Halifax, Nova Scotia, 20 May, 2022 – Today, MedMira Inc. (MedMira) (TSXV: MIR) provides an update on the Company’s regulatory work for Canada for its VYRA™ product line. On the 10th of May 2022, Health Canada issued to all stakeholder further information about the current Interim Order No. 3. As a result, the regulators have clearly defined the pathway to achieve the Interim Order and with it provided the Company with the last requirement to complete its final application for their review.
The final condition for MedMira is to complete an additional Canadian based clinical study to supplement its existing data. At this stage, MedMira has engaged a renowned third-party in Canada and already forwarded the clinical protocol to the Ethics Committee for acceptance. At the time of receiving the acknowledgment by the Ethics Committee, the clinical partner is capable to complete the study within weeks. With the completion of this final part, the Company has fulfilled all necessary requirements to seek for the authorization to sell the VYRA™ product line during and beyond the Interim Order No. 3.
“In our recent discussions with a representative of Health Canada, we felt a strong commitment to Canadian manufactured products. At the same time, they emphasized their priority being quality COVID-19 home tests. This combination will unburden the health care system with immediate access to products directly supplied within Canada rather than relying on importation.“ says Hermes Chan, CEO of MedMira. “This is the last step to complete our final application to Health Canada. After a lengthy waiting time, we have now clear defined milestones that are realistic and achievable within a short period. We are delighted to finally move forward and appreciate the pro-active work by the regulators to have a home-made product available in Canada.”
MedMira’s commencement of its applications in Canada will further expand and strengthen its product portfolio during a time when COVID-19 resurgence is being reported worldwide. Globally the confirmed number of COVID-19 cases is reported to be over 520 million cases and attributed to 6 million deaths. In Canada alone, as of May 2022, over 3 million cases and over 40,000 deaths have been reported. The Center for Disease Control and Prevention, US (CDC) reported, on May 11th, 2022, a moving average daily case count of over 84,000, which was a 30.7% increase compared to the previous week. Health officials in Canada predict this spike in infections to occur in the upcoming summer months and have voiced concerns on whether the healthcare system can handle that stress again.
VYRA™ COVID-19 Antigen Test (VYRA™ COVID-19) and VYRA™ CoV2Flu Antigen Test (VYRA™ CoV2Flu) were designed to be easy-to-use, manually performed, visually interpreted diagnostic tests. Compared to traditional lateral flow rapid diagnostic tests, MedMira’s Rapid Vertical Flow Technology® (RVF) allows the VYRA™ line of diagnostic tests to provide efficient and significantly faster detection with high sensitivity and specificity.