mytriade wrote: TORONTO, April 21, 2020 (GLOBE NEWSWIRE) -- Datametrex AI Limited (the “Company” or “Datametrex”) (TSXV: DM, FSE: D4G, OTC:DTMXF ) wishes to provide additional specifics on the previously announced news release regarding acquiring the rights to import COVID-19 test kits from South Korea. An application for approval was made to Health Canada under the Fast-Track program on April 9th, 2020.
As part of the submission, the Company has submitted a Medical Devices Interim Order Request Form under Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 pursuant to subsection 30.1(1) of the Food and Drugs Act signed by the Minister of Health on March 18, 2020. This Interim Order (IO) will allow Health Canada to issue expedited review and approval for the sale of these test kits in Canada.
The Company has represented to Health Canada that it will be able to provide a minimum first order of 200,000 units, followed by an additional 100,000 units on a weekly basis. Any purchase of the test kits by the Canadian government is conditional on prior receipt of Health Canada approval. Datametrex is currently working with Dr. Lisa Palleson-Stallan and Dr. Joseph Curtis to assist with obtaining Health Canada approval, and each has agreed to join the Company’s advisory board.
Dr. Joseph Curtis is the Chief Scientific Officer and founder of BioQuant Laboratories (BQL) an independent testing laboratory providing analytical testing services to firms across the U.S. and Canada developing natural product medicines for human and animal health. Dr. Curtis has twenty-five years of experience across and has held various executive positions within public and private sector firms. Working across the public health emergency medical countermeasures continuum, he supported the USA’s blood and tissue preparedness and response programs managed by the American Red Cross. In this capacity, he served as the Director, Biomedical Headquarters Facility Quality Assurance coordinating performance excellence programs across a nation-wide network of manufacturing and testing facilities delivering $2 billion of cellular therapies and transfusion medicine products to over 3,000 hospitals across the US.
Dr. Lisa Palleson-Stallan obtained her Ph.D in International Business with Honours in the U.K. She ran a European Union funded project on technology and Innovation and completed post doctoral work at the World Health Organization (WHO) publishing on Tobacco Cessation. She created her first retail company, Lotuswear, which grew into a 100 employee + company and had the role as presidentand CEO. She became an early adopter in several industries and has continued building value from the ground up. She has built a successful consultancy company that targets the Asian marketplace within the Health space. Dr Palleson-Stallan has been given role and title of Global Health Advisor to assist the Chinese Government with unconditional support and authority to conduct negotiations regarding how to best to combat the spread of Covid-19.
“We are thrilled to be in a position to bring high quality test kits to Canada to help flatten the curve and save lives. We are doing everything we can to provide Health Canada with the required information to move forward. We are looking forward to solving these problems alongside Dr. Palleson-Stallan and Dr. Curtis.”, says Marshall Gunter, CEO of the Company.
Datametrex anticipates that it will have little or no upfront costs associated with importing these test kits. Assuming Health Canada approves the test kits and they are subsequently purchased by the Canadian government, manufacturer will ship the test kits directly to the Canadian government or hospitals, and Datametrex will not be involved in the shipping, warehousing or distribution process.