Investors

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.

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