VANCOUVER, BRITISH COLUMBIA, Apr. 20, 2010 (Marketwire) -- Pyng Medical Corp. (TSX VENTURE:PYT) (the "Company" or "Pyng") today announced that the United States Food and Drug Administration ("FDA") completed its review of the Company's 510(k) submission for its CRIC(TM) Kit Cricothyrotomy device.
The Company pursued FDA approval to market CRIC(TM) in the United States via 510(k) premarket notification. FDA determined CRIC(TM) to not be substantially equivalent to the predicate device (a legally marketed device in its category) used in the company's submission and therefore is not eligible to be cleared for commercial distribution via the 510(k) process. Due to this result, Pyng intends to pursue a different path to FDA clearance and will resubmit CRIC(TM) for review after obtaining additional data and field-usage experience on the safety and efficacy of the product.
CRIC(TM) previously received the CE mark in Europe via the European Medical Device Directive 93/42/EEC, and has also been cleared by Health Canada and the Australian Therapeutic Goods Administration. As a result, CRIC(TM) is currently for sale in Europe, Canada, Australia and other countries which accept these major regulatory agency approvals.
CRIC(TM) is indicated for use in obtaining a surgical airway for patients where intubation is not an option and the product provides a rapid Cricothyroidotomy solution (including illumination) in a single compact device. Testing performed to date has indicated that CRIC(TM) delivers fast and effective airway access via this singular device as opposed to current methods which require several kit components.
Robert Di Silvio, Pyng President and CEO, commented "Previous clearance for commercial distribution of CRIC(TM) in Europe, Canada, Asia and South America will allow Pyng to grow in these international markets, where substantial opportunity exists, while working in parallel on FDA clearance in the United States."
About Pyng Medical Corp.
Pyng Medical Corp. 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.
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