TruSpine Technologies PLC FDA Update (1002R)
November 02 2021 - 8:29AM
UK Regulatory
TIDMTSP
RNS Number : 1002R
TruSpine Technologies PLC
02 November 2021
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.
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(TM) 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(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.
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.
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 Tel: +44 (0)20 3179 5300
Robert Hayward / Mike Seabrook /
Chris Crawford
Walbrook PR (Financial PR Tel: +44 (0) 20 7933 7870 or +44 (0) 7876
& IR) 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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