ENDRA Life Sciences completes FDA pre-submission meeting for TAEUS liver device

ENDRA Life Sciences Inc.

In-person FDA pre-sub meeting held May 16, 2024, on TAEUS liver device clinical trial design for de novo submission.
FDA feedback deemed highly constructive; ENDRA to update pivotal study protocol and statistical plan.
Company expects to complete clinical studies by Q4 2024 or Q1 2025, with de novo filing in first half 2025.
Provided background data from 45 historical participants; demonstrated TAEUS procedure with liver phantoms.

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