Financials
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
| Catalyst | Drug / Treatment | Stage | Prob. of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
PDUFA 2026 | Example Drug Treatment for example condition requiring FDA review | Phase 3 | Small Molecule | Oncology | - |
BCDA Catalyst Timeline
Dated clinical, regulatory and corporate events for BioCardia, Inc.
Catalyst Timeline
Dated clinical, regulatory & corporate events for BioCardia, Inc.
Upcoming catalysts 2
Event history 50
Past FDA Catalysts and PDUFA Decisions
How BCDA actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| 2025-03-30 | CardiAMP (autologous cell therapy) | Phase 3 data readout | Phase 3 |
Drug Pipeline Intelligence
| Drug | Indication | Phase | PTRS | rNPV | Status | Enroll | Velocity | Design | Est. Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Autologous cell therapy Cell therapyCompletedNCT02438306 | Heart Failure, Systolic | Phase 3 | COMPLETED | 125 | Jun 1, 2025 |
Clinical Trial Results
Readouts, endpoints and source filings for every BCDA program
| Drug Name | Indication | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
| CardiAMP Breakthrough | Chronic Myocardial Ischemia | 2026-05-21 | exercise tolerance increase: 179 seconds; angina reduction: 82%Read More | BioCardia Announces CardiAMP Chronic Myocardial Ischemia Trial Results Presented at EuroPCR Showed Durable Improvements in Exercise Tolerance with Reduced Angina FrequencyRead More |
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| Altman PeterDirector, Officer (President and CEO) | Buy | 1,000 384,885 held | $1.03 | 09/29/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in BCDA
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| No hedge fund reported a 13F position in BCDA for Q2 2026. | ||||
BCDA Institutional Ownership Trends
Options Data
Option Volume
Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
|---|
Real-Time Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last | Vol | OI | Last | Vol | OI | |
| No data available | ||||||
Calls vs Puts by Expiry
Competitive positioning
How BCDA ranks across every disease it competes in
BCDA News
BioCardia Presents CardiAMP HF II Trial Design at Heart Failure Society of America Annual Scientific Meeting
BioCardia, Inc. will present the CardiAMP HF II trial design at the Heart Failure Society of America Annual Scientific Meeting. The trial aims to evaluate the efficacy of high-dose autologous cell treatment for patients with ischemic heart failure. The FDA has approved a category B designation for the CardiAMP cell therapy system, which may support future FDA approval.
Read more →BioCardia Files Revised De Novo Pre-Submission for FDA Approval of Helix™ Catheter
BioCardia has submitted a revised De Novo pre-submission to the FDA for its Helix catheter, aimed at therapeutic and diagnostic delivery to the heart. The FDA has indicated two pathways for marketing clearance and raised no safety concerns. If approved, Helix could be the first of its kind, backed by extensive clinical data from prior trials.
Read more →BioCardia Confirms Timing and Provides Update on FDA Helix Pre-Submission and PMDA CardiAMP HF Shonin Submission
BioCardia, Inc. has announced updates regarding its regulatory submissions for the CardiAMP therapy and Helix delivery platform. The company is preparing for a Shonin submission in Japan and is actively enrolling participants in the CardiAMP HF II clinical study, which may support a Pre Marketing Application. Additionally, BioCardia plans to submit a De Novo pre-submission for the Helix system to the FDA.
Read more →BioCardia to Present CardiAMP Regulatory and Corporate Progress at H.C. Wainwright 28th Annual Global Investment Conference
BioCardia, Inc. will present its CardiAMP regulatory and corporate progress at the H.C. Wainwright 28th Annual Global Investment Conference. CEO Peter Altman will discuss advancements towards regulatory approval in Japan and the U.S., the ongoing CardiAMP HF II pivotal trial, and the company's innovative delivery platforms. The conference will take place from September 14-16, 2026, in New York City.
Read more →BioCardia Announces FDA Confirms Helix Transendocardial Delivery Catheter Meeting Minutes Supporting Follow-On De Novo Pre-Submission for Approval
BioCardia has received FDA confirmation regarding the Helix Transendocardial Delivery Catheter's Pre-Submission Meeting. The FDA accepted the meeting minutes from May 2026, allowing BioCardia to proceed with a follow-on pre-submission for Helix. This could lead to approval through the De Novo pathway, enhancing the development of its therapeutic agents.
Read more →BioCardia Reports Second Quarter 2026 Business Highlights and Financial Results
BioCardia, Inc. reported positive developments in its second quarter 2026 results, highlighting support from regulatory agencies in Japan and the U.S. for its CardiAMP Cell Therapy. The company is preparing for a regulatory submission in Japan and actively enrolling patients in clinical trials. Financially, BioCardia raised $4.9 million and reported a decrease in net loss compared to the previous year.
Read more →BioCardia to Host Q2 2026 Financial Results and Corporate Update Conference Call on August 12, 2026
BioCardia, Inc. announced a conference call scheduled for August 12, 2026, to discuss its Q2 financial results and provide a corporate update. The call will include a question-and-answer session, allowing participants to engage with management. Interested parties can register online to receive dial-in details or listen via a live webcast.
Read more →BioCardia Letter to Stockholders on 2026 Priorities and Strategic Opportunities
BioCardia's CEO, Peter Altman, outlined the company's strategic priorities in a letter to shareholders, emphasizing the submission for CardiAMP Cell Therapy approval in Japan as a key focus. The company aims to address the needs of ischemic heart failure patients and leverage its innovative delivery systems. With a recent capital raise, BioCardia is well-positioned for upcoming milestones and potential partnerships.
Read more →BioCardia Announces $4.4 Million Financing
BioCardia, Inc. has successfully raised $4.4 million through the sale of shares, which is expected to extend its cash runway into the first quarter of 2027. This funding will support the anticipated submission of CardiAMP Cell Therapy to the Japan PMDA in Q4 2026. The company continues to develop its innovative cell therapies for cardiovascular and pulmonary diseases.
Read more →FDA Confirms CardiAMP HF II May Support Premarket Approval of CardiAMP Cell Therapy for Ischemic HFrEF
BioCardia, Inc. announced that the FDA's minutes from a recent meeting indicate that the ongoing CardiAMP Heart Failure II Trial may support the Premarket Approval of the CardiAMP Cell Therapy for ischemic heart failure with reduced ejection fraction (HFrEF). This therapy utilizes the patient's own bone marrow cells and aims to improve heart function. The FDA's recognition of the trial's potential is significant for the treatment of HFrEF, which affects a large patient population.
Read more →BioCardia Announces Japan PMDA Record Of Advice Supports Regulatory Submission For Approval Of CardiAMP Cell Therapy For Ischemic Heart Failure
BioCardia has received support from Japan's PMDA for the regulatory submission of CardiAMP Cell Therapy aimed at treating ischemic heart failure. The PMDA confirmed the credibility of clinical trial outcomes and outlined requirements for the submission. The therapy could potentially benefit around 20,000 patients in Japan, highlighting an urgent clinical need.
Read more →BioCardia Announces CardiAMP Chronic Myocardial Ischemia Trial Results Presented at EuroPCR Showed Durable Improvements in Exercise Tolerance with Reduced Angina Frequency
BioCardia has announced promising results from their CardiAMP Cell Therapy in a trial for Chronic Myocardial Ischemia, presented at the EuroPCR conference. The trial's open-label cohort demonstrated durable improvements in exercise tolerance and a significant reduction in angina frequency among patients treated with the novel therapy. Participants showed an average increase in exercise tolerance by 179 seconds and an 82% reduction in angina episodes within six months of treatment. These findings support the continued clinical development of CardiAMP therapy as an innovative solution for patients suffering from refractory angina.
Read more →BioCardia to Participate in a Fireside Chat at the Alliance Global Partners (A.G.P) Healthcare Company Showcase
BioCardia, Inc. will participate in a virtual fireside chat at the A.G.P. Healthcare Company Showcase on May 20, 2026, at 11:40 AM ET. The company is known for its innovative cellular and cell-derived therapeutics aimed at treating cardiovascular and pulmonary diseases. Investors can register to attend the event and learn more about BioCardia's advancements.
Read more →BioCardia Reports First Quarter 2026 Business Highlights and Financial Results
BioCardia, Inc. reported its Q1 2026 financial results, highlighting significant progress in its CardiAMP cell therapy for ischemic heart failure. The company received positive feedback from both the FDA and PMDA regarding the therapy's safety and efficacy. BioCardia is advancing towards regulatory approval in Japan and has ongoing clinical trials in the U.S. Despite a net loss of $2.3 million, the company remains optimistic about its future prospects.
Read more →BioCardia to Host Q1 2026 Financial Results and Corporate Update Conference Call on May 15, 2026
BioCardia, Inc. will host a conference call on May 15, 2026, to discuss its Q1 financial results and provide a corporate update. The call will include a formal presentation followed by a question-and-answer session. Participants can register online to receive dial-in information, and a replay will be available after the call.
Read more →BioCardia and FDA Align on Helix Transendocardial Delivery Catheter Clearance Pathways
BioCardia announced a successful Pre-Submission Meeting with the FDA regarding its Helix Transendocardial Delivery Catheter System. The FDA identified two potential pathways for marketing clearance and expressed no concerns regarding safety or performance. The preferred route aligns Helix approval with the CardiAMP cell therapy system for heart failure treatment.
Read more →BioCardia Announces Allowance of Japanese Patent on Proprietary Heart3D™ Fusion Imaging Software for Procedure Planning and Realtime Navigation During CardiAMP Cell Therapy Procedures
BioCardia has announced the allowance of a Japanese patent for its Heart3D Fusion Imaging software, which aids in treatment planning and navigation during CardiAMP Cell Therapy procedures. This technology is designed to enhance the visualization of the heart using 3D imaging techniques. The company is also preparing for regulatory submissions in Japan and the U.S. following positive consultations with authorities.
Read more →BioCardia and Japan PMDA Align on Acceptability of CardiAMP Clinical Data to Support Regulatory Approval in Ischemic Heart Failure
BioCardia, Inc. has received positive feedback from Japan's PMDA regarding its CardiAMP Cell Therapy for ischemic heart failure. The agency believes the clinical data is likely sufficient for market clearance. The meeting confirmed the acceptability of foreign clinical data and outlined the next steps for potential filing in Japan.
Read more →BioCardia Files Request for Meeting With FDA to Discuss Accelerated Approval Pathway for CardiAMP® System in Ischemic Heart Failure
BioCardia has submitted clinical study data to the FDA and requested a meeting to discuss the accelerated approval pathway for its CardiAMP System, aimed at treating ischemic heart failure. The company aims to receive feedback on its proposed submission based on positive safety and efficacy data from its trials. The CardiAMP System has shown promising results, particularly in high-risk patients, demonstrating significant reductions in cardiac events.
Read more →