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USCOM LIMITED — Regulatory Filings 2009
Jul 12, 2009
65979_rns_2009-07-12_de252f11-b777-4e82-9999-b11ab4a13af9.pdf
Regulatory Filings
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MARKET ANNOUNCEMENT
USCOM standard of care for ICU fluid management
Monday, 13 July 2009: Uscom (ASX Code: UCM) today notified shareholders of a new publication in the journal Critical Care from The University of Washington School of Medicine, St Louis, recommending the routine use of USCOM for ICU patients requiring intravenous (IV) fluid therapy in preference to invasive catheter based approaches.
Giving fluids is one of the most common and universal medical interventions and has a direct effect on cardiovascular function which can be either positive or negative. Currently, using invasive catheters guidance, less than half of all fluid interventions in ICU patients are necessary. However this study determined that USCOM can determine with approximately 90% accuracy who will benefit from fluid treatment and who will not. The study concluded “(USCOM) can predict volume responsiveness in a variety of unselected medical ICU patients. …… underscoring the need for routine application of (USCOM) when VE (fluid) is considered”.
Uscom CEO, Mr. Paul Butler said “This is a landmark publication in an area of practice in which there is a huge clinical need. We developed USCOM to provide the accuracy to allow development of new approaches to fluid management and this paper confirms that outcome. This paper further supports our claim that USCOM is a standard of care in the ICU.”
Mr Rob Phillips, Executive Chairman and Director of Clinical Science said “This study will shift thinking in critical care medicine worldwide. Fluid management is controversial and generally done poorly because of the inadequate tools to guide clinicians, but USCOM simplifies this practice. This study suggests that USCOM will improve treatment, and save vital healthcare dollars.”
References: Thiel SW, Kollef MH, Isakow W. Non-invasive stroke volume measurement and passive leg raising predict volume responsiveness in medical ICU patients: an observational cohort study. Critical Care 2009 13: R111, doi10.1186/cc7955.
Michard F, Teboul JL. Predicting Fluid Responsiveness in ICU Patients: A Critical Analysis of the Evidence. Chest 2002;121:6:2000-2008.
www.uscom.com.au
Uscom Limited Level 7, 8-10 Loftus Street Sydney NSW 2000 Australia Phone: 61-2-9247 4144 Fax: 61-2-9247 8157 ABN: 35 091 028 090
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About Uscom
Uscom Limited is an Australian medical device company, listed on the Australian Stock Exchange since December 2003. Uscom has developed a device for the safe and accurate measurement of cardiac output, a non-invasive alternative to the current invasive methods. Uscom offers a completely safe, painless and quick method of accurately measuring how well the heart is pumping. With its real-time beat-to-beat information across multiple parameters of cardiac function and advanced serial measurement capabilities, clinicians can accurately quantify the impact of therapy. The device is ideally suited to the Emergency Care setting where it is critical to monitor changes in cardiac output as fluids are applied.
The Company has secured regulatory approval for sale of the Uscom Monitor in Australia, Europe and a number of Asian markets, including Japan, China and Taiwan. Uscom also has a CE Mark certification for Europe and a license from the State Food & Drug Administration for China. The Company received the necessary regulatory clearance for the United States market in February 2005 with the receipt of a 510K Pre Market Notification from the US Food & Drug Administration (FDA).
Uscom Contacts Paul Butler Chief Executive Officer Office: +1 646 379 3278 [email protected]
Rob Phillips Executive Chairman Office: 02 9247 4144 [email protected]
www.uscom.com.au
Uscom Limited Level 7, 8-10 Loftus Street Sydney NSW 2000 Australia Phone: 61-2-9247 4144 Fax: 61-2-9247 8157 ABN: 35 091 028 090