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Pyng Medical Corp. (PYNGF) Receives US FDA 510(k) Clearance for FASTx(TM)


9/2/2010 6:16:51 AM

VANCOUVER, BRITISH COLUMBIA--(Marketwire - September 01, 2010) - Pyng Medical Corp. (TSX VENTURE: PYT) announces today that it has received 510(k) clearance from the US FDA to market the FASTx™ Sternal Intraosseous Device. The company will now begin ramping up production to meet the anticipated demand for this next generation IO product.

The FASTx™ Sternal Intraosseous Device is indicated for use in establishing a sternal intraosseous access route in adult and adolescent patients (12 years of age and older) that require vascular administration of drugs or fluids to facilitate emergency resuscitation. FASTx™ Sternal Intraosseous Device is a 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 an integrated, easy, pull-to-remove infusion tube, light and compact form factor made for single-handed use.

"These improvements were implemented in direct response to feedback from Pyng's key customers based on real life applications on the battlefield, Hospital, and EMS environments," said Robert Di Silvio, President and CEO. "As part of our ongoing commitment to technological innovation we've achieved procedural efficiencies and further enhanced the ease-of-use for our market-leading FAST1® Intraosseous Infusion System. "We also have both Health Canada and CE Mark approvals for FASTx™," adds Di Silvio.

About Pyng Medical Corp.

Pyng Medical Corp. commercializes award-winning trauma and resuscitation products for front-line critical care personnel. Pyng's expanded product portfolio includes a variety of innovative, lifesaving tools. With growing markets in North America, Europe and Asia, Pyng offers user-preferred medical devices for use by hospital staff, emergency medical services and military forces worldwide.

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 Regulatory Service Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.


Contacts:
Pyng Medical Corp.
Bob DiSilvio
Chief Executive Officer
1-800-349-7964 (x208)
www.pyng.com


Read at BioSpace.com


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