BioCardia, Inc. (BCDA): History, Ownership, Mission, How It Works & Makes Money

When you look at the biotechnology sector, how do you value a company like BioCardia, Inc. (BCDA), which is pioneering cell-derived therapeutics for heart disease but reported $0 in total revenue for the third quarter of 2025? The answer isn't in sales-it's in the science, specifically their FDA Breakthrough Device Designation for the CardiAMP system, a minimally invasive cell therapy aiming to treat heart failure and refractory angina. This is a high-stakes, high-reward bet, and with a cash balance of $5.3 million as of September 30, 2025, giving them runway into Q2 2026, you need to understand exactly how their proprietary Helix delivery system works, who owns the company, and what their path to market looks like.

BioCardia, Inc. (BCDA) History

BioCardia, Inc. is a clinical-stage biotechnology company focused on cardiovascular regenerative medicine. Its current form is the result of a strategic corporate restructuring, a common path for biotech firms aiming for public market access and a focused therapeutic pipeline.

Given Company's Founding Timeline

Year established

The core technology roots trace back to Bioheart, Inc., founded in 1999. However, the current publicly traded entity, BioCardia, Inc., was effectively established in 2016 following a reverse merger with a public company, which allowed it to list on the NASDAQ exchange under the ticker BCDA.

Original location

While originally headquartered in San Carlos, California, the company's principal executive offices are now located in Sunnyvale, California.

Founding team members

The leadership team that guided the company through its critical transition and clinical development includes Peter Altman, PhD, who serves as President and CEO. Dr. Altman brought continuity from the earlier Bioheart development programs, ensuring the core mission remained intact.

Initial capital/funding

As a development-stage company, capital is defintely the lifeblood. Following the 2016 formation, a key capital infusion came from a public offering in 2017, which raised approximately $10.4 million to accelerate the CardiAMP and CardiALLO cell therapy programs.

Given Company's Evolution Milestones

Given Company's Transformative Moments

The company's trajectory has been shaped by three core strategic pivots, moving it from a device-centric firm to a precision medicine platform.

The first transformative decision was the 2016 reverse merger. This move instantly provided a public listing and concentrated resources on the high-potential cell therapy assets acquired from Bioheart, shifting the primary focus from devices to therapeutics.

Second, the firm made a critical, data-driven choice to focus its confirmatory Phase III CardiAMP Heart Failure II (HF II) trial on a specific, high-risk patient population-those with elevated biomarkers of heart stress. This is precision medicine in action.

• The original trial data showed the strongest signals in patients with elevated NTproBNP and BNP biomarkers.
• The CardiAMP HF II trial is now actively enrolling this subset, significantly increasing the probability of hitting the primary composite endpoint.

Finally, the current Q4 2025 regulatory push is a major inflection point. The CEO has stated that the next two quarters promise to be truly transformative. They are simultaneously advancing two major regulatory submissions:

• Submitting the Helix Transendocardial Delivery Catheter for FDA approval via DeNovo 510(k), which could open up the entire field of local cardiac biologic delivery.
• Holding an anticipated Q4 2025 meeting with the FDA to discuss the approvability pathway for the CardiAMP Cell Therapy System.

This dual focus-device approval plus therapy approvability-is a smart, two-pronged strategy to ensure the proprietary delivery platform is commercialized alongside the cell therapy. For a deeper look at the long-term strategic vision, you should review the Mission Statement, Vision, & Core Values of BioCardia, Inc. (BCDA).

BioCardia, Inc. (BCDA) Ownership Structure

The ownership and governance of BioCardia, Inc. are straightforward, reflecting a small-cap biotech firm where management and insiders hold a significant stake, giving them strong control over strategic decisions.

This structure means the company's direction is defintely tied to the vision of its founders and executives, but also that institutional oversight is relatively low compared to larger peers.

BioCardia, Inc.'s Current Status

BioCardia, Inc. is a publicly traded company, listed on the Nasdaq stock exchange under the ticker symbol BCDA. This status subjects the company to the rigorous reporting and compliance requirements of the Securities and Exchange Commission (SEC), including the filing of quarterly (10-Q) and annual (10-K) reports.

As of November 2025, the company is primarily focused on advancing its cell therapy pipeline, such as the CardiAMP cell therapy for heart failure, and its Helix transendocardial delivery catheter. The company reported a cash balance of $5.3 million as of September 30, 2025, following a $6.0 million financing round, which is expected to provide a cash runway into the second quarter of 2026.

BioCardia, Inc.'s Ownership Breakdown

The company's ownership structure, based on data near the end of the 2025 fiscal year, shows a high concentration of shares held by insiders and a large public float, which is typical for a clinical-stage biotechnology company with a relatively small market capitalization of approximately $13.69 million.

The significant 18.98% insider ownership demonstrates a strong alignment of interests between the company's leadership and its shareholders. The remaining 75.77% public float means the stock's price can be subject to higher volatility due to the trading activity of individual retail investors.

BioCardia, Inc.'s Leadership

The strategic direction is steered by a small, experienced leadership team focusing on clinical development and regulatory milestones. The key executives were confirmed on the Q3 2025 earnings call in November 2025.

• Peter Altman, Ph.D.: President, Chief Executive Officer (CEO), and Director. Dr. Altman is the driving force behind the company's cell therapy and device strategy, having recently expressed optimism about transformative growth in the next two quarters.
• David McClung: Chief Financial Officer (CFO). Mr. McClung oversees the company's financial health, including the management of the $6.2 million net loss reported for the nine months ended September 2025.
• Edward Gillis: Senior Vice President of Devices. He is critical for the development and regulatory submission of the Helix transendocardial delivery catheter.
• Debby Holmes-Higgin, MPH: Vice President of Clinical. She manages the ongoing clinical trials, including the actively enrolling CardiAMP HF II Phase 3 trial.

The leadership team is small and focused, which helps keep selling, general, and administrative (SG&A) expenses low, which decreased to $2.4 million for the nine months ended September 2025. For a deeper dive into the company's core principles, you can review the Mission Statement, Vision, & Core Values of BioCardia, Inc. (BCDA).

BioCardia, Inc. (BCDA) Mission and Values

BioCardia, Inc.'s mission is centered on tackling debilitating cardiovascular and pulmonary diseases using advanced cell-based therapies, reflecting a deep commitment to patient outcomes over simple incremental treatments. This purpose is defintely the cultural DNA driving their significant investment in research and development (R&D), even while the company is still pre-revenue.

You can see this commitment in their financials: R&D expenses for the nine months ended September 30, 2025, totaled $3.8 million, up from $3.0 million in the prior year, showing they are putting capital directly into their core purpose. Here's the quick math: that's a 26.7% increase in R&D spending year-over-year, which is a big signal of their long-term aspiration. For a detailed look at who is funding this, check out Exploring BioCardia, Inc. (BCDA) Investor Profile: Who's Buying and Why?

BioCardia, Inc.'s Core Purpose

The company's core purpose is to pioneer cellular and cell-derived therapeutics (like their CardiAMP® and CardiALLO™ platforms) for conditions where current treatments fall short. They focus on precision medicine, meaning they aim to identify and treat the patients most likely to benefit from their therapies.

This focus on precision is why their CardiAMP cell therapy for heart failure has received the FDA's 'Breakthrough' designation. That designation isn't given lightly; it acknowledges a therapy that may provide a substantial improvement over available treatments for a serious condition.

Official mission statement

The formal mission statement is clear and patient-focused:

• Improve the lives of patients with cardiovascular and pulmonary diseases.
• Achieve this through the development of meaningful therapeutics.

It's a simple, powerful statement. It frames every development decision-from the CardiAMP® autologous (using a patient's own cells) approach to the CardiALLO™ allogeneic (using donor cells) approach-around creating a meaningful difference for patients with unmet needs.

Vision statement

While not a single, coined phrase, the company's vision is demonstrated through its strategic goals and technology platforms. It's about enabling a new era of localized, regenerative medicine.

• Become a global leader in cellular and cell-derived therapeutics for heart and lung disease.
• Advance personalized and precision medicine strategies to maximize patient benefit.
• Enable targeted delivery of biologic agents to the heart using proprietary systems like the Helix™ transendocardial biotherapeutic delivery system.

The company is actively working toward a Q4 2025 submission for approval of the Helix™ delivery catheter, which is a key step in realizing this vision for local biologic therapy.

BioCardia, Inc. slogan/tagline

The most concise phrase that captures their work, often used in corporate communications, acts as their functional tagline:

• Advancing targeted cellular precision medicines for cardiovascular and pulmonary diseases.

This isn't just marketing fluff; it highlights the two core components of their strategy: the cellular therapeutics and the precision delivery systems. For instance, the safety data for the Helix™ system is supported by over 4,000 intramyocardial deliveries, which is a huge number that validates their delivery platform.

BioCardia, Inc. (BCDA) How It Works

BioCardia, Inc. works by developing and commercializing cell-based therapies and the specialized delivery systems needed to administer them directly into the heart muscle, aiming to regenerate damaged tissue from cardiovascular and pulmonary diseases.

The company's core value comes from its proprietary platforms-the cell therapies themselves (CardiAMP and CardiALLO) and the catheter-based delivery technology (Helix and Morph)-which together form a complete system for targeted biotherapeutic delivery.

BioCardia, Inc.'s Product/Service Portfolio

You need to see the specific products that drive the company's value, even if they are still in clinical trials. Here's the quick math: the potential commercial value of the delivery systems is immediate, but the real long-term payoff is in the cell therapies, particularly the CardiAMP system with its FDA Breakthrough Designation. To be fair, the company is still a clinical-stage entity, so revenue is not the primary metric; pipeline progression is.

BioCardia, Inc.'s Operational Framework

The company's operational process is centered on advancing its clinical pipeline and securing regulatory approvals, which is typical for a clinical-stage biotech. They create value by moving their investigational new drugs (INDs) closer to commercialization, which de-risks the asset and increases its valuation.

For the nine months ended September 30, 2025, BioCardia spent $3.8 million on Research and Development (R&D), a clear indicator of this focus.

• Cell Sourcing and Processing: For CardiAMP, they use a proprietary system to process a patient's own bone marrow cells (autologous) to ensure a high concentration of therapeutic cells for injection.
• Targeted Delivery: The proprietary Helix delivery catheter is the key tool; it allows a cardiologist to inject the cell therapy directly into the damaged heart muscle, maximizing local effect and minimizing systemic side effects.
• Clinical and Regulatory Advancement: The main operational output right now is clinical data. They are actively enrolling patients in the 250-patient, randomized, placebo-controlled CardiAMP Heart Failure II trial. Also, they are preparing for significant regulatory submissions, including a request for an FDA meeting on CardiAMP approvability and a DeNovo 510(k) submission for the Helix system, both expected in the fourth quarter of 2025.
• Financial Runway Management: The company ended Q3 2025 with a cash balance of $5.3 million, which is expected to provide a runway into the second quarter of 2026 without additional financing. This is a tight window, so every R&D dollar must count.

BioCardia, Inc.'s Strategic Advantages

The competitive edge in regenerative medicine is almost always a mix of intellectual property and clinical validation. BioCardia has a defintely strong hand in the delivery mechanism, which is a critical bottleneck for many cell therapies.

• Integrated Platform IP: They own both the therapeutic (CardiAMP) and the delivery system (Helix/Morph). This vertical integration is powerful because it ensures the cell therapy is delivered optimally, a significant challenge for competitors.
• FDA Breakthrough Designation: The CardiAMP system has this designation for heart failure, which can expedite the development and review process, potentially shortening the path to market in the US.
• Clinical Data Consistency: Prior trials for CardiAMP have shown consistent results supporting safety and patient benefit, especially in the target population with elevated biomarkers of heart stress. This consistent data reduces risk for future investors and regulators.
• Global Regulatory Head Start: BioCardia is strategically targeting the Japanese market, having received a positive preliminary clinical consultation from the Pharmaceutical and Medical Devices Agency (PMDA) on CardiAMP, which could lead to a faster path to commercialization there.

If you want to dive deeper into the balance sheet, especially how that $6.2 million nine-month net loss compares to their cash burn, you should read Breaking Down BioCardia, Inc. (BCDA) Financial Health: Key Insights for Investors.

BioCardia, Inc. (BCDA) How It Makes Money

BioCardia, Inc. is a clinical-stage biotherapeutic developer, meaning its primary financial engine is not commercial product sales but rather capital raised through equity financing and non-dilutive funding like grants and partnerships to advance its cell therapy and delivery system pipeline. The company is currently investing heavily in its clinical trials-specifically the CardiAMP Heart Failure II Phase 3 trial-to create future revenue streams from its proprietary cell therapies and the Helix transendocardial delivery catheter.

BioCardia, Inc.'s Revenue Breakdown

The company's revenue remains nominal as it is pre-commercial. For the third quarter of 2025, BioCardia reported $0 in revenue, which is typical for a biotech firm focused on late-stage clinical development. Analyst projections for the full fiscal year 2025 revenue are approximately $51,000, reflecting minimal, non-core income.

This revenue structure shows the company is defintely not a sales-driven business yet; its value is tied to clinical and regulatory milestones, not current sales volume. You need to look past the top line here.

Business Economics

The economics of BioCardia are defined by a high-burn, high-potential model common in the biotech sector, where the primary cost is research and development (R&D) and the primary financial risk is the cash runway. The company has essentially a 0% gross margin on commercial product sales because there are no sales to measure against the cost of goods sold (COGS). The entire business operates on a negative operating margin.

• Capital Dependence: The business is entirely reliant on raising capital, evidenced by the $6.0 million financing closed in September 2025, which provided net proceeds of $5.2 million.
• Value Creation: The true economic value is created by achieving regulatory milestones, such as the planned DeNovo 510(k) submission for the Helix catheter in Q4 2025, and advancing the CardiAMP HF II Phase 3 trial. These events are the catalysts for future commercial revenue and partnership deals.
• Cost Structure: The vast majority of spending is on R&D for clinical trials. Selling, general, and administrative (SG&A) expenses are tightly managed, decreasing to $0.6 million in Q3 2025 from $0.8 million in the prior year quarter.

The core economic fundamental is simple: spend now on R&D to prove efficacy, then monetize through commercialization or a partnership later. You can't analyze this business with a traditional price-to-earnings ratio.

BioCardia, Inc.'s Financial Performance

As of November 2025, the financial performance shows a company diligently managing its burn rate while pushing critical clinical programs forward. The focus is on cash management and reducing the net loss year-over-year, even with increased trial activity.

• Cash Position: The company reported a cash balance of $5.3 million as of September 30, 2025, which is projected to provide a cash runway into the second quarter of 2026, exclusive of any further capital raises.
• Net Loss: The net loss for the third quarter of 2025 was $1.5 million, a reduction from $1.7 million in the same period a year ago. However, the nine-month net loss for 2025 increased to $6.2 million, up from $5.7 million, reflecting the increased R&D investment.
• R&D Investment: Research and development expenses for the nine months ended September 30, 2025, were $3.8 million, an increase from $3.0 million in the comparable period, driven by closeout activities for the prior trial and enrollment in the new CardiAMP HF II trial.
• Operational Cash Burn: Net cash used in operations for the nine months ended September 2025 was $4.9 million, a slight decrease from $5.5 million in the same period of 2024.

The immediate action for you, as a decision-maker, is to monitor the Q4 2025 regulatory submissions-the Helix catheter DeNovo 510(k) and the FDA approvability meeting for the CardiAMP System. These are the real financial drivers. Breaking Down BioCardia, Inc. (BCDA) Financial Health: Key Insights for Investors

BioCardia, Inc. (BCDA) Market Position & Future Outlook

BioCardia, Inc. is positioned as a clinical-stage specialist in cardiac cell therapy and delivery, with its future trajectory hinging on a series of critical regulatory and clinical milestones expected by the end of 2025 and early 2026. The company's core strategy is to validate its proprietary Helix Transendocardial Delivery System and advance its two lead cell therapy candidates, which, if successful, could disrupt the chronic heart failure and chronic myocardial ischemia markets.

The company's financial position reflects its development stage, reporting a net loss of $1.5 million for the third quarter of 2025, a slight improvement from the $1.7 million loss in Q3 2024. With a cash balance of $5.3 million as of September 30, 2025, the current cash runway is expected to sustain operations only into the second quarter of 2026, making the pursuit of non-dilutive funding an immediate priority.

Competitive Landscape

In the regenerative medicine space, competition is less about current revenue share-BioCardia's projected full-year 2025 revenue is only $51,000-and more about the strength of the underlying platform technology. BioCardia's differentiation comes from its unique delivery system, which is crucial for the safe and precise injection of cells into the heart muscle. Honestly, everyone in this niche is fighting for clinical validation right now.

Opportunities & Challenges

The near-term outlook is a balance of high-impact regulatory opportunities and classic biotech funding risks. You need to watch the regulatory calendar defintely, as those Q4 2025 submissions are the biggest catalysts.

Industry Position

BioCardia's industry standing is that of a specialized, high-potential clinical-stage company. They are not a market share leader in revenue, but a technological leader in the delivery of cell therapies for the heart, which is a massive unmet need.

• The Helix system is a key differentiator, providing a minimally invasive, patented method for targeted cell delivery that competitors lack, which is why it's being developed as a standalone product.
• The dual-product strategy-autologous (CardiAmp) and allogeneic (CardiALLO)-hedges their clinical bets, targeting both personalized and off-the-shelf treatment paradigms.
• Nine-month Research and Development (R&D) expenses for 2025 reached $3.8 million, showing a clear commitment to advancing the pipeline despite the small size.

To be fair, the company is small, but its focus on both the cell (the therapeutic) and the catheter (the delivery tool) gives it two shots on goal in a multi-billion-dollar market. You can read more about the institutional interest in this space by Exploring BioCardia, Inc. (BCDA) Investor Profile: Who's Buying and Why?

Next step: Investor Relations: Prepare a detailed risk-mitigation plan for the Q2 2026 cash runway deadline by the end of the month.