OxySure Systems, Inc. (OXYS) Announces Progress on CE Marking
Frisco, TX - (Marketwired - September 24, 2013) - OxySure Systems, Inc. (OTCQB: OXYS) ("OxySure" or the "Company") a medical technology company that has pioneered an FDA-approved solution to produce medically pure oxygen from dry, inert powders for emergency/short duration use today announced progress with regard to the CE Marking of its flagship product, the OxySure Model 615.
The Company received notice on September 12, 2013 of an opinion rendered by the Medicines and Healthcare products Regulatory Authority (MHRA) in the United Kingdom related to the classification of the OxySure Model 615 as a medical device. An opinion of this nature by a competent authority is a key step in the CE Marking process.
"We are pleased with this opinion from MHRA," stated Mark Gilmore, Managing Partner of Aero Healthcare, OxySure's partner in the United Kingdom. Added Gilmore, who oversees the CE Marking process: "In addition, we have already substantially completed our technical file for the CE Marking process and we plan to move forward post haste with our notified body on the next steps of the CE Marking of OxySure."
The CE marking indicates a product's compliance with European Union legislation and enables the free movement and sale of products within the European market. CE Marking will allow OxySure's approved products to be sold in approximately 31 countries in the European Economic Area (EEA), comprising the 28 Member States of the European Union and the European Free Trade Association (EFTA) countries of Iceland, Norway, and Liechtenstein. As of January 1, 2012, the population of the European Union was approximately 503.5 million people.
About OxySure Systems, Inc.
OxySure Systems, Inc. (OTCQB : OXYS) is a medical technology company that focuses on the design, manufacture and distribution of specialty respiratory and medical solutions. The company pioneered a safe and easy to use solution to produce medically pure (USP) oxygen from inert powders. The company owns numerous issued patents and patents pending on this technology which makes the provision of emergency oxygen safer, more accessible and easier to use than traditional oxygen provision systems. OxySure’s products improve access to emergency oxygen that affects the survival, recovery and safety of individuals in several areas of need: (1) Public and private places and settings where medical emergencies can occur; (2) Individuals at risk for cardiac, respiratory or general medical distress needing immediate help prior to emergency medical care arrival; and (3) Those requiring immediate protection and escape from exposure situations or oxygen-deficient situations in industrial, mining, military, or other “Immediately Dangerous to Life or Health” (IDLH) environments. www.OxySure.com
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements contained in this release that are not historical facts, including, without limitation, statements that relate to the Company's expectations with regard to the future impact on the Company's results from new products in development, may be deemed to be forward-looking statements. Words such as "expects", "intends", "plans", "may", "could", "should", "anticipates", "likely", "believes" and words of similar import also identify forward-looking statements. These statements are subject to risks and uncertainties. Forward-looking statements are based on current facts and analyses and other information that are based on forecasts of future results, estimates of amounts not yet determined and assumptions of management. Readers are urged not to place undue reliance on the forward-looking statements, which speak only as of the date of this release. Except as may be required under applicable law, we assume no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release. Additional information on risks and other factors that may affect the business and financial results of OxySure Systems, Inc. can be found in the filings of OxySure Systems, Inc. with the U.S. Securities and Exchange Commission.