USCOM LIMITED — Regulatory Filings 2018

Feb 11, 2018

ASX MEDIA RELEASE

Uscom BP+ Approved by International Hypertension Society (BIHS)

SYDNEY, Australia, Monday 12[th] February 2018: Uscom Limited (ASX code: UCM) (the Company or Uscom ) today announced that the Uscom BP+ central blood pressure (BP) monitor has been approved for specialist use by The British and Irish Hypertension Society (BIHS). The approval of the BP+ followed independent evaluation of the Uscom BP+ technology and associated clinical evidence by BIHS experts.

The prestigious BIHS provides “the only independent, peer-reviewed list of blood pressure monitors that is not governed by commercial interest”. The BIHS review system for BP monitors was established to improve the standards of BP devices in clinical practice. BIHS internally reviews published validation studies of various BP monitors and approves those that meet their standards. The BP+ was approved under the most demanding “specialist use” category. This listing has become a de facto standard for BP monitors and is a key endorsement for large scale purchasing groups worldwide. The BP+ received CE Mark in December, which is the formal regulatory requirement for sale into Europe and is distinct from an independent recommendation from the BIHS approval.

The Uscom BP+ is a digital technology which provides direct measures of BP and pulse pressure waves at the heart (central BP), as well as basic BP information in the arm as current devices measure; thus the device is called the BP+. Previously such measurements were only available using invasive cardiac catheters, but the BP+ provides these data entirely noninvasively in 45 seconds.

Uscom CEO Associate Professor Rob Phillips said, “The Uscom BP+ is a sophisticated clinical technology that is changing the way we measure and manage hypertension, and is rapidly emerging as the global standard of care in this area of specialty. Recognition, by the prestigious BIHS, provides independent endorsement of the quality and accuracy of the BP+ technology. BIHS approval is a respected worldwide, and while we have had a number of outstanding publications confirming the superior clinical resolution of the Uscom BP+, independent societal endorsement is another step supporting volume sales. The BP+ has CE (European) regulatory approval, and is currently undergoing review for CFDA (China) and FDA (USA), which are expected later in the year.”

Approximately one third of all the worlds adults have hypertension, while only 20-30% of those affected have the disease controlled. Hypertension causes approximately 9.4M deaths per year and is responsible for approximately 50% of all heart disease and stroke deaths. These results may be improved by more accurate and relevant BP measurement methods and devices. Recent studies have identified that central BP measurements, such as measured by the BP+, improved diagnosis of hypertension and reduce the number and doses of drugs for effective hypertension management compared with the current BP devices that use simple cuff measurements from the arm.

References:

https://bihsoc.org/bp-monitors/for-specialist-use/

Mills KT, Bundy JD, Kelly TN, et al. Global Disparities of Hypertension Prevalence and Control. A Systematic Analysis of Population-Based Studies From 90 Countries. Circulation. 2016;134:441-450. doi.org/10.1161/CIRCULATIONAHA.115.018912. Boos CJ, Vincent E, Mellor A, Woods DR, New C, Cruttenden R, Barlow M, Cooke M, Deighton K, Scott P, Clarke S, O’Hara J. The effect of high altitude on central blood pressure and arterial stiffness. Journal of Human Hypertension 2017;31:715 – 719. McEniery CM, Cockcroft JR, Roman MJ, Franklin SS, Wilkinson AB. Central blood pressure: current evidence and clinical importance. Euro Heart J 2014;doi10.1093/eurojeartj/eht565. Roman M, Devereaux RB, Kizer JR, Lee ET, Galloway JM, Ali T, Umans JG, Howard BV. Central Pressure More Strongly Relates to Vascular Disease and Outcomes Than Does Brachial Pressure. The Strong Heart Study. Hypertension 2007;50:197-203. https://www.cdc.gov/bloodpressure/facts.htm

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

ASX MEDIA RELEASE

About Uscom

Uscom Limited (UCM) is 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 is 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+ is 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, 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, trend measure progress over time, analyse pulse pressure waves and generate a summary report.

Uscom SpiroSonic digital ultrasonic spirometers are high fidelity, digital, pulmonary function testing devices based on multi path ultrasound technology. They are simple and accurate to use and provide 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 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. The SpiroSonic devices are supported by the proprietary SpiroReporter, an innovative stand alone software solution that provides a digital platform to archive patient examinations, trend measure progress over time, analyse spirometry outputs and generate a summary report.

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

Uscom Contacts

Rob Phillips Executive Chairman rob@uscom.com.au

Brett Crowley Company Secretary secretary@uscom.com.au

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