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USCOM LIMITED — Capital/Financing Update 2021
Apr 18, 2021
65979_rns_2021-04-18_85aa7b6a-abc9-4836-9575-54fd5173a736.pdf
Capital/Financing Update
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ASX MEDIA RELEASE
China NMPA Approves Uscom BP+
SYDNEY, Australia, Monday 19[th] April, 2021: Uscom Limited (ASX code: UCM) (the Company or Uscom ) today notified the market that its patent protected high fidelity central blood pressure monitor, BP+, has received Chinese National Medical Products Administration (NMPA) approval for sale into China. The NMPA certificate will be issued within the next 10 working days.
The approval follows a rigorous 26 months’ process of testing and validation of the technology and now allows the Uscom BP+ to be sold in China, contributing a new sales revenue stream to Uscom.
The Uscom BP+ is a patent protected digital suprasystolic oscillometric device that measures 34 parameters of blood pressure (BP) from each of 3 different sites in the arteries, providing unique information only previously available from invasive cardiac catheters. Coupled with the Uscom BP+ Reporter, the BP+ provides the most advanced technology for BP monitoring of hypertension and vascular health. The BP+ is applicable to home care and across multiple hospital departments including ICU, Emergency, Cardiology, CCU, Obstetrics and ED’s, etc.
Hypertension occurs in approximately 1/3 of all adults (>1.13B adults worldwide), and is the leading modifiable risk factor for cardiovascular disease and death. In China more than 85% of patients with hypertension, ~230m adults, have ineffective diagnosis and control. The new BP+ technology allows for more precise monitoring and improved therapy and outcomes. The NMPA approval of the BP+ is an important advancement for both Uscom and hypertensive and vascular care in China. The Uscom BP+ is installed on the International Space Station for advanced cardiovascular research, and is currently in eHealth studies with some of the world’s leading medical technology companies in the US and Europe.
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The digital BP+ and BP+ Reporter is leading the central BP revolution, changing the standards from clinical measurements of BP in the arm to suprasystolic monitoring of BP at the heart.
To date Uscom China’s business has been based on a single NMPA approved device, the USCOM 1A cardiovascular monitor, which has generated ~$3.75m AUD in annual revenue in 2020, and continues to grow quickly. Uscom China is a wholly owned subsidiary in Beijing and is also progressing approval of the SpiroSonic series of digital ultrasonic spirometers for diagnosis and treatment of asthma, COPD and post COVID syndrome. 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 “We are deeply committed to China and the NMPA approval of the BP+ is a significant endorsement for our technology and an incremental financial opportunity for Uscom China’s business as we move from one product to two. While the 1A is
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
a hospital sale, the BP+ is an advanced consumer product with a far larger market, and, combined with the BP+ Reporter, sets new standards for monitoring hypertension and vascular health worldwide. The BP+ solution is anticipated to generate significant new revenue as the devices are fed into our growing network of Chinese distributors.”
The NMPA is the regulatory body that regulates medical device approval in China and is focused on assuring the safety and efficacy of new medical technologies.
References: Accessed 15[th] April - - https://www.who.int/news room/fact sheets/detail/hypertension - https://www.who.int/china/health topics/hypertension
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