BioCardia Files Pre-Submission for FDA Approval of Helix™ Transendocardial Delivery Catheter for Therapeutic and Diagnostic Agent Delivery to the Heart

Rhea-AI Summary

BioCardia (Nasdaq: BCDA) completed a Pre-Submission to FDA under the Q-Submission program seeking approval of its Helix Transendocardial Delivery Catheter for intramyocardial therapeutic and diagnostic delivery.

Support includes safety and effectiveness data from 15 well-controlled clinical trials across three primary cardiac indications. BioCardia aims to align with FDA on the regulatory pathway and timing within 45 days, with a market clearance application to follow.

Positive

• Completed FDA Pre-Submission under the Q-Submission program
• Safety and effectiveness data drawn from 15 well-controlled clinical trials
• Helix underlies the CardiAMP Cell Therapy System FDA Breakthrough Designation
• Company seeks regulatory alignment with FDA within 45 days

Negative

• No FDA market clearance has been granted yet
• Timeline to approval is proposed but not guaranteed despite 45-day alignment goal

News Market Reaction – BCDA

-0.79%

3 alerts

-0.79% News Effect

+15.8% Peak Tracked

-$106K Valuation Impact

$13M Market Cap

0.0x Rel. Volume

On the day this news was published, BCDA declined 0.79%, reflecting a mild negative market reaction. Argus tracked a peak move of +15.8% during that session. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $106K from the company's valuation, bringing the market cap to $13M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Supporting clinical trials: 15 trials Cardiac indications: 3 indications FDA alignment window: 45 days +5 more

8 metrics

Supporting clinical trials 15 trials Well-controlled trials of cell and gene therapy delivery using Helix

Cardiac indications 3 indications Primary cardiac clinical indications in Helix supporting data

FDA alignment window 45 days Company seeks to align with FDA on pathway and timing

Current share price $1.25 Price before Helix FDA pre-submission news

52-week high $3.20 Stock trades well below its 52-week high level

Today’s volume 41,049 shares Compared with 20-day average volume of 69,600 shares

Relative volume 0.59x Volume vs. 20-day average ahead of this FDA-related update

Market capitalization $13,265,918 Equity value at the pre-news share price

Market Reality Check

Price: $1.14 Vol: Volume 41,049 is at 0.59x...

low vol

$1.14 Last Close

Volume Volume 41,049 is at 0.59x its 20-day average of 69,600 shares. low

Technical Price 1.25 is trading below the 200-day MA at 1.76, and 60.94% below the 52-week high of 3.2.

Peers on Argus

Sector peers show mixed moves: scanner flagged PHIO up 60.0% and BRTX down 16.75...

1 Up 1 Down

Sector peers show mixed moves: scanner flagged PHIO up 60.0% and BRTX down 16.75%. With sector momentum marked false and BCDA’s own direction unspecified, this news appears more company-specific than part of a broad biotech rotation.

Common Catalyst Select biotech peers also had regulatory/clinical updates (e.g., PHIO safety committee news), but BCDA’s FDA pre-submission is a distinct catheter-device catalyst.

Previous Fda approval Reports

3 past events · Latest: Aug 04 (Positive)

Same Type Pattern 3 events

Date	Event	Sentiment	Move	Catalyst
Aug 04	Regulatory timelines	Positive	-8.0%	Outlined FDA and Japan PMDA approval plans for CardiAMP and Helix systems.
Aug 21	Trial protocol change	Positive	-12.9%	FDA approved protocol amendment for CardiAMP Heart Failure II Phase 3 trial.
Jul 30	Device 510(k) filing	Positive	-4.1%	Submitted 510(k) seeking FDA clearance for Morph DNA steerable introducer.

Pattern Detected

Across prior 3 FDA approval–tagged updates, BCDA shares moved negatively despite positive regulatory progress, suggesting a pattern of weak or fading price responses to similar news.

Recent Company History

Over recent FDA-related milestones, BioCardia has repeatedly advanced its CardiAMP and Helix platforms. On Aug 04, 2025, it outlined timelines for FDA and Japan PMDA approvals for CardiAMP and the Helix catheter. Earlier, on Aug 21, 2024, FDA approved a protocol amendment for the CardiAMP Heart Failure II trial, and on Jul 30, 2024 the company submitted a 510(k) for Morph DNA introducer sheaths. Despite these seemingly constructive steps, each event saw a negative 24-hour price reaction, framing today’s Helix pre-submission within a history of cautious market responses.

Historical Comparison

-8.3% avg move · In the past three FDA-related updates, BCDA’s average 24-hour move was -8.33%, showing a tendency to...

fda approval

-8.3%

Average Historical Move fda approval

In the past three FDA-related updates, BCDA’s average 24-hour move was -8.33%, showing a tendency toward weak or negative immediate reactions to regulatory milestones.

The company’s FDA-tagged history shows steady regulatory advancement: from Morph DNA device submissions, to CardiAMP protocol optimization, to laying out approval timelines for CardiAMP and Helix, now followed by a Helix pre-submission under the CardiAMP Breakthrough Designation.

Market Pulse Summary

This announcement details an FDA pre-submission for the Helix catheter, backed by data from 15 well-...

Analysis

This announcement details an FDA pre-submission for the Helix catheter, backed by data from 15 well-controlled trials across 3 cardiac indications and linked to the CardiAMP Breakthrough program. Historically, BCDA’s FDA-related updates have seen muted or negative next-day moves, despite constructive content. The company’s shares traded at $1.25 with subdued volume relative to average, and recent Form 4 filings show insider buying. Key metrics to watch include upcoming FDA feedback within the next 45 days and any subsequent clearance application.

Key Terms

transendocardial, intramyocardial, cell and gene therapy, breakthrough designation, +3 more

7 terms

transendocardial medical

"Helix Transendocardial Delivery Catheter (“Helix”) for intramyocardial therapeutic"

Transendocardial describes a method of delivering a drug, cell therapy, or device by passing through the heart’s inner lining (the endocardium) directly into the heart muscle. Investors should care because this targeted, catheter-based approach can improve effectiveness and reduce systemic side effects compared with general delivery, but it also brings procedural risks, specialized equipment needs, and specific regulatory and reimbursement considerations—like sending a repair crew straight through the engine housing rather than treating the whole car.

intramyocardial medical

"for intramyocardial therapeutic and diagnostic agent delivery."

Intramyocardial describes something placed into or acting within the myocardium, the thick muscular wall of the heart — for example, a drug, a cell therapy, or a device delivered directly into heart muscle rather than into the bloodstream. For investors, this matters because direct delivery can change how well a treatment works, its safety profile, and its regulatory and clinical development path — like planting seeds directly into soil instead of scattering them from above.

cell and gene therapy medical

"clinical trials of cell and gene therapy delivery to the heart using Helix"

Therapies that use living cells or altered genes to treat or cure disease by repairing, replacing or reprogramming parts of the body; think of it as swapping or reprogramming malfunctioning hardware or software inside the body. Investors watch these treatments closely because they can command high prices and offer one-time or long-lasting benefits, but they also carry big development costs, complex manufacturing and regulatory risks that can cause large swings in a company’s value.

breakthrough designation regulatory

"made under the CardiAMP Cell Therapy System FDA Breakthrough Designation"

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.

minimally invasive medical

"best-in-class minimally invasive delivery technology for cardiovascular cell"

Medical procedures described as minimally invasive use small cuts, flexible tubes or tiny cameras to treat or diagnose problems with far less cutting than traditional surgery — like using a keyhole instead of tearing down a wall. Investors care because these approaches can shorten hospital stays, lower complication rates and change equipment and reimbursement needs, which can speed adoption and reshape market demand for devices, supplies and services.

chronic myocardial ischemia medical

"for the treatment of Heart Failure and Chronic Myocardial Ischemia."

Chronic myocardial ischemia is a long-lasting condition where the heart muscle receives less blood and oxygen than it needs, often because coronary arteries are narrowed. Think of it like a continually kinked garden hose that limits water to a lawn; over time the lawn weakens and needs repair. Investors watch this condition because its prevalence and severity drive demand for drugs, medical devices, procedures, clinical-trial results and regulatory approvals, all of which can affect healthcare spending and company revenues.

heart failure medical

"cell therapies for the treatment of Heart Failure and Chronic Myocardial Ischemia."

A condition in which the heart cannot pump enough blood to meet the body's needs, causing fatigue, shortness of breath, fluid buildup, and reduced activity. It matters to investors because it drives demand for medicines, medical devices, hospital care, and long-term support services; outcomes, trial results, approvals, or changes in treatment guidelines can materially affect company revenues, healthcare costs, and market valuations. Think of it as a central pump losing efficiency and changing the economics of care.

AI-generated analysis. Not financial advice.

SUNNYVALE, Calif., Feb. 10, 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 it has completed its Pre-Submission to FDA under its Q-Submission program for the approval of its Helix Transendocardial Delivery Catheter (“Helix”) for intramyocardial therapeutic and diagnostic agent delivery.   

The data supporting safety and effectiveness for the Helix Pre-Submission is from fifteen well-controlled clinical trials of cell and gene therapy delivery to the heart using Helix, where patients were enrolled in three primary cardiac clinical indications. The Helix Pre Submission has been made under the CardiAMP Cell Therapy System FDA Breakthrough Designation, which the Helix underlies. BioCardia seeks to align with FDA on the regulatory pathway and timing for approval in the next 45 days. An application for market clearance could soon follow.

“This Pre-Submission and discussion with FDA should lead to our Helix catheter being the first approved transendocardial delivery catheter system in the United States,” said Peter Altman, PhD, BioCardia’s President and CEO. “FDA clearance of Helix will streamline the future approvals of BioCardia’s autologous and allogeneic cell therapies for the treatment of Heart Failure and Chronic Myocardial Ischemia. Approval should also reduce development risk for biopharmaceutical and biotechnology partners seeking to employ our best-in-class minimally invasive delivery technology for cardiovascular cell, gene, and protein development programs aiming to address enormous unmet medical needs.”  

About the Helix Transendocardial Delivery Catheter
The Helix transendocardial delivery catheter is an enabling platform for minimally invasive targeted delivery of therapeutic and diagnostic agents to the heart intramyocardially. It enables agents to be delivered precisely within the heart with superior retention over other therapeutic delivery modalities, and to many regions of the heart that other delivery methods cannot reach. The Helix includes a specialized small distal helical needle which engages the heart tissue from within the chamber of the heart and provides stability within the dynamic beating heart to safely enable agent delivery. 

The Helix delivery catheter is intended to be used by interventional cardiologists, electrophysiologists, and cardiac surgeons trained to perform endovascular and transendocardial procedures. In independent reviews of clinical experience with Helix relative to other transendocardial delivery catheters, it has shown superior procedural safety¹ and in pre-clinical studies has demonstrated a three-fold increase in effective dosing compared to open surgical access intramyocardial biotherapeutic delivery and eighteen-fold increase compared to intracoronary artery infusion². The Helix catheter is further enhanced by BioCardia’s FDA approved Morph^® DNA™ steerable introducer product, which physicians use to navigate the Helix with superior control in the heart.

About BioCardia

BioCardia, Inc., headquartered in Sunnyvale, California, is developing 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 platforms. For more information visit: www.BioCardia.com.

References:

1. Raval AN and Pepine CJ. Clinical Safety Profile of Transendocardial Catheter Injection Systems: A Plea for Uniform Reporting, Cardiovasc Revasc Med, 2021.
2. Mitsutake Y, Pyum WB, Rouy D, et al. Improvement of local cell delivery using Helix Transendocardial Delivery Catheter in a porcine heart, Int Heart J. 2017. 
   
   

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, references to the approval of the Helix Transendocardial Delivery Catheter, delivery partnerships, the efficacy and safety of our products, regulatory timelines, and other statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. 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. 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.” 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 BioCardia announce about the Helix catheter (BCDA) on February 10, 2026?

BioCardia completed a Pre-Submission to FDA for the Helix catheter seeking approval. According to the company, the filing is supported by data from 15 well-controlled clinical trials across three cardiac indications and aims to clarify the regulatory path.

How much clinical data supports BioCardia's Helix Pre-Submission for BCDA?

The Pre-Submission relies on data from 15 well-controlled clinical trials supporting safety and effectiveness. According to the company, those trials enrolled patients across three primary cardiac clinical indications relevant to intramyocardial delivery.

What is BioCardia's timeline for FDA alignment on the Helix catheter (BCDA)?

BioCardia seeks to align with FDA on regulatory pathway and timing within 45 days. According to the company, that discussion could lead to a market clearance application following alignment on next steps.

Does the Helix catheter have any regulatory designations related to BCDA therapies?

Yes. The Helix underlies the CardiAMP Cell Therapy System Breakthrough Designation. According to the company, Helix is included in the regulatory context supporting faster development for associated cell therapy programs.

Will FDA clearance of Helix speed approvals for BioCardia's therapies (BCDA)?

Company says FDA clearance of Helix would streamline future approvals of its autologous and allogeneic cell therapies. According to the company, clearance could reduce development risk for these Heart Failure and Chronic Myocardial Ischemia programs.

What are the immediate next steps after BioCardia's Helix Pre-Submission for BCDA?

Next, BioCardia plans FDA discussions to align on pathway and timing and may submit a market clearance application. According to the company, those steps depend on successful alignment within the proposed 45-day window.