Skip to main content

AI assistant

Sign in to chat with this filing

The assistant answers questions, extracts KPIs, and summarises risk factors directly from the filing text.

USCOM LIMITED Regulatory Filings 2017

Mar 21, 2017

65979_rns_2017-03-21_b4d54b14-fdb5-4ac1-8262-f41e631c4723.pdf

Regulatory Filings

Open in viewer

Opens in your device viewer

ASX MEDIA RELEASE

China BP+ and SpiroSonic Regulatory Submissions

China regulatory submission, distributor training and CIIC sales

SYDNEY, Australia, Wednesday 22[nd] March 2017: Uscom Limited (ASX code: UCM) (the Company or Uscom ) has initiated China Food and Drug Administration (CFDA) submissions for approval to sell Uscom BP+ and Uscom SpiroSonic devices in China. CFDA approval is required before medical devices can be sold in China, and is valid for 5 years. The Uscom CFDA approval process is being managed by a specialist Beijing based regulatory consultant and overseen by Uscom Australia and our China Importation and wholesale partner, CIIC.

While the CFDA regulatory process is complex and of uncertain outcome and duration, both the BP+ and SpiroSonic product suites have current CE (European) regulatory approval and CFDA approved precedent devices, which may accelerate the approval timeline. The USCOM 1A has current CFDA approval, while this is the initial submission of the new Uscom BP+ and SpiroSonic devices.

China is an important market for Uscom, with much of it’s rapid revenue growth attributable to China sales of the USCOM 1A. The majority of current China sales have been derived from 5 distributors managed by Uscom’s Hong Kong based Asia Pacific distribution partners, Pacific Medical Systems. Uscom has recently increased it’s China activities and expanded its operations to include an additional partnership with a Shanghai based, Chinese state owned entity, CIIC Shanghai Science and Technology, and its distribution arm, Sense Medical. CIIC Shanghai Science and Technology will be responsible for the importation and wholesale of Uscom devices into China, while Sense Medical have been established to manage distribution of the Uscom devices into multiple Chinese provinces.

Uscom CEO Rob Phillips, Global Distribution Manager Denise Pater and Customer Relations Manager Bev Jacobson have just returned from initial training of 8 newly appointed distributors being managed by CIIC and Sense Medical. The training was accompanied by an order for 7 USCOM 1A devices.

Executive Chairman of Uscom, Associate Professor Rob Phillips said, “Success in China is very much a numbers and partners project. We have a state owned, Shanghai based importation and wholesale partner with growth aspirations beginning to feed our USCOM 1A into the 1.37B population Chinese market. The BP+ and SpiroSonic devices can then also be fed into these channels once we receive CFDA approvals. China has 32 provinces while we have previously only had 5 effective distributors. On this trip we trained 8 new CIIC appointed distributors covering previously un-served provinces, and further appointments are in process as we focus on onshore training and technical support. The new China importation and distribution model is planned to provide a platform for significantly increased distribution and revenue for the USCOM 1A, and then the new BP+ and SpiroSonic devices once they are approved for sale in China; this process is now underway.”

Uscom manufactures and markets the USCOM 1A, the Uscom BP+, and the Uscom SpiroSonic digital ultrasonic spirometry technologies. These premium digital medical devices are changing the way we diagnose and treat cardiovascular and pulmonary diseases, including hypertension, heart failure, asthma, COPD and sleep disorders. The products are integral for optimising management of sepsis and guidance of fluid, inotropes and vasoactive therapies in critical care monitoring, and in clinical and home care delivered asthma and COPD medications.

Uscom Limited (ABN 35 091 028 090) Suite 1, Level 7 10 Loftus 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 hemodynamic 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 hemodynamic monitor that measures cardiovascular function, detects irregularities and is used to guide treatment. The USCOM 1A device has major applications in Pediatrics, Emergency, Intensive Care Medicine and Anesthesia, and is the device of choice for management of adult and pediatric 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 standalone 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 multi-path ultrasonic spirometers : 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 [email protected]

Brett Crowley Company Secretary [email protected]

Uscom Limited (ABN 35 091 028 090) Suite 1, Level 7 10 Loftus Street, Sydney NSW 2000 Australia T: +612 9247 4144 E: [email protected] W: www.uscom.com.au