TruSpine Technolgs. - Further re: FDA Update
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: +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

truspine@walbrookpr.com

 

 

 

 

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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