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: +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)207 448 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 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.

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our Privacy Policy.
 
END
 
 
UK 100

Latest directors dealings