BioCardia Cell Therapy for Ischemic Heart Failure to Progress to Formal Clinical Consultation with Japan PMDA

Rhea-AI Summary

BioCardia (NASDAQ: BCDA) completed a third preliminary clinical consultation with Japan’s PMDA on CardiAMP Cell Therapy for ischemic heart failure (HFrEF) on Dec 16, 2025. PMDA indicated BioCardia may advance to a formal clinical consultation to assess whether existing clinical data are acceptable for a regulatory submission in Japan. The company says its compiled Phase I, II and III data show favorable safety and efficacy signals, including improved survival, reduced major adverse cardiovascular events, and better heart function and quality of life versus controls. The data remain subject to ongoing regulatory discussions in Japan and the United States, and a formal PMDA determination would be required before a Japan regulatory filing.

Positive

• PMDA allowed advancement to formal clinical consultation (Dec 16, 2025)
• Compiled Phase I, II, III data reportedly support efficacy signals
• If accepted, company could file for regulatory approval in Japan

Negative

• No formal PMDA acceptance yet; submission depends on consultation outcome
• Clinical outcomes cited are not presented with quantified readouts in this release
• Regulatory discussions remain ongoing in both Japan and the United States

Key Figures

Completed CardiAMP trials 3 trials (Phase I, II, III) Clinical data package cited to support safety and efficacy

Market Reality Check

$1.28 Last Close

Volume Volume 81,004 vs 20-day average 66,279 (relative volume 1.22x) indicates elevated trading activity ahead of this update. normal

Technical Shares at $1.30 are trading below the $1.95 200-day moving average, reflecting a weak longer-term trend.

Peers on Argus

BCDA fell 10.34% while several biotech peers also traded lower (e.g., ADAP -17.57%, PHGE -23.79%, BCTX -8.23%). However, momentum data do not flag a coordinated sector move, pointing to a more stock-specific reaction.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 03	Board change	Positive	+3.6%	New director with commercial and regulatory experience joined the board.
Dec 01	Conference participation	Neutral	-4.1%	Upcoming invited presentation on intramyocardial cell therapy at HF congress.
Nov 24	Earnings & financing	Neutral	+0.7%	Q3 2025 results with $6.0M financing and clinical program updates.
Nov 10	Clinical trial update	Positive	-0.8%	First patient enrolled in Phase 3 CardiAMP HF II pivotal HFrEF trial.

Pattern Detected

Recent news has often seen muted or negative price reactions, even on operational or clinical milestones, with only one clearly positive alignment out of four events.

Recent Company History

Over the last six weeks, BioCardia has reported governance changes, conference participation, leadership additions, earnings/financing, and a Phase 3 trial enrollment milestone. Reactions have been modest, with three of four prior events showing negative moves despite generally constructive updates. Today’s PMDA consultation progress builds on earlier mentions of positive preliminary interaction with the agency and continued advancement of CardiAMP HF II, but the pre-news trend remained weak, with shares about 59.38% below the 52-week high and below the $1.95 200-day moving average.

Market Pulse Summary

This announcement highlights that BioCardia completed a third preliminary consultation with Japan’s PMDA and may advance CardiAMP Cell Therapy for HFrEF to formal clinical consultation. The agency will assess whether data from three completed Phase I, II and III trials sufficiently demonstrate safety and efficacy to support a potential approval filing. Investors may track upcoming PMDA interactions, parallel U.S. regulatory discussions, and how the existing clinical package—emphasizing survival, cardiovascular events, and quality-of-life outcomes—evolves into formal submissions.

Key Terms

pharmaceutical and medical device agency (pmda) regulatory

"completed a third preliminary clinical consultation with Japan’s Pharmaceutical and Medical Device Agency (PMDA)"

Pharmaceutical and Medical Device Agency (PMDA) is Japan’s national regulator that reviews and approves medicines, medical devices and related safety measures, assesses clinical data, and oversees post‑market surveillance and inspections. For investors, PMDA actions—approvals, rejections, label changes or safety warnings—directly affect a product’s ability to reach and stay on the market, the timing of revenue, and the regulatory risk profile of companies, acting like a gatekeeper for commercial access.

cardiamp cell therapy medical

"on our CardiAMP Cell Therapy intended for treatment of Heart Failure"

A cardiamp cell therapy is a medical treatment that uses living cells—typically taken from a patient’s own bone marrow or blood—to help repair damaged heart muscle and improve blood flow. Think of it as using a repair crew made from a homeowner’s own materials to patch a leaky roof; for investors, it matters because such therapies can offer new alternatives to surgery or drugs, carry high development and regulatory costs, and can meaningfully affect market demand and reimbursement if proven effective.

heart failure with reduced ejection fraction (hfrEF) medical

"treatment of Heart Failure with Reduced Ejection Fraction (HFrEF)"

A chronic heart condition in which the heart’s main pumping chamber cannot push out as much blood with each beat as a healthy heart, measured by a lower “ejection fraction” (the percentage of blood pumped out). Think of the heart as a water pump that no longer pushes a full load. It matters to investors because it drives demand for medicines, medical devices, hospital care and clinical trials, and outcomes, approvals or reimbursement shifts can materially affect company revenues and healthcare costs.

major adverse cardiovascular events medical

"reduced major adverse cardiovascular events, along with improved heart function"

Major adverse cardiovascular events (often abbreviated MACE) are a grouped set of serious heart- and blood-vessel problems—commonly heart attack, stroke, and death from cardiovascular causes—used as a single “scorecard” in clinical studies. Investors watch MACE results because they directly affect whether a treatment or device is seen as safe and effective, which in turn shapes regulatory approval, market access, potential sales, and legal or reputational risk.

autologous minimally invasive cell therapy medical

"Our autologous minimally invasive cell therapy presents a new mechanism of action"

A treatment that uses a patient’s own living cells, collected and returned with only small incisions or injections rather than major surgery. Think of it like taking a cuttings from a plant and replanting them nearby to help it heal—using the body’s own material reduces rejection risk and can speed recovery. Investors watch these therapies for their potential safety advantages, lower regulatory hurdles, cost and scalability challenges, and commercial market opportunity.

microvascular repair medical

"a new mechanism of action of microvascular repair for ischemic heart failure patients"

Microvascular repair is the medical process of restoring or rebuilding very small blood vessels that supply oxygen and nutrients to tissues, often using surgery, implants, or biologic therapies. For investors, it signals potential markets for devices, drugs, or procedures that can improve healing in conditions like wounds, organ transplants, or limb salvage; success can drive regulatory approvals, clinical adoption, and revenue similar to fixing the fine plumbing that keeps a building functioning.

AI-generated analysis. Not financial advice.

SUNNYVALE, Calif., Dec. 16, 2025 (GLOBE NEWSWIRE) -- BioCardia^®, Inc. [NASDAQ: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announces it has completed a third preliminary clinical consultation with Japan’s Pharmaceutical and Medical Device Agency (PMDA) on our CardiAMP Cell Therapy intended for treatment of Heart Failure with Reduced Ejection Fraction (HFrEF). The meeting was held in further preparation for formal clinical consultation on acceptability of the existing clinical data for submission of an application for approval. Based on the discussions in the most recent meeting, PMDA said it will allow BioCardia to advance to formal clinical consultation. Should PMDA agree in formal consultation that the available data provides sufficient evidence of safety and efficacy, BioCardia would be able to file for regulatory approval in Japan.  

“Our autologous minimally invasive cell therapy presents a new mechanism of action of microvascular repair for ischemic heart failure patients evidencing active heart failure while on guideline directed medical therapy who have few additional therapeutic options.” said Peter Altman, PhD, BioCardia’s Chief Executive Officer. “The data from the three completed Phase I, II and III trials support positive outcomes in significant clinical efficacy endpoints, including improved survival and reduced major adverse cardiovascular events, along with improved heart function and quality of life measures relative to control patients.”

The existing clinical data supporting safety and efficacy of CardiAMP Cell Therapy for HFrEF is subject to ongoing regulatory discussions in Japan and the United States. The compilation includes data from the three clinical studies that BioCardia believes demonstrate a favorable benefit to risk profile.  

About CardiAMP Autologous Cell Therapy

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

CardiAMP Cell Therapy Clinical Development Highlights

Phase 1: TABMMI Heart Failure Trial; open label, n=20 (NCT00507468) ¹

• 90% of treated patients alive and well at three years
• Left ventricular ejection fraction (LVEF) improved by 7% at 24 months (p=0.001)
• Exercise tolerance improved 125 seconds at 24 months (p=0.006)
  
  

Phase 2: TACHFT Trial; double-blind placebo-controlled, n=33 with 29 randomized (NCT00768066) ^2,3

• All (100%) treated patients alive at one year (end of study); major adverse cardiac events (MACE) reduced 20% relative to controls
• Six-minute walk distance improved 56.3 meters at 12 months for treated patients compared to controls (p = 0.049)
• Quality of life measured using Minnesota Living with Heart Failure Quality of Life Questionnaire improved by 17.4 points (p=0.039) for treated patients compared to controls
  
  

Phase 3: CardiAMP HF Trial; multi-center, double-blind placebo-procedure controlled with 24-month follow-up, N=125, with 115 randomized (NCT02438306) ^{4, 5}

• Roll-in cohort patients demonstrated improved heart function measures, and the study procedure was feasible with an excellent safety profile
• Treated patients in the full study cohort had reduced fatal and nonfatal MACE, along with improved quality of life and echocardiography heart function measures on top of guideline-directed medical therapy compared to controls
• The primary Finkelstein Schoenfeld composite outcome endpoint including 6-minute walk test distance (6MWT) was not met due to potential confounding of this effort-based measure.
  
  

The subgroup of randomized patients with elevated NTproBNP before study enrollment (n=57) demonstrated strong efficacy signals, including:

• Met Finkelstein Schoenfeld composite endpoint consisting of fatal cardiac death, non-fatal MACE, and quality of life (p = 0.04)
• Demonstrated improved left ventricular systolic and diastolic volume measures at 24 months (LVESVi, p=0.01; LVEDVi, p=0.01) as assessed by the blinded echocardiography core lab, suggesting significantly improved heart function compared to controls through the end of the study

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.

References

¹ De la Fuente LM, Stertzer SH, Argentieri J. et al. Transendocardial autologous bone marrow in myocardial infarction induced heart failure, two-year follow-up in an open-label phase I safety study (the TABMMI study). EuroIntervention. 2011; 7(7):805-812.

² Wong Po Foo C, Rouy D, Hare JM, et al. The transendocardial autologous bone marrow mononuclear cells in ischemic heart failure trial (TAC-HFT-BMC). Regenerative Medicine. 2015; 10(7S): S169.

³ Heldman AW, DiFede DL, Fishman JE, et al. Transendocardial mesenchymal stem cells and mononuclear bone marrow cells for ischemic cardiomyopathy: the TAC-HFT randomized trial. JAMA. 2014; 311(1):62-73.

⁴ Raval AN, Johnston PV, Duckers HJ, Cook TD, Traverse JH, Altman PA, Dhingra R, Hematti P, Borrello I, Anderson RD, Pepine CJ. Point of care, bone marrow mononuclear cell therapy in ischemic heart failure patients personalized for cell potency: 12-month feasibility results from CardiAMP heart failure roll-in cohort. Int J Cardiol. 2021 Mar 1;326:131-138. doi: 10.1016/j.ijcard.2020.10.043. Epub 2020 Oct 20. PMID: 33091520.

⁵ Raval AN on behalf of the CardiAMP HF Investigators: A Double-blind, Randomized Controlled Trial of an Autologous Cell Therapy in Patients with HFrEF: Principal Results from the CardiAMP-HF Trial, American College of Cardiology Late Breaking Clinical Trials 2025.

Forward Looking Statements
This press release contains forward-looking statements that are subject to risks and uncertainties. Forward-looking statements include, among other things, references to the Company’s investigational product candidates, future regulatory submissions, future regulatory meetings, and outcomes of these regulatory discussions. 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,” and in our 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 BioCardia announce about PMDA consultation for CardiAMP on Dec 16, 2025?

BioCardia said PMDA will allow it to advance to a formal clinical consultation regarding CardiAMP data acceptability in Japan.

Does the PMDA clearance mean BioCardia can file for approval in Japan now?

Not yet; BioCardia can pursue a formal consultation but a positive PMDA determination is required before a Japan filing.

What clinical evidence does BioCardia cite for CardiAMP HFrEF (BCDA)?

The company cites compiled results from Phase I, II and III trials reporting improved survival, fewer major adverse cardiovascular events, and better heart function and quality of life versus controls.

How does the PMDA meeting affect BioCardia shareholders (BCDA)?

Advancing to formal consultation is a regulatory milestone that could enable a Japan submission if PMDA accepts the available data.

Are there any regulatory hurdles remaining for CardiAMP after the Dec 16, 2025 meeting?

Yes; the company states the data remain subject to ongoing regulatory discussions in Japan and the United States.