Empower Clinics Inc said its MediSure Canada subsidiary has formally submitted an application to Health Canada for an interim approval order to manufacture and sell MediSure Canada Lateral Flow Rapid coronavirus (COVID-19) Antigen Tests.
Empower said MediSure Canada is leveraging its experience in the manufacturing and distribution of diabetes management solutions and medical devices, to meet the critical need for expanded COVID-19 testing supply.
The Vancouver, British Columbia-based company said that the approval of this application initiates the commercialization and distribution of its MediSure COVID-19 Rapid Antigen Tests in Canada.
Empower Clinics anticipates a response on the application in early 1Q 2022 as Health Canada is continuing to expedite the review of coronavirus-related applications under its interim order no. 2.
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The project represents a planned expansion and diversification for MediSure, moving the division forward for growth, leveraging its significant Health Canada expertise to bring important new medical devices to Canadians, that can be sold directly to consumers and through its vast network of pharmacy partners, the company said.
"We acquired MediSure precisely to support their plans to diversify their medical device portfolio. This Health Canada submission demonstrates how these goals are being achieved," said Steven McAuley, CEO of Empower, in a statement.
He added: "As a Canadian company, we're proud to provide made-in-Canada testing solutions as we navigate another challenging winter. We're working closely with Health Canada, so we can begin distribution as soon as possible."
Mario Cortis, president of MediSure noted that utilizing MediSure's two decades of healthcare manufacturing experience, “we're able to begin manufacturing COVID-19 tests with the utmost quality control in mind".
"When approved, these tests will expand the supply of COVID-19 tests at a time when Canadians need them the most," he added.
Provincial governments have rolled out rapid testing programs in recent days, and they are seeing enormous uptake and supply chain issues. Ontario's pickup sites ran out of kits within the first day of the program.
Rapid testing is expected to be an integral part of Canada's pandemic response throughout the winter months as Canadians seek additional layers of protection beyond vaccinations and mask-wearing.
MediSure said that it is preparing various activation steps in order to make its tests available as soon as it receives approval. The company is also working to apply for US Food & Drug Administration (FDA) Emergency Use Authorization (EUA) allowing access to the US market.
Contact Ritika at ritika@proactiveinvestors.com