT through the above regulatory pathways to enable devices incorporating the EMVT to be deployed in medical fields in target markets. Development of the underlying EMVT has progressed over the last 10 years from initial concept and proof-of-concept experiments through pre-clinical research. The Company is now poised to begin the human testing phase of product development for its initial target application of brain injury with a focus on rapid stroke diagnosis and monitoring in accordance with Stage 3 – Pathway to Approval as per the development pathway.
The Company intends to expand upon its existing and future clinical collaborations and seek to attract potential commercial partners throughout its clinical program. If the Company achieves regulatory clearance for the Brain Scanner, the Company will aim to secure a major distribution partner, which it considers would be a key milestone towards commercialisation and potential profitability, noting that there is no guarantee that the Company will secure commercial partnerships or agreements or profitability.
ASX Codes, Offer Opening and Closing Dates are proposed only and are subject to change without notice.
The IPO information on the website provided by 61 Financial only serves general information purposes, it does not constitute financial product advice. All IPO information is retrieved from the Company’s Prospectus. They are subject to change at any time without notice. Investors shall refer to the Prospectus for detailed information.