TruSpine Technologies PLC Further re: FDA Update (4382O)

TIDMTSP

RNS Number : 4382O

TruSpine Technologies PLC

03 October 2023

3 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 25 July 2023, the Company has received communication from the U.S. Food and Drug Administration ("FDA") in relation to its FDA 510(k) application.

The FDA has confirmed that it has completed the technical screening of the Company's submission and is seeking further clarification on certain matters, which the Board believe they can provide in the near future. The application has been placed on technical screening hold until such time the relevant information requested has been provided to the FDA. The submission can remain on hold until 25 March 2024.

CEO Laurence Strauss commented: "On behalf of the TruSpine board we are pleased to report progress with our 510(k) FDA application. Our technical team and advisers are working to provide the requisite clarifications to the FDA. I look forward to reporting on 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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October 03, 2023 02:00 ET (06:00 GMT)

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