10 September 2026
10 September 2026
The FDA's decision follows a clinical assessment of the Emboliner, including the PROTECT H2H IDE study.
TwoStep will begin a Phase I study of TS-104, with patient enrolment expected to commence later this year.
The expansion will support clinical trial sponsors with consistent scientific and operational oversight in multinational studies.
The multi-centre, single-arm, open-label study achieved its primary endpoint.
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