Further re: FDA Update

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: [phone]
Laurence Strauss, Chief Executive Officer
Cairn Financial Advisers LLP (AQSE Corporate Adviser)	Tel: [phone]
Liam Murray / Ludovico Lazzaretti
Peterhouse Capital Limited (Broker & Financial Adviser)	Tel: [phone]
Lucy Williams / Duncan Vasey
Novus Communications (PR and IR)	Tel: [phone]
Alan Green / Jacqueline Briscoe	[e-mail]

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.

 

END