BioCardia
BioCardia is a clinical-stage biotechnology company developing autologous and allogeneic cell therapies for cardiovascular and pulmonary diseases, anchored by its FDA Breakthrough-designated CardiAMP program and proprietary Helix transendocardial delivery platform.
- Company typePublic
- Founded1999
- HeadquartersSan Carlos, United States
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What BioCardia does
BioCardia, Inc. (Nasdaq: BCDA) is a clinical-stage biotechnology company headquartered at 320 Soquel Way, Sunnyvale, California, developing cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases. The company operates with a lean staff of approximately 22 employees and a market capitalization of roughly $10-12 million. Its lead program, CardiAMP Cell Therapy, is an autologous bone marrow-derived mononuclear cell therapy delivered via catheter to treat ischemic heart failure with reduced ejection fraction (HFrEF); it has received FDA Breakthrough Device designation, and FDA has confirmed that the ongoing CardiAMP HF II Phase 3 pivotal trial may support Premarket Approval. A secondary allogeneic platform, CardiALLO (with PulmALLO for pulmonary indications), uses NK1R+ mesenchymal stem cells with an immunomodulatory mechanism of action; the BCDA-03 low-dose cohort completed in May 2026 without adverse events.
The therapeutic platforms are enabled by BioCardia's proprietary delivery and procedural toolset. The Helix Transendocardial Delivery System is a minimally invasive catheter with a helical needle that the company reports achieves approximately 3-fold higher cell retention than alternative delivery methods, with FDA-confirmed dual clearance pathways. The Morph DNA and Avance steerable introducer sheaths received FDA market clearance and are commercially available, while the investigational Heart3D Fusion Imaging platform fuses pre-procedure MRI/CT 3D models with real-time 2D X-ray for procedural navigation. BioCardia holds an extensive patent portfolio across the US, Japan, and India covering the steerable catheter (US 11,716,859, expiring 2035), NK1R+ MSC technology (US 11,642,377, expiring 2039), and the Helix delivery catheter in Japan (JP7282649B2, expiring September 2034).
BioCardia's current revenue model is essentially pre-commercial: reported revenue was $0 in 2025, $58K in 2024, and $1.4M in 2022, derived primarily from collaborative partnership performance obligations. The go-to-market strategy operates on two tracks — internal clinical development of CardiAMP through PMA, and selective out-licensing of the Helix delivery platform to third-party biotherapeutic developers (CellProthera in Europe, BlueRock Therapeutics, plus active discussions with eight additional gene/cell therapy developers). The company has secured CMS reimbursement code C9782 covering up to $20,000 per CardiAMP procedure, intends to file for Japan PMDA approval in Q4 2026, and has financed operations through a series of recurring public offerings and private placements totaling approximately $28.5 million between December 2022 and June 2026, with cash runway extended into Q1 2027.
BioCardia firmographics
Firmographics- Name
- BioCardia
- Legal name
- BioCardia, Inc.
- Website
- https://biocardia.com
- Company type
- Public
- Founded year
- 1999
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- BioCardia is a clinical-stage biotechnology company developing autologous and allogeneic cell therapies for cardiovascular and pulmonary diseases, anchored by its FDA Breakthrough-designated CardiAMP program and proprietary Helix transendocardial delivery platform.
- Ownership category
- akta.pro rank
BioCardia industry classification
Industry- Product category
- Cardiac Cell Therapy
- NAICS
- Biological Product (except Diagnostic) Manufacturing (325414), Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)
- SIC
- Biological Products, (No Disgnostic Substances) (2836), Surgical & Medical Instruments & Apparatus (3841)
- akta.pro primary industry
- Cardiovascular & Vascular Regeneration (vascular grafts, angiogenesis) (HLAAAGAJ)
- akta.pro secondary industry
- Cardiac Assist & Heart Failure Therapies (Implantables, Neuromodulation) (HLAHAFAL)
Keywords
Where BioCardia is headquartered
LocationHeadquarters
- HQ city
- San Carlos
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
BioCardia business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales, Others
Revenue model
- Collaborative partnerships: Revenue from partnerships with biotherapeutic companies using BioCardia's delivery platforms, including development support, licensing fees, and potential royalties on commercialized products
- Grant funding: Support from Maryland Stem Cell Research Fund for clinical development of CardiAMP Cell Therapy
- Product revenues: Minimal product revenues from collaborative partners and fulfillment of performance obligations; $1.4M in 2022, $64K in Q1 2023
- Future commercial sales: Anticipated commercial revenue from CardiAMP Cell Therapy if regulatory approvals obtained in US and Japan
Go-to-market motion2 records
Distribution channels3 records
Marketing channels6 records
BioCardia product offering
Product offeringCore offering
BioCardia is a clinical-stage biotechnology company developing cellular and cell-derived therapeutics (CardiAMP autologous and CardiALLO allogeneic cell therapies) for cardiovascular and pulmonary diseases. Its proprietary Helix transendocardial delivery catheter and Morph DNA/Avance introducer sheaths enable minimally invasive targeted delivery of biologic therapies into heart tissue. BioCardia also licenses its Helix platform selectively to biotherapeutic developers for use in their own cardiac delivery programs.
Product overview
BioCardia is a clinical-stage biotechnology company developing cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases. The company's portfolio consists of two biotherapeutic platforms: CardiAMP (autologous bone marrow-derived mononuclear cell therapy) and CardiALLO/PulmALLO (allogeneic NK1R+ mesenchymal stem cell therapies). These therapeutic platforms are enabled by proprietary delivery systems including the Helix Transendocardial Delivery Catheter for targeted intramyocardial injection, Morph DNA and Avance steerable introducer sheaths for vascular access, and the Heart3D fusion imaging platform for procedural navigation. The company operates primarily through development partnerships and direct clinical trials, with multiple product candidates in Phase 1-3 development for heart failure, chronic myocardial ischemia, and pulmonary conditions.
Differentiator
Problem solved
Functional benefit
Brands
- CardiAMP: Autologous mononuclear cell therapy for the treatment of ischemic heart failure with reduced ejection fraction (HFrEF) and chronic myocardial ischemia.
- CardiALLO
- Helix
- Morph DNA
- Heart3D
- PulmALLO
Products and services
- CardiAMP Autologous Cell Therapy Autologous bone marrow-derived mononuclear cell therapy using the patient's own cells, delivered via the Helix catheter to treat ischemic heart failure with reduced ejection fraction (HFrEF) and chronic myocardial ischemia. Holds FDA Breakthrough Device designation and is supported by CMS reimbursement code C9782.
- CardiALLO Allogeneic Cell Therapy
Quantifiable outcome
- 37% relative risk reduction in all-cause cardiac death and equivalents at 24 months
- +5 more outcomes
Companies that use BioCardia
Customer profileNamed customers4 records
Segments3 records
Ideal customer profiles3 records
BioCardia technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
BioCardia partnerships and signals
Strategic signalPartnerships
Six partnerships are on record, tiered core and minor.
- Henry Ford HealthcoreEnrolling patients in Phase 3 CardiAMP HF II cell therapy pivotal trial for ischemic heart failure with reduced ejection fraction
- University of Wisconsin School of Medicine and Public HealthcoreEnrolled first patient in Phase 3 CardiAMP HF II pivotal trial; Statistical Data Analysis Center located at UW; Co-National Principal Investigator Dr. Amish Raval
- CART-TechcoreExclusive partnership to develop and commercialize Heart3D Fusion Imaging for interventional cardiology. Combines BioCardia's biotherapeutic delivery expertise with CART-Tech's imaging technology for enhanced cardiac procedure navigation.
- Emory University School of MedicinecorePatient enrollment site for ongoing CardiAMP HF II pivotal study for ischemic heart failure treatment
- CellProtheracoreExtended partnership for CellProthera's use of BioCardia's Helix transendocardial delivery system in Phase I/IIb EXCELLENT study of ProtheraCytes for acute myocardial infarction. Agreement includes intention for early access commercialization beginning 2024 and future full commercialization. BioCardia receives low single digit royalty on net sales of ProtheraCytes delivered transendocardially.
- BlueRock Therapeutics LPminorAgreement for delivery of BlueRock's cell therapy product candidates for heart failure treatment utilizing BioCardia's biotherapeutic delivery product candidates.
Scale indicators10 records
Recent moves6 records
Expansion highlights6 records
BioCardia competitors and assessment
Company assessmentDirect peers
- Mesoblast: Mesoblast develops allogeneic mesenchymal stem cell therapies including remestemcel-L for inflammatory conditions and has historically pursued cardiovascular indications; it is a direct comparator in cardiac cell therapy development and commercialization strategy.
- Capricor Therapeutics: Capricor is developing CAP-1002 (allogeneic cardiosphere-derived cells) for Duchenne muscular dystrophy-associated cardiomyopathy and other cardiac indications, making it a direct peer in cardiac cell therapy with overlapping delivery and indication considerations.
- Vericel: Vericel commercializes autologous cell therapies (Carticel, MACI) and has expanded into cardiac programs, providing a comparable commercial-stage reference point for cell therapy reimbursement and manufacturing economics relevant to BioCardia.
- CellProthera: CellProthera is developing ProtheraCytes (autologous CD34+ stem cells) for acute myocardial infarction using BioCardia's Helix delivery system; it is both a partner and a direct peer in cardiac stem cell therapy, with shared technology and overlapping indication.
- BlueRock Therapeutics: BlueRock Therapeutics (a Bayer subsidiary) is advancing iPSC-derived cardiomyocyte therapies for heart failure and is both a BioCardia delivery platform partner and a direct competitor pursuing similar cardiac regenerative indications with substantially greater funding.
Emerging players
- Pluristem Therapeutics: Pluristem develops placenta-derived allogeneic cell therapies with applications in cardiovascular and peripheral ischemia, providing a comparable emerging cell therapy peer with similar regulatory and commercialization challenges.
- Tenaya Therapeutics: Tenaya is developing gene therapies for heart failure and other cardiomyopathies, representing an adjacent emerging modality competing for the same cardiac patient population and clinician relationships that BioCardia targets with CardiAMP.
Broad incumbents
- Edwards Lifesciences: Edwards Lifesciences is a broad incumbent in cardiovascular devices and heart failure therapies (surgical valves, transcatheter valves, critical care); it competes indirectly with BioCardia for hospital budget and clinician attention in advanced heart failure treatment pathways.
- Medtronic: Medtronic is a broad incumbent across interventional cardiology, heart failure devices, and catheter delivery technologies; its catheter and cardiac device portfolio represents the standard-of-care infrastructure against which BioCardia's Helix delivery platform must compete.
- Abbott: Abbott operates a broad cardiovascular portfolio including heart failure diagnostics, structural heart devices, and catheter-based delivery systems, positioning it as a broad incumbent competitor for both BioCardia's therapeutic franchise and its delivery devices.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights7 records
Customer concentration
BioCardia social profiles
Digital presenceBioCardia financial estimates
Financial estimateRevenue estimate
Valuation estimate
BioCardia leadership team
Management profileNumber of profiles
Profiles5 records
BioCardia funding detail
Funding detailFunding overview
Funding rounds9 records
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
BioCardia M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about BioCardia
What does BioCardia do?
BioCardia is a clinical-stage biotechnology company developing cellular and cell-derived therapeutics (CardiAMP autologous and CardiALLO allogeneic cell therapies) for cardiovascular and pulmonary diseases. Its proprietary Helix transendocardial delivery catheter and Morph DNA/Avance introducer sheaths enable minimally invasive targeted delivery of biologic therapies into heart tissue. BioCardia also licenses its Helix platform selectively to biotherapeutic developers for use in their own cardiac delivery programs.
Is BioCardia a public or private company?
BioCardia is a public company. It is classified as public and is currently operating.
When was BioCardia founded?
BioCardia was founded in 1999. It employs 11 to 50 people.
Where is BioCardia based?
BioCardia is headquartered in San Carlos, United States, in the North America region.
How does BioCardia make money?
Four revenue lines are on record. Collaborative partnerships are the primary driver. The others are grant funding, product revenues and future commercial sales.
Who are BioCardia's main competitors?
Direct peers on record are Mesoblast, Capricor Therapeutics, Vericel, CellProthera and BlueRock Therapeutics. Emerging players are Pluristem Therapeutics and Tenaya Therapeutics. Broad incumbents are Edwards Lifesciences, Medtronic and Abbott.
Does BioCardia have an API?
No public API is recorded for BioCardia.
What industry is BioCardia in?
BioCardia's product category is Cardiac Cell Therapy. Its primary akta.pro industry code is HLAAAGAJ, Cardiovascular & Vascular Regeneration (vascular grafts, angiogenesis), with a secondary code of HLAHAFAL, Cardiac Assist & Heart Failure Therapies (Implantables, Neuromodulation). Its NAICS code is 325414 and its SIC code is 2836.