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BioCardia (NASDAQ: BCDA) pursues FDA accelerated path for CardiAMP HF

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8-K

Rhea-AI Filing Summary

BioCardia, Inc. submitted CardiAMP HF clinical study data to the FDA and requested a meeting to discuss an accelerated approval pathway for the CardiAMP System to treat ischemic chronic heart failure with reduced ejection fraction. The planned meeting is expected during the current quarter under the program’s existing FDA Breakthrough Designation.

BioCardia aims to confirm whether its proposed approval submission is acceptable based on safety from the CardiAMP HF Trial, clinical response data in 125 ischemic HFrEF patients, and a favorable benefit–risk profile in a subgroup with elevated biomarkers of heart stress. In this higher‑risk subgroup, cells delivered showed a 47% relative risk reduction in all‑cause cardiac death, a 37% relative risk reduction in non‑fatal major adverse cardiac events, and meaningful quality‑of‑life improvement with a reported p=0.04.

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Insights

BioCardia advances CardiAMP toward potential accelerated approval with promising subgroup data but still faces key FDA and funding risks.

BioCardia has submitted CardiAMP HF clinical data to the FDA and requested a meeting this quarter to discuss an accelerated approval pathway for treating ischemic HFrEF. The discussion will occur under the program’s existing FDA Breakthrough Designation, signaling prior recognition of unmet need and potential benefit.

The company’s strategy centers on a subgroup of ischemic HFrEF patients with elevated biomarkers of heart stress. In this higher‑risk cohort, CardiAMP treatment showed a reported 47% relative risk reduction in all‑cause cardiac death, a 37% reduction in non‑fatal major adverse cardiac events, and statistically significant quality‑of‑life gains (p=0.04) on top of guideline‑directed medical therapy over two years.

The meeting’s key objective is to secure FDA feedback on whether these safety and response data can support an approval submission. Forward‑looking statements highlight uncertainty, pointing to factors such as BioCardia’s liquidity and its ability to raise additional funds, as well as successful progression of clinical trials, as important to eventual outcomes.

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.
Ischemic HFrEF patients in CardiAMP HF trial 125 patients Clinical response data set discussed with FDA
Relative risk reduction in all-cause cardiac death 47% Subgroup with elevated biomarkers of heart stress over two years
Relative risk reduction in non-fatal major adverse cardiac events 37% Same high-risk subgroup in CardiAMP HF trial
Quality of life significance level p=0.04 Quality-of-life improvement in high-risk subgroup
Meeting timing indication during this quarter Expected timing of FDA meeting request for CardiAMP
accelerated approval pathway regulatory
"plans to meet with the FDA to discuss the accelerated approval pathway for the CardiAMP® System"
The accelerated approval pathway is a process that allows new medicines to be approved more quickly based on early evidence that they may be effective, rather than waiting for full proof. This can help patients access promising treatments faster, but it also means ongoing studies are needed to confirm the benefits. For investors, it highlights potential faster market entry and earlier revenue opportunities, along with some uncertainty about long-term outcomes.
Breakthrough Designation regulatory
"The meeting will be held under BioCardia’s FDA Breakthrough Designation for the CardiAMP System."
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.
relative risk reduction financial
"include an additional 47% relative risk reduction in all cause cardiac death, 37% relative risk reduction in non-fatal major adverse cardiac events"
Relative risk reduction measures how much a treatment or action lowers the chance of an outcome compared with no treatment, expressed as a percentage. If 10 out of 100 people in a control group experience an event and 5 out of 100 do with the treatment, the relative risk reduction is 50%. Investors use it to gauge headline effectiveness but should also check the actual change in event rates and the study size, since percentages can overstate real-world impact.
guideline directed medical therapy medical
"already on stable American Heart Association and American College of Cardiology guideline directed medical therapy."
Guideline directed medical therapy is the set of treatments and care steps that leading medical experts recommend for a particular disease based on accumulated evidence, like a well-tested recipe doctors follow. For investors, it matters because products or procedures that match, improve on, or displace these standard recommendations affect clinical adoption, reimbursement, market size and regulatory expectations—similar to how a new tool that fits an industry playbook can be widely accepted or resisted.
investigational use regulatory
"CAUTION - Limited by United States law to investigational use."
major adverse cardiac events medical
"37% relative risk reduction in non-fatal major adverse cardiac events (stroke, myocardial infarction, and hospitalization)"
Major adverse cardiac events (MACE) is a clinical composite measure that counts serious heart-related outcomes such as heart attack, stroke, urgent need for a heart procedure, or death from cardiovascular causes. Investors care because MACE is used to judge whether a drug, device, or treatment meaningfully reduces life‑threatening heart problems — like a safety and effectiveness scorecard — and outcomes can directly affect a medical product’s approval, market size, and commercial value.
Understanding 8-K Material Events →
false 0000925741 0000925741 2026-04-02 2026-04-02
 
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): April 2, 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 April 2, 2026, BioCardia, Inc. issued a press release reporting submission to United States Food and Drug Administration (FDA) of the CardiAMP HF clinical study data and on its plans to meet with the FDA to discuss the accelerated approval pathway for the CardiAMP® System for ischemic chronic heart failure with reduced ejection fraction (HFrEF). 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 April 2, 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: April 2, 2026
  
 
 
 

Exhibit 99.1

 

BIOCARDIA FILES REQUEST FOR MEETING WITH FDA TO DISCUSS ACCELERATED APPROVAL PATHWAY FOR CARDIAMP® SYSTEM IN ISCHEMIC HEART FAILURE

 

SUNNYVALE, Calif. – April 02, 2026- BioCardia®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported submission to United States Food and Drug Administration (FDA) of the CardiAMP HF clinical study data and on its plans to meet with the FDA to discuss the accelerated approval pathway for the CardiAMP® System for ischemic chronic heart failure with reduced ejection fraction (HFrEF).

 

This meeting request is in line with previous guidance and BioCardia expects to have the meeting during this quarter. The meeting will be held under BioCardia’s FDA Breakthrough Designation for the CardiAMP System.

 

The key objectives of the meeting are to obtain FDA feedback on the acceptability of BioCardia’s proposed submission for approval based on the safety seen in the CardiAMP HF Trial, the well-characterized clinical response data for the 125 ischemic HFrEF patients enrolled into the trial, and the low risk and high potential benefit profile in the subgroup with elevated biomarkers of heart stress participating in the trial.

 

For the CardiAMP HF trial subgroup with elevated biomarkers of heart stress, the cells delivered have shown meaningful benefit for these higher-risk patients already on stable American Heart Association and American College of Cardiology guideline directed medical therapy. Demonstrated benefits in the subgroup, in addition to benefits the patients received from guideline directed medical therapy over two years, include an additional 47% relative risk reduction in all cause cardiac death, 37% relative risk reduction in non-fatal major adverse cardiac events (stroke, myocardial infarction, and hospitalization), and meaningful improvements in quality of life (p=0.04). The latest results from this study were presented at the THT (Technology and Heart Failure Therapeutics) 2026 Annual Meeting and are available on the BioCardia website.

 

 
 

 

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.

 

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 FDA approval of CardiAMP, the planned meeting and the likelihood of safety and patient benefit. 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, 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

 

 

Source: View Original Filing on SEC EDGAR

FAQ

What did BioCardia (BCDA) announce about its CardiAMP HF program?

BioCardia reported submitting CardiAMP HF clinical study data to the FDA and requesting a meeting to discuss an accelerated approval pathway. The meeting, expected this quarter, will review safety, clinical response in 125 ischemic HFrEF patients, and a favorable benefit–risk profile in a defined high‑risk subgroup.

What is the goal of BioCardia’s planned FDA meeting for CardiAMP HF?

The primary goal is to obtain FDA feedback on the acceptability of BioCardia’s proposed approval submission for CardiAMP. Discussion will focus on trial safety data, clinical responses in 125 ischemic HFrEF patients, and outcomes in patients with elevated biomarkers of heart stress already on guideline‑directed therapy.

What clinical benefits were reported for CardiAMP in high-risk ischemic HFrEF patients?

In patients with elevated biomarkers of heart stress, CardiAMP treatment showed a 47% relative risk reduction in all‑cause cardiac death and a 37% reduction in non‑fatal major adverse cardiac events. These patients also experienced meaningful quality‑of‑life improvements with a reported p=0.04 over two years of follow‑up.

How many patients were included in the CardiAMP HF clinical trial described by BioCardia?

The reported CardiAMP HF clinical data cover 125 ischemic HFrEF patients enrolled in the trial. BioCardia is using safety outcomes and well‑characterized clinical response data from this population, along with subgroup analyses, to support its discussion with the FDA on a potential accelerated approval pathway.

Does CardiAMP therapy for heart failure have any special FDA status?

Yes. CardiAMP Autologous Cell Therapy has been granted FDA Breakthrough Designation, which is intended for therapies addressing serious conditions with preliminary evidence of substantial improvement. The upcoming FDA meeting on an accelerated approval pathway will be held under this existing Breakthrough Designation framework.

Is CardiAMP Cell Therapy currently approved for ischemic heart failure treatment in the United States?

CardiAMP Cell Therapy is currently limited by United States law to investigational use. BioCardia is developing it for ischemic chronic heart failure with reduced ejection fraction and is now seeking FDA feedback on whether existing trial safety and efficacy data can support a future approval submission.

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