Relay Medical Corp. (“
Relay” or the
“
Company”) (CSE: RELA, OTC: RYMDF, Frankfurt:
EIY2), a developer of MedTech innovation, announces that it has
entered into a binding letter of intent (the “
Letter of
Intent”) with Proprietary Innovation Labs Inc.
(“
PIL”) relating to the exclusive sale and
distribution of rapid diagnostic tests for COVID-19 (the
“
Products”). The binding LOI was signed November
9, 2020.
Under the terms of the LOI agreement Relay
Medical’s diagnostics subsidiary, HemoPalm Corp. will acquire the
exclusive global rights excluding China to Proprietary Innovation
Labs’ COVID-19 product line including CE approved antibody and
antigen lateral flow rapid diagnostic tests (RDT).
PIL has developed both antigen and antibody
tests for the SARS-CoV-2 virus with its manufacturing partners.
These test kits are suitable for point of care testing and are
based on lateral flow chromatographic immunoassay for qualitative
detection. The tests are easy to use, require no extra equipment,
possess high diagnostic accuracy and results are available in as
little as 10 minutes. Test kits are packaged with all necessary
materials to run the test which is read visually in a manner like
pregnancy-test sticks. Through its contract manufacturing
facilities PIL can produce over 25 million tests per month.
“Screening, testing and tracing is absolutely
crucial to the effective management of day-to-day life during a
global pandemic like COVID-19. This is a global infection, and
management will require a plethora of solutions, technologies and
protocols to allow people to return back to school, work and
recreation with confidence. Even after a worldwide mass
deployment of a vaccine, continuous testing support will likely be
needed for a significant period of time.” said Yoav Raiter, CEO,
Relay Medical Corp.
“The partnership between Relay and PIL is as
exciting as it is important. We are now able to offer a complete
holistic solution using our antigen and antibody tests in tandem
with Relay’s cloud-based verification, tracking, and reporting
technology. This partnership is an exciting moment for PIL and
their initiatives to combat the COVID-19 pandemic.” said Richard
Waters, President, Proprietary Innovation Labs Inc.
View the PIL Antibody RDT instructional video by
clicking the link: PIL COVID-19 Antibody Test
According to PIL, the clinical sensitivity
(confirmed positive with a PCR nucleic test) for the antigen tests
is 95.0% and the clinical specificity (confirmed negative with a
PCR nucleic test) is 99.6%. For the PIL antibody tests the clinical
sensitivity is 93.3% for samples collected after the onset of
symptoms with a clinical specificity of 99.0%.
These tests can help healthcare professionals
identify active SARS-CoV-2 infections (antigen) and immune
responses (antibody) in people suspected to be carrying the virus
or confirming previously exposure allowing for better patient
management as well as more effective use of healthcare resources.
The company believes that rapid antibody tests can play an
important role in characterizing a vaccine-induced immune response
meaning that these tests could be used to evaluate the
effectiveness of COVID-19 vaccines when they are deployed.
Early detection using rapid antigen tests can also provide
further protection to front-line workers as a possible screening
tool for the identification of COVID-19 amongst front line health
care workers and employees.
The PIL antigen and antibody detection kits have
CE certification meaning that the manufacturer and products have
met EU declaration of standards for health, safety and
environmental protection, allowing these products to be sold within
the 22 countries in the European Economic Area. PIL and Relay will
consider applying to submit these tests for further approvals to
the FDA for emergency use authorization (EUA) and to Health Canada
for approval under the Medical Devices Interim Order (IO).
Relay and PIL intend to source additional
clients for the Products which will be manufactured pursuant to
PIL’s guidelines and protocols and will consist of an identifiable
exclusive brand to be mutually agreed by the parties. Relay
and PIL will share the profits earned from the sale of the
Products, with the party sourcing the purchaser earning 60% and the
other party earning 40%. The Company and PIL plans to sell
these kits in all countries where the kits have been approved for
sale.
Relay and PIL have agreed to negotiate and
execute a definitive agreement setting out the terms of its
relationship in greater detail which will contain the terms,
covenants, representations, warranties and indemnities as set forth
in the Letter of Intent, and such other terms as agreed by the
parties. The Letter of Intent will terminate if a definitive
agreement has not been entered into by the parties within 45 days
following a due diligence process.
Relay is issuing 400,000 common shares to the
shareholders of PIL as consideration of the agreement.
*Clinical Accuracy
The clinical performance of the PIL Antigen tests
was evaluated compared to RT-PCR positive cases at one
hospital:
|
Method |
|
PCR Test |
|
|
|
PIL AntigenRapid Test Kit |
Results |
Positive |
Negative |
Total |
|
|
Positive |
96 |
1 |
97 |
|
|
Negative |
5 |
219 |
224 |
|
|
Total Results |
|
101 |
220 |
321 |
|
Relative
Sensitivity |
96/101 |
95.0% |
Relative Specificity |
219/220 |
99.6% |
Accuracy |
315/321 |
98.1% |
The clinical performance of the PIL Antibody tests
was evaluated using 536 clinical serum samples collected after
diagnosis of COVID-19 infection with symptoms:
|
|
Sensitivity |
Specificity |
|
|
IgM+IgG |
93.3% |
99.7% |
|
|
IgM |
85.8% |
99.5% |
|
|
IgG |
90.2% |
99.0% |
|
**The Companies are not making any express
or implied claims that its product has the ability to eliminate,
cure or contain the COVID-19 (or SARS-2 Coronavirus) at this
time.
SUBSCRIBE: For more information on
Relay or to subscribe to the Company’s mail list visit:
https://www.relaymedical.com/news
About Proprietary Innovation Labs
Inc. Founded in 2013, PIL invents, develops, innovates,
and manufactures unique products, solutions, and technologies for
mass-market sale around the world. Initially starting with
innovative glass technology, PIL has developed strategic business
relationships overseas to enable large scale manufacturing of
reliable, accurate, and cost-effective COVID-19 test technologies.
PIL executes on its strategic ability to reliably upscale existing
manufacturing processes with an important emphasis on rigorous
quality management implementations. More information:
www.proinnolabs.com
About Relay Medical Corp.
Relay Medical is a MedTech innovation Company headquartered in
Toronto, Canada focused on the development of novel technologies in
the diagnostics and AI data science sectors.
Relay Medical Corp. website:
www.relaymedical.com
Contact: W. Clark Kent President
Relay Medical Corp. Office. 647-872-9982 ext. 2 TF. 1-844-247-6633
ext. 2
investor.relations@relaymedical.com
Bernhard Langer EU Investor Relations Office.
+49 (0) 177 774 2314 Email: blanger@relaymedical.com
Forward-looking Information Cautionary
Statement
Except for statements of historic fact, this
news release contains certain "forward-looking information" within
the meaning of applicable securities law.
Forward-looking information is frequently characterized by words
such as "plan", "expect", "project", "intend", "believe",
"anticipate", "estimate" and other similar words, or statements
that certain events or conditions "may" or "will"
occur. Forward-looking statements are based on the
opinions and estimates at the date the statements are made, and are
subject to a variety of risks and uncertainties and other factors
that could cause actual events or results to differ materially from
those anticipated in the forward-looking statements including, but
not limited to, delays or uncertainties with regulatory
approvals. There are uncertainties inherent in
forward-looking information, including factors beyond the Company’s
control. In particular, there is no guarantee that the
parties will successfully negotiate and enter into a definitive
agreement or complete the sale of any Products contemplated
herein. The Company undertakes no obligation to update
forward-looking information if circumstances or management's
estimates or opinions should change except as required by
law. The reader is cautioned not to place undue
reliance on forward-looking statements. Additional
information identifying risks and uncertainties that could affect
financial results is contained in the Company’s filings with
Canadian securities regulators, which filings are available at
www.sedar.com.
Neither CSE nor its Regulation Services Provider
accepts responsibility for the adequacy or accuracy of this
release.
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