The USCOM Cardiac Output monitor has been issued a product registration number by the State Food and Drug Administration (SFDA). The special fast-tracked approval process was made possible due to the potential use of this non-invasive monitoring device in the management of the Severe Accurate

Respiratory Syndrome (SARS), a potentially fatal infection which attacks the lungs and affects the heart.

The USCOM Cardiac Output monitor is a non-invasive device that utilizes ultrasound Doppler to measure blood flow and pressure in and around the heart. It provides instantaneous haemodynamic information about changes in cardiac function, which is important in the management of patients with heart and lung disease.

Jules Flach, CEO and Founder of Pacific Medical Systems Limited, the USCOM marketing and distribution management hub for north Asia, said: "We are very pleased that our efforts in procuring an expedient registration in China have paid off. It signifies the beginning of one of the world's most important markets for the USCOM product and also help in the crusade to fight SARS."

The Chairman of USCOM, Mr Rob Phillips said: "We believe USCOM has an important role to play in the Chinese medical system. We are delighted to be working closely with the Chinese authorities on the introduction of USCOM especially as a potential collaborator in the fight against SARS.

Commenting on the announcement today, USCOM Chief Executive, Gary Davey said: "This is an extremely important milestone for USCOM. China is a complex market, but with more than 100,000 hospitals, it represents a vast opportunity for a product like ours.

Background - USCOM:

USCOM Pty Ltd is an Australian start-up company in the development of non-invasive medical devices. USCOM has secured worldwide patents to the use of Ultrasound for the transcutaneous monitoring of intracardiac flow. The company’s technology is protected under the international patent pending protocols and its core patent has been formally accepted in both Australia and the United States.

USCOM (Ultrasonic Cardiac Output Monitors) measures blood flow across the heart valves using Continuous Wave (CW) Doppler Ultrasound, a technique which can accurately show variations in haemodynamic patterns. The USCOM machine displays real-time data about cardiac function across multiple parameters, ranging from Heart Rate to Litres-Per-Minute.

This vital information is instantly displayed in numerical and graph form, comparing current values against previous measures and averages. Until now, cardiac monitoring has needed specialised equipment and personnel and has often required an invasive procedure.

The most widely used method of measuring cardiac output is the Swan-Ganz catheter, which involves the insertion of a probe, through the patients’ groin or neck for the measurement of flow through the heart chambers. The USCOM technology is totally non-invasive, painless and operated hands-free yet produces data which is accurate, reliable and immediate.

USCOM secured Australian regulatory clearance in December 2001, with the issue of a Listing with TGA (Therapeutic Goods Administration). USCOM is a privately held Australian company, which attracted investment from the Bell Potter Medical Innovation Trust in November 2002, injecting $1.65 million for 11% of the equity of the company.

The remainder of the equity is owned by the founders of the company. USCOM is a member of the Australian Made Campaign and the Australian Technology Showcase and in 2001 was presented by the Federal Department of Science and Industry an Award for Innovation.

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