TruSpine Technologies PLC FDA Update (9284Q)
July 01 2022 - 1:00AM
UK Regulatory
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RNS Number : 9284Q
TruSpine Technologies PLC
01 July 2022
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.
Further to the announcement of 28 April 2022, the Company is in
a position to file its 510k FDA submission, however it is awaiting
the FDA's response to the Company's request for a Breakthrough
Technology Designation ("BTD").
Once a decision has been communicated to the Company, the
Company will file either a BTD 510k application or a standard 510K
application following receipt of FDA response. The Directors
anticipate that the FDA response and subsequent submission are
expected by the end of July 2022 and an announcement will be made
in due course.
If "Breakthrough Device Technology" designation is conferred it
should bring significant long-term benefits in the
commercialisation of Cervi-LOK(TM), 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.
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.
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END
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