New CardiAMP HF echo data from BioCardia (NASDAQ: BCDA) highlight ventricular remodeling

Rhea-AI Filing Summary

BioCardia, Inc. reported late-breaking echocardiography results from its Phase III CardiAMP HF trial in ischemic heart failure with reduced ejection fraction. The data, presented at the Technology and Heart Failure Therapeutics conference, focus on how the investigational autologous cell therapy affects heart structure over time.

Patients receiving CardiAMP therapy showed positive evidence of decreased pathological left ventricular remodeling compared to controls, aligning with previously reported reductions in major adverse cardiovascular events and improved quality-of-life measures. In a prespecified subgroup with elevated myocardial stress biomarkers, differences in ventricular volumes were both clinically meaningful and statistically significant, supporting BioCardia’s belief in the therapy’s potential benefit.

Insights

Biotech clinical-trial analyst

Phase III subgroup echo data strengthen CardiAMP HF signal but remain exploratory.

The new CardiAMP HF echocardiography data show treated patients had less pathological left ventricular remodeling than controls, with outcomes measured by a blinded Yale core laboratory. This structural effect is consistent with earlier reports of fewer major cardiovascular events and better quality of life for treated patients.

Importantly, a prespecified subgroup with elevated myocardial stress biomarkers showed clinically meaningful and statistically significant reductions in ventricular volumes, which BioCardia links to more favorable long-term prognosis. However, the therapy remains investigational and subject to regulatory review and funding constraints outlined in the forward-looking statements.

Subsequent company filings and updates on the CardiAMP HF program will clarify how these findings influence overall development plans, regulatory interactions, and potential commercialization pathways, especially given the trial’s Breakthrough designation and external support from entities such as the Maryland Stem Cell Research Fund and CMS.

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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): March 3, 2026

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 March 3, 2026, BioCardia, Inc. issued a press release reporting late breaking echocardiography results from its Phase III clinical trial for ischemic heart failure of reduced ejection fraction (HFrEF), which were presented by Dr. Amish Raval, M.D., Professor of Medicine at University of Wisconsin School of Medicine and Public Health and CardiAMP HF Trial National Co-Principal Investigator, in the late breaking clinical trial oral presentation session of the Technology and Heart Failure Therapeutics conference. 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		BioCardia, Inc. press release dated March 3, 2026
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: March 3, 2026

Exhibit 99.1

BioCardia Late Breaking Echocardiography Clinical Results from CardiAMP HF Trial Presented at Technology and Heart Failure Therapeutics (THT)

Echocardiography outcomes show treated patients having reduced negative remodeling of heart volumes

SUNNYVALE, Calif., March 3, 2026 (GLOBE NEWSWIRE) – BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported late breaking echocardiography results from its Phase III clinical trial for ischemic heart failure of reduced ejection fraction (HFrEF), which affects millions of patients in the United States.

The clinical results were presented by Dr. Amish Raval, M.D., Professor of Medicine at University of Wisconsin School of Medicine and Public Health and CardiAMP HF Trial National Co-Principal Investigator, in the late breaking clinical trial oral presentation session of the Technology and Heart Failure Therapeutics (THT) on behalf of the CardiAMP HF Investigators. The presentation was titled: Autologous Cell Therapy May Curb Pathological Ventricular Remodeling in Chronic Ischemic HFrEF Patients Selected for Favorable Cell Characteristics - Late Breaking Echocardiography Results from the CardiAMP HF Trial.

Dr. Raval reported that patients receiving the autologous CardiAMP cell therapy under investigation demonstrated positive evidence of decreased pathological left ventricular remodeling over time compared to patients not receiving the treatment. These results correlated to findings for the trial primary and key secondary endpoints of reduced fatal and non-fatal major adverse cardiovascular events and improved quality of life measures for treated patients. Echocardiography outcomes were measured by the blinded echo cardiography core laboratory at the Yale University Cardiovascular Research Group. The Yale core laboratory measured both left ventricular end diastolic volume, when the heart ventricle is fully dilated (p = 0.06), and left ventricular end systolic volume, when the heart is fully contracted (p=0.09). For the prespecified subgroup of patients having elevated biomarkers of heart stress, the differences between the treated and control patients were both clinically meaningful (>20ml/m² and 15 ml/m², respectively) and statistically significant (p = 0.02 and p = 0.01, respectively).

“In patients with baseline elevated NTproBNP levels, a biomarker of myocardial stress, CardiAMP treatment is associated with less adverse cardiac remodeling according to core-lab measured left ventricular volumes, “said Wilson Tang, MD, Professor of Medicine, Research Director of Heart Failure and Transplant, at Cleveland Clinic in Cleveland Ohio, and member of the Executive Steering Committee for the CardiAMP HF trials.

“The burden of heart failure continues to grow, cardiac ischemia dominates the cause, and the impact of current pharmaceuticals remains limited,” said Carl Pepine, MD, MACC, Professor of Medicine at University of Florida at Gainesville, and Co-National Principal Investigator for the CardiAMP HF trial.  Today’s results from the CardiAMP-HF cell therapy trial are promising and show the potential of optimally targeting subgroups for treatment.”

BioCardia believes these results provide additional evidence in support of benefit for the CardiAMP Cell Therapy for patients with ischemic heart failure of reduced ejection fraction. Reduced ventricular size in ischemic heart failure has long been recognized as highly prognostic for more positive long-term outcomes for patients.^{1, 2}

Today’s presentation is available on the BioCardia website: THT2026 CardiAMP HF

About CardiAMP Autologous Cell Therapy

Granted FDA Breakthrough designation, CardiAMP Cell Therapy uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure intended to increase capillary density and reduce tissue fibrosis of myocardial tissue to address microvascular dysfunction. Clinical development of the CardiAMP Cell Therapy for heart failure is supported by the Maryland Stem Cell Research Fund and is reimbursed by Centers for Medicare and Medicaid Services (CMS). CAUTION - Limited by United States law to investigational use. 

About BioCardia^® 

BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP^® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three cardiac clinical stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms, and soon the Heart3D™ fusion imaging platform. BioCardia selectively partners on biotherapeutic delivery with peers developing important biologic therapies.  For more information visit www.biocardia.com.

References

1. Kramer DG, Trikalinos TA, Kent DM, Antonopoulos GV, Konstam MA, Udelson JE. Quantitative evaluation of drug or device effects on ventricular remodeling as predictors of therapeutic effects on mortality in patients with heart failure and reduced ejection fraction: a meta-analytic approach. J Am Coll Cardiol. 2010 Jul 27;56(5):392-406. doi: 10.1016/j.jacc.2010.05.011. PMID: 20650361; PMCID: PMC4523221.

2. Ito K, Li S, Homma S, Thompson JLP, Buchsbaum R, Matsumoto K, Anker SD, Qian M, Di Tullio MR; WARCEF Investigators. Left ventricular dimensions and cardiovascular outcomes in systolic heart failure: the WARCEF trial. ESC Heart Fail. 2021 Dec;8(6):4997-5009. doi: 10.1002/ehf2.13560. Epub 2021 Sep 20. PMID: 34545701; PMCID: PMC8712869.

Forward Looking Statements 

This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. Such risks and uncertainties include, among others, the inherent uncertainties associated with developing new products or technologies, regulatory approvals, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue BioCardia’s business and product development plans, the ability to enter into licensing and partnering arrangements, and overall market conditions. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements.

We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. Factors that could cause or contribute to such differences include, but are not limited to, the Company’s liquidity position and its ability to raise additional funds, as well as the Company’s ability to successfully progress its clinical trials. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 26, 2025, under the caption titled “Risk Factors” and in its subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.  

###

Media Contact:
Miranda Peto, Marketing / Investor Relations
Email: mpeto@BioCardia.com
Phone: 650-226-0120

Investor Contact:
David McClung, Chief Financial Officer
Email: investors@BioCardia.com
Phone: 650-226-0120

FAQ

What did BioCardia (BCDA) report from the CardiAMP HF Phase III trial?

BioCardia reported late-breaking echocardiography results from its Phase III CardiAMP HF trial in ischemic heart failure with reduced ejection fraction. Treated patients showed positive evidence of decreased pathological left ventricular remodeling versus controls, aligning with prior reductions in major cardiovascular events and quality-of-life improvements.

How did CardiAMP treatment affect heart structure in BioCardia’s HFrEF study?

CardiAMP treatment was associated with less adverse cardiac remodeling, measured as reduced left ventricular volumes over time. A blinded Yale core laboratory assessed end diastolic and end systolic volumes, showing favorable trends overall and statistically significant improvements in a prespecified high–heart-stress subgroup.

What were the key echocardiography results for the high-risk subgroup in BCDA’s trial?

In patients with elevated biomarkers of myocardial stress, treated with CardiAMP, differences in left ventricular volumes versus controls exceeded 20 ml/m2 and 15 ml/m2 and were statistically significant (p = 0.02 and p = 0.01). BioCardia views these findings as clinically meaningful support for CardiAMP’s potential benefit.

Who presented BioCardia’s CardiAMP HF echocardiography data and where?

The echocardiography data were presented by Dr. Amish Raval, Professor of Medicine and CardiAMP HF Trial National Co-Principal Investigator. He delivered a late breaking clinical trial oral presentation at the Technology and Heart Failure Therapeutics conference on behalf of the CardiAMP HF Investigators.

What is CardiAMP Autologous Cell Therapy as described by BioCardia (BCDA)?

CardiAMP Autologous Cell Therapy uses a patient’s own bone marrow cells, delivered via a minimally invasive catheter procedure. It aims to increase capillary density and reduce myocardial fibrosis to address microvascular dysfunction in heart failure and has been granted FDA Breakthrough designation for development.

What risks and uncertainties did BioCardia highlight regarding CardiAMP HF progress?

BioCardia noted risks typical for new therapies, including development uncertainties, regulatory approvals, unexpected expenditures, and the need to raise additional funding. The company also cited dependence on licensing or partnering arrangements and overall market conditions as factors that can materially affect actual results versus forward-looking statements.

Filing Exhibits & Attachments

5 documents

Press Releases

• EX-99.1 EXHIBIT 99.1 16.1 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA 3.5 KB
• EX-101 XBRL TAXONOMY EXTENSION DEFINITION LINKBASE 11.2 KB
• EX-101 XBRL TAXONOMY EXTENSION LABEL LINKBASE 15.0 KB
• EX-101 XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE 11.3 KB