Pyng Medical Corp.

Pyng Medical Corp.

April 20, 2010 13:08 ET

Pyng Receives Response from FDA Concerning CRIC™

VANCOUVER, BRITISH COLUMBIA--(Marketwire - April 20, 2010) - 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™ Kit Cricothyrotomy device.

The Company pursued FDA approval to market CRIC™ in the United States via 510(k) premarket notification. FDA determined CRIC™ 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™ for review after obtaining additional data and field-usage experience on the safety and efficacy of the product.

CRIC™ 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™ is currently for sale in Europe, Canada, Australia and other countries which accept these major regulatory agency approvals.

CRIC™ 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™ 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™ 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™ 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™ 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.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Contact Information

  • Pyng Medical Corp.
    Bob DiSilvio
    1-800-349-7964 (x208)