Therma Bright Enters into
Co-Development Agreement with Orpheus
Medica's
COVID-19
Rapid
Saliva
Test,
CoviSafe™
Toronto,
Ontario – August 27,
2020 – InvestorsHub NewsWire --
Therma Bright Inc. (TSXV: THRM) ("Therma" or the "Company"), a progressive
medical device technology company, is pleased to announce that it
has signed
a co-development definitive agreement with
Orpheus Medica
Inc. ("Orpheus") or (Therma &
Orpheus, the
"Parties"). This agreement will allow
Therma access to Orpheus' novel biological platform and the joint
development of a rapid saliva test for
the screening and
detection of the
virus (SARS-CoV-2) causing COVID-19.
Under this
agreement, Therma will provide
funding for the project in phases ("Phase" or
"Phases") as certain developmental
milestones
are
achieved, Therma will commit up
to
$300,000 for
Phase 1 which will focus on the identification
of
anti-COVID-19 poly-peptides
to be utilized in
the test prototype development
stage. Therma and Orpheus
expect Phase 1 to take approximately
45 days
to
complete. Therma and Orpheus have
identified several 3rd
party providers
to assist with the Phase 1 development
path.
During Phase
2,
Therma's and Orpheus' partnership with
various clinical institutions will focus on clinical
validation of the test prototype in up to 250 clinical samples. After Phase
2,
Therma can decide
to advance to Phase 3 only upon success with
Phases 1 and 2. Phase 3
will
include regulatory
enabling
studies where the Parties expect to apply for
EUA approvals during Phase 3 including
commercialization activities.
Upon
approval by regulatory bodies
of CoviSafe™, Therma and Orpheus expect
to market its rapid test for use by education
systems,
businesses of all types, public events and other
venues,
sporting events or activities where a
COVID-19 test is required and useful.
As stated in the
Therma press release on August 20, 2020, CoviSafe™ is intended to have unique
features such as high accuracy, sensitivity, and specificity
while delivering results in less than 20
minutes.
CoviSafe™ screens and
directly
detects
the virus rather
than its genetic material
in saliva or as
needed in other biological samples. It can be tested anywhere
without the need for the test sample to be sent to a lab
for processing by a trained technician. The test can be used
alongside current testing methods in areas where laboratory access
is limited or non-existent.
Additionally,
Therma has negotiated terms in the co-development agreement for the
right to invest in a COVID-19 therapeutic drug development program
currently underway by the same management team as Orpheus' and
under a separate corporate entity. Therma's participation
will be by way of an equity investment to be announced at the time
of investment.
Mr. Rob Fia, CEO
of Therma Bright commented, "We are excited to have entered into this
co-development arrangement with
the Orpheus' team and its vast network
of academic and clinical institution
collaborators. Therma is committed to an
expedited path to regulatory approval of
the
CoviSafe™ test
by providing its
expertise in medical device engineering,
compliance,
and
regulatory
affairs".
Dr. Saeid Babaei,
Chairman & CEO of Orpheus Medica commented,
"Orpheus
can leverage the partnership
with Therma by
using its internal core capabilities including research and development, and
clinical trial operations and validation to improve the speed, accuracy,
accessibility, and affordability of COVID-19 testing, a major step
in helping to prevent the spread of
COVID-19.
We have
assembled a number of key collaborations
with various industry and
academic entities to innovate and
accelerate our developmental
timelines
in addition to engaging with our trusted and
established suppliers, manufacturers
and service
providers".
About
Therma Bright
Inc.
Therma
Bright is
a progressive medical device technology company focused on
providing consumers and medical professionals with quality medical
devices that address their medical and healthcare needs. The
Company's initial breakthrough proprietary technology delivers
effective, non-invasive and pain-free skincare. Therma Bright
received a Class
II medical device status from the FDA for its platform technology
that is indicated for the relief of the pain, itch, and
inflammation of a variety of insect bites or stings. The Company
received clearance for the above claims from the US FDA in
1997.
Therma
Bright Inc. trades on the TSXV
(TSXV: THRM). For more information visit:
www.thermabright.com and
www.coldsores.com.
About Orpheus Medica Inc.
Orpheus Medica is
a fully
integrated research-driven Canadian biotech company
focused on the development and commercialization of innovative
diagnostic and therapeutics for unmet medical needs. Orpheus, with
its fully integrated R&D infrastructure, provides strategic
partners and collaborators access to its proven and proprietary
discovery and development of novel biopharmaceutical products. Our
team has over 15 years of proven and validated computational
capabilities for analysis and optimization of antibodies and
peptides as well as small molecules.
For further
information, please contact:
Therma
Bright
Rob Fia,
CEO
rfia@thermabright.com
Orpheus
Medica
Saeid Babaei,
Chairman & CEO
sbabaei@orpheusmed.com
FORWARD
LOOKING STATEMENTS
Certain
statements in this news release constitute "forward-looking"
statements. These statements relate to future events such as
development and commercialization of a rapid COVID-19 viral assay
and related instrumentation to support the Company's
future performance. as described in the news release. All such
statements involve substantial known and unknown risks,
uncertainties and other factors which may cause the actual results
to vary from those expressed or implied by such forward-looking
statements. Forward-looking statements involve significant risks
and uncertainties, they should not be read as guarantees of future
performance or results, and they will not necessarily be accurate
indications of whether or not such results will be achieved. Actual
results could differ materially from those anticipated due to a
number of factors and risks. Although
the forward-looking statements contained in this news release are
based upon what management of the Company believes are reasonable
assumptions on the date of this news release, the Company cannot
assure investors that actual results will be consistent with these
forward-looking statements. The forward-looking statements
contained in this press release are made as of the date hereof and
the Company disclaims any intention or obligation to update or
revise any forward-looking statements whether as a result of new
information, future events or otherwise, except as required under
applicable securities regulations.
Neither the 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 press release.
This press
release is not an offer of the securities for sale in the United
States. The securities have not been registered under the U.S.
Securities Act of 1933, as amended, and may not be offered or sold
in the United States absent registration or an exemption from
registration. This press release shall not constitute an offer to
sell or the solicitation of an offer to buy nor shall there be any
sale of the securities in any state in which such offer,
solicitation or sale would be unlawful.