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USCOM LIMITED Regulatory Filings 2020

Aug 3, 2020

65979_rns_2020-08-03_9b429c1d-e978-4bc7-920c-2e8f0210a55a.pdf

Regulatory Filings

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ASX MEDIA RELEASE

Uscom VENTITEST Global Release

SYDNEY, Australia, Tuesday 4[th] August 2020: Uscom Limited (ASX code: UCM) (the Company or Uscom ) today notified the market of the global release of the Uscom SpiroSonic VENTITEST ventilator test device. The device IP is globally protected by Patent Cooperation Treaty (PCT) for eighteen months and can then transition to patent applications for discrete jurisdictions.

The VENTITEST device was developed from Uscom’s digital ultrasonic spirometry technology in Uscom’s R&D centre in Budapest to meet the rapidly increasing demand for accurate ventilator calibration. Ventilator sales have dramatically increased for installation in critical care units worldwide to assist management of severe cases of COVID-19 and other infectious diseases. The release of the VENTITEST further diversifies Uscom’s product portfolio and revenue stream in a time of global uncertainty.

The VENTITEST provides high fidelity, simple and precise measurement of the flow, pressure and volume outputs of respiratory assist devices such as ventilators, anaesthesia devices, and home ventilations systems such as CPAP, and respiratory drug administration systems. These devices simply pump a prescribed flow of air, gas and medications into the lungs when natural breathing is impaired or needs support. With use the devices “slip” and require daily, weekly, monthly or annual calibration depending on the technology and the accuracy required of the device.

Uscom’s VENTITEST-S software that accompanies the device provides archiving, display, and analysis of flow, pressure, and volume waveforms with extended calculations, data logging and test report generation and printing.

Current test devices predominantly use differential pressure, turbine or thermopile technology but the VENTITEST is the first digital ultrasonic calibration device. Digital multipath ultrasound has a resolution in the order of 2.5% for flow measurement, and combined with multiple piezoresistive monolithic silicon pressure sensors and on-board ambient pressure, temperature and humidity sensors provide the optimal and most stable flow, pressure measurement and calibration technology.

The initial VENTITEST business model is based on capital sales, however it is ideally suited for a “calibration as a service model” ensuring a continuous revenue stream from hospitals manufacturers, and home care respiratory support systems such as CPAP machines.

The global ventilator market was predicted, before COVID-19, to reach ~$2.8B (USD) in 2020 and further reach $27B by 2027, a ~10-fold increase. It’s estimated the US alone requires an additional 880,000 ventilators to deal with the current COVID-19 pandemic. Assuming clinical departments require 1 VENTITEST per 10 ventilators, and with a 10% market penetration the gross revenue is approximately $25M AUD.

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

The VENTITEST is expected to receive regulatory approval for sale into China, SE Asia, Europe and the US within three months following an accelerated non-medical device pathway, with device testing already complete.

Executive Chairman of Uscom, Professor Rob Phillips said “Uscom devices are developed to set new standards of accuracy and cost-effectiveness, and the VENTITEST is another of our premium products. The VENTITEST will be sold into hospitals, respiratory device manufacturers and home consumers across the world, all of which depend on accurate calibration of their respiratory devices for effective operation and optimal clinical outcomes. The global medical ventilators market is one of the fastest-growing segments in medical devices, and while it’s not difficult to manufacture ventilators, ventilator calibration requires technology with high levels of precision, and our ultrasonic sensors have been in development and clinical use for over 15 years. For Uscom this is a rational business expansion; specialising our own patented protected technologies into new products for a rapidly expanding market and unprecedented global needs. We are very proud of the VENTITEST and the accompanying VENTITEST-S, and look forward to marketing the device into our major markets of China, SEAsia, Europe, and the US. The response so far from dealers and distributors has been enthusiastic.”

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VENTITEST brand, VENTITEST sensor and VENTITEST-S flow pressure analysis screen

Uscom manufactures and markets the USCOM 1A , the Uscom BP+ , and the Uscom SpiroSonic digital ultrasonic spirometry technologies and the VENTITEST and VENTITEST-S ultrasonic ventilator calibration devices for optimising respiratory device performance.

References:

https://www.globenewswire.com/news-release/2020/06/18/2049929/0/en/Insights-on-the-WorldwideVentilator-Industry-to-2030-Pre-During-and-Post-COVID-19.html

https://www.nsmedicaldevices.com/analysis/coronavirus-ventilators-global-demand/

https://www.globenewswire.com/news-release/2020/04/14/2015758/0/en/Ventilator-Market-To-Reach-USD26-66-Billion-By-2027-Reports-and-Data.html

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 app’s and proprietary SpiroSonic software, SpiroReporter , with wireless interfacing to provide remote tele-monitoring of pulmonary disease. The devices are specialised for assessment of COPD, sleep disordered breathing, asthma, industrial lung disease and monitoring of pulmonary therapeutic compliance. VENTITEST: Digital ultrasonic ventilator calibration solution is a new system for calibrating ventilators. All ventilators and respiratory support devices 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 calibration solution that provides for simple and accurate calibration, archiving, analysis and reporting and optimal ventilation performance.

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

Authorised by:

Rob Phillips Executive 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