BioCardia, Inc.

BioCardia, Inc. is a U.S.-based clinical-stage cardiovascular biotherapeutics company focused on catheter-based delivery systems and cell therapy candidates for heart failure and arrhythmia-related procedures. Its platform centers on the Helix transendocardial delivery system, Morph DNA steerable introducers, and the CardiAMP autologous cell therapy program. The company also develops fusion imaging technology for cardiac biotherapeutic delivery and biopsy, including through a collaboration with CART-Tech, B.V. BioCardia currently has limited commercial revenue and is still primarily funded through equity, grants, and partnering arrangements while it advances regulatory and clinical milestones.

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1.12

— BioCardia, Inc.
	%
Cell therapy programs	10% Autologous and allogeneic cardiac cell therapy candidates being developed for heart failure and other cardiovascular indications.
Delivery systems and introducers	45% Catheter-based tools used to deliver therapies into the heart, including Helix and Morph DNA/AVANCE products.
Fusion imaging technology	15% Imaging systems and related intellectual property for guiding cardiac biotherapeutic delivery and biopsy.
Partnering and licensing	20% Development, license, distribution, and option agreements that support commercialization and provide collaboration revenue.
Clinical and regulatory services	10% Research, trial support, and regulatory development services provided to partners and for internal programs.

BioCardia sells primarily to hospitals, interventional cardiologists, electrophysiologists, and clinical trial centers...

Hospitals and cardiac procedure centersprimary
Buy delivery systems and introducers for transseptal and left-ventricular procedures because the tools support complex catheter access and therapy delivery.
Interventional cardiologists and electrophysiologistsprimary
Use Morph DNA/AVANCE and Helix-based systems to improve catheter control in mapping, ablation, biopsy, and cell/gene delivery procedures.
Clinical trial investigators and research centerssecondary
Use CardiAMP and related systems in studies because BioCardia provides devices, protocol support, and commercialization-readiness services.
Strategic development partnerssecondary
License or co-develop fusion imaging and delivery technologies to accelerate product development and market access.
Payers and reimbursement-dependent providersemerging
Influence adoption of CardiAMP because procedure reimbursement affects whether hospitals can economically deploy the therapy.

BioCardia is headquartered in the United States and its core commercial and clinical activity is centered there...

•United States is the main operating base and primary commercialization market
•Canada participates in CardiAMP clinical enrollment and evidence generation
•Japan is a key future market for potential regulatory approval and launch
•Netherlands exposure comes through the CART-Tech fusion imaging partnership
•Worldwide rights for biotherapeutic delivery expand partnering optionality
•Geography is driven more by trials and approvals than by current sales

BioCardia’s near-term strategy is to preserve liquidity while advancing its most promising clinical and commercial...

Secure additional financingshort-term

The company states current cash is not sufficient to fund planned expenditures beyond the near term, so financing is required to continue operations.

Advance CardiAMP regulatory pathwaymedium-term

Clinical and regulatory progress is the main route to future product revenue and potential commercialization in heart failure.

Commercialize Morph DNA / AVANCE productsshort-term

These FDA-cleared products are already available commercially and can generate nearer-term product revenue.

Monetize partnering and IPmedium-term

Partnerships can provide revenue, validation, and non-dilutive funding while the company remains development-stage.

BioCardia faces substantial going-concern and financing risk because management has disclosed that existing cash is not...

critical

Insufficient cash to fund operations

Management disclosed that current cash and expected financing are not enough to meet planned expenditures beyond the near term.

Scope: Development programs, overhead, and clinical trials
Materiality: high

high

Clinical and regulatory failure

The company’s value depends on trial outcomes and FDA/PMDA acceptance for CardiAMP and related programs.

Scope: CardiAMP HF, allogeneic MSC and other therapeutic candidates
Materiality: high

high

Nasdaq delisting

Non-compliance with listing requirements could reduce liquidity and impair access to capital.

Scope: Public equity financing and market confidence
Materiality: high

high

Dilution from capital raises

The company expects to rely on equity or other financing that may be highly dilutive.

Scope: Existing shareholders
Materiality: high

medium

Commercial adoption and reimbursement uncertainty

Even approved products need physician uptake and payer support to generate meaningful revenue.

Scope: CardiAMP and Morph product commercialization
Materiality: medium

Collaboration agreement revenue recognition

Can cause large swings in reported revenue despite limited underlying commercial sales

Research and development cost timing

Affects operating loss and comparability across periods

Going-concern and liquidity assessment

Important for evaluating solvency, financing needs, and disclosure risk

Equity financing and issuance costs

Can create dilution and affect net loss per share and equity balances

BioCardia, Inc.

Insufficient cash to fund operations

Clinical and regulatory failure

Nasdaq delisting

Dilution from capital raises

Commercial adoption and reimbursement uncertainty

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