TruSpine Technologies PLC Further re: FDA Update (4478U)

TIDMTSP

RNS Number : 4478U

TruSpine Technologies PLC

01 August 2022

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, provides an update in relation to its FDA submission.

Further to the announcement of 1 July 2022, the Company confirms that the FDA 510k submission process is still ongoing.

The instrument sterilisation testing which was referenced in FDA 510k update on 28 April 2022 has been delayed due to supply chain issues with medical grade steel. The US based supplier of the steel has confirmed it should be available by mid-August 2022, at which time the instruments will be manufactured and sent to the packaging plant to complete the outstanding FDA submission requirements for the 510k application process to be completed.

Ian Roberts, Chief Executive Officer, commented:

"I am proud of the TruSpine team for their diligence and hard work in these final stages of the FDA process. Whilst we acknowledge these delays are frustrating for shareholders this is highly technical and complex process which must adhere to the highest regulatory and testing regime in order to meet the FDA standards."

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: [phone] 
 Ian Roberts, CEO 
 
 Cairn Financial Advisers LLP (AQSE Corporate     Tel: [phone] 
  Adviser) 
 Liam Murray / Ludovico Lazzaretti 
 
 Oberon Capital (Joint Broker)                    Tel: [phone] 
 Mike Seabrook / Chris Crawford 
 
 Peterhouse Capital Limited (Joint Broker         Tel: [phone] 
  & Financial Adviser) 
 Lucy Williams / Duncan Vasey 
 
 Walbrook PR (Financial PR                Tel: [phone] or +44 
  & IR)                                                   (0) 7876 741 001 
 Anna Dunphy                                       [e-mail] 
 
 

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.

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August 01, 2022 06:03 ET (10:03 GMT)