Oridion Receives FDA Clearance for Novel Monitoring Device That Provides Earliest Possible Detection of Respiratory Adverse Events That Can Occur During Procedural Sedation.

Business/Technology Editors and Health/Medical Writers

JERUSALEM--(BW HealthWire)--Nov. 26, 2001

Smart CapnoLine(TM) O2 First to Enable the Display of "Ultimate Wave Form" of Carbon Dioxide in Breath Samples from Sedated, Non-Intubated Patients while Delivering Oxygen from Separate Channel at the Same Time

Oridion Systems Ltd. (ORIDN on SWX New Market), today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a monitoring device for non-intubated patients, the Smart CapnoLine(TM) O2, that yields carbon dioxide (CO2) samples of exhaled breath with unprecedented clarity, resulting in state-of-the-art accuracy. This next generation capnography device helps to alert caregivers to the earliest possible warning signs of potentially fatal adverse events that can develop during procedural sedation, including apnea, ventilatory depression and airway obstruction.

Procedural sedation is typically administered with potent sedatives and narcotics. Its use is growing dramatically, accelerated by the surge in minimally invasive procedures, such as colonoscopy, endoscopy, MRI and CAT Scan (mainly for pediatrics), that are now commonly performed in non-acute settings. Unless continually monitored for early warning signs that are often undetectable to the human eye and conventional technologies like pulse oximetry, patients are at increased risk for a range of potentially fatal adverse events. To address this issue, new standards from the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the American Society of Anesthesiologists and the American Heart Association all call for monitoring ventilation such as with capnography, which is the continuous and non-invasive measurement of carbon dioxide in exhaled human breath.

Oridion's Smart CapnoLine(TM) O2 can help bring caregivers into rigorous compliance with the updated 2001 JCAHO standards and guidelines. By collecting breath samples for CO2 analysis from both nose and mouth while also supplying oxygen to the patient, the Smart CapnoLine(TM) O2 sets a new industry standard for accurately and continuously measuring and monitoring a non-intubated patient's ventilation vital sign. The device is equipped with Oridion's proprietary uni-junction, a single meeting point for nose and mouth breath sample sources. The uni-junction automatically identifies and selects the nose or mouth breath source providing the highest-pressure sample for a smooth gas flow, and then carries the sample back to the monitor for an uninterrupted waveform during sedation.

"This is a big safety improvement for the increasing number of patients receiving potent IV sedative-hypnotic medications for procedures such as colonoscopies," said John H. Eichhorn, M.D., Professor and Chairman, Department of Anesthesiology at the University of Mississippi Medical Center. "This new smart technology allows continuous and meaningful capnography in sedation patients for the first time. In a darkened room where caregivers are watching the procedure, it is much too late in the evolution of a critical incident when the pulse oximeter alarm goes off. The sharp waveform and end-tidal CO2 value will show airway obstruction or central hypoventilation from over-sedation immediately, allowing diagnosis and treatment long before any desaturation."

Based on Oridion's Microstream(R) platform technology, the Smart CapnoLine(TM) O2 breaks additional new ground through its unique ability to simultaneously provide patients with a gentle "cloud" of oxygen delivered from a separate, dedicated chamber. Oridion has already received two patents for the Smart CapnoLine(TM) O2 product and two additional patents are pending.

"We are extremely pleased to receive FDA clearance for the Smart CapnoLine(TM) O2, which is our seventh U.S. regulatory clearance this calendar year," said Patricia Hennessey, Senior Vice President of Field Operations, Capnography Business Unit. "This device meets a critical need for the earliest possible detection of apnea and adverse events, and its exceptional ease-of-use should afford it rapid acceptance by the increasing number of physicians performing procedural sedation outside of the operating room."

The Smart CapnoLine(TM) O2 easily secures continuous and accurate EtCO2 data by improving the issue of CO2 dilution due to changes in patients' breathing patterns or the introduction of room air and/or supplemental oxygen, which can compromise the sampling. In addition to its cutting-edge accuracy, the separate oxygen and breath channels are integrated into one compact, ergonomic nosepiece molded from exceptionally soft and lightweight plastic that improves patient comfort.

The Smart CapnoLine(TM) O2 is compatible with any Microstream(R) respiratory monitoring hardware system. The lightweight and comfortable nasal cannula device also considerably improves patient comfort and is available in a range of sizes to fit pediatric, intermediate and adult patients. The product is also equipped with a unique built-in patented filtering system, designed to eliminate moisture interference with the sample.

About Oridion Systems Ltd.

Oridion Capnography Inc. is a subsidiary of Oridion Systems Ltd. Oridion Systems Ltd. operates through its wholly owned subsidiaries in the United States, Europe, Asia Pacific and Israel and is a global medical device company with patented technologies using breath samples in respiratory care monitoring and point-of-care diagnostics for both acute and non-acute settings. Oridion operates two business units: The Capnography Business Unit promotes the enhancement of patient safety monitoring by developing proprietary medical devices and consumables for the measurement of carbon dioxide in human breath to determine the status and adequacy of a patient's ventilation during procedural, or conscious, sedation. The Breath Testing Business Unit develops proprietary medical devices and consumables used in the non-invasive diagnosis of the status of a patient's internal organs. For more information, visit the Company online at www.oridion.com.

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, 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 product's, 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.