TSO3 gets FDA okay for expanded claims

TSO3 (TSX:TOS) has received the green light from the FDA to expand the intended claims of its Sterizone 125L sterilizer, including sterilization of packaged, multi-channel flexible endoscopes, such as colonoscopes, gastroscopes, bronchoscopes, ureteroscopes and choledochoscopes.

In a statement, CEO Ric Rumble said FDA clearance indicates the company can pass the rigorous standards of the U.S. agency in a timely manner and these same procedures have been followed during the recent development of TSO3’s new cycles.

“These new cycles are intended to maintain the same sterile efficacy, while taking less time and being gentler on many medical devices,” he said, adding that the company expects to submit them to the FDA in coming weeks.