Trinity Biotech Announces withdrawal of Troponin FDA 510(k) Submission
October 04 2016 - 8:30AM
Trinity Biotech plc (Nasdaq:TRIB), a leading developer and
manufacturer of diagnostic products for the point-of-care and
clinical laboratory markets, announced today that it is withdrawing
its 510(k) premarket notification submission for the Meritas
Troponin-I Test and Meritas Point-of-Care Analyzer.
The company held a meeting with the FDA on
Thursday 29 September, in order to obtain an update on the
company’s Meritas Troponin submission. At this meeting the
FDA asked Trinity to consider withdrawing their submission, due to
some concerns they have about the submission. Their primary
concerns relate to the device’s operating temperature range and
that the Troponin-I clinical performance is not consistent with the
clinical performance data presented by the most recently cleared
laboratory Troponin device.
Whilst we believe that the Meritas product
demonstrates excellent performance for a point-of-care product and
is superior to all existing point-of-care Troponin products in the
market, we decided yesterday to withdraw the submission. Over the
coming weeks we will engage with the FDA to gain a better
understanding of the nature of their concerns. However, it is our
understanding that in order for any new point-of-care Troponin
product to obtain clearance, the FDA will require it to demonstrate
performance equivalent to the most recently cleared laboratory
based device. Our decision to withdraw is based on the fact that,
notwithstanding its excellent performance characteristics, we
believe that there is no certainty that this level of performance
can be achieved by the Meritas product even with the benefit of
further development efforts.
We will now embark upon an internal process to
determine the best future opportunity for this technically
excellent platform, concentrating on which products and markets we
should focus on, including establishing the optimal strategic
outcome for Troponin. This process is expected to take between 9
and 12 months. In the meantime we have decided to move the
technology from our Swedish facility in Uppsala to our facility in
Bray, Ireland where it will be incorporated into our existing
R&D and manufacturing infrastructure. This will result in
the closure of the Uppsala facility, which will result in
approximately 40 redundancies.
Consequently expenditure levels, which are
currently running at an annualised rate of over $9m, will be
reduced to approximately $1.5m per annum. There will however, be
Swedish redundancy and closure costs which are currently in the
process of being determined. The company will also recognise
a non-cash write-off in excess of $50m, representing the costs
incurred on the project, which will be recognised in our Q4 income
statement.
Conference Call
announcement
The Company has scheduled a conference call for
today, Tuesday, October 4, 2016 at 11:00am ET (4:00pm BST) to
discuss the matter further.
Interested parties can access the call by
dialing:
USA: |
|
1-844-861-5499 |
International: |
|
1-412-317-6581 |
Conference ID #: |
|
10094060 |
|
|
|
A simultaneous webcast of the call can be
accessed at: https://www.webcaster4.com/Webcast/Page/1135/17597
A replay of the call can be accessed until October 11, 2016 by
dialing:
USA: |
|
1-877-344-7529 |
International: |
|
1-412-317-0088 |
Conference ID #: |
|
10094060 |
|
|
|
The webcast of the call will be available for 30 days at:
https://www.webcaster4.com/Webcast/Page/1135/17597
Forward-looking statements in this release are
made pursuant to the "safe harbor" provision of the Private
Securities Litigation Reform Act of 1995. Investors are
cautioned that such forward-looking statements involve risks and
uncertainties including, but not limited to, the results of
research and development efforts, the effect of regulation by the
United States Food and Drug Administration and other agencies, the
impact of competitive products, product development
commercialisation and technological difficulties, and other risks
detailed in the Company's periodic reports filed with the
Securities and Exchange Commission.
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 Haemoglobin 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.
Contact:
Trinity Biotech plc
Kevin Tansley
(353)-1-2769800
E-mail: kevin.tansley@trinitybiotech.com
Lytham Partners LLC
Joe Diaz, Joe Dorame & Robert Blum
602-889-9700
Trinity Biotech (NASDAQ:TRIB)
Historical Stock Chart
From Mar 2024 to Apr 2024
Trinity Biotech (NASDAQ:TRIB)
Historical Stock Chart
From Apr 2023 to Apr 2024