Mr. Robert Thast reports

IZOTROPIC CONFIRMS FDA PRE-SUBMISSION MEETING DATE

Izotropic Corp. has confirmed a presubmission meeting date with the U.S. Food and Drug Administration (FDA) scheduled for Oct. 25, 2023.

Further to its news release on Sept. 6, 2023, Izotropic completed a presubmission application to the FDA to solidify its plans to pursue market clearance for IzoView as a Class II device through a 510(k) premarket notification submission.

The purpose of the coming meeting is to discuss the application, obtain feedback and confirm next steps. The meeting will take place in Rockville, Md., and will be attended by Izotropic's management, technical and engineering team members, and its FDA consultant, Matrix Medical Devices.

The company will issue a news release in due course after the meeting to report on its progress.

We seek Safe Harbor.