Empower Clinics Subsidiary MediSure Submits Health Canada Application For Its Rapid COVID-19 Antigen Tests
Health Canada Approval opens opportunities for increased sales of MediSure branded COVID-19 Rapid Antigen Tests in Canada. Empower Clinics Inc.'s subsidiary, MediSure Canada, has submitted an application for an Interim Order to manufacture and sell these tests. The Company expects a response by early Q1 2022 and aims to address the critical demand for testing amid rising COVID-19 cases. MediSure plans to leverage its expertise and partnerships with pharmacies for distribution and is also pursuing FDA Emergency Use Authorization for the U.S. market.
- Application submitted for Health Canada approval of COVID-19 Rapid Antigen Tests expected to address critical testing shortages.
- Strong potential for sales growth with planned distribution to consumers and pharmacy networks.
- Pursuing FDA Emergency Use Authorization for access to the U.S. market.
- Approval from Health Canada is pending, adding uncertainty to the timeline for product availability.
- Potential supply chain issues may affect the timely manufacturing and distribution of tests.
Health Canada Approval Opens a Path For Increased Sales and Distribution of MediSure Branded Rapid Antigen Tests In Canada
VANCOUVER, BC / ACCESSWIRE / December 24, 2021 / EMPOWER CLINICS INC. (CSE:CBDT)(Frankfurt:8EC)(OTCQB:EPWCF) ("Empower" or the "Company") an integrated healthcare company - serving patients through medical centers, telemedicine platforms, a medical device company, and a high complexity medical diagnostics laboratory - is pleased to announce that the Company's subsidiary, MediSure Canada, has formally submitted an application to Health Canada for an Interim Order ("IO") Approval to manufacture and sell MediSure Canada Lateral Flow Rapid COVID-19 Antigen Tests ("MediSure™ COVID-19 Rapid Antigen Tests").
MediSure Canada, a wholly owned subsidiary, 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. Approval of this application initiates the commercialization and distribution of its MediSure™ COVID-19 Rapid Antigen Tests in Canada. The Company anticipates a response on the application in early Q1 2022 as Health Canada is continuing to expedite the review of COVID-19 related applications under its Interim Order No. 2.
This 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 direct to consumer and through its vast network of pharmacy partners.
"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, Chairman and CEO of Empower. "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."
"I'm immensely proud of the MediSure team for its diligence and agility in the face of yet another COVID-19 wave," said Mario Cortis, President of MediSure. "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."
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 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 FDA Emergency Use Authorization (EUA) allowing access to the U.S. market.
This press release is available on the Empower Clinics Verified Forum on AGORACOM for shareholder discussion, questions and engagement with management https://agoracom.com/ir/EmpowerClinics
ABOUT MEDISURE:
MediSure Canada is a wholly owned subsidiary of Empower Clinics. It is a Canadian medical device company dedicated to bringing value to the high cost of diabetes, both to patients and insurers. MediSure's products are designed and manufactured with safety and durability in mind, meeting all ISO standards with world-class quality controls. Equipped with features that lead the industry in technology, MediSure's products are designed to offer a user-friendly experience and an overall improved approach to diabetes management.
ABOUT EMPOWER:
Empower is an integrated healthcare company that provides body and mind wellness for patients through its clinics, with digital and telemedicine care, a medical device company and world-class medical diagnostics laboratories. Supported by an experienced leadership team, Empower is aggressively growing its clinical and digital presence across North America. Our Health & Wellness and Diagnostics & Technology business units are positioned to positively impact the integrated health of our patients, while simultaneously providing long term value for our shareholders.
ON BEHALF OF THE BOARD OF DIRECTORS:
Steven McAuley
Chief Executive Officer
CONTACTS:
Media:
Steven McAuley CEO
s.mcauley@empowerclinics.com
604-789-2146
Investors:
Tamara Mason
Business Development & Communications
t.mason@empowerclinics.com
416-671-5617
DISCLAIMER FOR FORWARD-LOOKING STATEMENTS
This news release contains certain "forward-looking statements" or "forward-looking information" (collectively "forward looking statements") within the meaning of applicable Canadian securities laws. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates and projections as at the date of this news release. Forward-looking statements can frequently be identified by words such as "plans", "continues", "expects", "projects", "intends", "believes", "anticipates", "estimates", "may", "will", "potential", "proposed" and other similar words, or information that certain events or conditions "may" or "will" occur. Forward-looking statements in this news release include statements regarding: the Company's plans with respect to the offering of other Empower services and products; and that MediSure™ COVID-19 Rapid Antigen Tests will receive Health Canada approval; and that commercialization and distribution of the products will take place; that the Company can meet a critical need for expanded COVID-19 testing suopply; and that the Company will have a response from Health Canada in early Q1 2022.. Such forward-looking statements are based on assumptions known to management at this time, and are subject to risks and uncertainties that may cause actual results, performance or developments to differ materially from those contained in the forward-looking statements, including: that the Company may be unable to enter into definitive agreements, or close transactions with respect to, proposed future clinic openings; that due diligence with respect to anticipated clinic openings and acquisitions may not be satisfactory to the Company; risks related to delays in permitting or construction; risks related to supply chains and access to labour; that legislative changes may have an adverse effect on the Company's business and product development; that the Company may not be able to obtain adequate financing to pursue its business plan; that the Company will be able to commence and/or complete build-outs and tenants improvements for new clinics; general business, economic, competitive, political and social uncertainties; and other factors beyond the Company's control. No assurance can be given that any of the events anticipated by the forward-looking statements will occur on the terms or in the time expected, or at all, or, if they do occur, what benefits the Company will obtain from them. Readers are cautioned not to place undue reliance on the forward-looking statements in this release, which are qualified in their entirety by these cautionary statements. The Company is under no obligation, and expressly disclaims any intention or obligation, to update or revise any forward-looking statements in this release, whether as a result of new information, future events or otherwise, except as expressly required by applicable securities laws.
SOURCE: Empower Clinics Inc.
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FAQ
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