Truspine Technologies #TSP – Further re: FDA Update July 25, 2023 – Posted in: Blog, TruSpine Plc (TSP) – Tags: , , ,

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: +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)20 7448 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.