FDA minutes support BioCardia (NASDAQ: BCDA) CardiAMP HF II PMA pathway

Rhea-AI Filing Summary

BioCardia, Inc. announced that FDA Center for Biologics Evaluation and Research meeting minutes confirm the ongoing CardiAMP Heart Failure II Trial may be used to support a Premarket Approval (PMA) application for the CardiAMP Cell Therapy System in ischemic heart failure with reduced ejection fraction.

The company notes that FDA typically prefers two well-designed trials for large indications such as HFrEF, where there are potentially over one million U.S. patients who could benefit from CardiAMP Cell Therapy, so FDA’s acknowledgement of this single ongoing trial as potentially sufficient is an important regulatory step.

CardiAMP Cell Therapy has FDA Breakthrough designation and uses a patient’s own bone marrow cells delivered via a minimally invasive catheter procedure to improve microvascular function in myocardial tissue. Regulatory discussions in Japan suggest three completed heart failure trials may provide enough safety and efficacy evidence for approval there, while U.S. trials have received reimbursement from the Centers for Medicare and Medicaid Services.

Insights

Biotech regulatory strategist

FDA minutes signal a clearer PMA pathway for BioCardia’s lead heart-failure therapy.

The FDA CBER meeting minutes confirm the ongoing CardiAMP Heart Failure II Trial may support a Premarket Approval application for the CardiAMP Cell Therapy System in ischemic HFrEF. PMA is the agency’s most rigorous marketing pathway for high-risk medical devices, focused on demonstrating safety and effectiveness.

Previously, FDA indicated it typically prefers two well-designed trials for large indications like HFrEF, which may affect over one million potential U.S. patients for this therapy. Recognizing this single ongoing trial as potentially adequate narrows the regulatory path, though approval still depends on trial outcomes and submission quality.

Japan’s regulator has suggested that results from three completed trials likely provide sufficient evidence for a successful submission there, and U.S. CardiAMP HF trials have already secured CMS reimbursement. Future company filings will show whether BioCardia completes CardiAMP HF II as planned and advances formal PMA and Japan approval submissions.

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.

Key Figures

Potential U.S. patients: over one million patients Completed HF trials: three completed clinical trials FDA pathway: Premarket Approval (PMA) +1 more

4 metrics

Potential U.S. patients over one million patients Ischemic heart failure of reduced ejection fraction addressable by CardiAMP Cell Therapy

Completed HF trials three completed clinical trials Ischemic heart failure studies referenced by Japan PMDA as supporting approval

FDA pathway Premarket Approval (PMA) Most rigorous FDA device marketing application for high-risk devices

FDA meeting type Q-Sub Meeting minutes CBER feedback confirming CardiAMP HF II may support PMA

Key Terms

Premarket Approval (PMA), Q-Sub Meeting, Breakthrough designation, Centers for Medicare and Medicaid Services (CMS), +2 more

6 terms

Premarket Approval (PMA) regulatory

"The meeting minutes from FDA confirm that the ongoing CardiAMP Heart Failure II Trial may support Premarket Approval (PMA) for market clearance."

Premarket Approval (PMA) is the strict regulatory review process used by the U.S. authority for high-risk medical devices to prove they are safe and effective before they can be sold. For investors, a granted PMA is like receiving a key to a locked market: it can open exclusive sales opportunities, reduce near-term competition, and justify higher valuations, while also signaling that the company has cleared a costly, time-consuming hurdle.

Q-Sub Meeting regulatory

"receipt of FDA minutes from its Q-Sub Meeting with FDA Center for Biologics Evaluation and Research (CBER)"

A Q‑Sub meeting is a formal request to a medicine or medical-device regulator for written or verbal guidance on a planned regulatory submission, essentially asking the agency to review plans and point out problems before the full application is filed. For investors, such meetings signal where a product stands in the approval process and can reveal whether regulators see major issues or a clear path forward, helping assess development risk and timing — like showing an inspector your blueprint before building.

Breakthrough designation regulatory

"Granted FDA Breakthrough designation, CardiAMP Cell Therapy uses a patient’s own bone marrow cells"

A breakthrough designation is a regulatory fast-track status granted to an experimental medical treatment that shows early signs of substantial improvement over existing options. For investors, it matters because it speeds up and intensifies scrutiny by regulators—like giving a promising drug a VIP lane—raising the chance of quicker approval and higher commercial value, though it does not guarantee final approval or market success.

Centers for Medicare and Medicaid Services (CMS) financial

"to enable the Centers for Medicare and Medicaid to reimburse as done in the CardiAMP HF trials."

The Centers for Medicare & Medicaid Services (CMS) is a U.S. federal agency that runs the country’s major public health insurance programs and sets rules for how providers get paid and how medical products are covered. Investors care because CMS decisions on coverage, payment rates, and rules can change how much revenue healthcare companies earn—think of CMS like a giant client or regulator whose pricing and coverage choices can make or break a product’s market.

Post Marketing Study regulatory

"submit for regulatory approval in Japan, where additional safety and efficacy evidence of CardiAMP Cell Therapy will be gathered in a Post Marketing Study."

microvascular dysfunction medical

"intended to increase capillary density and reduce tissue fibrosis of myocardial tissue to address microvascular dysfunction."

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Understanding 8-K Material Events →

false 0000925741 0000925741 2026-06-05 2026-06-05

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): June 5, 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 June 5, 2026, BioCardia, Inc. issued a press release announcing receipt of FDA minutes from its Q-Sub Meeting with FDA Center for Biologics Evaluation and Research (CBER) on the CardiAMP Cell Therapy System for the treatment of ischemic heart failure of reduced ejection fraction (HFrEF). The meeting minutes confirm that the ongoing CardiAMP Heart Failure II Trial may be used to support Premarket Approval (PMA) for market clearance.

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 June 5, 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: June 5, 2026

Exhibit 99.1

FDA CONFIRMS CARDIAMP HF II MAY SUPPORT PREMARKET APPROVAL OF CARDIAMP CELL THERAPY FOR ISCHEMIC HFrEF

SUNNYVALE, Calif. – June 5, 2026 -BioCardia^®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced receipt of FDA minutes from its Q-Sub Meeting with FDA Center for Biologics Evaluation and Research (CBER) on the CardiAMP Cell Therapy System for the treatment of ischemic heart failure of reduced ejection fraction (HFrEF).

The meeting minutes from FDA confirm that the ongoing CardiAMP Heart Failure II Trial may support Premarket Approval (PMA) for market clearance. PMA is the most rigorous type of device marketing application required by the agency. It is used to establish the safety and effectiveness of high-risk medical devices prior to them being approved for public use.

FDA had previously indicated that they typically like to see two well designed trials for approval, particularly in large clinical indications such as HFrEF, where there are potentially over one million patients who could benefit from CardiAMP Cell Therapy in the United States. FDA has also previously demonstrated that they consider the CardiAMP Cell Therapy System safe, as this FDA determination is required to enable the Centers for Medicare and Medicaid to reimburse as done in the CardiAMP HF trials.

“The mechanism of cell therapy driven microvascular repair appears synergistic with current strategies for guideline directed medical therapy.” said Peter Altman, PhD, BioCardia’s Chief Executive Officer. “We are working to complete this trial in the United States for PMA and submit for regulatory approval in Japan, where additional safety and efficacy evidence of CardiAMP Cell Therapy will be gathered in a Post Marketing Study.”

About CardiAMP 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. Japan Pharmaceutical and Medical Device Agency has indicated that the clinical results from three completed clinical trials for the treatment of ischemic heart failure likely provide sufficient evidence of safety and efficacy to support a successful submission for approval.

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.

Upcoming Catalysts in 2026:

● CardiAMP HF Manuscript Published

● CardiAMP HF Japan PMDA Submission Q4 2026

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 relating to submission for and subsequent market clearance of the CardiAMP Cell Therapy. These forward-looking statements are made as of the date of this press release.

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 24, 2026, 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, 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 FDA communicate to BioCardia (BCDA) about CardiAMP HF II?

FDA CBER meeting minutes confirm the ongoing CardiAMP Heart Failure II Trial may support a Premarket Approval application for CardiAMP Cell Therapy. This clarifies that a single, well-conducted trial could underpin market clearance in ischemic heart failure with reduced ejection fraction.

What is the significance of Premarket Approval (PMA) for BioCardia’s CardiAMP therapy?

Premarket Approval is FDA’s most rigorous marketing pathway for high-risk medical devices, requiring strong safety and effectiveness evidence. Having CardiAMP Heart Failure II potentially support PMA outlines a defined route to U.S. market clearance if trial results are favorable.

How large is the potential U.S. patient population for BioCardia’s CardiAMP Cell Therapy?

FDA has previously indicated there are potentially over one million U.S. patients with ischemic heart failure of reduced ejection fraction who could benefit from CardiAMP Cell Therapy. This highlights a substantial addressable population if the therapy ultimately gains regulatory approval.

What regulatory feedback has Japan provided on CardiAMP Cell Therapy for heart failure?

Japan’s Pharmaceutical and Medical Device Agency indicated that clinical results from three completed ischemic heart failure trials likely provide sufficient safety and efficacy evidence to support a successful approval submission. This suggests a potentially advanced regulatory position for CardiAMP in Japan.

Does BioCardia’s CardiAMP Cell Therapy have any special FDA designations?

CardiAMP Cell Therapy has been granted FDA Breakthrough designation, which is intended to expedite development and review of therapies addressing serious conditions. The designation reflects FDA’s view that the treatment may offer substantial improvement over existing options for ischemic heart failure.

How is the CardiAMP Heart Failure clinical program being funded and supported?

Clinical development of CardiAMP Cell Therapy for heart failure is supported by the Maryland Stem Cell Research Fund and reimbursed by the Centers for Medicare and Medicaid Services in the CardiAMP HF trials. This backing helps advance the program through late-stage clinical evaluation.

Filing Exhibits & Attachments

5 documents

Press Releases

• EX-99.1 EXHIBIT 99.1 12.2 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