TIDMTSP
RNS Number : 2873M
TruSpine Technologies PLC
20 September 2021
THIS ANNOUNCEMENT AND THE INFORMATION CONTAINED HEREIN IS NOT
FOR PUBLICATION, RELEASE OR DISTRIBUTION, DIRECTLY OR INDIRECTLY,
IN WHOLE OR IN PART, IN OR INTO THE UNITED STATES OF AMERICA,
CANADA, AUSTRALIA, NEW ZEALAND, THE REPUBLIC OF SOUTH AFRICA OR
JAPAN OR IN OR INTO ANY OTHER JURISDICTION WHERE TO DO SO WOULD
BREACH ANY APPLICABLE LAW OR REGULATION.
THIS ANNOUNCEMENT IS FOR INFORMATION PURPOSES ONLY AND DOES NOT
ITSELF CONSTITUTE AN OFFER FOR SALE OR SUBSCRIPTION OF ANY
SECURITIES IN THE COMPANY. THIS ANNOUNCEMENT DOES NOT CONSTITUTE OR
CONTAIN ANY INVITATION, SOLICITATION, RECOMMENDATION, OFFER OR
ADVICE TO ANY PERSON TO SUBSCRIBE FOR, OTHERWISE ACQUIRE OR DISPOSE
OF ANY SECURITIES OF TRUSPINE TECHNOLOGIES PLC IN ANY JURISDICTION
WHERE TO DO SO WOULD BREACH ANY APPLICABLE LAW OR REGULATION.
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION AS DEFINED IN
ARTICLE 7 OF THE MARKET ABUSE REGULATION NO. 596/2014 AS IT FORMS
PART OF THE UK LAW BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT
2018 ("MAR"). UPON THE PUBLICATION OF THIS ANNOUNCEMENT, THIS
INSIDE INFORMATION IS NOW CONSIDERED TO BE IN THE PUBLIC DOMAIN
.
TruSpine Technologies plc
("TruSpine" or the "Company")
Fundraise & Issue of Warrants, FDA update and Appointment of
Broker
TruSpine Technologies plc, (AQSE: TSP) the medical device
company focused on the development of its pioneering "screwless,"
spinal (vertebral) stabilisation systems announces that it has: (1)
conditionally raised GBP650,000 through a Fundraise of 6,500,000
new Ordinary Shares at a price of 10p per share; (2) the
appointment of Oberon Capital; and (3) update on the FDA
submission.
Fundraise & Issue of Warrants
The Fundraise comprises a Placing and a Subscription. 2,300,000
New Ordinary Shares will be issued by way of the Placing raising
gross proceeds of GBP230,000 and 4,200,000 New Ordinary Shares will
be issued through the Subscription raising gross proceeds of
GBP420,000. The Subscription shares and Placing shares will be
issued at a price of 10 p per share.
An additional 125,000 New Ordinary Shares at a price of 10 p per
share will be issued to a third-party involved in the Fundraise in
lieu of services rendered ("Fee Shares").
The Fundraise is conditional, inter alia, on the admission of
the Placing shares, the Subscription shares and the Fee Shares to
trading on AQSE, which is expected to occur on or around 30
September 2021.
Each New Ordinary Share issued pursuant to the Fundraise has one
warrant attached granting the holder the right to subscribe for an
additional one New Ordinary Share at an exercise price of 15 pence
per share for a period of 3 years following Admission.
The net proceeds of the Placing and Subscription will be used to
complete Cervi-LOK(TM) validation & testing, instrumentation,
and product moulds, FDA compliant quality management systems,
product launch marketing and general working capital.
Appointment of Broker
The Company announces that it has appointed Oberon Capital, part
of the Oberon Investments Group plc as sole broker to the Company
with immediate effect.
FDA Update
We continue to work with our key partners as we advance towards
our FDA 510k application, expected to be lodged in Q4 2021.
The following have now been completed since the last update to
market in April 2021:
-- Testing and design freeze of Cervi-LOK(TM) product
-- Testing and design freeze of Cervi-LOK(TM) instrumentation
-- Completion of three Cadaver Studies
-- Appointment of Anthony Swoboda as US Vice President of sales and marketing,
-- Appointment of consultant neurosurgeon Nik Patel as a Non-Executive Director
-- Appointment of William Lavalle, M.D., as the Chairman of our Medical Advisory board
The following are underway or contracted, in preparation for the
FDA 510k application:
-- Implementation of a Quality Management System, with our
regulatory partner, Emergo in conjunction with Greenlight Guru
leaders in document management systems. Manufacture of
Cervi-LOK(TM) moulds - manufacturer Forum Plastics LLC appointed in
August 2021
-- Manufacture of sealed sterile implant and instrumentation
packs - manufacturer Guardian Medical appointed in September 2021.
Independent product testing to be performed in the Lab of Vijay
Goel, Ph.D., at the University of Toledo.
-- Linkotek validation and verification testing
-- Completion of all regulatory filings in collaboration with Emergo
In parallel with the 510K application, TruSpine has commissioned
Emergo, to prepare and file a submission requesting that the FDA
examine the Cervi-LOK(TM) to be designated as a "Breakthrough
Device". This requires a new Q-Sub application which will require
additional time to prepare but will confer significant long-term
benefits on the Cervi-LOK(TM) and its commercialisation. This can
include higher margin returns through preferred insurance coding
and hospital reimbursement.
Total Voting Rights
Following Admission, the Company's issued share capital will
consist of 101,388,967 ordinary shares with voting rights. The new
ordinary shares will rank pari passu with the existing ordinary
shares. No ordinary shares are held in treasury at the date of this
announcement and therefore following the Admission, the total
number of Ordinary Shares in the Company with voting rights will be
101,388,967.
The above total voting rights figure may be used by shareholders
as the denominator for the calculation by which they will determine
if they are required to notify their interest in, or a change to
their interest in the Company.
Ian Roberts, CEO of Truspine commented: "We are pleased to
provide an update on the above matters to our shareholders. The
team are working extremely hard alongside our partners as we
advance the Cervi-LOK(TM) through this critical phase leading up to
lodgement of FDA 510k application. Our decision to pursue FDA
"Breakthrough Device" designation while adding time to the FDA
process, if successful will have significant long-term benefits for
the commercial development of the Cervi-LOK(TM) . We look forward
to moving rapidly to commercialisation phase during 2022."
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
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END
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September 20, 2021 04:47 ET (08:47 GMT)
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