Further re: FDA Update

TruSpine Technologies PLC

25 July 2023

 

25 July 2023

TruSpine Technologies plc

("TruSpine" or the "Company")

Further re: FDA Update

TruSpine Technologies Plc, the medical device company focused on the spinal (vertebral) stabilisation market, announces that, further to the announcement on 1 August 2022, the Company confirms that the FDA 510k submission for Cervi-LOK has been made to the FDA.

The FDA's decision to provide clearance normally takes up to 90 days, following which the Company will be able to commence marketing and sales of Cervi-LOK in the US, if clearance is received from the FDA.

CEO Laurence Strauss commented: "Following a challenging period for the Company, I am delighted to report further significant progress. The FDA submission for Cervi-LOK represents a major milestone for TruSpine, and, if clearance is received the prospect of sales revenue generation will be potentially transformational for the Company. I look forward to reporting back to you 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.

 

END