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USCOM LIMITED — Regulatory Filings 2014
Feb 3, 2014
65979_rns_2014-02-03_880fef94-edd5-4fc2-87bb-cd27f0611bf2.pdf
Regulatory Filings
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Uscom Limited
ABN 35 091 028 090 Suite 1, Level 7, 10 Loftus Street Sydney NSW 2000 Australia T +612 9247 4144 F +612 9247 8157 www.uscom.com.au
M A R K E T A N N O U N C E M E N T
Uscom BP+ receives CE Mark for sales into Europe
Tuesday 4th of February 2014: Uscom (ASX code: UCM)
Uscom Limited today announced receipt of the CE Mark for the BP+, allowing the Uscom BP+ device to be sold into the European Economic Area. The Uscom BP+ already has FDA 510K status and is currently in the process of TGA review.
In anticipation of the confirmation of CE status Uscom has been developing a European distribution network and volume manufacturing strategy so that the BP+ can be rapidly delivered to market to meet demand.
The Uscom BP+ is a practice leading blood pressure (BP) measurement device based on patent protected suprasystolic oscillometric technology. While conventional methods measure BP in the arm, the BP+ directly measures blood pressure at the heart, a more effective approach. The BP+ also provides unique central pulse pressure waveforms that have previously only been acquired using catheters into the heart. These accurate noninvasive central BP measurements are revolutionising the way hypertension and heart failure are diagnosed and managed with central BP now being proven to be more predictive of outcomes and a better method to guide hypertension treatment.
Executive Chairman of Uscom, Rob Phillips said, “The Uscom BP+ technology is leading the changes in thinking on blood pressure and hypertension globally. The confirmation of the completion of the CE Mark process means we can now sell the device into European jurisdictions. We are also preparing for increased manufacturing of the BP+ to meet current orders and to feed the product into our newly developed European distribution channels. The Uscom BP+ is an excellent complement to the USCOM 1A cardiac output monitor in our portfolio as both are breakthrough products.”
The USCOM 1A and Uscom BP+ technologies are premium cardiovascular devices manufactured and distributed by Uscom Limited and sold into global markets. The BP+ simplifies and improves the accuracy of blood pressure measurement and management and is used as a research tool and clinical device for advanced management of hypertension.
References:
- McEniery CM, Cockcroft JR, Roman MJ, Franklin SS, Wilkinson AB. Central blood pressure: current evidence and clinical importance. Euro Heart J 2014;doi10.1093/eurojeartj/eht565 - Avolio A. Central aortic blood pressure and management of hypertension: confirmation of a paradigm shift? Hypertension Editorial 2013; Sept 23
Uscom Limited
ABN 35 091 028 090 Suite 1, Level 7, 10 Loftus Street Sydney NSW 2000 Australia T +612 9247 4144 F +612 9247 8157 www.uscom.com.au
M A R K E T A N N O U N C E M E N T
About Uscom
Uscom Limited is an ASX listed cardiovascular medical device company (UCM). Uscom is an innovative developer and manufacturer of premium cardiovascular devices and has two practice leading technologies in the field of cardiovascular monitoring, the USCOM 1A and the BP+. The devices are both clinically validated with FDA, CE and TGA regulatory approval, and are currently being marketed into global distribution networks.
The USCOM 1A is a simple, cost-effective and non-invasive device that measures heart function, detects irregularities and guides treatment. The USCOM device has major applications in Paediatrics, Emergency, Intensive Care Medicine and Anesthesia, and is the device of choice for management of adult and paediatric sepsis, and for the guidance of fluid therapy.
The Uscom BP+ is a supra systolic Central Blood Pressure monitor and replaces older and more widespread BP sub systolic Blood Pressure monitoring technology. Central Bood Pressure is becoming the new standard of care measurement in hypertension and heart failure. The Uscom BP+ provides a highly accurate & repeatable measurements 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 cardiology, intensive care, general practice and home care.
For more information, please visit: http://www.uscom.com.au
Uscom Contacts Rob Phillips Executive Chairman [email protected]
Catherine Officer Company Secretary [email protected]