VYRA™ Product Line Update
20 Mayo 2022 - 7:52AM
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.
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 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.
MedMira ContactMarkus MeileChief
Financial Officer MedMira Inc.ir@medmira.com
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