Oridion Receives FDA 510(k) Clearance for Capnostream(TM)20 Monitor With Integrated Pulmonary Index(TM)

February 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.”

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
, 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(R) capnography technology is the standard of care in ventilation

About Oridion

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

Oridion develops proprietary medical devices and patient interfaces,
based on its patented Microstream(R) 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.

    For further Oridion information please contact

    Alan Adler, Chairman and Chief Executive Officer
    Walter Tabachnik, Chief Financial Officer
    Elena Gerberg, Investor Relations
    e-mail: investor@oridion.com
    website: http://www.oridion.com
    phone: +972-2-589-9159
    address: Oridion Systems Ltd., P.O. Box 45025, 91450 Jerusalem, Israel

SOURCE Oridion Systems Ltd.

Source: newswire

comments powered by Disqus