AI assistant
USCOM LIMITED — Regulatory Filings 2014
Aug 24, 2014
65979_rns_2014-08-24_01f4d879-88bd-4dcc-a4a9-07a15af16578.pdf
Regulatory Filings
Open in viewerOpens in your device viewer
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
==> picture [57 x 49] intentionally omitted <==
M A R K E T A N N O U N C E M E N T
TGA Approval for Uscom BP+ Central Blood Pressure BP+ device now has FDA, CE Mark and TGA approval.
Monday 25th of August 2014: Uscom (ASX code: UCM) is pleased to announce notice of the listing of the Uscom BP+ device on the Australian Register of Therapeutic Goods. The Australian Therapeutic Goods Administration (TGA) lists devices which meet Australian Government standards of quality, safety, efficacy and timely availability on the Australian Register of Therapeutic Goods. Listing on the TGA register is essential prior to sale of a medical device in Australia.
The Uscom BP+ uses patent protected suprasystolic oscillometry to measure the blood pressure at the heart, information previously only provided by cardiac catheterization, and which better predicts cardiovascular risk and provides better treatment guidance. The patent protected Uscom suprasystolic oscillometric central blood pressure technology has advantages over simple sub systolic oscillometry, which only measures the cuff blood pressure in the arm. The TGA listing now means the Uscom BP+ can be sold in Australia by distributors and directly by the Company to Hospitals, clinics, researchers and consumers concerned with improved management of hypertension and other diseases related to blood pressure abnormalities such as heart failure. The current global BP device market is estimated at approximately $2b USD and growing at 11.5% per year.
Executive Chairman of Uscom, Dr Rob Phillips said, “Regulatory approval is becoming a significant hurdle for market entry as the regulatory process becomes increasingly complicated. We are delighted to have FDA, CE and now TGA approval for the Uscom BP+, and are currently preparing for Chinese CFDA submission. Australian Doctors are responsive to new and improved technologies and the Uscom supra systolic oscillometric central blood pressure device, the BP+, represents a breakthrough technology in the field. We are now targeting Hospitals, cardiovascular researchers, clinics and individuals with hypertension or heart failure that require highly accurate clinical blood pressure measurements and improved management.”
Uscom manufactures and markets the USCOM 1A and the Uscom BP+, both premium cardiovascular devices changing the way we diagnose and treat cardiovascular diseases, including hypertension, heart failure and sepsis, and improving guidance of fluid, inotropes and vasoactive therapies.
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
==> picture [57 x 49] intentionally omitted <==
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. 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 abnormalities 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, heart failure, 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 Blood Pressure is becoming the new standard of care measurement in hypertension and heart failure. The Uscom BP+ provides a highly accurate and repeatable measurement 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 hypertension, cardiology, intensive care, general practice and home care.
For more information, please visit: www.uscom.com.au
Uscom Contacts Rob Phillips Executive Chairman [email protected]
Catherine Officer Company Secretary [email protected]