TruSpine Technologies PLC FDA Update
2024年2月19日 - 4:00PM
RNS Regulatory News
RNS Number : 5223D
TruSpine Technologies PLC
19 February 2024
19 February 2024
TruSpine Technologies
plc
("TruSpine" or the
"Company")
FDA Update
TruSpine Technologies Plc, the
medical device company focused on the spinal (vertebral)
stabilisation market, announces an update on its U.S. Food and Drug
Administration ("FDA") process in relation to its FDA 510(k)
application for its Cervi-LOK product.
Further to the announcement on 5
January 2024, the Company confirms it has submitted additional
documentation to the FDA in respect of the additional
clarifications that the FDA were seeking. In the weeks leading up
to the FDA submission, the Company has been in dialogue with FDA
representatives in order to ensure all clarifications were
discussed and answered to the extent possible. A further
announcement will be made in due course.
This announcement contains inside
information for the purposes of the UK Market Abuse Regulation, and
the Directors of the Company are responsible for the release of
this announcement.
Enquiries:
TruSpine Technologies
Plc
|
Tel: +44 (0)20 7118 0852
|
Laurence Strauss, Chief Executive
Officer
|
|
|
|
Cairn Financial Advisers LLP
(AQSE Corporate Adviser)
|
Tel: +44
(0)20 7213 0880
|
Liam Murray / Ludovico
Lazzaretti
|
|
Peterhouse Capital Limited
(Broker & Financial Adviser)
|
Tel: +44 (0)20 7469 0930
|
Lucy Williams / Duncan
Vasey
|
|
Novus Communications (PR and
IR)
|
Tel: +44
(0)207 448 9839
|
Alan Green / Jacqueline
Briscoe
|
novuscomms@truspine.org
|
Caution regarding forward looking
statements
Certain statements in this
announcement, are, or may be deemed to be, forward looking
statements. Forward looking statements are identified by their use
of terms and phrases such as ''believe'', ''could'', "should"
''envisage'', ''estimate'', ''intend'', ''may'', ''plan'',
''potentially'', "expect", ''will'' or the negative of those,
variations or comparable expressions, including references to
assumptions. These forward-looking statements are not based on
historical facts but rather on the Directors' current expectations
and assumptions regarding the Company's future growth, results of
operations, performance, future capital and other expenditures
(including the amount, nature and sources of funding thereof),
competitive advantages, business prospects and opportunities. Such
forward looking statements reflect the Directors' current beliefs
and assumptions and are based on information currently available to
the Directors.
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END
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