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USCOM LIMITED Regulatory Filings 2021

May 3, 2021

65979_rns_2021-05-03_7b25ad7e-8595-45da-9d17-825fb77534d6.pdf

Regulatory Filings

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ASX MEDIA RELEASE

Two New Uscom Devices for China

SYDNEY, Australia, Tuesday 4[th] May, 2021: Uscom Limited (ASX code: UCM) (the Company or Uscom ) has completed the development of two new specialised cardiovascular monitors, the “USCOM O2” and the “USCOM Basic”. The development of these two new monitors creates for Uscom a three-tier range of Uscom haemodynamic monitors for sale into China.

Uscom is required to obtain regulatory approval of the China National Medical Products Administration (NMPA) for the two new specialised cardiovascular monitors prior to the commencement of sales. The NMPA process involves 9 steps including document writing, collection, translation, review and product testing, and is estimated to take 12 months for approval, if milestones are achieved according to guidelines.

The USCOM 1A is an advanced haemodynamic monitor which can be used to diagnose and manage sepsis, heart failure, hypertension, and fluid, inotrope and vasoactive administration in adults, children and neonates. The new “USCOM O2” is the high end of the Uscom technology range and includes direct measurement of blood oxygen saturation generating beat to beat measures of oxygen delivery, a complex and critical measure of cardiovascular performance. The new “USCOM Basic” is a defeatured device which will be marketed competitively against lower functioning technologies in price sensitive tenders. These new monitors will be marketed through Uscom China’s current Chinese distribution network.

Uscom has sold >500 USCOM 1A units into China, and its Beijing subsidiary, Uscom China, generates ~70% of Uscom’s global sales. The USCOM 1A is recommended as a preferred method for management of serious COVID 19 cases by the National Health and Medical Commission of the People’s Republic of China. In 2020 Uscom China installed 56 USCOM 1A units in specialised hospitals designated for treatment of severe COVID 19 cases. Uscom China has been listed as a National High Tech Medical Enterprise by China’s Ministry of Science.

Executive Chairman of Uscom, Associate Professor Rob Phillips said “More devices equals more revenue, and additional devices for sale in China, our major market, is the logical strategic next step to promote strong on going revenue growth. These new devices will expand the market reach of our successful USCOM 1A by creating a three-tiered range of haemodynamic monitoring technologies, each with specialised features for different levels of clinical complexity and price. These new devices will also be prepared for regulatory submission in our other global markets.”

Uscom recently received NMPA approval for sale into China of its advanced hypertension monitoring technology, the BP+ susprasystolic oscillometric BP monitor. The BP+ is currently being prepared for market in China as Uscom’s second product and should be generating revenue within the next 3 months. The NMPA is the body that regulates medical device sales in China and is focused on determining the safety and efficacy of new technologies.

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

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 apps and proprietary SpiroSonic software, SpiroReporter , with wireless interfacing to provide remote telemonitoring of pulmonary disease. The devices are specialised for assessment of COPD, sleep disordered breathing, asthma, occupational lung disease and monitoring of pulmonary therapeutic compliance.

VENTITEST digital ultrasonic ventilator testing solution is a new system for testing ventilators. All ventilators require calibration to maintain the accuracy with which they measure the pressure, flow and volume of air they deliver. VENTITEST and VENTITEST-S, based on advanced SpiroSonic technology provides a testing solution that provides for simple and accurate testing, archiving, analysis and reporting to optimise ventilation performance.

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

Uscom Contacts Rob Phillips Chairman [email protected]

Brett Crowley Company Secretary

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