UCM could be back above $3 today. US FDA approval. Huge news!!!
USCOM TO TACKLE US MARKET FOLLOWING FDA CLEARANCE Wednesday, February 16, 2005: USCOM Limited (ASX Code: UCM) today announced plans to target the significant US market having received formal notification of regulatory clearance for entry into the United States market earlier today. The US Food & Drug Administration (FDA) issued the necessary 510K Pre-Market Notification in Washington today. USCOM had submitted its 510 application in November 2004. Commenting on the announcement, the Chief Executive of USCOM, Mr Gary Davey said: “Securing FDA clearance is the most significant milestone in USCOM’s history paving the way for first commercial sales into the vast US market. It follows regulatory clearance and first sales in eleven other countries thus far. The FDA documentation allows the company to activate its sales and distribution strategy for the US market, taking the USCOM opportunity to a whole new level.” The United States constitutes the world’s largest single market for medical devices, representing approximately 50% of global devices turnover. USCOM has been presenting and exhibiting its technology at medical conferences in the US for approximately 2 years in anticipation of today’s announcement. The company has already signed high level collaborative agreements with some of America’s leading institutions in Emergency Care, Intensive Care, Paediatrics and Cardiology, acting as luminary research and reference sites. The Chairman of USCOM, Mr Rob Phillips, said “This fundamentally changes the USCOM business opportunity. We are extremely proud of having reached this critical milestone. This is great news for our company, our staff and our investors. We have worked hard to establish our company at the highest levels of US clinical practice. Apart from the sheer scale of the US market, there is no doubt that our activities there will contribute to a global shift towards non-invasive cardiovascular assessment.” USCOM’s United States management team is led by Mr Barry Zakar, the company’s Director of Operations for North America, based in California. Mr Zakar joined USCOM in August 2004, following a 25 year career in the US medical devices industry. The first sales of the USCOM device in the North American market are anticipated during the current financial year. To date, regulatory approvals have been secured for marketing of the device in: Australia; Japan; China and Europe. Commercial sales have already been made in each of those regions, totaling 11 different countries.
