Healthcare Industry News: Oridion Systems
News Release - February 23, 2009
Oridion Receives FDA 510(k) Clearance for Capnostream(TM)20 Monitor With Integrated Pulmonary Index(TM)JERUSALEM and NEEDHAM, Massachusetts, February 23 (Healthcare Sales & Marketing Network) -- Oridion Systems Ltd. (SIX Swiss Exchange: ORIDN). Oridion Systems Ltd. has received an FDA 510(k) clearance for its Capnostream(TM)20 Monitor with Integrated Pulmonary Index(TM).
The Integrated Pulmonary Index(TM), the latest Oridion Smart Capnography(TM) initiative, utilizes sophisticated algorithms to integrate the real time measures and interactions of four complex parameters - end tidal CO2 (EtCO2), respiration rate, pulse rate and SpO2 (oxygen saturation) into a single index value. The result is displayed on a scale from 1-10, where 10 indicates optimal pulmonary status.
By using the Integrated Pulmonary Index(TM), clinicians can quickly and easily assess a patient's ventilation status and monitor a patient's changing condition, thus facilitating more timely interventions to reduce patient risk and improve outcomes.
The Integrated Pulmonary Index(TM) has been clinically validated as evidenced by medical research studies conducted and presented at major conferences in 2008 and 2009. At the recent annual meeting of the Society for Technology in Anesthesia (STA) in San Antonio, Texas, research findings were presented by Dr. David Gozal, MD from Hadassah University Hospital and Prof. Ya'acov Gozal, MD from Shaare Zedek Medical Center, both in Jerusalem, on the validity and application of the Integrated Pulmonary Index(TM) in the pediatric population. The study concluded the Integrated Pulmonary Index(TM) would be "particularly useful for non-expert personnel monitoring patients undergoing procedures requiring sedation or recovering from them". Based on a further study on its reliability in the post-operative setting, Prof. Ya'acov Gozal stated that since the Integrated Pulmonary Index(TM) is displayed as a single value, "it may simplify the monitoring of patients in a busy PACU."
In addition, a study presented at the American Society of Anesthesiologists (ASA) in Orlando, Florida in October, 2008, demonstrated how the Integrated Pulmonary Index(TM) provides an accurate, uncomplicated and inclusive assessment of a patient's ventilatory status.
"We are encouraged and delighted by this FDA clearance," said Gerry Feldman, President of Oridion. "Oridion has worked hard to develop safer and easier patient safety technologies. The Integrated Pulmonary Index(TM) will make sophisticated determinations of pulmonary adequacy far more efficient for the diagnosing clinician. More importantly, it will enable the general floor nurse to confidently decide when to call for help. Our mission is to take risk and cost out of medicine and the Integrated Pulmonary Index(TM) is an important success on that journey."
Oridion is the global leader of capnography monitoring solutions and its Microstream® capnography technology is the standard of care in ventilation monitoring.
Oridion Systems Ltd. (www.oridion.comwww.oridion.com) is a global medical device company specializing in patient safety monitoring. The Company operates through wholly owned subsidiaries in the United States, Europe, and Israel.
Oridion develops proprietary medical devices and patient interfaces, based on its patented Microstream® technologies, for the enhancement of patient safety through the monitoring of the carbon dioxide (CO2) in a patient's breath. These products provide effective, proven airway management and are used in various clinical environments, including procedural sedation, pain management, operating rooms, critical care units, post-anesthesia care units, emergency medical services, transport, alternate care and other settings where patients' ventilation may be compromised and at risk.
Certain statements made herein that are not historical are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. The words "estimate" "project" "intend" "expect" "believe" and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties. Many factors could cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements, including, among others, our ability to maintain profits, the market demands for our Capnography products, our ability to focus our team on the Capnography business, changes in general economic and business conditions, inability to maintain market acceptance to the Company's products, inability to timely develop and introduce new technologies, products and applications, rapid changes in the market for the Company's products, loss of market share and pressure on prices resulting from competition, introduction of competing products by other companies, inability to manage growth and expansion, loss of key OEM partners, inability to attract and retain qualified personnel, inability to protect the Company's proprietary technology.
Furthermore, this press release does not constitute an offer to sell or a solicitation of an offer to buy any securities. The Company's shares issued have not been, and will not be, registered under the US Securities Act of 1933, as amended (the "Securities Act"), or under any of the relevant Securities Laws of any state of the United States. The Company's shares may not be offered, sold or delivered, directly or indirectly, to, or for, the account of any US person (as defined in regulation S under the Securities Act) in or into the United States, or by use of the US mail, or by any means or instrumentality of United States interstate commerce, absent registration, or an exemption from registration under the Securities Act.
Source: Oridion Systems
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