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MedMira receives Health Canada approval for its Reveal® G4 Rapid HIV-1/2 Test for Point-of-Care use

Halifax, Nova Scotia – January 14, 2025 – MedMira Inc. (MedMira) (TSXV: MIR) announced today that it has received today the approval from Health Canada for its Reveal® Rapid G4 HIV-1/2 Test (Reveal® HIV test) for Point-of-Care (POC) use. The Reveal® HIV rapid test has achieved a sensitivity of 99.64% and a specificity of 99.71% and with it is highly suitable for health care professionals who require a fast, reliable, and high-quality result to be used in any health care setting.

The Reveal® HIV test enables an immediate result to accurately detect HIV-1/2 antibodies with only a small sample using a finger prick. The less then 1-minute easy steps to complete the test (after sample collection), allows an operator to achieve an immediate result that does not fade away. This together with the no special storage requirement makes the Reveal® HIV test a highly suitable tool for any health care setting.

The product is based on MedMira’s unique and patented Rapid Vertical Flow Technology with an in-build reagent and procedural control line which enables users to be sure the test is performed correctly. This distinctive feature provides the comfort and security that a test has been correctly completed. An essential part for any rapid testing, especially for life changing diagnoses such as HIV.

“Our REVEAL® HIV test is one of the fastest and most reliable solutions for HIV detection. As the rates of HIV infections continue to rise in Canada, healthcare providers need diagnostics that are not only accurate but also simple, cost-effective, and accessible in any setting. Whether in underserved remote areas or urban centres facing overburdened healthcare systems, our test is designed to provide immediate and actionable results. ,” said Hermes Chan, CEO of MedMira. “Together with our partners, such as REACH Nexus, we are committed to rapidly deploying our innovative solutions and supporting Canada’s public health efforts to modernize and expand HIV screening.”

The latest data from the Public Health Agency of Canada, shows that new HIV diagnoses soared more than 35% from 2022 to 2023, with rates in Manitoba rising by more than 40%. In Saskatchewan, the rate of HIV was 19.4 per 100,000 people, more than three times the national rate.

This approval comes after the received approval of MedMira’s Multiplo® TP/HIV rapid test on the 24th of December 2024. The Company’s aim is to provide the Canadian market with a suite of alternatives as certain health care settings and programs or professionals aim for a specific disease. Hence the Company offers its Multiplo® TP/HIV combination test or its Reveal® single marker tests such as Reveal® HIV test. MedMira anticipates the approval of the Reveal® TP test in the coming weeks.

G4

About MedMira
MedMira is a leading developer and manufacturer of Rapid Vertical Flow diagnostics. The Company’s tests providehospitals, labs, clinics, and individuals with instant disease diagnosis, such as HIV, Syphilis, Hepatitis, and SARS-CoV-2, in just three easy steps. The Company’s tests are sold globally under the REVEAL®, REVEALCOVID-19®, Multiplo® and Miriad® brands. Based on its patented Rapid Vertical Flow Technology, MedMira’s rapid HIV test is the only one inthe world to achieve regulatory approvals in Canada, the United States, China and the European Union. MedMira’s corporate offices and manufacturing facilities are located in Halifax, Nova Scotia, Canada. For more information visit medmira.com. Follow us on LinkedIn, X and Youtube.

This news release contains forward‐looking statements, which involve risk and uncertainties and reflect the Company’s current expectation regarding future events, including statements regarding possible regulatory approval, product launch, future growth, and new business opportunities. Actual events could materially differ from those projected herein and depend on a number of factors including, but not limited to, changing market conditions, successful and timely completion of clinical studies, uncertainties related to the regulatory approval process, establishment of corporate alliances and other risks detailed from time to time in the company quarterly filings.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

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MedMira Inc.

Markus Meile

Chief Financial Officer

ir@medmira.com

Phone 902-450-1588

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Committed to quality
Certified & Proven Quality

Our quality management system is ISO 13485:2016 certified, compliant with the United States Food and Drug Administration’s current Good Manufacturing Practices (cGMP: Quality System Regulation Part 820 of CFR Title 21, Volume 8), European Union’s Directive 98/79/EC on in vitro diagnostic medical devices, and Health Canada Medical Device Regulations (SOR/98-282).

Additionally, we adhere to ISO 14971 (Application of Risk Management to Medical Devices) and ISO 2859 (Sampling Procedures for Inspection by Attributes). Certification and compliance to these requirements attests to our ability to maintain the highest standard of quality in medical device manufacturing, product development and corporate conduct.

Our products have been approved by regulators and UN agencies worldwide.

FDA

Health Canada

International Trade Centre (ITC)

Pan American Healtch Organization (PAHO)

UN Development Programme (UNDP)

UN Office for Project Services (UNOPS)

UN Office at Vienna (UNOV)

UN Population Fund (UNFPA)

United States Agency for International Development (USAID)

CFO & Head of Commercialization

Markus Meile

Markus joined MedMira in 2010, and moved into the role of Chief Financial Officer in 2014.

He previously served on the Company’s Board of Directors, as a member of the Audit Committee, and as the Senior Director of International Markets.

Prior to joining MedMira, Markus worked with a number of financial institutions in Switzerland, England, and Hong Kong. He holds a BSc from Royal Holloway University of London and has studied business management, strategic planning, investment and accounting at business school in Zurich. Previously, Markus worked in the medical device industry in Africa, Asia Pacific, and Europe.

He will combine his financial expertise with his broad range of international business knowledge to build financial and corporate strategies supporting MedMira’s continuing growth and increasing shareholder value.

Director of the Audit Committee, Nomination and Compensation Committee

Jianhe Mao

Jianhe Mao is the owner of Unipec, a consulting firm based in St. Gallen, Switzerland. Unipec focuses on helping European companies enter the Chinese market, through operational restructuring and ownership and management optimization.

In addition to leading Unipec, Mr. Mao is involved in several industrial projects and start-up ventures including Monsatec AG, a new company bridging the gap between laboratories and clinics with a cold plasma medical device. He serves on the boards of several European companies and is regarded as a trusted expert in legal cases, corporate corruption, operational turnarounds, and mergers and acquisitions.

Mr. Mao began his career as a project engineer and has gained experience in business development and real estate investment. He holds M.E. from Ruhr University Bochum.

CEO, Co-Founder & Co-Inventor

Hermes Chan, D.Sc. (h.c.)

Hermes Chan, our Chief Executive Officer and Co-Founder, leads our passionate and committed team in driving the strategic direction and growth of MedMira.

Hermes, who was named BioScience Innovator of the Year by The Economist in 2007, is the inventor of our patented rapid flow-through diagnostic technology platform.

Since the company’s inception in 1994 Hermes has held progressively senior management roles including Research Scientist, General Manager, Senior Vice President, and Chief Operating Officer.

Prior to creating MedMira, Hermes worked with another Canadian biotechnology company in the diagnostics research sector.

Chair member of the Audit Committee, Nomination and Compensation Committee

Steven Cummings

Mr. Steven Cummings is the Founder & President of Cambridge Financial Services, one of the leading full service accounting, tax, and business advisory firms in Nova Scotia.

Under Mr. Cummings leadership, Cambridge Financial has earned an enviable reputation among businesses and industry for a commitment to high standards. Along with his leadership responsibilities at Cambridge Financial Services, Mr. Cummings was engaged as MedMira’s interim Chief Financial Officer in 2007.

With more than 30 years of financial and entrepreneurial experience, Mr. Cummings is a frequent guest speaker on issues surrounding provincial taxation, taxation of seniors, and business ownership

Intellectual property

China

ZL02819646.5

Rapid Diagnostic Device and Assay

Intellectual property

European union

EP1417489

Rapid Diagnostic Device and Assay

EP1328811

HCV Mosaic Antigen Composition (2021)

Intellectual property

USA

9,164,087

Rapid Diagnostic Device, assay and multifunctional Buffer

9,086,410

Downward or vertical flow diagnostic device and assay

8,025,850

Rapid Diagnostic Device, Assay and Multifunctional Buffer

8,287,817

Rapid Diagnostic Device, Assay and Multifunctional Buffer

8,586,375

Rapid Diagnostic Device, Assay and Multifunctional Buffer

7,531,362

Rapid Diagnostic Device, Assay and Multifunctional Buffer

D706945

Diagnostic Device

D706466

Diagnostic Device

11,353,450

Analyte Detection Using Raman Spectroscopy

Intellectual property

Canada

CA2,493,616

Rapid Diagnostic Device, Assay and Multifunctional Buffer

CA2,740,902

Downward or Vertical Flow Diagnostic Device and Assay

CA2,949,634

Analyte Detection Using Raman Spectroscopy

MiROQ Vision

Handheld Device

A future concept built on the same MIROQ technology, designed to deliver lab-grade precision in the palm of your hand.

We envision a future where testing can happen anywhere, anytime – from hospitals and clinics to remote regions or even at home – enabling early disease detection and turning knowledge into real impact. No large equipment or complex infrastructure required.

For: Doctor’s offices, small and mobile clinics

Future application: Home use

Connectivity: Bluetooth, Wifi and USB