Dr. Sam Ratnam reports

MEDMIRA PROVIDES PROGRESS UPDATE

Medmira Inc. has appointed Dr. Sam Ratnam as Medmira s director of scientific and regulatory affairs, in addition to releasing an update on its regulatory progress in the United States market.

U.S. regulatory update on COVID-19 products

The recent announced recommendation by the U.S. FDA (Food and Drug Administration) to IVD (in vitro diagnostics) manufacturers to apply for the traditional regulatory path 510(k) approval outlines the continuous need for quality COVID-19 rapid test. While the emergency use authorisation (EUA) is continuing, the regulators prepare for the future endemic situation and initiate the standard transition protocol for prevailing diseases. In contrary to the EUA application, where manufacturer does not require to meet a high-quality standard, traditional approval process such as the 510(k) requires full compliance with the FDA Quality System Regulation (21 CFR Part 820). It is the most important mandate for all regulators including FDA and Health Canada to approve the highest quality product to serve the public need. Such requirements may include an existing FDA establishment license and the Medical Device Single Audit Program (MDSAP) certification. Medmira's product lines Revealcovid-19 and VYRA have the data supporting such an application and can provide additional data if such may be required. At the same time, Medmira's quality system has been certified for the MDSAP; the company holds both the FDA and Health Canada establishment license for its North-American based facility. The company continues with its dual strategy to receive the EUA(s) and the 510(k). This enables Medmira and its distributors to offer the highest regulatory approved products when available to market. While Medmira is in the EUA process, the company is preparing the 510(k) presubmission. Medmira will provide further updates on both applications when available.

U.S. regulatory update on hepatitis C product

The company has previously announced the intention of seeking FDA approval for its Point of Care Reveal rapid hepatitis C (HCV) antibody test. According to U.S. Centers for Disease Control and Prevention (CDC), the incidence rate of acute hepatitis C in 2020 has more than doubled since 2013, a 124-per-cent increase. Medmira has taken immediate steps and a Q-submission (Q220148) was made to FDA and has received positive feedback. The submitted clinical and non-clinical protocols have been reviewed, and the company has received clear instructions toward obtaining approval for this greatly demanded product in the U.S. and other parts of the world.

Growth of scientific and regulatory support

Medmira has eight regulatory applications pending and is aiming to add three additional regulatory submission in the coming months to the company's three key markets. Therefore, the management has appointed Dr. Sam Ratnam as director of scientific and regulatory affairs to support Medmira in its growth by introducing more products into the North-American and European markets.

Dr. Ratnam brings over 40 years of experience in public health and regulatory affairs, and has been the principal in a number of important regulations set forward by the health authorities, such as the guidelines on syphilis, hepatitis C and HPV (human papilloma virus). His invaluable expertise and intrinsic knowledge of the regulatory and clinical trial framework in Canada and the United States will provide the company even further momentum to push forward on its current and future applications.

Trademark Revealcovid-19

Medmira is delighted to announce the receipt of the United States of America trademark for its Revealcovid-19 brand. The trademark complements the Medmira's portfolio of trademarked brands and further strengthen its uniqueness. Additional trademarks are currently in the final process which includes VYRA (virus-based antigen tests), BYRA (bacteria-based antigen/antibody tests) and PYRA (parasite-based antigen/antibody tests).

About Dr. Ratnam

Dr. Ratnam, MSc (medical microbiology; Madras), PhD (medical microbiology; Delhi), MPH (Johns Hopkins), FCCM (fellow of Canadian College of Microbiologists), is clinical professor at Memorial University, St. John's, and adjunct professor, McGill University, Montreal, Canada. He was director of public health laboratory, government of Newfoundland, St. John's, and served as adviser to the National Microbiology Laboratory, Public Health Agency of Canada, Winnipeg, and interim adviser to the public health laboratory, St. John's. He has served as chair or member of many Canadian federal and provincial advisory committees and working groups and as temporary adviser to the WHO (World Health Organization). His research interests are clinical and public health microbiology with focus on STI (sexually transmitted infection) diagnostics (200 scientific articles and abstracts).

Next updates

Medmira will provide further updates on its CE (European Conformity) and Health Canada progress in a separate announcement.

About Medmira Inc.

Medmira is a leading developer and manufacturer of Rapid Vertical Flow diagnostics. The company s tests provide hospitals, labs, clinics and individuals with instant disease diagnosis, such as HIV (human immunodeficiency virus), 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.