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USCOM LIMITED Regulatory Filings 2017

Dec 19, 2017

65979_rns_2017-12-19_aca079d1-e887-49fa-b190-aa5952562707.pdf

Regulatory Filings

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ASX MEDIA RELEASE

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CE Mark for Uscom BP+ Sale in Europe

SYDNEY, Australia, Wednesday 20[th] December 2017: Uscom Limited (ASX code: UCM) (the Company or Uscom ) announced that the new Uscom BP+ is now eligible for Conformité Européenne (CE) mark allowing it for retail sale in Europe. This means that the new Uscom BP+ can now be sold into Hospital and Clinical markets in CE jurisdictions. This jurisdiction includes the 28 member states of the EU, plus Iceland, Norway, Liechtenstein, Switzerland and Turkey.

The Uscom BP+ suprasystolic oscillometric method is patent protected in many international jurisdictions and is currently being rolled out as regional regulatory approvals permit. Revenue is beginning and is expected to accelerate throughout 2018. The US FDA and Chinese CFDA submissions are currently in process and are expected within the next 12 months. The CE mark also opens the door to many other countries around the world including Asia and the Middle East where approval leverages off CE.

Executive Chairman of Uscom, Associate Professor Rob Phillips said “The CE mark provides us with the opportunity to sell our revolutionary Uscom BP+ into UK and Europe, and many jurisdictions which use CE as a regulatory standard. We currently have a network of distributors waiting on manufactured product with outstanding orders. The development and testing of this device has taken time, but the product represents revolutionary and practice changing science, as the recent publication recommending its routine use in pharma trials from authors at the Uni of Auckland (Auckland), Imperial College (London), Uni Cambridge (Cambridge), University College (London), Mass General/Harvard (Boston), the Austrian Institute of Technology (Vienna) and the Uni of Otago (Christchurch) demonstrated. While we could previously sell an earlier version of BP+ with limited functionality, this new CE marked product will deliver the full power of Uscom BP+ technology to the massive hypertension and heart failure market.”

The global hypertension device market is reported to be in the order of $5B USD, while $74B PA is reportedly spent on management of hypertension and hypertension complications in the US alone, making the scale of the global Uscom BP+ opportunity both substantial and difficult to define. While Uscom plans to retain the BP+ technology as a foundation for accelerated revenue growth over the next decade, it could also be strategically licensed or on sold into international distributors.

Uscom Limited (ABN 35 091 028 090) Suite 2, Level 8, 66 Clarence Street, Sydney NSW 2000 Australia T: +612 9247 4144 E: [email protected] W: www.uscom.com.au

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ASX MEDIA RELEASE

About Uscom

Uscom Limited (UCM) : An ASX listed innovative medical technology company specialising in development and marketing of premium non-invasive cardiovascular and pulmonary medical devices. Uscom has a mission to demonstrate leadership in science and create noninvasive devices that assist clinicians improve clinical outcomes. Uscom has three practice leading suites of devices in the field of cardiac, vascular and pulmonary monitoring; the USCOM 1A advanced haemodynamic monitor, Uscom BP+ central blood pressure monitor, and the Uscom SpiroSonic digital ultrasonic spirometers. Uscom devices are premium resolution, noninvasive devices which deploy innovative and practice leading technologies approved or submitted for FDA, CE, CFDA and TGA regulatory approval and marketing into global distribution networks.

The USCOM 1A : A simple to use, cost-effective and non-invasive advanced haemodynamic monitor that measures cardiovascular function, detects irregularities and is used to guide treatment. The USCOM 1A device has major applications in Paediatrics, Emergency, Intensive Care Medicine and Anaesthesia, and is the device of choice for management of adult and paediatric sepsis, hypertension, heart failure and for the guidance of fluid, inotropes and vasoactive cardiovascular therapy.

The Uscom BP+ : A supra-systolic oscillometric central blood pressure monitor which measures blood pressure and blood pressure waveforms at the heart, as well as in the arm, information only previously available using invasive cardiac catheterisation. The Uscom BP+ replaces conventional and more widespread sub-systolic blood pressure monitors, and is the emerging standard of care measurement in hypertension, heart failure and vascular health. The Uscom BP+ provides a highly accurate and repeatable measurement of central and brachial blood pressure and pulse pressure waveforms using a familiar upper arm cuff. The BP+ is simple to use and requires no complex training with applications in hypertension and pre-eclampsia, heart failure, intensive care, general practice and home care. The Uscom BP+ is supported by the proprietary BP+ Reporter , an innovative stand alone software solution that provides a digital platform to archive patient examinations and images, trend measure progress over time, analyse pulse pressure waves and generate summary reports.

Uscom SpiroSonic digital multi-path ultrasonic spirometers : High fidelity, digital, pulmonary function testing devices based on multi path ultrasound technology. They require no calibration, are simple to disinfect, and are simple and accurate to use providing research quality pulmonary function testing in small hand held devices that can be used in research, clinical and home care environments. The devices can be coupled with mobile phone applications and proprietary SpiroSonic software platforms with wireless interfacing to provide remote telemonitoring of pulmonary disease. The devices are specialised for assessment of COPD, sleep disordered breathing, asthma, industrial lung disease and monitoring of pulmonary therapeutic compliance. The SpiroSonic devices are supported by the proprietary SpiroReporter , an innovative stand alone software solution that provides a digital platform to archive patient examinations and images, trend measure progress over time, analyse spirometry outputs and generate summary reports.

For more information, please visit: www.uscom.com.au

Uscom Contacts

Rob Phillips Executive Chairman [email protected]

Brett Crowley Company Secretary [email protected]

Uscom Limited (ABN 35 091 028 090) Suite 2, Level 8, 66 Clarence Street, Sydney NSW 2000 Australia T: +612 9247 4144 E: [email protected] W: www.uscom.com.au