Healthcare Industry News: vascular access
News Release - February 19, 2008
Pyng Medical Receives US FDA ClearanceEnhanced FAST1(TM) Intraosseous Infusion System Now Available in the US
VANCOUVER, BRITISH COLUMBIA--(Healthcare Sales & Marketing Network)--Feb 19, 2008 -- Pyng Medical Corp. (CDNX:PYT.V ) today announced the Company has received Special 510(K) regulatory clearance from the US Food and Drug Administration to market its new and improved version of the award-winning FAST1(TM) Intraosseous (IO) Infusion System throughout the US, effective immediately.
FAST1(TM) is the most rapid, reliable and safe alternative to conventional IV infusion providing lifesaving vascular access for fluid and drug resuscitation in shock and trauma victims. The Company's lead clinical product has been re-engineered with a superior infusion tube that no longer requires the use of a removal tool. The product shipped to all non-FDA jurisdictions during the fourth quarter of 2007 and now begins shipment into the US.
"These improvements were implemented in direct response to feedback from Pyng's key customers based on real life applications on the battle field and EMS environments," said David Christie, President and CEO. "As part of our ongoing commitment to technology innovation we've achieved procedural efficiencies and further enhanced the ease-of-use for our market-leading FAST1(TM) Intraosseous Infusion System. We look forward to showcasing further developments in our next generation FASTX Sternal IO System at leading industry events later this year," adds Christie.
About Pyng Medical Corp.
Pyng Medical Corporation is the developer and manufacturer of the proprietary, award-winning FAST1(TM) Intraosseous Infusion System. Pyng was selected in the "2007 TSX Venture 50" Top 10 companies in Life Sciences based on solid financial metrics for the year ending December 31, 2006. With expanding markets in North America, Europe and Asia, the FAST1(TM) has worldwide application for use with hospitals, emergency medical services and military forces.
Safe Harbour Statement; Forward-Looking Statements: This release may contain forward-looking statements based on management's expectations, estimates and projections. All statements that address expectations or projections about the future, including statements about the Company's strategy for growth, product development, market position, expected expenditures and financial results are forward-looking statements. Some of the forward-looking statements may be identified by words like "expects", "anticipates", "plans", "intends", "projects", "indicates", and similar expressions. These statements are not guarantees of future performance and involve a number of risks, uncertainties and assumptions. Many factors, including those discussed more fully elsewhere in this release and in documents which may be filed with the British Columbia Securities Commission, the Alberta Securities Commission, the Ontario Securities Commission, the TSX Venture Exchange, as well as other USA Commissions, could cause results to differ materially from those stated. These factors include, but are not limited to changes in the laws, regulations, policies and economic conditions, including inflation, interest and foreign currency exchange rates, of countries in which the Company does business; competitive pressures; successful integration of structural changes, including restructuring plans, acquisitions, divestitures and alliances; cost of raw material, research and development of new products, including regulatory approval and market acceptance; and seasonality of sales in some products.
Source: Pyng Medical
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