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USCOM LIMITED — Regulatory Filings 2009
Apr 19, 2009
65979_rns_2009-04-19_c2921836-1096-40d8-aeb5-418dcae15f8a.pdf
Regulatory Filings
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MARKET ANNOUNCEMENT
USCOM validated in pregnancy
Monday, 20th April 2009: Uscom (ASX Code: UCM) today announced the publication of a new study validating the use of USCOM during pregnancy. The study was published in the Australian and New Zealand Journal of Obstetrics and Gynaecology by a team from the Department of Obstetrics and Gynaecology at The Lyell McEwin Hospital, University of Adelaide in South Australia. The study assessed the feasibility and reproducibility of USCOM use on pregnant women and established normal values for circulation during pregnancy which will serve as reference values for detection and management of maternal hypertension.
Hypertension, or pre-eclampsia, in pregnancy is a common and life threatening condition for the mother and child and requires well-guided clinical care. Central to this effective management is the measurement of cardiovascular function, which is currently performed by complex and expensive methods, but which can be improved and replaced by USCOM.
The study of 172 pregnant women found the USCOM determined values were consistent with current published data using other methods, and that correlation of measures by different observers was good (94 and 96%). The study concluded “USCOM appears to be a reliable and fast method to measure cardiac output compared with existing highly complex ultrasounds machines used in cardiology. It is easy to learn, cheap and quite reproducible between different observers.”
Uscom CEO, Mr. Paul Butler said “This study paves the way for USCOM to become a standard of clinical care in obstetrics, and another significant market opportunity. Not only did the study conclude that USCOM was effective and simpler than current methods, but it also offers a cost saving to the practitioner or Hospital.”
Mr Rob Phillips, Executive Chairman and Director of Clinical Science said “Any contribution to improved management of the mother and foetus during pregnancy has important clinical and social ramifications. Being simpler and less expensive than current methods, USCOM can potentially provide improved obstetric care beyond the developed economies. Critically it is the first step in application of USCOM in hypertension, a pandemic circulatory disease in the general community.”
Further USCOM studies are proposed to focus on hypertension in pregnancy.
Reference: Kager CCM, Dekker GA, Stam MC. Measurement of cardiac output in normal pregnancy by a non-invasive two-dimensional independent Doppler device. ANZ J Obs Gyn 2009 DOI: 10.1111/j.1479828X.2009.00948.x
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
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