Further re: FDA Update

TruSpine Technologies PLC

12 October 2023

 

12 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 3 October 2023, the Company has submitted additional documentation and provided further clarification in regard to the questions raised by the U.S. Food and Drug Administration ("FDA") relating to the Company's FDA 510(k) application.

TruSpine CEO Laurence Strauss commented: "We are pleased the US FDA have responded promptly regarding our 510(k) application for Cervi-LOK. Our board have sought to clarify the matters raised and responded promptly with the required documentation. The Board believes the information provided should assist the FDA and help them to complete their technical review. I look forward to reporting back with further 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.

 

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