TruSpine Technologies PLC Further re: FDA Update (4478U)
August 01 2022 - 5:03AM
UK Regulatory
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: +44 (0)20 3638 5025
Ian Roberts, CEO
Cairn Financial Advisers LLP (AQSE Corporate Tel: +44 (0)20 7213 0880
Adviser)
Liam Murray / Ludovico Lazzaretti
Oberon Capital (Joint Broker) Tel: +44 (0)20 3179 5300
Mike Seabrook / Chris Crawford
Peterhouse Capital Limited (Joint Broker Tel: +44 (0)20 7469 0930
& Financial Adviser)
Lucy Williams / Duncan Vasey
Walbrook PR (Financial PR Tel: +44 (0) 20 7933 7870 or +44
& IR) (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
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.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
NEXUAVKRUKUWRRR
(END) Dow Jones Newswires
August 01, 2022 06:03 ET (10:03 GMT)
TruSpine Technologies (AQSE:TSP)
Historical Stock Chart
From Apr 2024 to May 2024
TruSpine Technologies (AQSE:TSP)
Historical Stock Chart
From May 2023 to May 2024
