DARESBURY, UNITED KINGDOM--(NewMediaWire - Aug 16, 2016) -
Bio-AMD, Inc. and Bio-AMD UK Holdings Ltd., our majority
owned medical devices subsidiary (together "Bio-AMD", "We" or the
"Company") (OTCQB: BIAD) here provides a second quarter
update.
COAG
Following withdrawal of a development partner for our Point of
Care ("PoC)" prothrombin time/international normalized ratio
("PT/INR") monitoring system development project earlier this year
the Company has actively sought a new, suitable partner to continue
the development of its COAG technology. COAG is aimed at patients
using Warfarin based oral anticoagulants to enable them to more
easily manage their medication dosage and coagulation within a safe
therapeutic range.
We continue to believe that our clinically verified COAG test
strip, based on a direct mechanical rather than electrochemical
measurement of clotting time, is best in class. Electrochemical
devices are inherently susceptive to confounding factors, such as
other medical conditions, which have caused fatal measurement
inaccuracies. The US Food and Drug Administration is very much
alive to these issues and has proposed tightened accuracy
guidelines, which the Company believes it can easily meet with
COAG.
The current PoC and self-test PT/INR market, projected to grow
to around $1 billion p.a. in the next few years, is currently
dominated by a single company's electrochemical based device. In
July of this year this dominance was amplified when the former #2
PoC PT/INR monitor, also an electrochemical device, was voluntarily
withdrawn from the market by its maker on FDA advice, following a
FDA investigation into accuracy concerns. Another planned device
for self-test, based on an electrochemical test strip supplied to a
global company for professional PT/INR testing, has recently been
abandoned. We believe that these developments reflect, in some
part, the challenges of accuracy and FDA requirements, current and
prospective.
Our COAG test strip has demonstrated that it can deliver market
leading accuracy and reliability by a direct, mechanical
coagulation measurement, even prior to optimization in a final
device. We believe that our COAG strip is the ideal solution to
current PoC PT/INR measurement accuracy issues. The Company has
engaged with and has provided information to a number of interested
parties active in PoC and coagulation testing in its efforts to
find a replacement development partner for COAG. Discussions are
ongoing.
MIDS Project Commences
The Company, in partnership with a nano-cap medical detection
technology company has commenced the first stage of development of
the Company's novel MIDS universal immunoassay device technology
("MIDS Project").
This development is initially focused on applying our patented
MIDS technology into a rapid-test, PoC cardiac event detection
device able to process High Sensitivity (HS) Troponin tests. These
HS tests can currently only be assayed on large, expensive central
laboratory equipment. Currently work is underway to confirm
and demonstrate that the MIDS technology platform is accurate for
the detection and quantitation of small quantities of magnetic
nano-particles such as those used in these HS tests. Electronics
design is in progress to produce the printed circuit board suitable
for bench testing and optimising the design of the highly
sensitive, bespoke Hall effect sensors central to the magnetic
detection of target nanoparticles.
The Company believes there is a large potential market for
highly accurate cardiac marker assays conducted by a hand held
device at the Point of Care ("PoC"). The MIDS Project aim is to
develop an easy to use, hand-held device which can achieve gold
standard central laboratory accuracy, or better, at a fraction of
the capital cost, with results delivered at the PoC within
minutes.
About Bio-AMD, Inc.
Bio-AMD has two main majority owned UK subsidiaries: Bio-AMD UK
Holdings Limited, a technology developer for medical diagnostic
devices; and WOCU Ltd, the owner of the WOCU®, 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 www.bioamd.com.
Forward-Looking Statements
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, 2015 filed on March 30, 2016, 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.