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MarketScreener Homepage  >  Equities  >  Swiss Exchange  >  Oridion Systems Ltd    ORIDN   IL0010837818

ORIDION SYSTEMS LTD

(ORIDN)
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Oridion Systems Ltd : Oridion – FDA Import Alert Modification

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01/19/2012 | 01:13am EDT
News Release Oridion - FDA Import Alert Modification Jerusalem/Needham - January 19, 2012 - Oridion Systems Ltd. (SIX Swiss Exchange: ORIDN), announced today that the United States Food and Drug Administration (FDA) has advised the company that the import alert issued on all of Oridion's medical devices has been significantly narrowed. The scope of the import alert now only applies to infant neonatal intubated CO2 sampling lines. While the infant neonatal CO2 sampling lines remain on import alert and will not be commercially available in the United States until further notice, the company has immediately resumed shipments of all other products including CO2 sampling lines, modules and patient monitors.

FDA issued the import alert in December, 2011 in part, due to concerns that particulate matter may be found in the single-unit packaged CO2 sampling lines. The source of the particulates originates from the paper insert, warning label and banding tape inside the package. In rare cases involving airway adapters only, particulate may be located inside the airway adapter and may potentially enter a patient's respiratory system.

The company has had no reports of any adverse incidents relating to the presence of particulate and Oridion has not identified any evidence of a serious health risk from the particulates.

Oridion continues to work with FDA to assure that this issue is thoroughly resolved and is fully committed to addressing all FDA concerns for ensuring that its products consistently meet all quality and regulatory requirements. Oridion is sending a letter to clinicians to advise them of certain precautionary steps.

North American hospitals or customers with questions about the narrowed scope of the import

alert, or about Oridion's products, are encouraged to contact Oridion Capnography Inc. at:

- via email: info@oridion.com

- via website to view the latest updates under "FDA Alert Status": www.oridion.com

- by phone- Direct: +1-781-972- 1252 or Toll free: +1-888-674-3466 ext: 1252

Notice to Shareholders

Oridion will hold a conference call for the media and financial community today, January 19, 2012 at

15:00 hours CET / 09:00 hours EST. Dial-in numbers are +41 (0)91 610 5600 for Europe,

+44 (0)203 059 5862 for UK, +1 (1)866 291 4166 for USA (toll-free).
A replay of the call will also be available for 24 hours under the following numbers:
+41 (0)91 612 4330 for Europe, +44 (0)207 108 6233 for UK, +1 (1)866 416 2558 (USA), Access Code for the replay is 13104

For further information regarding the conference call 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

About Oridion

Oridion Systems Ltd. (www.oridion.com) is a global medical device company specializing in patient safety monitoring. The Company operates through wholly owned subsidiaries in Israel and the United
States.
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, 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; resolution of the final nature of the recall; future actions of the FDA with respect to the Company's implementation of the recall; future actions of the FDA or any other regulatory body or government authority that could delay, limit or suspend product development, manufacturing or sale or result in seizures, injunctions, monetary sanctions or criminal or civil liabilities; product quality or patient safety issues.

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.

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