Further re: FDA Update

TruSpine Technologies PLC

30 October 2023

 

30 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 12 October 2023, the Company has received communication from the U.S. Food and Drug Administration ("FDA") that its FDA 510(k) application has been progressed to the substantive review stage.

CEO Laurence Strauss commented: "I am delighted that after the prompt response of the Company in providing clarification and documentation to the US FDA in support of our 510(k) application for Cervi-LOK,  the FDA have moved the application on to the substantive review stage. I hope to be able to provide news of further developments in the near future."

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.

 

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