CardiAMP trial primary endpoint results disclosed by BioCardia (BCDA)

Rhea-AI Filing Summary

BioCardia, Inc. filed a current report describing a communication about one of its clinical programs. The company furnished a press release announcing primary endpoint results from the open label roll-in cohort of its CardiAMP Cell Therapy in Chronic Myocardial Ischemia Trial. The press release is included as Exhibit 99.1 and is treated as furnished, not filed, under securities law.

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, 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 18, 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 September 18, 2025, BioCardia, Inc. issued a press release announcing primary endpoint results of the open label roll-in cohort of the CardiAMP Cell Therapy in Chronic Myocardial Ischemia Trial. 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 September 18, 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: September 18, 2025

FAQ

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

BioCardia reported that it issued a press release announcing primary endpoint results from the open label roll-in cohort of its CardiAMP Cell Therapy in Chronic Myocardial Ischemia Trial. The press release is furnished as Exhibit 99.1 to the report.

Which BioCardia trial is mentioned in the September 18, 2025 8-K?

The 8-K refers to the CardiAMP Cell Therapy in Chronic Myocardial Ischemia Trial. Specifically, it highlights primary endpoint results from the open label roll-in cohort, which were announced in a press release furnished as Exhibit 99.1.

How are the CardiAMP trial results treated under securities law in this BioCardia filing?

The CardiAMP trial results are provided through a press release furnished under Regulation FD. The company states this information, including Exhibit 99.1, is furnished and not filed for purposes of Section 18 of the Exchange Act.

What exhibit is attached to BioCardia’s September 18, 2025 8-K?

The filing attaches Exhibit 99.1, which is the BioCardia press release dated September 18, 2025 discussing primary endpoint results for the CardiAMP Cell Therapy in Chronic Myocardial Ischemia Trial. An Inline XBRL cover page data file is also referenced as Exhibit 104.

Who signed the September 18, 2025 BioCardia 8-K?

The report was signed on behalf of BioCardia, Inc. by Peter Altman, Ph.D. He is identified in the document as the company’s President and Chief Executive Officer and signed the 8-K on September 18, 2025.