Universal Biosensors : Siemens announces full launch of Xprecia Stride

Universal Biosensors Inc

ARBN 121 559 993

1 Corporate Avenue

Rowville VIC 3178

Australia

Telephone +61 3 9213 9000

Facsimile +61 3 9213 9099

Email info@universalbiosensors.com www.universalbiosensors.com

14 May 2015

Siemens Healthcare Diagnostics, Inc. ("Siemens") today announced the full commercial launch of the Xprecia StrideTM Coagulation Analyzer following successful completion of its limited European release. The system will now be marketed through Siemens' extensive sales and distribution network in a growing number of markets, currently excluding the U.S. (which will require FDA 510(k) clearance).

In addition, Siemens has today announced that the Xprecia StrideTM Coagulation Analyzer has been awarded the internationally respected Red Dot Award for Product Design for 2015. The Red Dot Product Design Competition started in Germany in 1954 and its award, the 'Red Dot,' is an internationally recognised quality seal. See www.red-dot.org for further details on the Red Dot competition and the award.

The Xprecia StrideTM Coagulation Analyzer delivers hand-held Prothrombin time testing (PT/INR) for point- of-care monitoring and management of the oral anticoagulation therapy (OAT), Warfarin. The product was specifically designed to meet the growing demand for fast and reliable PT/INR results in physician offices and walk-in clinics to help healthcare professionals make informed decisions about patient care. Universal Biosensors will be the manufacturer of PT/INR strips for Siemens at the Company's plant in Rowville, Victoria.

"The Xprecia StrideTM Coagulation Analyzer is among the most radical, user-friendly redesigns of a point- of-care coagulation analyzer since they became widely available more than 20 years ago. This analyzer includes a number of innovations and features not found on most other point-of-care analyzers," said David Stein, Ph.D., CEO of Siemens Diagnostics Point of Care Business Unit.

A copy of the press release by Siemens is attached.

UBI CEO Paul Wright said: "We are thrilled that the limited release has gone well and that Siemens will now be rolling out the Xprecia StrideTM Coagulation Analyzer. The Red Dot Award is a clear validation of the product's unique features that will deliver real benefits to patients and healthcare professionals."

The limited European release of the Xprecia StrideTM Coagulation Analyzer was initiated in December

2014.

Patients using Warfarin require frequent testing to assess the clotting tendency of their blood. The Prothrombin time (PT/INR) test allows physicians to adjust patient doses for diet and lifestyle changes. The worldwide point-of-care coagulation testing market was estimated at about US$1 billion in 2014 and is forecast to grow by about 9% per annum to about US$1.4 billion by 2018. The point-of-care coagulation testing market is dominated by PT/INR testing, which represents about 65% of this market.

Universal Biosensors Inc

ARBN 121 559 993

1 Corporate Avenue

Rowville VIC 3178

Australia

Telephone +61 3 9213 9000

Facsimile +61 3 9213 9099

Email info@universalbiosensors.com www.universalbiosensors.com
Enquiries:
Mr Paul Wright: 03 9213 9000

About Universal Biosensors

For additional information in relation to Universal Biosensors, refer to http://www.universalbiosensors.com.
Universal Biosensors is a specialist medical diagnostics company, founded in 2001, that is focused on the development, manufacture and commercialisation of a range of in vitro diagnostic tests for point-of-care use. These tests capitalise on a technology platform which uses a novel electrochemical cell that can be adapted for multiple analytes and provide for enhanced measurements in whole blood.

Forward-Looking Statements

The statements contained in this release that are not purely historical are forward-looking statements within the meaning of the Exchange Act. Forward-looking statements in this release include statements regarding our expectations, beliefs, hopes, intentions or strategies regarding the proposed offering. All forward-looking statements included in this release are based upon information available to us as of the date hereof, and we assume no obligation to update any such forward-looking statement as a result of new information, future events or otherwise. Our actual results could differ materially from our current expectations. We cannot assure you when, if at all, the proposed offering will occur, and the terms of any such offering are subject to change. Factors that could cause or contribute to such differences include, but are not limited to, factors and risks disclosed from time to time in reports filed with the SEC.

Press

Tarrytown, NY, May 13, 2015

Siemens Healthcare Diagnostics launches

Xprecia Stride Coagulation Analyzer

• A truly handheld portable analyzer for any point-of-care setting

• Features such as barcoded results, hands-free strip disposal and ease of navigation promote safety, accuracy and ease-of-use

Building on more than 30 years of central lab hemostasis leadership, Siemens Healthcare Diagnostics is introducing a first-of-its-kind, hand-held portable coagula- tion analyzer. The Xprecia Stride Coagulation Analyzer1 delivers fast, reliable Pro- thrombin time testing (PT/INR) for point-of-care monitoring and management of oral anticoagulation therapy (OAT) with warfarin, a vitamin K antagonist.
More than 800 million PT/INR tests will be administered world-wide this year2 as
part of therapy monitoring for patients with a host of conditions, including atrial fibril- lation, open and minimally invasive heart valve replacement, deep vein thrombosis, and congenital heart defects, among others. The Xprecia Stride Coagulation Ana- lyzer was specifically designed to meet the growing demand for fast and reliable PT/INR results in physician offices and walk-in clinics to help healthcare profession- als make informed decisions about patient care.
"Unlike our previous coagulation point-of-care analyzer, the Xprecia Stride analyzer does not place any limits on us as to the kinds of patients that can be tested," said Hematologist Dr. Maria Labrador of Hospital Cruz Roja in Cordoba, Spain, where the Xprecia Stride analyzer is currently being used to test patients on a daily basis. "We test around 50 patients a day for PT/INR using the Xprecia Stride analyzer and we have been happy with the results from the very beginning."
Winner of the internationally respected Red Dot Award: Product Design for 2015,

Communications and Government Affairs

Head: Stephan Heimbach

Reference number: HDX201505.013e tp

Wittelsbacherplatz 2

W80i3tt3e3lsbMaucnhiechrplatz 2

8G0e3r3m3aMnyunich

Germany

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the analyzer includes a number of innovations and features not found on most other point-of-care analyzers. No bigger than a large screen smartphone and weighing just 300g, the Xprecia Stride Coagulation Analyzer can be held at any angle and brought directly to the patient's finger for efficient and comfortable blood sample application.
"The Xprecia Stride Coagulation Analyzer is among the most radical, user-friendly redesigns of a point-of-care coagulation analyzer since they became widely availa- ble more than 20 years ago," said David Stein, Ph.D., CEO of Siemens Diagnostics Point of Care Business Unit. "Our analyzer is designed to be safer, more efficient and more ergonomically friendly than the products available today. The Xprecia Stride Analyzer uses simple icons and animation in a color display more commonly found in smartphones than medical instruments. Receiving the Red Dot award vali- dates this unique product design and reinforces our efforts to bring a highly usable, lab-accurate coagulation analyzer to the point of care."
To help increase workflow efficiency and usability, an integrated bar-code scanner simplifies data capture for accurate calibration of new lot numbers prior to testing.
The Xprecia Stride analyzer uses fresh capillary (finger stick) whole blood and re- sults are expressed in PT seconds or as a PT/INR (international normalized ratio). It utilizes the same Dade® Innovin® reagent used by Siemens central lab analyzers to minimize any potential for variability. Studies have shown the performance to be equivalent to a reference laboratory hemostasis system3, with results available with- in minutes.
Safety features include a first-of-its kind spring-loaded test strip eject button that allows the user to eject a used test strip and easily dispose of it without touching it, minimizing any potential biohazard exposure.
Other features include easy data transfer to a computer; color display and animated step-by-step instructions to help guide the user during testing. When taken together, all of these innovations become more important as the use of point-of-care PT/INR testing becomes critical to a growing number of procedures and treatments that uti-
lize anticoagulation therapy.

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1. Not available for sale in the U.S.

2. Jackson CM, and Esnouf MP.Clin, Chem, 2005;51(3):483-485

3. White Paper, Fernando R., Jacobson AK, Kenneday S., Scribner A, "PT/INR Test Performance of the

Exprecia Stride Coagulation Analyzer on Capillary Blood,"; Siemens Healthcare Diagnostics, Inc

For further information on Xprecia Stride Coagulation Analyzer, please visit:
www.siemens.com/xprecia

Siemens Healthcare, Media and Public Relations
John Gillespie, phone: +1 914-524-2636
E-mail: john.gillespie@siemens.com
Follow us on Twitter at: www.twitter.com/siemenshealth

The products/features (here mentioned) are not commercially available in all countries. Due to regulatory reasons their future availability cannot be guaranteed. Further details are available from the local Siemens organizations.

is available on the Internet at http://www.siemens.com.

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