Medical Device

TSO3 announced it held more dialogue with regulators in the US for their request for additional information on their submission for an extension of their claim of STERIZONE VP4 Sterilizer to include terminal sterilization of duodenoscopes.

TSO3 (TSX:TOS) announced it held more dialogue with regulators in the US for their request for additional information on their submission for an extension of their claim of STERIZONE VP4 Sterilizer to include terminal sterilization of duodenoscopes.
As quoted in the press release:

The Company now believes that the information it has provided to the Regulators addresses the majority of items listed within the initial AI request. For the remaining items, Regulators have recommended including additional data to support the claims.
“We continue to work productively with US regulators in pursuit of this new indication for use of our sterilizer,” stated Ric (R.M.) Rumble, President and CEO of TSO3 Inc.  “The Company has continued its testing and data compilation to further support our claims as a natural part of our internal processes. We believe these data, combined with the real-world data being collected from respected healthcare institutions utilizing our sterilizer to routinely sterilize these duodenoscopes, will allow us to effectively respond to the remaining items in the request for additional information.  Our next written exchange with Regulators is planned prior to the end of the year, after which another discussion will be scheduled in early 2018. The Company expects that final labeling could be submitted after that time.”

Click here to read the full press release.

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