Halifax, Nova Scotia, 30 September, 2022 – Today, MedMira Inc. (MedMira) (TSXV: MIR) announces the appointment of Dr. Sam Ratnam as MedMira’s Director of Scientific & Regulatory Affairs and provides an update on its regulatory progress in the U.S. market.
U.S. Regulatory Update on COVID-19 Products
The recent announced recommendation by the U.S. FDA to IVD manufacturers to apply for the traditional regulatory path 510(k) approval outlines the continuous need for quality COVID-19 rapid test. While the Emergency UseAuthorisation (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 high quality standard, traditional approval process such as the 510(k) requires full compliance with the FDAQuality 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 hasbeen certified for the MDSAP and the Company holds both the FDA and Health Canada establishment license for itsNorth-American based facility. The Company continues with its dual strategy to receive the EUA(s) and the 510(k). Thisenables 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) pre-submission. MedMira will providefurther 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 US Centers for Disease Control and Prevention (CDC), the incidence rate of acute hepatitis C in 2020 has more than doubled since 2013, a 124% 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 towards obtaining approval for this greatly demanded product in the USA 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 our three key markets. Therefore, the management has appointed Dr. Sam Ratnam as DirectorScientific & Regulatory Affairs to support MedMira in its growth by introducing more products into the North-Americanand European markets.
Dr. Ratnam brings over 40 years of experience in public health, 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. His invaluable expertise and intrinsic knowledge of the regulatory and clinical trial frameworkin Canada and the United States, will provide the Company even further momentum to push forward on itscurrent 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 antigentests), BYRA™ (Bacteria based antigen/antibody tests) and PYRA™ (Parasite based antigen/antibody tests).
About Dr. Sam Ratnam
Dr. Sam 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 Advisor to the National Microbiology Laboratory, Public Health Agency of Canada, Winnipeg, and Interim Advisor 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 advisor to the WHO. His research interests are clinical and public health microbiology with focus on STI diagnostics (200 scientific articles and abstracts).
Next updates
MedMira will provide further updates on its CE and Health Canada progress in a separate announcement.
About MedMira
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, 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, 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.
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