STERIS Corporation Submits New Sterilization System to FDA and Announces Developments on SYSTEM 1 Warning Letter
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o New Liquid Chemical Sterilization System Submitted for 510(k) Clearance
o Third Quarter Earnings Announcement Scheduled for January 27, 2009
MENTOR, Ohio, Jan. 20 -- STERIS Corporation (NYSE: STE) today announced that it has submitted to the U.S. Food and Drug Administration (FDA) a new liquid chemical sterilization system for 510(k) clearance. The new submission follows discussions with the FDA regarding issues raised in a May 2008 warning letter relating to the Company's SYSTEM 1 Sterile Processing System. The new liquid chemical sterilization system submitted to the FDA addresses the changes referenced by the FDA in the warning letter and includes additional technology updates.
The Company is communicating to Customers that STERIS will continue supporting the existing SYSTEM 1 installed base by providing accessories, sterilant, service and parts, and replacement processor units for at least a two year period. In the U.S., STERIS will continue sales of SYSTEM 1 processors only as replacements for existing units. Customers can continue using SYSTEM 1 without any change. The FDA has reviewed and accepted these actions and is not requiring modification of clinical practices or notification to doctors or patients. Once the new liquid chemical sterilization system is cleared for market use by the FDA, the Company will work with Customers to transition them to the new product.
"Our highest priorities are patient safety, legal and regulatory compliance, and Customer satisfaction," said Walter Rosebrough, president and chief executive officer of STERIS Corporation. "We are pleased that our discussions with the FDA have resulted in the submission of a new liquid chemical sterilization system and a path forward in resolving the warning letter related to SYSTEM 1. We look forward to working with the Agency to obtain clearance of our new system, and resolving any remaining regulatory issues."
For fiscal 2009, ending March 31, 2009, the Company anticipates that this development will not have a material impact on its consolidated financial results. Beginning in fiscal 2010, the Company anticipates that annualized revenues will be modestly impacted by approximately $10 million until the new product is cleared and commercialized.
Third Quarter Conference Call
The Company will issue fiscal 2009 third quarter earnings before the market opens on January 27, 2009, followed by a conference call at 10:00 a.m. Eastern time. The conference call can be heard live over the Internet at www.steris-ir.com or via phone by dialing 1-888-392-9976 in the United States and Canada, and 1-517-645-6486 internationally, then referencing the password "STERIS."
About SYSTEM 1
SYSTEM 1 is a low temperature liquid sterilizer which allows healthcare providers to sterilize heat sensitive medical instruments, primarily flexible endoscopes. Revenues for SYSTEM 1, including the capital equipment, related consumables and accessories, are approximately 10% of total Company revenues.
About STERIS
The mission of STERIS Corporation is to provide a healthier today and safer tomorrow through knowledgeable people and innovative infection prevention, decontamination and health science technologies, products and services. The Company's more than 5,000 dedicated employees around the world work together to supply a broad array of solutions by offering a combination of equipment, consumables and services to healthcare, pharmaceutical, industrial and government Customers. The Company is listed on the New York Stock Exchange under the symbol STE. For more information, visit www.steris.com.
Source: STERIS Corporation
CONTACT:
News Media:
Stephen Norton,
+1-440-392-7482,
Web site: www.steris.com/
