Miraculins Provides Updates on Current Initiatives
2014年4月24日 - 7:30PM
Marketwired
Miraculins Provides Updates on Current Initiatives
WINNIPEG, MANITOBA--(Marketwired - Apr 24, 2014) - Miraculins
Inc. (TSX-VENTURE:MOM) ("Miraculins" or the "Company"), a medical
diagnostic company focused on acquiring, developing and
commercializing diagnostic tests and risk assessment technologies
for unmet clinical needs, today provides an update on current
initiatives.
Master Investor Technology Showcase
The Company is pleased to announce that it will be a featured,
new technology exhibitor at the upcoming Master Investor Conference
to be held Saturday, April 26, 2014 in London, England. The
conference will provide a unique profile for Miraculins'
technologies within the UK investment community by showcasing and
demonstrating the Scout DS® Non-Invasive Diabetes Screening Test
and the PreVu® Non-Invasive Skin Cholesterol Test to conference
attendees.
Master Investor is regarded as the leading investor show in the
UK, uniting highly respected speakers and exhibiting companies from
a broad range of sectors. This year's Master Investor is expected
to draw an audience of well over 3,500 motivated investors, brokers
and industry analysts who come to research, analyze and invest.
Scout DS® - USFDA Pre-Submission Process
On December 23, 2013, Miraculins announced it had filed
pre-submission documentation with the USFDA (United States Food and
Drug Administration) towards securing Scout DS® marketing clearance
in the United States. Miraculins met with USFDA on March 19, 2014
to discuss the Company's Pre-Submission document. Scout DS®
performance, reported in recently published clinical studies, was
discussed at the meeting, as well as the proposed intended use of
the device. USFDA provided helpful advice to Miraculins and
requested additional information in order to issue guidance
regarding appropriate regulatory pathways for the product. The
additional information, in the form of a Pre-Submission Supplement,
is expected to be sent to the USFDA by the end of April. Scout DS®
has received regulatory clearance in Canada and throughout the
European Union.
Scout DS® - Chinese Distribution Agreement Negotiations
On January 31, 2014, Miraculins announced that it had executed a
term sheet ("Term Sheet") with Cachet Pharmaceutical Co., Ltd.
("Cachet") to appoint Cachet as the exclusive Chinese distributor
for the Scout DS® Non-Invasive Diabetes Screening Test. The Term
Sheet established the principal terms and conditions of the
proposed distribution agreement (the "Agreement") and provided
Cachet with an exclusive period of ninety days within which to
finalize definitive documentation. The parties continue to advance
discussions and make progress towards finalizing the definitive
documentation.
The completion of the definitive documentation and the execution
of the Agreement remain subject to all necessary contractual,
regulatory and corporate approvals of both Miraculins and Cachet
and the completion of satisfactory due diligence. The Term Sheet
provisions are not legally binding except for provisions regarding
exclusivity, confidentiality and governing law. There is no
assurance that the parties will enter into definitive documentation
or execute the Agreement contemplated by the Term Sheet.
Neither the TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in the policies of the TSX
Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release.
Scout DS® and PreVu® are
registered trademarks of Miraculins Inc. All Rights Reserved.
2014.
Miraculins Inc.Christopher J. MoreauPresident &
CEO204-477-7599204-453-1546info@miraculins.comwww.miraculins.com
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