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BioCardia (NASDAQ: BCDA) wins PMDA support to file CardiAMP heart failure therapy in Japan

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

BioCardia reported that Japan’s Pharmaceutical and Medical Device Agency (PMDA) issued a Consultation Record that supports submission for regulatory approval of its CardiAMP cell therapy for ischemic heart failure with reduced ejection fraction. The agency confirmed alignment on remaining questions and noted the trial’s positive outcomes were credible.

The company plans to submit in approximately seven months, with the regulatory submission anticipated in Q4 2026. BioCardia estimates that 20,000 of 300,000 ischemic heart failure patients in Japan could initially be eligible if approved. Prior trials showed the minimally invasive procedure was well tolerated, with average exercise tolerance improving 179 seconds and angina episodes reduced by 82%.

Positive

  • PMDA Consultation Record supports CardiAMP filing, confirming credible trial outcomes and alignment on remaining questions for a Japan approval submission anticipated in Q4 2026.
  • Defined initial addressable population in Japan, with BioCardia estimating 20,000 of 300,000 ischemic heart failure patients could be eligible if CardiAMP is approved.

Negative

  • None.

Insights

PMDA feedback supports a planned Japan approval filing for CardiAMP in late 2026.

The disclosure shows BioCardia has completed a key regulatory interaction in Japan. PMDA’s Consultation Record supports filing for approval of CardiAMP cell therapy for ischemic heart failure and confirms that trial outcomes were considered credible, which helps validate the existing clinical package.

PMDA outlined requirements such as confirming patients were on guideline-directed medical therapy, not eligible for revascularization, and providing detailed outcome data. It also requested post-marketing study plans and collaboration with Japanese academic societies. Actual commercial impact depends on successful submission, review and potential approval.

BioCardia targets a seven-month timeline to submit, with submission anticipated in Q4 2026. The company estimates 20,000 of 300,000 Japanese patients could initially qualify, indicating a defined target population if CardiAMP is ultimately approved.

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.
Planned PMDA submission timing Q4 2026 Submission for CardiAMP approval in Japan anticipated Q4 2026
Submission preparation timeline Seven months BioCardia’s timeline to complete PMDA submission
Initial eligible patients in Japan 20,000 patients Estimated initial CardiAMP-eligible ischemic heart failure patients
Total ischemic heart failure patients in Japan 300,000 patients Broader ischemic heart failure population referenced by BioCardia
Exercise tolerance improvement 179 seconds Average increase in exercise tolerance up to two-year follow-up
Reduction in angina episodes 82% Average reduction in angina by six months after treatment
Consultation Record regulatory
"reported the Consultation Record from Japan’s Pharmaceutical and Medical Device Agency (PMDA) supports submission"
guideline directed medical therapy medical
"patients with elevated biomarkers of heart stress (NTproBNP) on stable guideline directed medical therapy (GDMT)"
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.
post-marketing study regulatory
"the Agency requests post-marketing study plans including the criteria for patient selection"
A post-marketing study is research conducted after a drug or medical device is approved and sold to check how it performs in everyday use, tracking long-term safety, side effects, and effectiveness. For investors it matters because results can change sales forecasts, trigger label updates or warnings, lead to additional costs or legal exposure, or open new markets — like a car recall study revealing issues that affect a maker’s reputation and future earnings.
Designated Marketing Authorization Holder regulatory
"plans to submit with a Designated Marketing Authorization Holder as the optimal pathway"
The designated marketing authorization holder is the legal entity named on a drug or medical product’s approval certificate that is responsible for selling, promoting, and monitoring that product in a specific market. Think of it like the registered owner of a car: investors care because this holder carries the regulatory obligations, legal liability, and commercial rights tied to the product’s revenue and ongoing compliance, which can affect a company’s cash flow and risk profile.
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.
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 2026-05-28 2026-05-28
 
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): May 28, 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 May 28, 2026, BioCardia, Inc. issued a press release reporting the Consultation Record from Japan’s Pharmaceutical and Medical Device Agency (PMDA) supports submission for regulatory approval of the CardiAMP® cell therapy for the treatment of ischemic heart failure of reduced ejection fraction (HFrEF) based on the Company’s three completed clinical trials of this therapy in HFrEF. PMDA’s Consultation Record confirms alignment on remaining questions to address before, and as part of the submission, for regulatory approval for ischemic HFrEF patients with elevated biomarkers of heart stress (NTproBNP) on stable guideline directed medical therapy (GDMT). PMDA noted that the positive outcomes seen in the trial were credible. It is estimated that 20,000 of the 300,000 patients in Japan would initially be eligible for this therapy. PMDA requested BioCardia demonstrate that enrolled patients were on GDMT and not eligible for revascularization procedures, required per CardiAMP HF protocol, and provide additional details for each incidence of all-cause death, heart transplantation or left ventricular assist device implantation.
 
The results presented by Dr. Raval, on behalf of the CardiAMP CMI Investigators, showed that the minimally invasive CardiAMP Cell Therapy procedure was well tolerated with no treatment emergent major adverse cardiac events and patients demonstrated positive clinical outcomes including increased exercise tolerance and reduced frequency of angina episodes with the autologous cell therapy up through two years follow-up. Prior to treatment, all patients were on guideline-directed medical therapy and had received all available percutaneous and/or surgical options as appropriate for their medical condition. Patients experienced increased exercise tolerance, improving by an average of 179 seconds, which persisted for the two-year study follow-up. Angina episodes were reduced by an average of 82% by six-months after treatment.
 
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 May 28, 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: May 28, 2026
  
 
 

Exhibit 99.1

 

BIOCARDIA ANNOUNCES JAPAN PMDA RECORD OF ADVICE SUPPORTS REGULATORY SUBMISSION FOR APPROVAL OF CARDIAMP CELL THERAPY FOR ISCHEMIC HEART FAILURE

 

SUBMISSION ANTICIPATED IN Q4 2026

 

SUNNYVALE, Calif. – May 28, 2026- BioCardia®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported the Consultation Record from Japan’s Pharmaceutical and Medical Device Agency (PMDA) supports submission for regulatory approval of the CardiAMP® cell therapy for the treatment of ischemic heart failure of reduced ejection fraction (HFrEF) based on the Company’s three completed clinical trials of this therapy in HFrEF.

 

PMDA’s Consultation Record confirms alignment on remaining questions to address before, and as part of the submission, for regulatory approval for ischemic HFrEF patients with elevated biomarkers of heart stress (NTproBNP) on stable guideline directed medical therapy (GDMT). PMDA noted that the positive outcomes seen in the trial were credible. It is estimated that 20,000 of the 300,000 patients in Japan would initially be eligible for this therapy. PMDA requested BioCardia demonstrate that enrolled patients were on GDMT and not eligible for revascularization procedures, required per CardiAMP HF protocol, and provide additional details for each incidence of all-cause death, heart transplantation or left ventricular assist device implantation.

 

“PMDA’s recognition of the urgent unmet clinical need in HFrEF and their support of this novel therapy is valued,” said BioCardia Chief Executive Dr. Peter Altman. “We believe the clinical package prepared for this submission will be sufficient to support approval.”

 

As part of the submission review for approval of CardiAMP Cell Therapy, the Agency requests post-marketing study plans including the criteria for patient selection, the clinical decision-making framework, and appropriate medical infrastructure and specialist involvement. BioCardia has been guided to collaborate with relevant Japanese academic societies to establish proper-use guidelines and sufficiently consider product training, proctoring, and post market surveillance.

 

 
 

 

BioCardia’s timeline for PMDA submission is seven months. BioCardia plans to submit with a Designated Marketing Authorization Holder as the optimal pathway for regulatory submission, regulatory review, and to initiate commercialization of the CardiAMP Cell Therapy System while conducting the post market study in Japan. The PMDA review process will be rigorous, and BioCardia believes the documentation to support review is in good shape. BioCardia is ISO13485 compliant for the design, manufacture, and distribution of medical devices for cardiovascular procedures, including catheters for use in delivery of therapeutic agents directly to the heart, and currently manufactures FDA cleared products. When PMDA concludes its technical assessment and recommends approval, the Ministry of Health, Labour and Welfare (MHLW) ultimately issues the certificate enabling commercialization.

 

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 submission for and subsequent market clearance of CardiAMP Cell Therapy by PMDA. 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 Japan’s PMDA communicate about BioCardia (BCDA) and CardiAMP therapy?

Japan’s PMDA issued a Consultation Record that supports BioCardia’s submission for regulatory approval of CardiAMP cell therapy for ischemic heart failure. The agency confirmed alignment on remaining questions and stated that the positive outcomes observed in the company’s clinical trials were credible.

When does BioCardia (BCDA) plan to submit CardiAMP for PMDA review in Japan?

BioCardia plans to submit its CardiAMP cell therapy package to Japan’s PMDA in approximately seven months, with the regulatory submission anticipated in Q4 2026. This timing follows PMDA feedback detailing data requirements and post-marketing study expectations to support the approval review process.

How many patients in Japan could initially be eligible for BioCardia’s CardiAMP therapy?

BioCardia estimates that 20,000 of the 300,000 ischemic heart failure patients in Japan could initially qualify for CardiAMP cell therapy, assuming approval. These patients would have elevated NTproBNP levels and be on stable guideline-directed medical therapy according to the company’s target criteria.

What clinical benefits did BioCardia (BCDA) report for CardiAMP in coronary microvascular ischemia?

In the CardiAMP CMI study, BioCardia reported that patients experienced increased exercise tolerance, improving by an average of 179 seconds through two-year follow-up. Angina episodes were reduced by an average of 82% at six months, and the minimally invasive procedure was well tolerated without treatment-emergent major adverse cardiac events.

What post-marketing commitments did PMDA request from BioCardia for CardiAMP in Japan?

PMDA requested post-marketing study plans for CardiAMP, including patient selection criteria, clinical decision-making frameworks, and appropriate medical infrastructure. It also guided BioCardia to work with Japanese academic societies on proper-use guidelines, product training, proctoring, and post-market surveillance as part of the approval process.

What regulatory designations and support back BioCardia’s CardiAMP heart failure program?

CardiAMP Cell Therapy has FDA Breakthrough designation in the United States and its heart failure development is supported by the Maryland Stem Cell Research Fund. Treatment costs are reimbursed by the Centers for Medicare and Medicaid Services, reinforcing institutional support for ongoing clinical evaluation of this autologous cell therapy.

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