Trinity Biotech Announces That It Has Received 510(k) Clearance From The U.S. Food and Drug Administration for the Premier Resolution System
07 8월 2023 - 9:00PM
Trinity Biotech has received U.S. Food and Drug Administration
(FDA) 510(k) clearance for the Premier Resolution System, an
automated analyzer for the accurate & precise quantification of
hemoglobins F and A2, and the detection of >200 hemoglobin
variants. The Premier Resolution System is now cleared for sale in
the United States.
The Premier Resolution System is a lab-based
hemoglobin diagnostic system consisting of a high-performance
liquid chromatographic analyzer, reagents, analytical column, and
software which allows for the fractionation and quantitation of
fetal hemoglobin (Hb F), and hemoglobin A2 (Hb A2), and with
fractionation and presumptive identification of abnormal hemoglobin
variants. This is accomplished using the principles of ion-exchange
(IEX) high performance liquid chromatography (HPLC). The
Premier Resolution System is a modern successor to Trinity
Biotech’s Ultra System that held a leading position in the US
hemoglobin variant diagnostic market.
The hemoglobin variants detected by the Premier
Resolution can cause a range of medical conditions, including
thalassemias and Sickle Cell Disease, which significantly impact
the ability of red blood cells to efficiently transport oxygen. The
incidence of these variant conditions has been steadily growing
worldwide as global migration increases, and with this increase the
need for accurate diagnostic methods has become ever more
important. The Premier Resolution gives laboratories the tools to
easily identify clinically important variants.
Comments
Commenting, Aris Kekedjian, Chairman and Chief
Executive Officer of Trinity Biotech stated, “We welcome the news
that our Premier Resolution has received 510(k) clearance from the
FDA. Our intention is to regain our market leading position in
hemoglobin variant detection with a modern successor to the highly
regarded Ultra platform. The Premier Resolution System builds on
our Ion Exchange technology reputation for excellence in the
separation and identification of a broad range of rare hemoglobin
variants. It features a high degree of advanced feature flexibility
and a market leading combination of accuracy, speed and value. We
also expect this important 510(k) clearance from the FDA to drive
further penetration of the Premier Resolution System in key global
markets, including Brazil, and allow us to begin the regulatory
process for the Chinese market.
“This is an important milestone in the
transformation of Trinity Biotech, which is anchored by the
expansion of our hemoglobin and diabetes franchises. The Premier
Resolution represents the first in a number of expected product
roll-outs and investments in this space, with further product
upgrades in our core diabetes HbA1c platform expected to follow in
the new year.”
Premier Resolution System sales enquiries for
the US market should be sent to
louis.pastors@trinitybiotech.com
Forward Looking Statements
Certain statements made in this release that are
not historical are forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995. The
words “estimate”, “project”, “intend”, “expect”, “believe” and
similar expressions are intended to identify forward-looking
statements. These forward-looking statements involve known
and unknown risks and uncertainties. Many factors could cause
the actual results, performance or achievements of Trinity Biotech
to be materially different from any future results, performance or
achievements that may be expressed or implied by such
forward-looking statements, including, but not limited to, the
results of research and development efforts, risks associated with
the outbreak and global spread of the coronavirus (COVID-19), the
effect of regulation by the U.S. Food and Drug Administration and
other agencies, the impact of competitive products, product
development commercialization and technological difficulties.
For additional information regarding these and other risks and
uncertainties associated with Trinity Biotech’s business, reference
is made to our reports filed from time to time with the U.S.
Securities and Exchange Commission.
About Trinity Biotech
Trinity Biotech 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. The products are used to detect
infectious diseases and to quantify the level of Hemoglobin A1c and
other chemistry parameters in serum, plasma and whole blood.
Trinity Biotech sells direct in the United States, Germany, France
and the U.K. 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 plc
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Lytham Partners, LLC |
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Dr Gary Keating, CTO |
Joe Diaz |
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(353)-1-2769800 |
(1)-602-889-9700 |
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E-mail:
investorrelations@trinitybiotech.com |
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