TruSpine Technologies PLC - London Gatwick Airport-based medical device company - Confirms 510k submission made to US Food & Drug Administration for Cervi-LOK, further to an announcement on August 1 last year. Says an FDA decision to provide clearance normally takes up to 90 days, following which the cmpany will be able to commence marketing and sales of Cervi-LOK in the US, if clearance is received from the FDA.

Chief Executive Officer Laurence Strauss says: "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."

In August last year, it said instrument sterilisation testing which was referenced in FDA 510k update in April 2022 has been delayed due to supply chain issues with medical grade steel.

Current stock price: 2.00 pence on Aquis Stock Exchange in London, more than doubled on Tuesday

12-month change: down 57%

By Greg Rosenvinge, Alliance News reporter

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