.
Corporate Update
In December 2023, the Company received the 510(k) (FDA) approval for its Reveal® G4 Rapid HIV-1/2 antibody test. The Company’s completed clinical trials showed a sensitivity of 100% for HIV-1 and HIV-2 MedMira’s Reveal® G4 HIV-1/2 rapid antibody test achieved a flawless 100% specificity and was reactive in early HIV-2 infections and seroconverts. The inclusion of the HIV-2 component allows CLIA laboratories, clinics, or hospitals, to use MedMira’s test. Subsequent to the successful FDA 510(k) approval, the Company commenced its clinical trials in the US to achieve its CLIA waived approval for the Reveal® G4 HIV-1/2 rapid test. At this time the Company is in the final phase and will provide an update in the first month of 2025 on its regulatory status, anticipating to have a final date at such time.
During FY2024, the Company completed its Syphilis clinical trials and made the submission of its data to the Health Canada's In Vitro Diagnostic Division, Medical Device Directorate. At this stage, all relevant data and questions have been completed. While MedMira’s focus has been the achievement of the regulatory approval of its Reveal® TP (Syphilis) rapid test in Canada, the Company has made two additional submissions for regulatory clearance in Canada and provided all necessary details to the regulatory authority. At this point the Company is awaiting the approvals of all three rapid test and anticipates these at any time.
In Q4 FY2024, the Company signed two substantial partnership agreements for the distribution of all current and future product lines of MedMira in the United States of America. Subsequent to the financial year end, MedMira signed two additional distribution agreements to target federal and state tenders in the US, in preparation of the Q1 FY2025 awards period. With this the Company has further expanded its presence and outreach to large volume contracts for its current (Reveal® G4 HIV-1/2 rapid test and Miriad®) product line while preparing for its upcoming approval of the Reveal® G4 HIV-1/2 rapid test CLIA waived product.
Subsequent to FY2024, MedMira in partnership with REACH Nexus at St. Michael’s Hospital’s MAP Centre for Urban Health Solutions, received the full funding for the clinical trials from the Canadian Institute of Health Research (CIHR) for its Multiplo® Complete Syphilis (TP/nTP) Antibody Test (Multiplo® TP/nTP). This grant was received in response to Health Minister Mark Holland’s announcement to fight the growing syphilis pandemic in North America.
Outlook
According to the latest CDC (US) report published in November 2024, between 2019 and 2023, there has been a sharp increase in Syphilis cases. For example, the CDC (USA) recorded a 61% increase in Syphilis and a 106% increase among newborns. In Canada, according to CCDR, syphilis infections increased by 109% since 2018 and a significant increase of 599% among newborns.
MedMira has strategically positioned its product portfolio to focus on asymptomatic infections (infections without or mild symptoms) and unknown infection statuses for sexually transmitted diseases such as HIV, Syphilis and Hepatitis C. These diseases represent one of the most significant screening and diagnostic market after oncology. Therefore, the Company’s strategic aim is to achieve regulatory approvals in the Canadian and US market and offer the fastest rapid testing solution to its customers. Whereas the stringent and complex regulatory approval process in these target countries are time and resources consuming, the high entry barriers in these markets have a significant lower amount of competition and a more attractive return-on-investment.
Specifically in Canada, since the COVID-19 pandemic, the overall recognition of rapid tests has significantly increased. As a result, the overall market for MedMira’s products in Canada has become a major revenue opportunity for FY2025. The Company has recorded a high demand from various organisations which will have a major impact on the financial success of MedMira in the coming year.
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 and medmira.ca. Follow us on Twitter and LinkedIn.
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.
Corporate Update
In December 2023, the Company received the 510(k) (FDA) approval for its Reveal® G4 Rapid HIV-1/2 antibody test. The Company’s completed clinical trials showed a sensitivity of 100% for HIV-1 and HIV-2 MedMira’s Reveal® G4 HIV-1/2 rapid antibody test achieved a flawless 100% specificity and was reactive in early HIV-2 infections and seroconverts. The inclusion of the HIV-2 component allows CLIA laboratories, clinics, or hospitals, to use MedMira’s test. Subsequent to the successful FDA 510(k) approval, the Company commenced its clinical trials in the US to achieve its CLIA waived approval for the Reveal® G4 HIV-1/2 rapid test. At this time the Company is in the final phase and will provide an update in the first month of 2025 on its regulatory status, anticipating to have a final date at such time.
During FY2024, the Company completed its Syphilis clinical trials and made the submission of its data to the Health Canada's In Vitro Diagnostic Division, Medical Device Directorate. At this stage, all relevant data and questions have been completed. While MedMira’s focus has been the achievement of the regulatory approval of its Reveal® TP (Syphilis) rapid test in Canada, the Company has made two additional submissions for regulatory clearance in Canada and provided all necessary details to the regulatory authority. At this point the Company is awaiting the approvals of all three rapid test and anticipates these at any time.
In Q4 FY2024, the Company signed two substantial partnership agreements for the distribution of all current and future product lines of MedMira in the United States of America. Subsequent to the financial year end, MedMira signed two additional distribution agreements to target federal and state tenders in the US, in preparation of the Q1 FY2025 awards period. With this the Company has further expanded its presence and outreach to large volume contracts for its current (Reveal® G4 HIV-1/2 rapid test and Miriad®) product line while preparing for its upcoming approval of the Reveal® G4 HIV-1/2 rapid test CLIA waived product.
Subsequent to FY2024, MedMira in partnership with REACH Nexus at St. Michael’s Hospital’s MAP Centre for Urban Health Solutions, received the full funding for the clinical trials from the Canadian Institute of Health Research (CIHR) for its Multiplo® Complete Syphilis (TP/nTP) Antibody Test (Multiplo® TP/nTP). This grant was received in response to Health Minister Mark Holland’s announcement to fight the growing syphilis pandemic in North America.
Outlook
According to the latest CDC (US) report published in November 2024, between 2019 and 2023, there has been a sharp increase in Syphilis cases. For example, the CDC (USA) recorded a 61% increase in Syphilis and a 106% increase among newborns. In Canada, according to CCDR, syphilis infections increased by 109% since 2018 and a significant increase of 599% among newborns.
MedMira has strategically positioned its product portfolio to focus on asymptomatic infections (infections without or mild symptoms) and unknown infection statuses for sexually transmitted diseases such as HIV, Syphilis and Hepatitis C. These diseases represent one of the most significant screening and diagnostic market after oncology. Therefore, the Company’s strategic aim is to achieve regulatory approvals in the Canadian and US market and offer the fastest rapid testing solution to its customers. Whereas the stringent and complex regulatory approval process in these target countries are time and resources consuming, the high entry barriers in these markets have a significant lower amount of competition and a more attractive return-on-investment.
Specifically in Canada, since the COVID-19 pandemic, the overall recognition of rapid tests has significantly increased. As a result, the overall market for MedMira’s products in Canada has become a major revenue opportunity for FY2025. The Company has recorded a high demand from various organisations which will have a major impact on the financial success of MedMira in the coming year.
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 and medmira.ca. Follow us on Twitter and LinkedIn.
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.
