YUCAIPA, Calif., May 21, 2009 (GLOBE NEWSWIRE) -- Ingen Technologies, Inc. (Pink Sheets:IGNT) a leading Global Medical Device manufacturer focused in the $8 Billion global Respiratory Market for the growing ageing populations and emerging markets for Home (DME), Hospital and Aviation Industries announced today that they have signed agreements yesterday with Emergo Global Consulting LLC to prepare and register the required ISO and CE Mark certifications to market and sell Oxyview in Europe, Asia and Canada.
Emergo Group has become the authorized representative for medical devices and will produce the required technical file compilation for CE Mark compliance, and the quality system implementation in accordance with quality system requirements for ISO 13485:2003, CE Marking (Annex II or V), Canadian Medical Device Regulations and FDA Good Manufacturing Practices (GMP).
Emergo Group is an ISO registered medical device consulting firm with offices in the United States, Canada, Europe, China, Japan and Australia. By focusing on providing outstanding customer service and value for their clients, Emergo Group has grown to become one of the leading medical device regulatory consultants with expertise in CE Marking, Good Manufacturing Practices (GMP), ISO 13485 quality system implementation, Canadian licensing, China SFDA registration, Japanese device approval, in-country representation and many other areas.
Ingen Technologies' Oxyview product is required to meet the International Standards Organization (ISO requirement (ISO-13485) to be sold in China, Canada and the European Community. The company has distribution in China and Canada, and has pending contracts with several large distributors, such as Nidek Medical in Asia. The agreements between the company and Emergo Group require approximately $40,000 in fees and 3-4 months in preparation and filing to complete the ISO and CE Mark certifications.
The company has recently brought current their filings responsibilities with the SEC and Pink OTC Markets, as well as announced the new introduction of the Oxyview-Cannula that includes a partnership with Legend Medical Devices, Inc. "The respiratory markets outside of the U.S. represent even a better market for Oxyview and this market is now very receptive in wanting to purchase our Oxyview product. We have recently been issued a patent in China, and we have patents pending that are near being issued in Japan and the European Communities. We are well financed, and are moving full steam ahead with our growth plans," stated Scott Sand, Chief Executive Officer of Ingen Technologies.
About Oxyview:
Oxyview is a proprietary medical device with US issued patents that stands alone in an increasing patient home oxygen therapy market while there are 23 million patients diagnosed with chronic obstructive pulmonary disease (COPD) in the United States, according to the World Health Organization, and another 12 million patients that are undiagnosed in the US. COPD is the fifth leading cause of death in the US and there are 600 million COPD patients worldwide where in most cases, COPD is either the first or second leading cause of death in other countries. The majority of COPD patients require continued home oxygen therapy, which includes all of the required equipment supplied by the home (DME) provider. With the new regulations for oxygen reimbursement in the US, the home (DME) providers need to cut costs to stay in business. Oxyview provides a substantial savings as a result of decreasing the number of service calls for the home (DME) provider. Oxyview is a pneumatic metering device that displays oxygen flow near the patient. The Oxyview flow meter easily and quickly installs on to the oxygen tubing nearest the patient where oxygen flow matters the most. Without the Oxyview, patients cannot confirm oxygen flow, and as a result there is an increase in anxiety and the patient calls the home (DME) provider with concerns. Oxyview also allows the home (DME) provider to trouble-shoot other equipment problems over the telephone which eliminates an on-site visit with the patient. More important, the Oxyview provides the patient with more assurance that they are receiving adequate and prescribed oxygen flow. The Oxyview costs less than a single service call.
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Safe Harbor for Forward-Looking Statements: This news release includes forward-looking statements. While these statements are made to convey to the public the company's progress, business opportunities and growth prospects, readers are cautioned that such forward-looking statements represent management's opinion. Whereas management believes such representations to be true and accurate based on information and data available to the company at this time, actual results may differ materially from those described. The company's operations and business prospects are always subject to risk and uncertainties. Important factors that may cause actual results to differ are and will be set forth in the company's periodic filings with the U.S. Securities and Exchange Commission.