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USCOM LIMITED Regulatory Filings 2015

Jan 26, 2015

65979_rns_2015-01-26_cce501aa-36bf-430d-b1f6-8fe9c12daf75.pdf

Regulatory Filings

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Uscom Limited ABN 35 091 028 090 Suite 1, Level 7, 10 Loftus Street Sydney NSW 2000 Australia T +612 9247 4144 F +612 9247 8157 www.uscom.com.au

M A R K E T A N N O U N C E M E N T

USCOM 1A - New Regulatory Registration for China

SYDNEY, Australia, 27th January 2015: Uscom Limited (ASX code: UCM) (the Company or Uscom ), a revenue stage, cardiovascular medical technology company, today announced to market notification by the Chinese Food and Drug Administration ( CFDA ) of registration of the USCOM 1A device allowing sale into China.

The USCOM 1A examination and registration was conducted by the CFDA and comes after a rigorous review and permits the continued sale of the USCOM 1A into the Chinese market.

The USCOM 1A has previously had CFDA registration, however the new registration was attained under a process involving strict examination. This resulted in the USCOM 1A being reclassified as a Class II device and the new registration being for a 5 year period rather than the prior 3 years.

Executive Chairman of Uscom, Dr Rob Phillips said “ China is an important market for USCOM 1A, and the Chinese have been early users of Uscom technology, leading the way in adoption of advanced haemodynamics practices. We conduct education, training and certification courses throughout China and Chinese sales contribute a significant and growing component of our global revenue. We are now undertaking the approval process for the BP+ and look forward to this being reviewed under the new accelerated registration pathway so that our partners, China Pioneer Pharma, can activate BP+ sales.”

Uscom manufactures and markets the USCOM 1A and the Uscom BP+, both premium cardiovascular devices changing the way cardiovascular diseases are diagnosed and treated. The devices have specific application in hypertension, heart failure and sepsis, and improve the use of fluid, inotropes and vasoactive therapies.

About Uscom

Uscom Limited ( UCM ) is an ASX listed cardiovascular medical device company. Uscom is an innovative developer and manufacturer of premium cardiovascular devices and has two practice leading technologies in the field of cardiovascular monitoring - the USCOM 1A and the Uscom BP+. Both devices are clinically validated with FDA, CE, CFDA and TGA regulatory approval, and are currently being marketed into global distribution networks.

The USCOM 1A is a simple, cost-effective and non-invasive device that measures heart function, detects abnormalities and guides 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, heart failure, and for the guidance of fluid therapy.

The Uscom BP+ is a supra systolic Central Blood Pressure monitor and replaces older and more widespread BP sub systolic Blood Pressure monitoring technology. Central Blood Pressure is becoming the new standard of care measurement in hypertension and heart failure. 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 cardiology, intensive care, general practice and home care.

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

Uscom Contacts

Rob Phillips Executive Chairman [email protected] Ph: +61 2 9247 4144

Catherine Officer Company Secretary [email protected]