REDHAWK PARTNERS WITH PELICAN
ENGINEERING LLC
FOR GMP MANUFACTURING OVERSIGHT
RedHawk Nearing Completion of Steps
Necessary to Seek Medicare and
Medicaid Accreditation
LAFAYETTE, LOUISIANA
-- February
27, 2020 -- InvestorsHub
NewsWire -- RedHawk Holdings Corp.
(OTC:
SNDD) ("RedHawk" or the "Company")
a diversified
holding company engaged in sales and distribution of medical
devices, branded generic pharmaceutical drugs, commercial real
estate investment and leasing, point of entry full-body security
systems, and specialized financial services, announced today
that RedHawk
Research & Development LLC, a wholly-owned subsidiary of
the
Company,
has agreed
to partner
with Louisiana-based
Pelican
Engineering LLC ("Pelican") for the
supervision of the Company's quality assurance
and future research and development
programs.
Pelican is a
full-service electronics engineering design firm
that
provides engineering services and
component manufacturing in all aspects of the electrical,
electronics, and computer engineering
disciplines. Primarily focused on embedded printed circuit board hardware and software
development,
Pelican is capable of in-house engineering,
design, manufacturing,
and turn-key delivery of high-quality embedded systems.
Pelican was
instrumental in the redesign of the SANDD Pro™ as well as the new printed circuit
boards used
in the SANDD mini – HP™ and the
SANDD mini
– FR™. Separately, Pelican is also expected to
lead the development and redesign of "Centri", the Company's
controlled entry security system, a unique, closed
cabinet,
nominal dose transmission full-body x-ray scanner.
In June 2019, the
Company announced the transition and ongoing maintenance of its
current FDA-approved quality management system to the higher and
more stringent international medical device
standard,
ISO 13485:2016. The Company believes it
is now near completion of this
previously
announced quality management
transition and
has now partnered with Pelican to
develop and supervise the quality assurances testing
believed
necessary to
maintain adherence to the stringent standards of
ISO 13485:2016.
ISO
13485:2016 specifies global requirements for a quality management
system where an organization must demonstrate its ability, and the
ability of its suppliers, to provide medical devices and related
services
that consistently meet customer and applicable international
regulatory requirements. ISO 13485 was specifically developed with the
objective of harmonizing medical device
regulatory
requirements for quality management
systems in major markets around
the world
including
the
United
States,
Europe, Canada, Japan and Australia. ISO 13485 meets, or exceeds,
all
U.S. Food and Drug
Administration Quality System
Regulations Standard 21 CFR 820
which was
established in 1978 to outline Current Good
Manufacturing Practices
(GMP)
in the United
States.
Commenting on
the partnership with Pelican, G.
Darcy Klug, RedHawk's Chairman and Interim Chief Executive Officer,
said "We
believe the
previously announced partnership with the CKRX Enterprise sales
organization positions us well for the commercial launch of our
SANDD™ line of needle incineration
products.
Our next marketing focus is the consumer launch of
the SANDD™ line of needle incineration
devices. To properly position RedHawk for the consumer market, we
believe we
need to obtain Durable Medical Equipment
("DME") Accreditation of our quality assurance
program. The transition of our quality
assurance program to ISO 13485:2016 and the completion of the
quality assurance
partnership with Pelican is the next step in preparing for DME
Accreditation."
"DME
Accreditation is necessary for RedHawk to
obtain a DME supplier
license," continued Mr.
Klug.
"With
Pelican's support, we believe that we
are now positioned
to seek the necessary DME Accreditation
approvals. With DME Accreditation,
we
anticipate our customers will be eligible
to receive Medicare, Medicaid or insurance company reimbursement
for the purchase of our SANDD™ line of needle incineration
devices. Obtaining these approvals would be a major milestone
on the
path
for
RedHawk to
continue executing
on its business model."
# # #
About RedHawk Holdings Corp.
RedHawk Holdings Corp., formerly Independence Energy Corp., is
a diversified holding company which, through its subsidiaries, is
engaged in the sales and distribution of
medical devices, sales of branded generic
pharmaceutical drugs, commercial real estate
investment and leasing, sales of point of entry
full-body security systems, and specialized
financial services. Through its medical
products business unit, the Company sells
the Sharps and Needle Destruction Device
(SANDD™), WoundClot Surgical - Advanced Bleeding
Control, and the Carotid Artery
Digital Non-Contact Thermometer. Through our
United Kingdom based subsidiary, we manufacture and market
branded generic pharmaceuticals. RedHawk Energy holds the
exclusive U.S. manufacturing and distribution rights for the Centri
Controlled Entry System, a unique, closed cabinet, nominal dose
transmission full-body x-ray scanner. For more
information, please visit: http://www.redhawkholdingscorp.com
Cautionary Statement Regarding Forward-Looking
Statements
This release may contain forward-looking statements.
Forward-looking statements are all statements other than
statements of historical fact. Statements contained in this release
that are not historical facts may be deemed to be forward-looking
statements. The words "anticipate," "may," "can," "plans,"
"believes," "estimates," "expects," "projects," "targets,"
"intends," "likely," "will," "should," "to be,"
"potential" and any similar expressions are intended to identify
those assertions as forward-looking statements.
Investors are cautioned that forward-looking statements are
inherently uncertain. Actual performance and results may
differ materially from that projected or suggested herein due to
certain risks and uncertainties. In evaluating
forward-looking statements, you should consider the various factors
which may cause actual results to differ materially from
any forward-looking statements including those listed in the "Risk
Factors" section of our latest 10-K report. Further, the
Company may make changes to its business plans that could or will
affect its results. Investors are cautioned that the Company will
undertake no obligation to update any forward-looking
statements.
Company
Contact:
G. Darcy
Klug, Chairman,
CEO and CFO
(337)
269-5933
darcy.klug@redhawkholdingscorp.com
Investor
Relations:
Stephanie
Prince, Managing Director
PCG Advisory
(646)
762-4518
sprince@pcgadvisory.com
Media
Contact:
Valerie
Allen
Valerie Allen
Public Relations
(310)
382-7800
valerie@valerieallenpr.com
RedHawk (CE) (USOTC:SNDD)
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