Steris Corporation Still Awaiting FDA Clearance of Key Accessory to System 1E Device

Published: Nov 15, 2011

In the hopes of reversing the trend of “disappointing” sales of its replacement flagship sterilization device, STERIS (NYSE:STE) is eagerly awaiting FDA clearance of an accessory part for the device. But unfortunately for the Mentor, Ohio-based company, STERIS has had to keep waiting (… and waiting … and waiting) to begin marketing the part — a so-called “biological indicator” for the company’s System 1E, a liquid chemical sterilization system for heat-sensitive medical instruments. And that wait is taking a toll on STERIS. System 1E sales are lagging. The company’s losing customers. Its stock price has fallen 9 percent in the last three weeks. Its financial outlook for its next fiscal year isn’t too rosy.

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