TIDMTSP
RNS Number : 6172J
TruSpine Technologies PLC
28 April 2022
TruSpine Technologies plc
("TruSpine" or the "Company")
US Reseller and Funding Agreement
Proposed Board Changes
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
entered into a master agreement ("Funding Agreement") with Proffitt
Brothers Investments, LLC ("Proffitt Brothers") and Spartan
Medical, Incorporated ("Spartan Medical") setting out an agreement
on a strategic partnership and to provide funding, and an exclusive
US Reseller Agreement ("Reseller Agreement") to market and
distribute the Cervi-LOK(TM) device to US Government healthcare
facilities once the Cervi-LOK(TM) has completed FDA clearance.
Funding Agreement
The Funding Agreement, provides that Proffitt Brothers, the
investment vehicle of Spartan Medical will provide the Company with
$US400,000 of funding (of which $100,000 has been received by the
Company), as set out below:
Tranche 1 $US100,000 on signing of the master agreement (payment
received)
Tranche 2 $US100,000 on lodgement 510k FDA application
-------------------------------------------------------
Tranche 3 $US200,000 on FDA clearance of Cervi-LOK(TM) device
-------------------------------------------------------
Furthermore, the Company has agreed to immediately issue
Proffitt Brothers a warrant over one million shares exercisable at
20 pence per share, expiring on 31 December 2026 and a further
warrant over one million shares exercisable at 20 pence per share
on completion of Tranche 3 funding.
Reseller Agreement
The Company has also entered into a Reseller Agreement with
Spartan Medical for initial term of two years from FDA clearance
with an extension of a further two years subject to minimum $US 2
million sales by Spartan Medical in first period and a further two
years extension with minimum $US 7 million sales in second
period.
The Reseller Agreement provides for an exclusive right to market
and sell Cervi-LOK(TM) to Government Healthcare Facilities in the
US.
Spartan Medical is a leader in US medical device sales with
rapid revenue growth of 183% in 2021, reaching a turnover of almost
$32 million. It was founded in 2008 by a former US Air Force
Intelligence Officer, Vince Proffitt with the mission of providing
an extensive portfolio of advance medical devices to meet the
specific needs of the US Department of Veterans Affairs ("VA") and
the US Department of Defence, each of which have contracted with
Spartan Medical as a preferred partner.
The VA is the largest healthcare system in the United
States-nearly the size of the UK's NHS-with an annual budget of
over $220 billion, serving nearly 10 million veterans, and
operating 171 hospitals and surgical centres in all 50 states. As a
Service-Disabled Veteran-Owned business, Spartan Medical has a long
track record of successfully meeting the VA's needs as part of an
ongoing, department-wide, $2.1 billion long-term supply
contract.
Proposed Board Changes
Vince Profitt is a veteran of the United States Air Force
("USAF") where he spent five years of his service as an
Intelligence Officer ("IO"). In his last Active Duty assignment, he
was responsible for the management and strategic planning of the
USAF IO Officer training course, and directly supervised over 40
instructors and managed over 1150 hours of training syllabus.
Following his time in the USAF, Vince joined Medtronic, a
healthcare technology solutions company, as a sales representative
where he became one of the top 10 sales reps in the country for
surgical products as a President's Club inductee. He founded
Spartan Medical in 2008 to supply a broad and thorough product line
dedicated to best-in-class technologies. He is nationally
recognised as a medical device expert, a successful business owner,
and an industry thought leader.
FDA 510K update
The Company confirms it expects to lodge the FDA 510k submission
prior to end of Q2 2022 and provides the following updates from its
respective technical partners:
-- all third party biomechanical testing has been completed on
Cervi-LOK(TM) with final reports being prepared for FDA
submission;
-- packaging sterilisation verification and validation has commenced on Cervi-LOK(TM);
-- instrumentation sterilisation verification and validation
will commence in early May 2022; and
-- all regulatory components of the FDA 510k submission
application to be completed by the first week of May 2022.
Ian Roberts, CEO of TruSpine commented: "This is a validation of
our ground-breaking first spinal stabilisation device, the
Cervi-LOK(TM) , which is advancing towards FDA clearance. We are
excited to have Vince join the TruSpine Board, his experience and
knowledge in the distribution of medical products will be
invaluable to our growth and development."
Spartan Medical's President Vince Proffitt stated: "The
Cervi-LOK(TM) is one of most exciting technologies our team has
seen in the past decade. We believe it can transform the way that
spinal stabilisation is efficiently and safely delivered for better
patient outcomes, nationwide, and even in forward operating medical
facilities."
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 (Broker) Tel: +44 (0)20 3179 5300
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. The
stated parameters of the planned agreement between the Company and
Spartan Medical, Inc. do not necessarily represent a final,
legally-binding contract. 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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