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Published on 12/16/2005 in the Prospect News Biotech Daily.

FDA approves OxySure's portable oxygen generator for over-the-counter sale

By E. Janene Geiss

Philadelphia, Dec. 16 - OxySure Systems, Inc. announced Friday that the company received approval from the Food and Drug Administration for over-the-counter sale for its revolutionary new catalytic, portable oxygen generator.

The OxySure Model 615 will create a new category for emergency oxygen availability in cardiovascular disease, respiratory emergency and general medical emergency markets, according to a company news release.

Like a fire extinguisher, the OxySure Portable Oxygen Generator, Model 615, can be safely prepositioned in homes, buildings and other public and private settings to provide immediate medical grade oxygen in an emergency, but without compressed gas container risks, officials said.

It also can provide temporary oxygen to aid escape in hazardous exposure situations or when necessary long term oxygen supplies are interrupted, officials said.

"Supplemental oxygen can mean the difference between serious brain damage and full recovery, and even between life and death, when someone suffers from oxygen deprivation. This can occur due to acute decompensation of heart failure or chronic lung disease, an acute asthma attack and many other unexpected medical emergencies. The OxySure product enables a loved one, bystander or even the person himself to provide that oxygen in a convenient, safe and inexpensive manner while awaiting the arrival of emergency medical responders," said Vincent Mosesso, medical director of pre-hospital care at the University of Pittsburgh Medical Center and medical director of the Sudden Cardiac Arrest Association, in the release.

OxySure said it has 19 patents pending on this unique technology that generates medically pure oxygen from two inert powders in the presence of an accelerant.

This technology makes oxygen-delivery devices safer, lighter, easier to use and much more accessible to the consumer. The OxySure Model 615 uses OxySure proprietary technology and consists of a thermoplastic device that produces in excess of 90 liters of medical grade oxygen in a safe and environmentally friendly manner. The device is activated in one step and uses replaceable cartridges for each use.

OxySure Systems is a Frisco, Texas, medical technology company focused on the design, manufacture and distribution of specialty medical and respiratory products.


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