BioCardia, Inc. (BCDA): Business Model Canvas [Dec-2025 Updated]

You're trying to map out the strategy for BioCardia, Inc. (BCDA) right now, and frankly, it's a high-stakes game focused entirely on clinical success. As an analyst who's seen this movie before, the model is clear: deliver a novel treatment for ischemic heart failure using their proprietary Helix delivery system, but the near-term risk is real. Here's the quick math: with operating expenses running near $6.2 million over the first nine months of 2025 (R&D plus SG&A) against only $5.3 million in cash at the end of Q3, every milestone matters. This Business Model Canvas distills exactly how BioCardia, Inc. is balancing that massive value proposition against their current cash runway and regulatory hurdles; you need to see the details below.

BioCardia, Inc. (BCDA) - Canvas Business Model: Key Partnerships

You're looking at the essential alliances that keep BioCardia, Inc. moving forward, especially as they push for regulatory milestones in late 2025. These aren't just names on a slide; they represent critical access to technology, funding, and patient care pathways.

Clinical Trial Sites

The active enrollment in the Phase 3 CardiAMP HF II confirmatory trial depends directly on the network of clinical sites. As of November 2025, the trial is accelerating in the United States. You should note the specific site activity:

• The CardiAMP Heart Failure II Phase 3 trial has four sites actively enrolling patients.
• Additional sites are currently in the onboarding process to expand capacity.
• Henry Ford Health announced enrolling its first patient in this pivotal trial on November 10, 2025.

Maryland Stem Cell Research Fund for Program Support

Program support from the Maryland Stem Cell Research Fund (MSCRF) is a crucial, non-dilutive resource for the CardiAMP clinical development for heart failure. This funding validates the science and helps cover operational costs for the trial sites located in Maryland. Here's a look at the fund's recent activity, which shows the environment BioCardia operates in:

The MSCRF Clinical grant program specifically supports human stem-cell based clinical trials, with applicants able to request up to $1,000,000 for up to 24 months. This support is vital, especially when considering BioCardia's Q3 2025 cash balance stood at $5.3 million.

CART-Tech for Heart 3D Fusion Imaging Technology

The exclusive development and commercialization agreement with CART-Tech, B.V., announced on August 13, 2025, is a major technology partnership. This deal centers on the Heart3D Fusion Imaging system, which fuses 2D x-ray images with annotated 3D anatomical heart models from MRI/CT scans to improve procedural precision.

The commercial terms of this partnership define BioCardia's market access:

• BioCardia secured exclusive worldwide distribution rights for biotherapeutic delivery procedures.
• BioCardia secured exclusive distribution rights in the United States for cardiac biopsy procedures.
• CART-Tech licensed global exclusive rights to BioCardia intellectual property for cardiac resynchronization therapy.

Management has attached a significant revenue potential to this technology; they estimate a single approved biologic therapy using this system could generate $100 million in annual revenue if it becomes the standard of care. Clinical advancement for this technology is targeted for 2026.

Centers for Medicare and Medicaid Services (CMS) for Reimbursement

Securing reimbursement coverage from Centers for Medicare & Medicaid Services (CMS) is essential for patient access and trial viability. CMS approval for reimbursement coverage for the confirmatory Phase III Heart Failure Study was announced in March 2024. This coverage applies to the CardiAMP cell therapy program.

For the CardiAMP cell therapy procedure in chronic myocardial ischemia, reimbursement is established:

• Reimbursement code used is C9782.
• This code covers both treated and controlled patients in the study.
• For Q2 2025, the reported Medicare reimbursement amount was $17,500 for both treated and control patients for this therapy.

This reimbursement structure helps offset the costs associated with the clinical trial, which saw Research and Development expenses reach $3.8 million for the nine months ended September 2025.

Strategic Distribution Partners (future focus)

While the CART-Tech agreement provides immediate, exclusive distribution rights for specific procedures globally and in the U.S., the future focus involves expanding commercial reach for the Helix biotherapeutic delivery system and the cell therapies themselves. The company anticipates an FDA submission for the Helix system via DeNovo 510(k) in Q3 2025. Success here will necessitate establishing a broader network of commercial distribution partners beyond the initial technology agreement.

BioCardia, Inc. (BCDA) - Canvas Business Model: Key Activities

You're looking at the core operational drivers for BioCardia, Inc. as of late 2025. These activities are what the company spends its time and capital on to move its pipeline forward.

Conducting CardiAMP HF II Phase 3 clinical trial

The CardiAMP HF II trial is the central focus for the lead autologous cell therapy, BCDA-01. This is a 250-patient randomized, multicenter, procedure placebo-controlled study targeting patients with ischemic heart failure with reduced ejection fraction (HFrEF) who have elevated NTproBNP.

Key operational metrics related to the trial include:

• 4 world-class centers actively enrolling patients as of the third quarter of 2025.
• First patient enrollment announced at Henry Ford Health on November 10, 2025.
• First patient enrollment announced at the University of Wisconsin School of Medicine and Public Health on November 25, 2025.
• The primary composite endpoint consists of all-cause death, nonfatal major adverse cardiac events (MACCE), and a validated quality of life measure.

Preparing FDA and PMDA regulatory submissions

BioCardia, Inc. is executing a dual-track regulatory strategy for its therapeutic platforms. The Helix Transendocardial Delivery System is targeted for a DeNovo 510(k) submission to the FDA, while the CardiAMP cell therapy seeks approval pathways in both the U.S. and Japan.

Regulatory milestones targeted for late 2025 include:

• Requesting a meeting with the FDA on the approvability of the CardiAMP system in the fourth quarter of 2025.
• Anticipating an in-person clinical consultation with Japan's PMDA in mid-fourth quarter 2025.
• Targeting a submission for the Helix system via DeNovo 510(k) in the fourth quarter of 2025.

The Helix system submission is supported by its performance in twelve cell and gene therapy clinical studies, which involved more than 4,000 intramyocardial deliveries. The CardiAMP cell therapy already holds an FDA Breakthrough Designation.

Research and development (R&D) of cell therapies

R&D activities are directly tied to advancing the pipeline, including the ongoing enrollment and closeout activities for prior trials and advancement of other candidates like BCDA-02 for chronic myocardial ischemia.

Here's how R&D expenses trended through the first nine months of 2025:

For the BCDA-02 program, top-line results at six months showed that 60% of patients demonstrated substantial improvements in both exercise tolerance and angina reduction. Previous Q2 2025 data for this program cited an average increase in exercise tolerance of 107-second and an 82% reduction in angina episodes.

Protecting proprietary delivery system intellectual property

Protecting the delivery technology is key, as the Helix system enables all three cardiac clinical stage product candidates. The company secured new intellectual property protection for its delivery catheter systems.

• A new US patent for biotherapeutic delivery catheter systems was granted (reported in Q2 2025).
• Specific patent numbers cited include U.S. 12,311,127 and Japan 7641330.

Securing non-dilutive funding for CardiALLO program

The CardiALLO allogeneic mesenchymal stem cell therapy (BCDA-03) is a separate platform where the company is actively seeking external, non-repayable capital to support its development.

The expectation for clarity on this funding stream is set for the first quarter of 2026.

The September 2025 financing of $6.0 million, with net proceeds of $5.2 million, is actively supporting the Helix submission and the CardiAMP approvability discussions, while the company's cash balance on September 30, 2025, stood at $5.3 million, providing runway into the second quarter of 2026.

Finance: draft 13-week cash view by Friday.

BioCardia, Inc. (BCDA) - Canvas Business Model: Key Resources

The core of BioCardia, Inc.'s business model as of late 2025 rests on its intellectual property, proprietary medical devices, and clinical validation of its cell therapies.

Financial Position as of September 30, 2025:

• Cash balance at the end of Q3 2025 was reported as $5.3 million.
• This cash on hand was expected to provide runway into the second quarter 2026 without needing additional financing.
• The company closed a $6.0 million financing in September 2025, resulting in net proceeds of $5.2 million.

Proprietary Technology Platforms:

• Proprietary Helix™ Transendocardial Delivery Catheter: This system has been used in more than 400 clinical procedures. BioCardia planned to submit the Helix Transendocardial Delivery System to the FDA as a DeNovo 510(k) application in the fourth quarter of 2025.
• CardiAMP® Cell Therapy Platform: This platform has received FDA Breakthrough Therapy Designation for the treatment of ischemic heart failure with reduced ejection fraction (HFrEF). The cell processing platform component is already approved in Japan for orthopedic applications.
• CardiALLO™ Cell Therapy Platform: The low-dose cohort for this program completed enrollment with no treatment-emergent adverse events reported.

The Key Resources are summarized below with supporting clinical and financial data:

Clinical Data Package Supporting CardiAMP Efficacy:

• The CardiAMP roll-in cohort showed an average 80-second increase in exercise tolerance at six months.
• The same cohort demonstrated an 82% mean reduction in angina episodes at six months.
• In the original CardiAMP HF Trial, the composite endpoint, which included all-cause death, nonfatal major adverse cardiac events, and quality of life, was statistically significant for patients with elevated NT-proBNP with a p-value of 0.02.
• The CardiAMP Heart Failure II confirmatory Phase 3 trial was actively enrolling at four centers as of late 2025.

BioCardia, Inc. (BCDA) - Canvas Business Model: Value Propositions

You're looking at the core reasons why a physician or patient would choose BioCardia, Inc.'s platform over the standard of care for ischemic heart failure. It's all about offering a tangible benefit where current optimized medical therapy falls short.

The primary value proposition centers on a novel cell therapy for ischemic heart failure with reduced ejection fraction (HFrEF). This isn't a replacement for existing Guideline-Directed Medical Therapy (GDMT); it's an add-on for patients who still show signs of heart stress. The ongoing CardiAMP HF II Phase 3 trial is testing this autologous therapy in a 250-patient, randomized, placebo-controlled design.

The delivery mechanism itself is a key differentiator. It's a minimally invasive, precise cardiac delivery system, the Helix biotherapeutic delivery catheter. This system is being submitted for standalone approval via a DeNovo 510(k) in Q3 2025. The precision matters; preclinical use with Heart3D fusion imaging required only 30 minutes to perform ten intramyocardial deliveries.

The potential to move the needle on hard outcomes is significant. For HFrEF patients with elevated NT-proBNP biomarkers-which was 50% of the enrolled patients in the earlier trial-the two-year data showed a 47% relative risk reduction in heart death equivalents (all-cause death, heart transplant, or LVAD). Also, the therapy targets microvascular dysfunction, which is a root cause for many patients.

Here's a quick look at how the clinical data supports the mortality and MACE reduction claims, alongside some relevant financial context from the nine months ended September 30, 2025:

This therapy is explicitly for patients with limited remaining options. HFrEF affects over 1 million patients in the US, and the annual mortality rate is around 10% even with the newest medicines. BioCardia, Inc. is positioning this as a durable benefit, as the improvements seen at two years suggest a single dose offers lasting effects.

The business model supports two distinct pathways to address this unmet need, offering flexibility:

• Autologous (Patient's Own) Cell Options: The flagship CardiAMP (BCDA-01) uses the patient's own bone marrow cells, processed at a CLIA laboratory partner.
• Allogeneic (Off-the-Shelf) Cell Options: The CardiALLO™ (BCDA-03) program uses donor cells, which has advantages for patients who might not qualify for autologous collection or for broader, faster deployment. The low-dose cohort of 20 million cells in the Phase 1/2 trial was completed with no treatment-emergent adverse events.

Finance: draft 13-week cash view by Friday.

BioCardia, Inc. (BCDA) - Canvas Business Model: Customer Relationships

The customer relationships for BioCardia, Inc. (BCDA) center on highly engaged, milestone-driven interactions with clinical partners, regulatory bodies, and the investment community to fund and advance its cell therapy platform.

High-touch collaboration with Principal Investigators

Collaboration with Principal Investigators (PIs) is intensive, directly supporting the ongoing CardiAMP HF II phase 3 confirmatory trial. This relationship is critical for data generation and site performance.

• CardiAMP HF II trial is actively enrolling patients in the United States.
• Enrollment momentum included four sites actively enrolling as of Q3 2025.
• A fifth site activation was imminent or expected within a few weeks of the Q3 2025 report.
• Henry Ford Health initiated enrollment in the trial.
• The prior CardiAMP HF trial involved 115 randomized patients for the primary outcome data freeze presented in March 2025.

Intensive regulatory engagement with FDA and PMDA

Engagement is focused on achieving key regulatory milestones for both the CardiAMP cell therapy and the Helix delivery system, leveraging the therapy's FDA Designated Breakthrough status.

The company reported a positive preliminary clinical consultation with Japan's Pharmaceutical and Medical Device Agency (PMDA) in September 2025.

Investor relations for continuous capital raising

Investor relations activities are geared toward securing necessary funding to bridge development gaps, as evidenced by recent financing actions.

• BioCardia announced a public offering in September 2025 with potential gross proceeds up to $12 million.
• The initial closing of the September 2025 offering generated gross proceeds of $6 million.
• The potential for an additional $6 million existed upon full exercise of accompanying short-term warrants.
• Net proceeds received from the September 2025 financing totaled $5.2 million.
• The cash balance on September 30, 2025, was $5.3 million.
• Cash on hand as of June 30, 2025, was $980,000.

The financial performance driving these relations included a net loss of $1.5 million for the three months ended September 2025.

Direct support for clinical trial sites

Direct support encompasses the operational and financial backing required to keep trials moving, which impacts the relationship with the sites executing the studies.

Net cash used in operations for the nine months ended September 2025 decreased to $4.9 million, compared to $5.5 million for the same period in 2024. Research and development expenses for the nine months ended September 2025 increased to $3.8 million, up from $3.0 million for the nine months ended September 2024, reflecting the start of the CardiAMP HF II Trial enrollment.

BioCardia, Inc. (BCDA) - Canvas Business Model: Channels

You're looking at how BioCardia, Inc. moves its value proposition-the cell therapies and delivery systems-to the market, which, as of late 2025, is almost entirely focused on generating the necessary clinical data for regulatory approval.

Global clinical trial network for data generation

The primary channel for data generation involves a network of clinical sites executing the ongoing and completed trials. This network is crucial for validating the safety and efficacy of the CardiAMP® Cell Therapy System and the Helix™ Transendocardial Delivery Catheter. The data collected is the product being channeled toward regulators and future commercial partners.

• Three completed clinical trials involved a total of 178 ischemic heart failure patients.
• The confirmatory Phase 3 CardiAMP® HF II trial is actively enrolling in the United States.
• As of Q1 2025, the CardiAMP HF II Trial was underway with three active enrollment sites, with a fifth site expected to be activated soon.
• The data supporting the Helix system draws from more than 4,000 intramyocardial deliveries across various studies, including those under CE-mark in Europe.
• The low-dose cohort of the Phase 1/2 clinical trial was completed in the first quarter of 2025.

Direct regulatory submissions (FDA, PMDA)

BioCardia, Inc. is channeling its clinical evidence directly to the U.S. Food and Drug Administration (FDA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) to secure market authorization. This is a direct-to-regulator channel, bypassing traditional commercial sales channels for now. The company has an FDA Breakthrough Therapy Designation for CardiAMP Cell Therapy for HFrEF, granted in April 2025.

Here's a look at the targeted regulatory channel activities for late 2025:

The company reported a positive preliminary clinical consultation with Japan's PMDA in September 2025.

Future specialized hospital and cardiology center sales

Commercial sales channels are not yet active, as the company is pre-revenue from product sales. Analyst projections for the full-year 2025 revenue point to a total of $51,000, with Q4 2025 estimates at $25,500, reflecting the development stage. Success in regulatory submissions is the key catalyst expected to unlock future sales channels through distribution partners and direct engagement with specialized centers.

The Helix catheter's superior therapeutic agent retention compared to other delivery approaches is a key value point for future hospital adoption. Furthermore, the CardiAMP Cell Therapy for Heart Failure has received Medicare reimbursement of $17,500 for both treated and control patients in the trial setting.

Academic and medical conference presentations

Presentations at major medical forums serve as a critical channel to disseminate clinical data to key opinion leaders, physicians, and researchers, influencing future adoption and standard-of-care discussions. This is how BioCardia, Inc. channels its scientific credibility into the medical community.

• Two-year results from the Phase 3 CardiAMP HF Trial were presented as a late-breaking clinical trial at the American College of Cardiology's Annual Scientific Sessions on March 30, 2025.
• The company is working toward a peer-reviewed publication of BCDA-02 data targeted for Q1 2026.

Finance: review Q3 2025 net cash used in operations of $1.5 million against the current cash balance of $5.3 million to confirm runway into Q1 2026.

BioCardia, Inc. (BCDA) - Canvas Business Model: Customer Segments

Ischemic heart failure patients with reduced ejection fraction (HFrEF)

• Targeted population in the U.S. and the EU is roughly 2 million ischemic HFrEF patients with NYHA Class II and III symptoms.
• The confirmatory Phase 3 CardiAMP HF II trial is a 250-patient, randomized, multicenter, procedure placebo-controlled study.
• The initial CardiAMP HF study included 115 randomized patients.
• Eligibility is anchored to elevated NT-proBNP, a biomarker-defined population.
• The Medicare reimbursement rate for the indication under investigation is $17,500 for both treated and control patients.

Interventional Cardiologists and Cardiac Surgeons

Cardiologists provided care to over 51 million Medicare beneficiaries in 2023.

Regulatory agencies (FDA, Japan PMDA)

• Planned DeNovo 510(k) submission for the Helix transendocardial delivery catheter to the FDA targeted for Q3 2025.
• FDA meeting on CardiAMP HF approvability targeted for Q4 2025.
• In-person PMDA clinical consultation for CardiAMP anticipated in mid-Q4 2025, potentially enabling approval submission for the Cardium system in Japan.
• The Helix system has over 4,000 intramyocardial deliveries including studies under CE-mark in Europe.

Institutional investors and biotech venture funds

• Institutional ownership of BioCardia stock was 20.57%.
• Market Capitalization as of December 3, 2025, was $15.070 M.
• Gross proceeds from a September 2025 public offering were expected to be $6 million, with net proceeds of $5.2 million.
• Specific institutional holdings from the previous two years included CM Management LLC at $190K, Brown Advisory Inc. at $90K, Geode Capital Management LLC at $68K, and Cetera Investment Advisers at $40K.

BioCardia, Inc. (BCDA) - Canvas Business Model: Cost Structure

You're looking at the core expenditures for BioCardia, Inc. as they push their cell therapies through late-stage development as of late 2025. For a clinical-stage biotech, the cost structure is heavily weighted toward the science and the trials, not sales.

The primary cost drivers are clearly in the R&D bucket, which is typical when you're pre-commercial. Here's the quick math on the major reported expenses for the nine months ended September 30, 2025:

The net loss for the nine months ended September 2025 was $6.2 million, which is higher than the $5.7 million loss for the same period in 2024, reflecting the increased R&D spend associated with trial progression. The company ended Q3 2025 with $5.3 million in cash, which they projected provided runway into the second quarter of 2026 without additional financing.

When breaking down the specific components you asked about, you have to look inside the main buckets, as BioCardia, Inc. doesn't report these as separate line items in their summary filings. Still, we can map the activities to the costs:

• Clinical trial management and enrollment costs: Included within the $3.8 million R&D expense, specifically driven by the closeout of the CardiAMP HF Trial and the start of enrollment in the CardiAMP HF II trial.
• Patent maintenance and legal fees: These are generally captured within SG&A, which was $2.4 million for nine months 2025. The decrease in SG&A was due to lower professional services.
• Manufacturing and quality control for cell therapies: For a clinical-stage company with no reported revenue in Q3 2025, these costs are embedded within R&D, as they relate to producing the therapy for ongoing trials, not commercial sales.

You can see the cost allocation trend in the quarterly data too, just to get a feel for the burn rate:

The R&D spend for the third quarter alone was $936,000. The SG&A for that same quarter was $0.6 million. Honestly, for a company at this stage, the cost structure is a direct reflection of clinical progress and regulatory momentum.

BioCardia, Inc. (BCDA) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of BioCardia, Inc. (BCDA) as of late 2025, and honestly, it's what you'd expect for a company deep in late-stage clinical development. The current revenue picture is dominated by capital raises rather than product sales, which is a key dynamic to understand for valuation.

The minimal projected 2025 revenue, based on analyst consensus, sits at approximately $51,000. To be fair, the actual reported revenue for the third quarter of 2025 was $0, matching expectations for a company focused on clinical advancement rather than immediate commercialization.

Future product sales from the CardiAMP and Helix systems are the long-term goal, but as of Q3 2025, the company reported no revenue from collaboration agreements. The near-term focus is clearly on achieving regulatory milestones to unlock those future sales streams.

The most concrete financial inflow in the recent period comes from equity financing. In September 2025, BioCardia, Inc. closed a public offering that brought in $6.0 million in gross proceeds. The net proceeds from this specific financing totaled $5.2 million. This offering was structured as shares and warrants, with the potential for an additional $6.0 million if all warrants were exercised, making the total potential raise up to $12.0 million.

Here's a quick look at the key financial components impacting the revenue side as of the third quarter of 2025:

Regarding non-dilutive funding, while the company is actively pursuing it, the current revenue stream relies on past support and future expectations. We know the CardiAMP Heart Failure Trial has been supported financially by the Maryland Stem Cell Research Fund and the Center for Medicare and Medicaid Services (CMS). Management is also actively seeking non-dilutive funding for the CardiALLO program, with expectations for clarity in the first quarter of 2026.

You should keep an eye on these potential non-dilutive sources, as they represent crucial, non-dilutive cash inflows that can significantly extend the runway without impacting shareholder equity:

• Anticipated non-dilutive funding for CardiALLO HF in Q1 2026.
• Past financial support from CMS for patient research costs.
• Past support from the Maryland Stem Cell Research Fund.

Finance: draft 13-week cash view by Friday.