TruSpine Technologies PLC Further re: FDA Update (0274H)
25 Julho 2023 - 3:00AM
UK Regulatory
TIDMTSP
RNS Number : 0274H
TruSpine Technologies PLC
25 July 2023
25 July 2023
TruSpine Technologies plc
("TruSpine" or the "Company")
Further re: FDA Update
TruSpine Technologies Plc, the medical device company focused on
the spinal (vertebral) stabilisation market, announces that,
further to the announcement on 1 August 2022, the Company confirms
that the FDA 510k submission for Cervi-LOK has been made to the
FDA.
The FDA's decision to provide clearance normally takes up to 90
days, following which the Company will be able to commence
marketing and sales of Cervi-LOK in the US, if clearance is
received from the FDA.
CEO Laurence Strauss commented: "Following a challenging period
for the Company, I am delighted to report further significant
progress. The FDA submission for Cervi-LOK represents a major
milestone for TruSpine, and, if clearance is received the prospect
of sales revenue generation will be potentially transformational
for the Company. I look forward to reporting back to you with
further progress."
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)20 7448 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
identi ed 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 re ect 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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July 25, 2023 02:00 ET (06:00 GMT)
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