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Oridion Receives FDA 510(k) Clearance for Capnostream(TM)20 Monitor With Integrated Pulmonary Index(TM)
Date:2/22/2009

JERUSALEM and NEEDHAM, Massachusetts, February 23 /PRNewswire-FirstCall/ -- 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."

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SOURCE Oridion Systems Ltd.
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