Trinity Biotech Receives Early Approval from the World Health Organization to Begin Offshore Manufacturing of TrinScreen HIV & Uni-Gold HIV
December 18 2024 - 10:00AM
Trinity Biotech plc (Nasdaq: TRIB), a commercial-stage
biotechnology company focused on human diagnostics and diabetes
management solutions, including wearable biosensors, today
announced an important update on its Comprehensive Transformation
Plan, which includes the transfer of manufacturing of both
TrinScreen HIV and Uni-Gold HIV to a lower-cost offshore
manufacturing partner. Trinity Biotech has received earlier than
expected approval from the World Health Organization (WHO) to
permit the later-stage manufacturing process of TrinScreen HIV and
Uni-Gold HIV at its outsourced provider. This approval was a key
prerequisite in the manufacturing transfer the Company has been
working towards as part of its Comprehensive Transformation Plan.
“We are pleased to have received the earlier
than expected regulatory approval from the WHO to begin the
later-stage manufacturing processes of both of our rapid HIV tests,
TrinScreen HIV and Uni-Gold HIV, at our offshore manufacturing
facility,” said John Gillard, CEO of Trinity Biotech. “This
achievement represents a significant milestone for Trinity Biotech
in our previously announced Comprehensive Transformation Plan and
demonstrates the strong execution of our team in collaborating with
global regulatory authorities. We expect to begin manufacturing our
rapid HIV tests at the new location in Q1, 2025, which will benefit
our future growth, improve our margins and create shareholder
value. I would like to thank all the Trinity Biotech employees who
have pushed hard to attain this goal in an expedited manner.”
Forward-Looking StatementsThis
release includes statements that constitute “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995 (the “Reform Act”), including but not limited to
statements related to Trinity Biotech’s cash position, financial
resources and potential for future growth, market acceptance and
penetration of new or planned product offerings, and future
recurring revenues and results of operations. Trinity Biotech
claims the protection of the safe harbor for forward-looking
statements contained in the Reform Act. These forward-looking
statements are often characterized by the terms “may,” “believes,”
“projects,” “expects,” “anticipates,” or words of similar import,
and do not reflect historical facts. Specific forward-looking
statements contained in this release may be affected by risks and
uncertainties, including, but not limited to, our ability to
capitalize on the Waveform transaction and of our recent
acquisitions, our continued listing on the Nasdaq Stock Market, our
ability to achieve profitable operations in the future, the impact
of the spread of COVID-19 and its variants, potential excess
inventory levels and inventory imbalances at the company’s
distributors, losses or system failures with respect to Trinity
Biotech’s facilities or manufacturing operations, the effect of
exchange rate fluctuations on international operations,
fluctuations in quarterly operating results, dependence on
suppliers, the market acceptance of Trinity Biotech’s products and
services, the continuing development of its products, required
government approvals, risks associated with manufacturing and
distributing its products on a commercial scale free of defects,
risks related to the introduction of new instruments manufactured
by third parties, risks associated with competing in the human
diagnostic market, risks related to the protection of Trinity
Biotech’s intellectual property or claims of infringement of
intellectual property asserted by third parties and risks related
to condition of the United States economy and other risks detailed
under “Risk Factors” in Trinity Biotech’s annual report on Form
20-F for the fiscal year ended December 31, 2023 and Trinity
Biotech’s other periodic reports filed from time to time with the
United States Securities and Exchange Commission. Forward-looking
statements speak only as of the date the statements were made.
Trinity Biotech does not undertake and specifically disclaims any
obligation to update any forward-looking statements.
About Trinity BiotechTrinity
Biotech is a commercial stage biotechnology company focused on
diabetes management solutions and human diagnostics, including
wearable biosensors. The Company develops, acquires, manufactures
and markets diagnostic systems, including both reagents and
instrumentation, for the point-of-care and clinical laboratory
segments of the diagnostic market and has recently entered the
wearable biosensor industry, with the acquisition of the biosensor
assets of Waveform Technologies Inc. and intends to develop a range
of biosensor devices and related services, starting with a
continuous glucose monitoring product. Our products are used to
detect infectious diseases and to quantify the level of Haemoglobin
A1c and other chemistry parameters in serum, plasma and whole
blood. Trinity Biotech sells direct in the United States and
through a network of international distributors and strategic
partners in over 75 countries worldwide. For further information,
please see the Company's website: www.trinitybiotech.com.
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Contact: |
Trinity Biotech plcLouise
Tallon(353)-1-2769800 |
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LifeSci Partners, LLCEric
Ribner(1)-646-751-4363investorrelations@trinitybiotech.com |
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RedChip Companies Inc.Dave Gentry,
CEO(1)-407-644-4256TRIB@redchip.com |
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