Bio-AMD, Inc.; COAG PT/INR Point of Care Hemostasis Project & Patent Update
Daresbury, England May 12, 2016; Bio-AMD, Inc. and Bio-AMD Holdings Ltd., our majority owned medical devices subsidiary (together “Bio-AMD”, “We” or the “Company” OTCQB: BIAD) here provides an update on its PT/INR COAG project and on other matters around its business.
COAG – Agreement Cancelation and Alternative Commercialisation Plans
As reported on our Form 8-K dated April 14, 2016, we were informed on April 12, 2016 by our former development partner that an agreement associated with a joint development of a PT/INR Point of Care (“PoC”) reader based on our COAG technology was to be terminated. No specific reason was given.
We believe that our COAG technology is now proven. Crucially, our unique PT/INR test strip, the principal element of COAG, is finalised. It is ready for production and integration into a final reader device with features to be specified, a relatively prosaic electronics development. We expect COAG to be attractive to other global players, particularly those that are established in PoC.
The Company notes that, despite the PoC PT/INR market being considered relatively immature, around 1,000,000 units of the directly comparable and market dominant CoaguChek XS PoC PT/INR device are in use worldwide, consuming approximately 250,000 test strips per day at a cost of around $3 to $4 per strip. The Company believes a finalised COAG device will be well able to compete with CoaguChek XS and other less popular devices; particularly on accuracy, reliability and price.
In its efforts to progress commercialization the Company has identified and contacted a list of suitable global companies, specialising in Hematology and more focused on PoC, as a matter of priority. Contact with these companies is at an early stage but the Company believes COAG offers several advantages over devices currently on the market:
- Direct Measurement. Because of COAG’s unique direct measurement system, common issues suffered by competitors such as Hematocrit variation, elevated Fibrinogen, Tissue Factor and other confounding medical conditions have little or no effect on the accuracy of COAG and/or can be addressed within the COAG system.
- Accuracy. Based on calibration plasma testing and correlated whole blood testing the Company believes COAG can easily meet the FDA newly proposed tightened accuracy standards across a broad INR range and can easily compete with the market leader, CoaguChek XS.
- Patient Comfort and Usability. The COAG test strip requires a smaller drop of blood sample (less than 5 microliters) than the market dominant CoaguChek XS. The test strip is of ergonomic design, making it easy and intuitive for limited dexterity self-testing patients to use.
COAG Patent Grant.
The COAG (microfluidic strip and reader technology) patent was granted in U.S. in 2015 and more recently, in March 2016, in China. A similar E.U. patent application is expected to be granted in due course.
Commercial enquires about COAG may be submitted via our website.
The Company has again taken action to materially reduce its ongoing overhead, particularly its accountancy and audit costs. We are happy with the changes in suppliers we have made but we may choose to extend by up to five days the filing of our forthcoming Form 10-Q report in order to ensure that we, our accountants and our auditor are not put under unnecessary pressure during this handover period.
About Bio-AMD, Inc.
Bio-AMD has two majority owned UK subsidiaries: Bio-AMD 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