Bio Alternative Medical Devices

COAG blood coagulation monitor - Proof of Concept Success

14 April 2011

Cheshire, United Kingdom: April 14, 2011 Bio-Alternative Medical Devices Ltd (‘Bio-AMD’) is pleased to announce that the novel magnetic drive system and detection method integral to its planned handheld COAG monitor has passed proof of concept testing.

Patients with cardiac problems are often medicated with life-long oral anticoagulation therapy, commonly Warfarin. COAG is designed to address the largely unmet need for cost-effective, convenient and frequent monitoring of blood coagulation rate (Prothrombin Time, ‘PT’ or International Normalized Ratio, ‘INR’), so that a patient may potentially self regulate doses of anticoagulation medication.

Bio-AMD’s COAG technology applies a combined magnetic drive system, double optical and magnetic detection techniques and a unique micro-fluidic strip design which requires minimal blood sample volumes.
The COAG technology has performed to design, testing having been carried out with reagent, demonstrating viability and validating the novel aspects of Bio-AMD’s COAG patent claims.

Dr Nasser Djennati, Managing Director of Bio-AMD, commented; ‘This is a very significant milestone in the development of our COAG device. Current testing methods are generally inconvenient, expensive, and require larger blood volumes. By this benchmark we can confidently progress toward a production ready prototype to address the need for cheaper, improved testing in this large market.’

Bio-AMD’s product lines in advanced development include a patented universal digital strip reader (‘DSR’) capable of reading a variety of lateral flow strips to detect differing conditions. The DSR platform technology is a method for reading and semi-quantifying traditional chromatography based lateral-flow immunoassay tests to provide an indication of the presence and / or concentration of a substance tested in a sample. DSR is based on a unique triple optical sensor arrangement, offering an improved, simplified, fully disposable and cost effective disposable reader.

Dr Nasser Djennati, Managing Director of Bio-AMD, added; ‘We are pursuing a commercialisation strategy to obtain the optimum mix of partners, resourcing and financing to take each of our product lines to market. We anticipate announcing further milestone achievements for our product pipeline during 2011’.

More information and contact details for Bio-AMD can be obtained 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. 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:

Dr Nasser Djennati, Managing Director
Tel: +44 (0) 1925 606 471

Robert Galvin, Director
Tel: +44 (0) 207 499 1730

Bio-AMD Update

23 August 2010

Bio-AMD is currently in various stages of developing and commercialising three core technologies integral to its planned range of hand held, Point Of Care (PoC), medical diagnostic devices:

DSR – a Digital Strip Reader able to read existing lateral flow test strips;
COAG – a Prothrombin Time (PT) blood coagulation monitor; and
MPR – a novel Magnetic Particle Reader multiple application diagnostic technology incorporating microfluidics.

Bio-AMD is targeting these technologies at the fast growing global PoC market which independent research indicates is expected to reach a total market size of $5.5bn in sales by the end of 2010 and to grow significantly beyond that date.

The Company and Bio-AMD believe that of these three technologies DSR offers early opportunity with the shortest estimated time to market and expect DSR to be applied to read existing test strips initially in the established pregnancy detection market, where there is a shift toward digital devices. In addition, Bio-AMD is working on developing strategic relationships in the cholesterol, cardiovascular and infectious disease markets where there are clear commercial and medical advantages to quick, accurate and affordable diagnosis results, near patient and without the need for laboratory intervention.

COAG is designed to address patient demand for self testing of anticoagulation therapy and treatment. Bio-AMD is currently working with a potential manufacturer to create a PT device to measure the clotting time of blood, which must be tested regularly by patients taking anticoagulants, so as to remain in his/her prescribed range.

The Company and Bio-AMD believe MPR is a next generation technology ideally suited to PoC devices and that MPR may open new markets for near patient diagnostic testing, where quantitative and timely measurement is required, including cardiac testing, infectious disease and oncology.

Intellectual Property Rights

Since Flex made its investment in Bio-AMD in March, 2010, Bio-AMD has filed two new patent applications designed to protect its COAG and MPR technologies. Bio-AMD expects to file a further patent application for a novel DSR technology in the next two months.

Product Development Accelerated

Bio-AMD has, as planned, prioritized the development of DSR as management believes it offers a significant opportunity for early revenues. A prototype device has been produced utilizing a bespoke optical sensor and is undergoing calibration and testing. Early talks have already commenced with third parties interested in potential manufacturing and marketing.

In addition, exploratory discussions with potential manufacturers have revealed strong interest in Bio-AMD’s COAG device, given the potential for this particular market. In response, Bio-AMD has brought forward the design and development of COAG. Bio-AMD has supplied a working demonstration prototype COAG meter to a potential manufacturer and distributor and plans to work with that party to test a new detection assembly, source the necessary coagulation reagent and design and prototype a board to take the new detection assembly using a new test strip.

Furthermore, a third party silicon wafer designer has indicated it intends to proceed with designing and prototyping the MPR “Lab-on-Chip” microfluidics test strip, which is expected to bring forward Bio-AMD’s development plans for this technology.

The nature of the collaborative arrangements means that this accelerated development of COAG and MPR is not currently expected to a draw materially on Bio-AMD’s financial resources, with Bio-AMD remaining in line with its original plan.

MEDICA Trade Fair

Bio-AMD will be represented at the MEDICA World Forum of Medicine International Trade Fair on 17 – 20 November 2010 in Dusseldorf, Germany. Interested parties can contact Bio-AMD to arrange meetings and obtain further information on Bio-AMD’s technologies at www.bioamd.com.

Nasser Djennati, Managing Director of Bio-AMD said; “Progress has been rapid. I am particularly pleased with the early interest shown from potential licensees and technology partners.”

Forward-Looking Statements

CONTACT:

Dr Nasser Djennati, Managing Director
Tel: +44 (0) 1925 606 471

Robert Galvin, Director
Tel: +44 (0) 207 499 1730