TruSpine Technologies Plc

Regulatory Filings • Nov 2, 2021

National Storage Mechanism | Additional information

RNS Number : 1002R

TruSpine Technologies PLC

02 November 2021

TruSpine Technologies plc

("TruSpine" or the "Company")

FDA Update

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.

On 20 September 2021, the Company announced that it had commissioned Emergo, its regulatory partner, to prepare and file a submission requesting that the FDA examine the Company's Cervi-LOK™ product to be designated as a "Breakthrough Device Technology".  This submission was made on 26 October 2021.  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.

If the Company is not successful in receiving its Breakthrough Device Technology designation, it will continue to complete its FDA 510k application which it anticipates would be made Q2 2022.

Ian Roberts, CEO of TruSpine commented: "This is a positive step for the Company, and if successful, would reduce the time to an FDA clearance by half."

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 3638 5025
Ian Roberts, CEO
Cairn Financial Advisers LLP (AQSE Corporate Adviser)			Tel: +44 (0)20 7213 0880
Liam Murray / Ludovico Lazzaretti
Oberon Capital		Tel: +44 (0)20 3179 5300
Robert Hayward / Mike Seabrook / Chris Crawford
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.

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