Bio-AMD, Inc.; Second Quarter Update
Bio-AMD, Inc.; Second Quarter Update
Daresbury, England August 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.
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this dominance was amplified when the former #2 PoC PT/INR monitor, also an electrochemical device, was voluntarily withdrawn from the market by its maker on FDA advice, following a FDA investigation into accuracy concerns.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 major 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 focussed 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.
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.
CONTACT: Bio-AMD, Inc.
Tom Barr, CEO
+44 (0)8445 861 910