BioCardia, Inc.

Submit Shonin pre-market regulatory submission to Japan's PMDA for CardiAMP Cell Therapy approval

Deadline not yet reached (65 days left)

Announced: 10 Sep 2026
Due: 31 Dec 2026

Deadline
Met
Late
Not met
Today

What the company said

“BioCardia is preparing a Shonin pre-market regulatory submission to Japan's Pharmaceutical and Medical Device Agency (PMDA) for approval of CardiAMP Cell Therapy for ischemic heart failure, targeted for the fourth quarter of 2026.”

SourceBioCardia, Inc. Form 8-K press release, 2026-09-10
FilingSEC filing index
Deadline as statedthe fourth quarter of 2026
Deadline used31 Dec 2026, the last day of the stated period
TypeRegulatory
Permanent referenceKI-C-2026-BCDA-000633
Cite as https://keptindex.org/c/KI-C-2026-BCDA-000633/ — this address never changes.

What we found

The deadline has not passed yet, so there is nothing to check. We look for evidence starting 30 days after 31 Dec 2026.

Commitment DNA

The structured record of this commitment. Fields the company did not state are left blank rather than guessed.

Event type: Regulatory other
Indicative materiality: Medium rules
Action: Submit
Language: Aspirational (“aims”, “intends”)

Tell me what happens

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How this entry was checked

Commitment recordedRecorded from the company's filing.
OutcomeNot yet assessed. Nothing is judged before the deadline.

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