30 Oct 2023 07:00
30 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 12 October 2023, the Company has received communication from the U.S. Food and Drug Administration ("FDA") that its FDA 510(k) application has been progressed to the substantive review stage.
CEO Laurence Strauss commented: "I am delighted that after the prompt response of the Company in providing clarification and documentation to the US FDA in support of our 510(k) application for Cervi-LOK, the FDA have moved the application on to the substantive review stage. I hope to be able to provide news of further developments in the near future."
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)1273 704473 |
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 identi?ed 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 re?ect the Directors' current beliefs and assumptions and are based on information currently available to the Directors.
Truspine Technologies Plc (TSP.PL)