BioCardia, Inc. (BCDA) Bundle
A Brief History of BioCardia, Inc. (BCDA)
Company Overview
BioCardia, Inc. (BCDA) is a biotechnology company focused on developing cardiovascular regenerative therapies. Founded in 2004, the company specializes in treatments that enhance the heart's healing process following injury, such as myocardial infarction.
Key Milestones
- 2004: BioCardia, Inc. is established.
- 2014: The company launched its first clinical trial, testing the CardiAMP cell therapy.
- 2019: BioCardia completed a successful Phase 2b clinical trial for its CardiAMP therapy.
- 2021: The company expanded its R&D efforts, focusing on ischemic heart disease.
- 2022: BioCardia announced a partnership aimed at accelerating development and commercialization of CardiAMP.
Financial Performance
BioCardia, Inc. is publicly traded on the NASDAQ under the ticker symbol BCDA. As of the end of Q3 2023, the company's market capitalization stood at approximately $31 million. The following table summarizes key financial metrics for BioCardia over recent fiscal years:
| Fiscal Year | Revenue ($ million) | Net Income ($ million) | Total Assets ($ million) | Total Liabilities ($ million) |
|---|---|---|---|---|
| 2020 | 0.12 | -5.21 | 5.78 | 2.52 |
| 2021 | 0.15 | -6.34 | 6.02 | 2.15 |
| 2022 | 0.08 | -8.76 | 5.54 | 2.90 |
| 2023 (Q3) | 0.05 | -4.50 | 5.25 | 3.10 |
Research and Development
BioCardia's primary focus has been on its CardiAMP cell therapy, which utilizes autologous bone marrow-derived cells. The therapy targets patients with heart failure due to ischemic heart disease. Key statistics from their recent clinical trials include:
| Trial Phase | Participants | Primary Endpoint Success Rate | Adverse Events |
|---|---|---|---|
| Phase 2a | 78 | 65% | 15% |
| Phase 2b | 150 | 72% | 12% |
Partnerships and Collaborations
BioCardia has engaged in various partnerships to enhance its research capabilities and market reach. Notable collaborations include:
- Collaboration with the University of California, San Francisco for research on cell therapy applications.
- Partnership with a leading contract research organization to facilitate clinical study management.
Regulatory Milestones
BioCardia received several regulatory approvals for its clinical trials, including:
- FDA approval for its investigational new drug application (IND) for CardiAMP in 2016.
- Fast Track designation for CardiAMP from the FDA in 2020.
Current Developments
As of October 2023, BioCardia is preparing to advance its CardiAMP therapy to Phase 3 trials, with funding initiatives aimed at raising up to $10 million for further research and development. The company reported a cash balance of $4.4 million as of September 30, 2023, which is allocated towards its ongoing clinical trials and operational expenses.
A Who Owns BioCardia, Inc. (BCDA)
Ownership Structure
BioCardia, Inc. (BCDA) is publicly traded and has a diverse ownership structure, including institutional investors, individual shareholders, and company insiders. As of the latest filings, the distribution of ownership is as follows:
| Owner Type | Ownership Percentage (%) | Number of Shares |
|---|---|---|
| Institutional Investors | 45.3% | 8,437,000 |
| Insider Ownership | 15.8% | 2,943,000 |
| Retail Investors | 38.9% | 7,292,000 |
Major Shareholders
The following individuals and institutions hold significant stakes in BioCardia, Inc.:
| Shareholder | Shares Owned | Ownership Percentage (%) |
|---|---|---|
| BlackRock, Inc. | 1,200,000 | 6.5% |
| Vanguard Group, Inc. | 1,000,000 | 5.4% |
| John Doe (CEO) | 500,000 | 2.7% |
| Jane Smith (CFO) | 400,000 | 2.1% |
| XYZ Capital | 600,000 | 3.2% |
Recent Transactions
The following table provides insights into recent transactions affecting ownership:
| Date | Transaction Type | Shares Traded | Price per Share ($) |
|---|---|---|---|
| 2023-10-10 | Purchase | 200,000 | 3.50 |
| 2023-09-15 | Sale | 150,000 | 4.00 |
| 2023-08-05 | Purchase | 100,000 | 3.75 |
Market Capitalization
As of the latest market data, BioCardia, Inc. has a market capitalization of approximately:
- $45 million
Stock Performance
The stock performance over the past year has reflected volatility, with the following statistics:
| Metric | Value |
|---|---|
| 52-week High ($) | 5.25 |
| 52-week Low ($) | 2.10 |
| Current Price ($) | 4.50 |
| Price-to-Earnings Ratio | N/A |
BioCardia, Inc. (BCDA) Mission Statement
Corporate Overview
BioCardia, Inc., incorporated in 2005, is a clinical-stage regenerative medicine company specializing in the development of innovative cell therapies to treat cardiovascular diseases. The company’s mission is to improve patient outcomes through the advancement of landmark regenerative therapies that are both transformative and accessible.
Strategic Objectives
BioCardia aims to:
- Develop effective cell-based therapies for heart diseases.
- Enhance patient access to cutting-edge treatments.
- Collaborate with leading healthcare institutions for clinical trials.
- Drive innovation in the field of regenerative medicine.
Recent Financial Data
| Year | Total Revenue | Net Loss | Cash and Cash Equivalents | Outstanding Shares |
|---|---|---|---|---|
| 2020 | $2.1 million | $(6.1 million) | $3.9 million | 14.2 million |
| 2021 | $1.8 million | $(6.4 million) | $6.7 million | 16.5 million |
| 2022 | $0.5 million | $(7.2 million) | $3.4 million | 19.1 million |
| 2023* | $0.8 million | $(5.9 million) | $2.9 million | 20.3 million |
Clinical Focus Areas
BioCardia concentrates on the following therapeutic areas:
- Myocardial Infarction
- Heart Failure
- Chronic Ischemic Heart Disease
- Cardiomyopathy
Key Products and Services
The company has developed several key products, including:
- CardiAMP - A cell therapy designed for chronic myocardial ischemia.
- CardiALLO - A product addressing heart failure.
- Clinical Trials - Ongoing research studies focused on regenerative therapies.
Partnerships and Collaborations
BioCardia has established partnerships with:
- Academic institutions
- Healthcare systems
- Regenerative medicine organizations
- Pharmaceutical companies
Market Position and Impact
As of 2023, the global market for regenerative medicine is valued at approximately $28 billion and is expected to grow at a compound annual growth rate (CAGR) of 10.5% from 2023 to 2030.
Future Directions
BioCardia plans to:
- Expand clinical trials for existing products.
- Develop new therapies targeting additional cardiac conditions.
- Increase engagement with healthcare providers and patients.
With its ongoing commitment to innovation, BioCardia strives to remain at the forefront of regenerative medicine.
How BioCardia, Inc. (BCDA) Works
Overview of BioCardia, Inc.
BioCardia, Inc., trading under the ticker symbol BCDA, focuses on developing regenerative medicine therapies for cardiovascular disease. The company specializes in cell-based therapies aimed at repairing the heart.
Key Technologies and Products
- Phase 3 Clinical Trials: BioCardia's lead product, AlloRestore, is focused on treating ischemic heart failure.
- CardiAMP: A cell therapy designed for patients with heart failure.
- CardiAQ: A catheter technology that facilitates heart-related interventions.
Financial Data
As of the third quarter of 2023, BioCardia reported the following financial figures:
| Financial Metric | Amount (USD) |
|---|---|
| Revenue | $1.2 million |
| Net Loss | $(8.7) million |
| Cash Reserves | $10 million |
| Operating Expenses | $(9 million) |
| Total Assets | $24 million |
| Total Liabilities | $6 million |
Market Position and Competition
BioCardia operates within a competitive landscape, primarily against companies such as:
- StemCells, Inc.
- Mesoblast Limited
- Vericel Corporation
The market for regenerative medicine is projected to grow at a CAGR of 25.1%, reaching approximately $49 billion by 2028.
Recent Developments
In September 2023, BioCardia announced successful interim results from its clinical trials:
| Trial Phase | Results |
|---|---|
| Phase 2 | 75% of patients showed improved heart function |
| Long-term follow-up | 62% of patients maintained improved outcomes after one year |
Strategic Partnerships
BioCardia has formed partnerships with various medical institutions to enhance its research capabilities:
- UCLA Health: Collaborative research on ischemic conditions.
- Johns Hopkins University: Investigating cellular repair mechanisms.
- Cleveland Clinic: Clinical trials for various heart therapies.
Stock Performance
As of October 2023, BioCardia (BCDA) shares traded at approximately $1.75, with a market capitalization of around $82 million. The stock has shown a volatility percentage of 5% over the last quarter.
Future Outlook
BioCardia's pipeline includes plans for expanding clinical trials and seeking FDA approvals for its therapies. The company aims to initiate its Phase 3 trials for CardiAMP in late 2023, targeting a market share increase by 15% within the next two years.
How BioCardia, Inc. (BCDA) Makes Money
Revenue Streams
BioCardia, Inc. primarily generates revenue through the development and commercialization of innovative therapies for cardiovascular diseases. The company focuses on regenerative medicine, specifically cell therapies and related technologies.
Product Offerings
The company’s flagship products include:
- Cardiac Cell Therapy: Products designed for treating heart failure.
- BioCardia's Helix Biotherapeutic Delivery System: A system used for precise delivery of cell therapies.
Clinical Trials and Partnerships
BioCardia is involved in various clinical trials that are crucial for product validation and subsequent commercialization. The company reports financial backing and collaboration with major healthcare institutions and research organizations.
As of the latest data, BioCardia was conducting Phase 3 clinical trials for its lead product, which can significantly influence revenue upon successful commercialization.
Funding and Financial Performance
In the fiscal year ending December 31, 2022, BioCardia reported total revenue of approximately $1.1 million. The revenue primarily stemmed from research grants and collaborations.
In Q1 2023, the company raised approximately $5 million through a registered direct offering, aimed at funding ongoing clinical trials and general corporate purposes.
| Year | Total Revenue | Net Loss | Research and Development Expenses | Cash Position |
|---|---|---|---|---|
| 2022 | $1.1 million | $11.2 million | $7.5 million | $9.4 million |
| 2021 | $532,000 | $9.6 million | $6.1 million | $8.6 million |
| 2020 | $745,000 | $8.3 million | $4.8 million | $7.5 million |
Market Potential
The global cardiovascular market is projected to reach around $43.8 billion by 2027, growing at a CAGR of 6.2%.
BioCardia’s focus on regenerative therapies places it in a lucrative segment of this market, potentially increasing its revenue streams through product adoption and partnerships.
Intellectual Property and Licensing
BioCardia holds several patents related to its cell therapy technologies, giving it a competitive advantage and potential revenue through licensing agreements. Licensing deals could augment revenue significantly as products move toward commercialization.
Future Outlook
BioCardia’s future financial performance will largely depend on successful completion and outcomes of clinical trials, FDA approvals, and subsequent market entry of its therapies. The company is positioned to capitalize on a significant market opportunity, contingent upon the execution of its development and commercialization strategy.
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