Pyng Medical Receives US FDA and Health Canada Clearance
For Expanded Use of FAST1™
Leading Sternal IO System Now Available For Both Adolescent and Adult Care Throughout the US, Canada and EU
Vancouver, BC – Pyng Medical Corp. (PYT: TSX .V) today announced it has received regulatory clearance from both the US Food and Drug Administration (FDA) and Health Canada to market its FAST1™ Intraosseous (IO) Infusion System for use in adolescent populations, in addition to adults throughout the US and Canada, effective immediately. FAST1™ also cleared for adolescent and adult use in the European Union (EU) through its CE Mark.
FAST1™ 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.
“We’ve enjoyed considerable success commercializing FAST1™ for use on adult populations internationally, with six consecutive quarters of strong sustained growth in revenue from product sales and profitability. As a result of the expanded market clearance in the US, Canada and Europe, we now look forward to providing life-saving technology to assist a broader demographic population ranging from 12 years of age through adulthood,” said David Christie, President and Chief Executive Officer. “FAST1™ is now the only single IO product cleared for use in both adolescents and adults, increasing the size of our markets and providing greater access for young people in their teenage years to Pyng’s award-winning emergency medical technology.”
Pyng Medical received regulatory clearance from both the US FDA and Health Canada for expanded use of the FAST1™ through a parallel expedited review process, each completed in less than one month. As a result, the Company’s lead clinical product will now be available for use on patients as young as 12 years of age throughout the US, Canada and EU.
About Pyng Medical Corp.
Pyng Medical Corp. is the developer and manufacturer of the proprietary, award-winning FAST1™ Intraosseous Infusion System. Pyng has received the exclusive 2008 Medical Device Company of the Year Award from LifeSciences British Columbia for its sustained achievements in commercializing the Company’s proprietary FAST1™ Intraosseous Infusion System. The Company was also 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™ has worldwide application for use with hospitals, emergency medical services and military forces.
For More Information
Bob DiSilvio
Pyng Medical Corp.
(604) 303-7964
www.pyng.com
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