Mr. Hermes Chan reports

U.S. FDA APPROVES MEDMIRA'S ADVANCED REVEAL G4 RAPID HIV-1/2 ANTIBODY TEST

Medmira Inc. has attained 510(k) clearance for the HIV-2 claim on the Reveal G4 rapid HIV-1/2 antibody test in the United States. This achievement marks a significant milestone for Medmira, positioning the company as a key player in the HIV testing landscape and addressing the demand for comprehensive HIV screening mandated by various state laws across the nation.

"We are thrilled to announce the 510(k) clearance for the HIV-2 claim on the Reveal G4 rapid HIV-1/2 antibody test in the United States," said Hermes Chan, chief executive officer at Medmira. "This milestone underscores our commitment to providing high-quality diagnostic solutions that align with the dynamic landscape of HIV screening. The inclusion of the HIV-2 claim not only meets regulatory requirements but also positions us as a front-runner in addressing the unique needs of health care providers and communities nationwide."

With the expanded claim and the continuing pursuit of clinical laboratory improvement amendment waiver status, Medmira anticipates a significant increase in demand for the Reveal G4 rapid HIV-1/2 antibody test in the coming year. The company is optimistic about the positive impact it can make in the fight against HIV by offering a high-quality, faster and more accessible antibody testing option to health care professionals and individuals across the United States.

The addition of the HIV-2 claim to the Reveal G4 rapid HIV-1/2 antibody test is particularly crucial, considering the diverse prevalence of HIV subtypes in the United States. This clearance not only meets the regulatory requirements but also aligns with the evolving needs of health care providers and public health initiatives, ensuring that individuals receive accurate and reliable results for both HIV-1 and HIV-2.

The Reveal G4 rapid HIV test has consistently demonstrated exceptional performance, and with the expanded claim, it is well positioned to meet the demand for a rapid and reliable testing solution. The inclusion of the HIV-2 claim further strengthens the test's utility and compliance with various state laws, making it an essential tool in the fight against HIV.

In light of this achievement, Medmira is actively pursuing the clinical laboratory improvement amendment waiver for the Reveal G4 rapid HIV-1/2 test. The CLIA waiver, once obtained, will streamline the accessibility of the test and empower a broader range of health care professionals to administer it. This strategic move is expected to enhance the reach and impact of the Reveal G4 HIV-1/2 test, making it more readily available to communities across the United States.

About Medmira Inc.

Medmira is a leading developer and manufacturer of rapid vertical flow technology diagnostics. The company's tests provide hospitals, 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 in the 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, N.S., Canada.

We seek Safe Harbor.