MedMira Inc. - CEO, Hermes Chan
CEO, Hermes Chan
Source: Saltwire
  • MedMira Inc. (MIR) announced the appointment of Dr. Sam Ratnam as a director and updated its regulatory progress in the U.S. market
  • MedMira is preparing a 510(k) pre-submission for its COVID-19 rapid tests
  • It has received next step instructions for obtaining approval for its Point of Care Reveal Rapid Hepatitis C (HCV) antibody test
  • MedMira has received the U.S. trademark for its REVEALCOVID-19 brand
  • MedMira Inc. (MIR) is unchanged, trading at $0.08 per share as of 1:47 p.m. ET

MedMira (MIR) has appointed Dr. Sam Ratnam as its Director of Scientific and Regulatory Affairs and updated its regulatory progress in the U.S. market.

MedMira is a developer and manufacturer of rapid tests provided to hospitals, labs, clinics and individuals with instant disease diagnosis for viruses such as HIV, Syphilis, Hepatitis, and COVID-19.

Regarding a recent U.S. Food and Drug Administration (FDA) recommendation, MedMira is preparing a 510(k) pre-submission for its COVID-19 rapid tests. Meanwhile, the Emergency Use Authorization process continues for the tests as industry regulators initiate the standard transition protocol for future endemic diseases.

Also, the company has been seeking FDA approval for its Point of Care Reveal Rapid Hepatitis C antibody test and has received next step instructions for obtaining approval for this product.

MedMira has another eight regulatory applications pending and is aiming to add three additional regulatory submissions to its three key markets in the coming months. As a result, the company has appointed Dr. Sam Ratnam to support growth by introducing more products into the North American and European markets.

Dr. Ratnam has over 40 years of experience in public health and regulatory affairs and has been a part of several important regulations set forward by the health authorities, such as the guidelines on Syphilis, Hepatitis C and HPV.

Finally, MedMira has received the U.S. trademark for its REVEALCOVID-19 brand. More trademarks are undergoing the final process, including its VYRA, BYRA and PYRA antigen tests.

MedMira Inc. (MIR) is unchanged, trading at $0.08 per share as of 1:47 p.m. ET.


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