Business
MedMira Reports FY2024 Fourth Quarter and Year End Financial Results
HALIFAX, NS / ACCESSWIRE / November 28, 2024 / MedMira Inc. (MedMira) (TSXV:MIR), reported today...
About this update from Medmira Inc.
[{"type":"text","content":"MedMira Reports FY2024 Fourth Quarter and Year End Financial ResultsHALIFAX, NS / ACCESSWIRE / November 28, 2024 / MedMira Inc. (MedMira) (TSXV:MIR), reported today on its financial results for the financial year ended July 31, 2024.Corporate UpdateIn 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 ...