FDA Update

01 July 2022

TruSpine Technologies plc, (AQSE: TSP) the medical device company focused on the development of its pioneering "screwless," spinal (vertebral) stabilisation systems, provides an update in relation to its FDA submissions.

Further to the announcement of 28 April 2022, the Company is in a position to file its 510k FDA submission, however it is awaiting the FDA's response to the Company's request for a Breakthrough Technology Designation ("BTD").

Once a decision has been communicated to the Company, the Company will file either a BTD 510k application or a standard 510K application following receipt of FDA response. The Directors anticipate that the FDA response and subsequent submission are expected by the end of July 2022 and an announcement will be made in due course.

If "Breakthrough Device Technology" designation is conferred it should bring significant long-term benefits in the commercialisation of Cervi-LOK™, including, higher margin as a result of preferred insurance coding and hospital reimbursement. The "Breakthrough Device Technology" designation would also reduce the time to an FDA 510k application clearance from 90 days to 60 days if granted.


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.



TruSpine Technologies Plc

Tel: +44 (0)20 3638 5025

Ian Roberts, CEO


Cairn Financial Advisers LLP (AQSE Corporate Adviser)

Tel: +44 (0)20 7213 0880

Liam Murray / Ludovico Lazzaretti


Oberon Capital (Joint Broker)

Tel: +44 (0)20 3179 5300

Mike Seabrook / Chris Crawford


Peterhouse Capital Limited (Joint Broker & Financial Adviser)

Tel: +44 (0)20 7469 0930

Lucy Williams / Duncan Vasey


Walbrook PR (Financial PR & IR)

Tel: +44 (0) 20 7933 7870 or +44 (0) 7876 741 001

Anna Dunphy

[email protected]


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.