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TruSpine Technolgs. - Further re: FDA Update

Announcement provided by

TruSpine Technologies Plc · TSP

12/10/2023 07:00

TruSpine Technolgs. - Further re: FDA Update
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.


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


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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