RE: Truspine3 Oct 2023 07:17
Further re: FDA Update
03 October 2023
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 25 July 2023, the Company has received communication from the U.S. Food and Drug Administration ("FDA") in relation to its FDA 510(k) application.
The FDA has confirmed that it has completed the technical screening of the Company's submission and is seeking further clarification on certain matters, which the Board believe they can provide in the near future. The application has been placed on technical screening hold until such time the relevant information requested has been provided to the FDA. The submission can remain on hold until 25 March 2024.
CEO Laurence Strauss commented: "On behalf of the TruSpine board we are pleased to report progress with our 510(k) FDA application. Our technical team and advisers are working to provide the requisite clarifications to the FDA. I look forward to reporting on 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