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Latest News

China BP+ and SpiroSonic Regulatory Submissions

March 22nd, 2017

China regulatory submission, distributor training and CIIC sales

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 Receives $0.5M R&D Cash Refund

March 20th, 2017

Uscom has received $0.496M from the Australian Tax Office under the Federal Government Research and Development (R&D) Tax Incentive Program related to R&D expenditure in the 2016 tax year. The Federal Government R&D program provides for the refund of 45% of eligible research and development expenditure during the previous financial year.

Uscom has an on-going program of R&D planned to ensure that its current products are continually improved with new and innovative features, and new products conceived and developed for national and international markets. Uscom invests shareholder’s funds carefully, particularly in R&D, and recognises that while outcomes are uncertain, R&D is vital for the future of the Uscom business. The financial incentive offered by this Federal Government rebate is significant when Uscom plans the scale and objectives of its internal spending programs.

Executive Chairman of Uscom, Associate Professor Rob Phillips said, “Innovation is our business, and it’s both an Uscom corporate culture and a valuable investment for shareholders. The financial support offered by this Federal Government R&D program is vital for many Australian bioscience companies seeking advances in medical science where lead times can be significant. Research and development has many uncertainties, and this cash refund underwrites some of the risks for Australian companies and investors. The R&D tax incentive is a well-designed, targeted and administered program, creating a genuine encouragement for science companies to innovate and develop Australian employment, IP and export revenue, and Uscom is grateful for this support.”

Uscom manufactures and markets the USCOM 1A, the Uscom BP+, and the Uscom SpiroSonic digital ultrasonic spirometry technologies. These premium digital 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.

New Uscom BP+ US Patent

March 6th, 2017

Applications in hypertension, heart failure and vascular Health

Uscom has received a Notice of Allowance from the United States Patent Office for a new method and apparatus patent related to its novel Uscom BP+ supra-systolic oscillometric central blood pressure monitor.

The patent describes a novel method and apparatus for producing a central pressure waveform in an oscillometric blood pressure system, and is central to the technology within the Uscom BP+ central blood pressure monitor. The patent was assigned the application number 15/224,821 and was filed on 1st August 2016, with a confirmation number 3711, and provides a 20 year period of commercial protection from the date of filing.

The patented technologies within Uscom BP+ improve the measurement of blood pressure, a fundamental clinical measurement of circulation, and represent some of the most advanced and innovative of cardiovascular technologies. The central pulse pressure wave measurements generated by the BP+ have application in the diagnosis and management of hypertension, heart failure and vascular health and have only previously been available using cardiac catheters. In children the device has been called the “non-invasive arterial line” for its potential to replace currently used arterial pressure catheters.
The BP+ measures central and brachial blood pressure and pulse pressure waves using supra-systolic oscillometry and is currently in regulatory review for approval for sale into China, Europe and the USA, with a number of new partnerships being negotiated for international distribution. By measuring directly into the aorta rather than measuring the arm BP, the Uscom BP+ provides potentially improved blood pressure monitoring measurements, and the devices has been invasively validated against catheters in children and adults.

Executive Chairman of Uscom, Associate Professor Rob Phillips said, “Patents are real value for shareholders and recognition of innovative and practice leading science. We see the Uscom BP+ and BP+ Reporter as the disrupting technologies for blood pressure, heart failure and critical care monitoring, and this new patent adds to the others in our BP+ suite. The BP+ is currently deployed on the International Space Station to provide novel insights into the cardiovascular physiology of astronauts. The Uscom BP+ has a real role in cardiovascular practice and we anticipate its adoption will grow rapidly once global approvals are granted over the next 12 months and as new specialist distributors are appointed.”

Uscom manufactures and markets the USCOM 1A, the Uscom BP+, and the Uscom SpiroSonic digital ultrasonic spirometry technologies. These premium digital 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.