BioCardia advances toward PMDA review for heart failure therapy

BioCardia, Inc. reported that Japan’s Pharmaceutical and Medical Device Agency has agreed to let the company move its CardiAMP Cell Therapy for the treatment of heart failure with reduced ejection fraction into a formal clinical consultation process.

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(Moderate)

Filing Sentiment

(Neutral)How Sentiment works

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Form Type

8-K

Rhea-AI Filing Summary

BioCardia, Inc. reported that Japan’s Pharmaceutical and Medical Device Agency has agreed to let the company move its CardiAMP Cell Therapy for the treatment of heart failure with reduced ejection fraction into a formal clinical consultation process. This follows completion of a third preliminary clinical consultation with the agency. If, in that formal consultation, the PMDA concludes that the available data provide sufficient evidence of safety and efficacy, BioCardia would be able to file for regulatory approval in Japan for this cell therapy.

8-K Event Classification

2 items: 7.01, 9.01

2 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 9.01 Financial Statements and Exhibits Exhibits

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

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What regulatory progress did BioCardia (BCDA) report in Japan?

BioCardia reported that Japan’s Pharmaceutical and Medical Device Agency will allow it to advance CardiAMP Cell Therapy to a formal clinical consultation after completing a third preliminary consultation.

Which therapy is involved in BioCardia (BCDA)'s Japanese regulatory update?

The update concerns BioCardia’s CardiAMP Cell Therapy, which is intended for the treatment of heart failure with reduced ejection fraction (HFrEF).

What must happen before BioCardia (BCDA) can seek regulatory approval in Japan?

In the formal consultation, the PMDA must agree that the available data provide sufficient evidence of safety and efficacy before BioCardia can file for regulatory approval in Japan.

Who is the Japanese regulator working with BioCardia (BCDA) on CardiAMP Cell Therapy?

The regulator is Japan’s Pharmaceutical and Medical Device Agency (PMDA), which oversees pharmaceuticals and medical devices in Japan.

How did BioCardia (BCDA) communicate this CardiAMP Cell Therapy update?

BioCardia issued a press release dated December 16, 2025, describing the completion of the third preliminary consultation and the PMDA’s agreement to allow a formal clinical consultation, and attached it as Exhibit 99.1.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 12/16/2025 - 08:00 AM

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): December 16, 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 7.01 Regulation FD Disclosure.

On December 16, 2025, BioCardia, Inc. issued a press release announcing it has completed a third preliminary clinical consultation with Japan’s Pharmaceutical and Medical Device Agency (PMDA) on the CardiAMP Cell Therapy intended for the treatment of Heart Failure with Reduced Ejection Fraction (HFrEF). Based on the discussions in this most recent meeting, the PMDA said it will allow BioCardia to advance to a formal clinical consultation. Should the PMDA agree in formal consultation that the available data provides sufficient evidence of safety and efficacy, the Company will be able to file for regulatory approval in Japan.

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

The information furnished pursuant to this Item 7.01, including Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities under that section, nor shall it be deemed to be incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
99.1 104		BioCardia, Inc. press release dated December 16, 2025 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: December 16, 2025

Source: View Original Filing on SEC EDGAR