Bio-AMD, Inc.; Annual Report and Operational Update
LONDON, UNITED KINGDOM -- (Marketwired) -- 03/31/14 -- Bio-AMD, Inc.
(OTCQB: BIAD) ("we", the "Company") is pleased to announce that on
March 28, 2014 it filed its 10K annual report for the year ending
December 31, 2013.
The Company here provides an operational update on progress at its
core subsidiary, Bio AMD Limited, a technology developer for Point of
Care ("POC") medical diagnostic devices.
Our strategy is to build a pipeline of POC products based across our
unique technology platforms and bring products to market by way of a
limited number of development and licensing deals with suitable
partners or licensees, i.e. large multi-billion market capitalisation
companies, ideally with a global reach. Our revenue model focuses on
licence fee/royalty income and we will assess opportunities to
manufacture in-house as they arise. During 2013 and to date we have
continued to work toward commercialising our subsidiary's two most
advanced technologies, COAG and DSR.
This strategy is designed to avoid "go-it-alone" development
associated with assuming the totality of risks and costs associated
with launching a med-tech device in a market largely serviced by
powerful players. However, as we are consequently aiming to conclude
a small number of significant, step-changing agreements this has
resulted in slow news flow to date.
We have set out below an update on COAG and DSR to provide
information on where the Company is in relation to potential
commercial agreements. In addition, we provide an update on our
Magnetic Immunoassay Detection System ("MIDS", formerly referred to
as Magnetic Particle Reader or MPR) technology strategy, which we
expect will underpin the next stage of our development.
2013, the POC blood coagulation market was estimated to be worth
approximately US $870 million globally and projected to grow to an
estimated US $1.1 billion by 2017.
Bio-AMD's COAG POC system is based on our disposable microfluidic
strip. During 2013 we further developed our strip design to
incorporate multi-chambers. This is expected to allow the testing of
coagulation immunoassays that utilize multiple reagents, and is
subject to a new patent application. We anticipate the newly designed
strip to detect not only for the commonly tested prothrombin time
("PT")/International Normalized Ratio ("INR"), but also other tests
such as Activated Partial Thromboplastin Time ("APTT").
We are in advanced and active discussions with a potential suitable
partner, and anticipate that we will enter into an agreement to
undertake a detailed feasibility study to assess our newly designed
multi-chamber microfluidic strip for coagulation tests using
immunoassays requiring single and multiple reagents.
We are delighted to have interested such a potential partner in our
COAG POC system and, subject to an acceptable formal agreement being
successfully concluded (of which there is no certainty), we look
forward to developing our COAG system for multiple coagulation tests.
Our DSR technology platform can read and quantify traditional
chromatography based, nitro-cellulose, lateral-flow immunoassay
tests, predicated on what we believe to be a unique optical sensor
arrangement. The DSR comprises a proprietary design incorporating
sensors, diagnostics, display and power management capabilities. A
key feature of our DSR technology is that its platform can be adapted
and applied to numerous and disparate lateral flow diagnostic tests.
During 2013 we undertook two extensive testing studies in conjunction
with a potential partner, enabling the assessment of our technology
for use in a disposable digital pregnancy test kit. The studies
involved the creation of a disposable handheld device incorporating
our technology to read lateral flow analogue test strips supplied by
the potential partner with strict protocol independent testing
undertaken by them. Discussions are on-going and whilst there can be
no assurance that a formal agreement will be concluded we are very
pleased with the results of these detailed studies.
MIDS, Magnetic Immunoassay Detection System
Demand is increasing for POC tests that can detect and fully quantify
low concentrations of a target analyte. Currently, these types of
test are laboratory based.
The MIDS POC platform, in early stage development, incorporates what
we believe to be a novel microfluidic strip design (including
multi-chamber), combining magnetic nanoparticle manipulation and a
double detection technique using bespoke Hall Effect sensors coupled
with the unique Bio-AMD optical sensor. It is anticipated that the
system can increase significantly the sensitivity and accuracy of the
test result, bringing laboratory quality results to the POC setting.
We are not aware that this method is being used in products currently
being offered in the market, or in development.
We believe that the Bio-AMD MIDS technology has considerable
potential to deliver the next generation of POC testing. This would
encompass sample collection, pre-treatment, analyte specific
reaction, signal production, signal reaction and final result: "from
sample to result in one step".
We plan to initially develop the system design using the critical
marker for cardiac myocardial infarction, troponin I (cTnI). Our
ultimate aim is to commercialize a POC system, using different strips
for different tests, aimed at the multiple cardiac marker testing
market currently estimated globally to be increasing to US $1.4
billion by 2017. We also envisage that the technology can be extended
into test areas such as oncology, infectious disease, drugs of abuse
and into new potential high growth areas such as companion
Tom Barr, CEO, commented, "We are a relatively small company that has
engaged the serious interest of at least two global companies in each
of our two most advanced POC technologies. This demonstrates the high
level credibility and unique skills of our operating management and
technical team. The engagement of potential suitable partners is,
necessarily, taking time. However, we also have a growth plan to
build upon the partnership deals we are seeking; our COAG
multi-chamber strip design greatly enhances the value of our
coagulation based system, and MIDS offers significant potential in
the medium term; we also remain alert to manufacturing opportunities,
such as producing strips in-house, which would significantly enhance
our value proposition."
About Bio-AMD, Inc.
Bio-AMD has two majority owned UK subsidiaries: Bio AMD Limited, a
technology developer for medical diagnostic devices; and the WOCU
Ltd, the owner of the WOCU(R), a global currency data reference
source for application in financial markets. (www.wocu.com).
To find out more about Bio-AMD (OTCQB: BIAD), visit our website at
Statements in this news release that are
not statements of historical fact are forward-looking statements,
which are subject to certain risks and uncertainties. Forward-looking
statements can often be identified by words such as "expects,"
"intends," "plans," "may," "could," "should," "anticipates,"
"likely," "believes" and words of similar import. Forward-looking
statements are based on current facts and analyses and other
information that are based on forecasts of future results, estimates
of amounts not yet determined and assumptions of management. Actual
results may differ materially from those expressed or implied by
forward-looking statements due to a variety of factors that may or
may not be foreseeable or within the reasonable control of the
Company. Readers are cautioned not to place undue reliance on such
forward-looking statements. Additional information on risks and other
factors that may affect the business and financial results of the
Company can be found in filings of the Company with the U.S.
Securities and Exchange Commission, including without limitation the
section entitled "Risk Factors" in the Company's Annual Report on
Form 10-K for the year ended December 31, 2013 filed on March 28,
2014, and in Company reports filed subsequently thereto. Except as
otherwise required by law, the Company disclaims any obligations or
undertaking to publicly release any updates or revisions to any
forward-looking statement contained in this news release to reflect
any change in the Company's expectations with regard thereto or any
change in events, conditions or circumstances on which any such
statement is based.
+44 (0)8445 861 910
Press spacebar to pause and continue. Press esc to stop.