BioCardia Confirms Timing and Provides Update on FDA Helix Pre-Submission and PMDA CardiAMP HF Shonin Submission

BioCardia details aligned US and Japanese regulatory steps for CardiAMP therapy and Helix delivery system, with key filings targeted in the next year.

Rhea-AI Summary

BioCardia (BCDA) outlined upcoming regulatory milestones for its CardiAMP autologous cell therapy and Helix transendocardial delivery platform.

For CardiAMP in ischemic heart failure, the company is working toward a Shonin pre-market regulatory submission to Japan’s PMDA in Q4 2026, following detailed responses to PMDA consultation questions and preparation of the Shonin application, Quality Management System Application, and Foreign Manufacturer Registration. PMDA support and a successful review could lead to market clearance by Q4 2027.

The confirmatory CardiAMP HF II clinical study is actively enrolling at four centers in the United States, and FDA’s CBER has indicated this study may support a Pre Marketing Application. For the Helix catheter system, BioCardia plans to file a follow-on De Novo pre-submission with FDA’s CDRH this quarter, with FDA aiming for an initial acceptance/refusal review within 15 days and feedback or a meeting within 70 days.

Positive

• CardiAMP PMDA timeline Shonin pre-market submission targeted for Q4 2026, with possible market clearance by Q4 2027
• CardiAMP HF II trial Confirmatory U.S. study is actively enrolling at four centers
• FDA CBER feedback CardiAMP HF II study may support a future Pre Marketing Application
• Helix platform Follow-on De Novo pre-submission to FDA CDRH planned for this quarter
• FDA review timing Initial acceptance/refusal in 15 days and feedback or meeting within 70 days targeted for Helix pre-submission

Negative

• None.

Market Context

The 5.56% 24-hour move recorded on Aug 12 accompanied a prior CardiAMP regulatory update, providing ...

Analysis

The 5.56% 24-hour move recorded on Aug 12 accompanied a prior CardiAMP regulatory update, providing program context for the current PMDA submission and FDA study-support details.

Key Figures

Targeted PMDA submission: Q4 2026 Potential market clearance: Q4 2027 Engaged study centers: 4 centers +2 more

Targeted PMDA submission

Q4 2026

CardiAMP Shonin pre-market submission

Potential market clearance

Q4 2027

Contingent on PMDA support and successful submission review

Engaged study centers

4 centers

U.S. CardiAMP HF II study is actively enrolling

Initial FDA review target

15 calendar days

Helix De Novo pre-submission acceptance/refusal review

FDA feedback target

70 calendar days

Helix De Novo pre-submission written feedback or meeting

Historical Context

2 past events · Latest: Aug 24

2 events

1. Aug 24

   Helix FDA update

   24h Move

   +5.0%

   FDA accepted Helix meeting minutes ahead of the planned follow-on De Novo pre-submission.

2. Aug 12

   Q2 regulatory update

   24h Move

   +5.6%

   PMDA supported a CardiAMP submission; FDA said HF II may support a U.S. filing.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

shonin, quality management system, pre marketing application, de novo

4 terms

shonin regulatory

"Shonin pre-market regulatory submission to Japan’s Pharmaceutical and Medical Device Agency"

A shonin is a formal approval or authorization granted by a person, committee, regulator, or board that allows a corporate action to proceed. Think of it as an official green light or signed permission needed before a company can complete a transaction, launch a product, or change governance. Investors care because a shonin affects whether and when planned actions become legally effective and can change a company’s prospects, risks, or timelines.

quality management system regulatory

"the Quality Management System Application"

A quality management system is an organized set of policies, procedures and records a company uses to ensure its products or services consistently meet required standards and regulations. Investors care because a strong system reduces the risk of product failures, recalls, regulatory fines and costly delays, much like a well-maintained checklist and routine for a kitchen that keeps meals safe and on schedule, protecting reputation and predictable earnings.

pre marketing application regulatory

"this study may support a Pre Marketing Application"

A pre marketing application is a formal submission to a health regulator seeking permission to sell a drug, medical device, or similar health product before it can be marketed. It compiles clinical data, manufacturing details and safety information so regulators can decide if the product is safe and effective. For investors, the filing marks a key regulatory milestone that can change a product’s commercial timeline much like a building permit signals when construction can legally begin.

de novo regulatory

"follow-on De Novo pre-submission for the Helix Transendocardial Delivery Catheter System"

De novo means “starting from scratch” — creating something new rather than buying, copying, or modifying an existing asset. For investors it signals a fresh venture or a first-time regulatory pathway where there is no operating history or precedent, which can mean higher upside if it succeeds but greater risk and uncertainty because outcomes, costs and approvals are less predictable; think of it as backing a new recipe instead of a well-known restaurant.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

SUNNYVALE, Calif., Sept. 23, 2026 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today provided an update on near term milestones.

CardiAMP^® Autologous Cell Therapy for Ischemic Heart Failure

• BioCardia is working towards a Shonin pre-market regulatory submission to Japan’s Pharmaceutical and Medical Device Agency (PMDA) in Q4 2026. The Company has recently provided detailed responses to PMDA consultation questions and is working with experienced partners on the Shonin Application, the Quality Management System Application, and Foreign Manufacturer Registration. PMDA support for the submission and a successful submission review could result in market clearance by Q4 2027.

• The confirmatory CardiAMP HF II clinical study is actively enrolling in the United States at four engaged world class centers. The Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) has indicated this study may support a Pre Marketing Application.
  
  

Helix™ Transendocardial Delivery Platform

• BioCardia intends to submit the follow-on De Novo pre-submission for the Helix Transendocardial Delivery Catheter System incorporating the FDA Center for Devices and Radiological Health (CDRH) this quarter. The FDA targets providing an initial acceptance/refusal review within 15 calendar days, and aims to issue written feedback or hold a meeting within 70 calendar days.

• An independent FDA clearance of Helix has the potential to expand BioCardia’s opportunities to partner with developers of investigational cell, gene and protein therapeutics requiring targeted delivery to the heart.
  
  

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 the timing and potential outcome of BioCardia’s regulatory submissions in Japan and the United States; the potential for the CardiAMP HF II trial to support Premarket Approval; submission for and subsequent market clearance of the Helix Transendocardial Delivery Catheter; business development and partnering opportunities; and the achievement of anticipated upcoming milestones.

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 and regulatory programs. 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

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What is the planned timing and scope of BioCardia’s PMDA Shonin submission for CardiAMP?

BioCardia plans to submit a Shonin pre-market regulatory application for CardiAMP autologous cell therapy for ischemic heart failure to Japan’s PMDA in Q4 2026. The work includes the Shonin Application itself, a Quality Management System Application, and Foreign Manufacturer Registration. With PMDA support and a successful review, market clearance could occur by Q4 2027.

What is the current status of the CardiAMP HF II clinical study in the United States?

The confirmatory CardiAMP HF II clinical study is actively enrolling patients in the United States at four engaged world-class centers. FDA’s Center for Biologics Evaluation and Research has indicated that this study may support a future Pre Marketing Application.

How will the Helix transendocardial delivery system be advanced with the FDA?

BioCardia intends to submit a follow-on De Novo pre-submission for the Helix Transendocardial Delivery Catheter System to FDA’s Center for Devices and Radiological Health this quarter. FDA targets an initial acceptance or refusal review within 15 calendar days and aims to provide written feedback or hold a meeting within 70 calendar days of receiving the pre-submission.