FDA Update

TruSpine Technologies PLC

19 February 2024

 

19 February 2024

TruSpine Technologies plc

("TruSpine" or the "Company")

FDA Update

TruSpine Technologies Plc, the medical device company focused on the spinal (vertebral) stabilisation market, announces an update on its U.S. Food and Drug Administration ("FDA") process in relation to its FDA 510(k) application for its Cervi-LOK product.

Further to the announcement on 5 January 2024, the Company confirms it has submitted additional documentation to the FDA in respect of the additional clarifications that the FDA were seeking. In the weeks leading up to the FDA submission, the Company has been in dialogue with FDA representatives in order to ensure all clarifications were discussed and answered to the extent possible. A further announcement will be made in due course.

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