BCDA announces first patient at Henry Ford Health in Phase 3 trial

Rhea-AI Filing Summary

BioCardia (BCDA) reported an operational milestone: it announced the first patient enrolled at Henry Ford Health in its ongoing Phase 3 CardiAMP HF II clinical trial for patients with “ischemia heart failure of reduced ejection fraction.”

The announcement was made via a press release furnished as Exhibit 99.1. The information is being furnished under Item 8.01 and is not deemed filed under the Exchange Act.

Insights

Biotech clinical trials analyst

First-patient enrollment at a site is an operational milestone; neutral.

BioCardia disclosed the first patient enrolled at Henry Ford Health in its ongoing Phase 3 CardiAMP HF II study. First-patient enrollment indicates that at least one site is active and screening/consenting processes are functioning.

The update was furnished as an Item 8.01 press release (Exhibit 99.1), which typically signals informational progress rather than a thesis-changing event. Actual impact depends on overall enrollment pace, site activation breadth, and subsequent clinical readouts, none of which are detailed in this excerpt.

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, or exhibit attachments filed with this report.

FAQ

What did BioCardia (BCDA) announce in this 8-K?

BioCardia announced the first patient enrolled at Henry Ford Health in its ongoing Phase 3 CardiAMP HF II clinical trial.

Which clinical study is referenced by BioCardia (BCDA)?

The ongoing Phase 3 CardiAMP HF II clinical trial for patients with ischemia heart failure of reduced ejection fraction.

Where was the first patient enrolled for BCDA's trial?

At Henry Ford Health.

How was the information provided by BioCardia (BCDA)?

Through a press release furnished under Item 8.01 and attached as Exhibit 99.1.

What exhibit contains the press release for BCDA?

Exhibit 99.1 contains the press release dated November 10, 2025.

Is the information considered filed or furnished?

It is being furnished and is not deemed filed under the Exchange Act.

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

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Accepted by SEC EDGAR 11/10/2025 - 08:02 AM Learn about SEC filing dates

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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): November 10, 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 November 10, 2025, BioCardia, Inc. issued a press release announcing the first patient enrolled at Henry Ford Health in its ongoing Phase 3 CardiAMP HF II clinical trial for patients with ischemia heart failure of reduced ejection fraction.

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

The information in this Item 8.01, including Exhibit 99.1 attached hereto, is being furnished and 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 of such section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.

Item 9.01   Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
99.1		BioCardia, Inc. press release dated November 10, 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: November 10, 2025