BioCardia (BCDA) reports positive PMDA consultation on CardiAMP Heart Failure Trial data

Rhea-AI Filing Summary

BioCardia, Inc. filed an 8-K to report that it has had a positive preliminary clinical consultation with Japan’s Pharmaceutical and Medical Devices Agency (PMDA) regarding the CardiAMP Heart Failure Trial results previously provided to the agency.

The meeting was held to prepare for a formal clinical consultation on whether the trial data will be acceptable for submission of an application for product approval in Japan. BioCardia also furnished the related press release as an exhibit to this report.

Insights

Biotech regulatory and clinical development analyst

BioCardia reports an encouraging but early regulatory interaction with Japan’s PMDA on its CardiAMP Heart Failure Trial data.

BioCardia describes a positive preliminary consultation with Japan’s PMDA about clinical results from the CardiAMP Heart Failure Trial. This type of meeting helps clarify how regulators view existing data and what might be needed for a potential approval application in that market.

The consultation was explicitly framed as preparation for a formal clinical consultation on acceptability of the data for an approval submission. This indicates progress in regulatory dialogue, but not yet a determination on approvability. Future outcomes will depend on the formal consultation and any subsequent application in Japan.

8-K Event Classification

2 items: 8.01, 9.01

2 items

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): September 22, 2025

BIOCARDIA, INC.

(Exact name of registrant as specified in its charter)

Delaware		001-38999		23-2753988
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

320 Soquel Way
Sunnyvale, California 94085

(Address of principal executive offices and zip code)

Registrant’s telephone number, including area code: (650) 226-0120

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.001	BCDA	The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter) ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 8.01         Other Events.

On September 22, 2025, BioCardia, Inc. issued a press release announcing it has had a positive preliminary clinical consultation with Japan’s Pharmaceutical and Medical Devices Agency (PMDA) on the CardiAMP Heart Failure Trial results previously provided to the agency. The meeting was held in preparation for the formal clinical consultation on acceptability of the clinical data for submission of an application for approval.

A copy of the press release is attached hereto as Exhibit 99.1 to this current report on Form 8-K.

Item 9.01   Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
99.1		BioCardia, Inc. press release dated September 22, 2025
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

BIOCARDIA, INC.

/s/ Peter Altman, Ph.D.

Peter Altman, Ph.D.

President and Chief Executive Officer

Date: September 22, 2025

FAQ

What did BioCardia (BCDA) disclose in its latest 8-K filing?

BioCardia disclosed that it held a positive preliminary clinical consultation with Japan’s PMDA about CardiAMP Heart Failure Trial results. The discussion prepared for a formal consultation on whether those data are acceptable for a future approval application in Japan.

What is the significance of BioCardia’s consultation with Japan’s PMDA?

The consultation indicates Japan’s PMDA has reviewed CardiAMP Heart Failure Trial data and provided preliminary feedback. It helps BioCardia understand regulatory expectations before a formal consultation on whether the data are suitable for submitting an approval application in Japan.

Which BioCardia program was discussed with Japan’s PMDA in this 8-K?

The discussion focused on the CardiAMP Heart Failure Trial. BioCardia reported that Japan’s PMDA provided a positive preliminary clinical consultation on trial results already submitted, ahead of a formal consultation on data acceptability for a potential approval application.

Is BioCardia’s PMDA meeting an approval of CardiAMP in Japan?

No, the filing describes a positive preliminary clinical consultation, not an approval. The meeting was held to prepare for a later formal clinical consultation on whether CardiAMP Heart Failure Trial data are acceptable for an eventual approval application in Japan.

What exhibit did BioCardia attach to this 8-K about the PMDA meeting?

BioCardia attached a press release as Exhibit 99.1. The press release, dated September 22, 2025, describes the positive preliminary clinical consultation with Japan’s PMDA regarding CardiAMP Heart Failure Trial data and provides additional context beyond the brief 8-K narrative.

Who signed BioCardia’s 8-K reporting the PMDA consultation?

The 8-K was signed on behalf of BioCardia by Peter Altman, Ph.D. He is identified as the company’s President and Chief Executive Officer, underscoring that the regulatory update regarding the PMDA consultation is an officially authorized corporate disclosure.