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

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.