Bio-AMD, Inc.; Annual Report and Operational Update
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.
In 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 diagnostics.
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, 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, 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.
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SOURCE: Bio-AMD, Inc.
March 31, 2014 – 11:19 AM EDT