TruSpine Technologies PLC Further re: FDA Update (8541P)
12 Outubro 2023 - 3:00AM
UK Regulatory
TIDMTSP
RNS Number : 8541P
TruSpine Technologies PLC
12 October 2023
12 October 2023
TruSpine Technologies plc
("TruSpine" or the "Company")
Further re: FDA Update
TruSpine Technologies plc, (AQSE: TSP) the medical device
company focused on the development of its pioneering "screwless,"
spinal (vertebral) stabilisation systems announces that, further to
the announcement on 3 October 2023, the Company has submitted
additional documentation and provided further clarification in
regard to the questions raised by the U.S. Food and Drug
Administration ("FDA") relating to the Company's FDA 510(k)
application.
TruSpine CEO Laurence Strauss commented: "We are pleased the US
FDA have responded promptly regarding our 510(k) application for
Cervi-LOK. Our board have sought to clarify the matters raised and
responded promptly with the required documentation. The Board
believes the information provided should assist the FDA and help
them to complete their technical review. I look forward to
reporting back 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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