BioCardia, Inc. is a clinical-stage biotherapeutic company. It engages in the business of developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases with significant unmet medical needs. The company was founded on January 12, 1994 and is headquartered in Sunnyvale, CA.
Clinical Trials
6
2 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
1999
Active, not recruiting
2
33.3%
Completed
2
33.3%
Recruiting
1
16.7%
Withdrawn
1
16.7%
No approval data available
- BioCardia is preparing a Shonin pre-market regulatory submission to Japan's PMDA in Q4 2026 for its CardiAMP autologous cell therapy in ischemic heart failure. - The company has answered detailed PMDA consultation questions and is working with partners on the Shonin Application, Quality Management System Application and Foreign Manufacturer Registration. - PMDA support and a successful review could yield market clearance by Q4 2027, while the confirmatory CardiAMP HF II study enrolls at four US centers. - BioCardia intends to file the follow-on De Novo pre-submission for the Helix Transendocardial Delivery Catheter System with FDA CDRH this quarter.
- BioCardia's CardiAMP cell therapy demonstrated an average 179-second improvement in exercise tolerance that persisted for two years in patients with refractory angina who had exhausted all conventional treatment options. - The open-label cohort showed an 82% reduction in angina episodes by six months with no treatment-emergent major adverse cardiac events, targeting a population of 600,000 to 1.8 million patients in the United States. - The therapy uses autologous bone marrow cells delivered via catheter with a proprietary pre-procedural cell analysis for patient selection, addressing reproducibility issues that plagued earlier cardiac cell therapy programs. - Results were presented at EuroPCR by Dr. Amish Raval, with the randomized controlled phase needed to determine whether improvements exceed placebo effects in this pain-dominant endpoint population.
- BioCardia announced the first patient enrollment at University of Wisconsin School of Medicine and Public Health in its ongoing Phase 3 CardiAMP HF II clinical trial for ischemic heart failure treatment. - The 250-patient randomized multicenter study evaluates CardiAMP autologous cell therapy as a one-time treatment for patients with ischemic heart failure with reduced ejection fraction on guideline-directed medical therapy. - CardiAMP cell therapy, which has FDA Breakthrough designation, uses a patient's own bone marrow cells delivered via minimally invasive catheter-based procedure to increase capillary density and reduce tissue fibrosis. - The trial aims to confirm safety and efficacy results from the previous CardiAMP HF study, which achieved statistical significance in patients with elevated NTproBNP markers.
- BioCardia's CardiAMP Cell Therapy demonstrated an 82% reduction in angina episodes and 80-second improvement in exercise tolerance at six months in patients with chronic myocardial ischemia. - The minimally invasive autologous cell therapy showed no major adverse cardiac events and outperformed current FDA-approved treatments like Ranolazine and Enhanced External Counter Pulsation. - The therapy addresses refractory angina, affecting 600,000 to 1.8 million U.S. patients who cannot be controlled by optimal medical therapy, angioplasty, or bypass surgery. - CardiAMP has FDA Breakthrough Therapy designation for ischemic heart failure and incorporates proprietary cell analysis, high-dose delivery, and advanced retention systems.
- BioCardia and CART-Tech have entered into an exclusive development and commercialization agreement for Heart3D Fusion Imaging, a system that enhances 2D x-ray images by fusing them with 3D anatomical heart models from MRI and CT scans. - The Heart3D system is designed to improve cardiac biotherapeutic delivery and biopsy procedures, initially launching as a research tool before seeking approval for standard clinical practice. - Management estimates that a single approved biologic therapy for a large cardiology indication could potentially generate $100 million annually from Heart3D services if it becomes standard of care. - BioCardia will have exclusive worldwide distribution rights for biotherapeutic delivery and US rights for cardiac biopsy, while CART-Tech retains all other distribution rights.
- BioCardia submitted its CardiAMP autologous cell therapy to Japan's PMDA for clinical consultation, marking a significant step toward potential regulatory approval in the key Japanese market. - The submission includes comprehensive clinical data from the CardiAMP HF Trial, which demonstrated statistically significant reduction in all-cause death and major adverse cardiac events in heart failure patients. - The FDA Breakthrough-designated therapy uses patients' own bone marrow cells delivered via minimally invasive catheter to increase capillary density and reduce tissue fibrosis. - Successful PMDA alignment could enable BioCardia to submit for market approval in Japan and potentially engage in post-marketing studies next year.
- BioCardia reported positive safety and meaningful benefits from their CardiAMP cardiac cell therapy for heart failure patients, addressing a significant unmet clinical need despite missing the primary endpoint in their previous trial. - The company is actively engaging with both the FDA and Japan's PMDA to align on regulatory pathways, with expectations for clarity on approval submission within six months from Japan's regulatory authority. - BioCardia is enrolling patients in the Cardiac Heart Failure 2 confirmatory trial, which is reimbursed by Medicare and focuses on the greatest responders with improved trial design and endpoints. - The company is preparing their Helix biotherapeutic delivery system for regulatory submission, potentially becoming the first approved transendocardial biotherapeutic delivery system in the United States.
- BioCardia has completed enrollment and dosing of the low-dose cohort in its CardiALLO Phase I/II trial, targeting ischemic heart failure patients with elevated markers of heart stress and inflammation. - The groundbreaking trial utilizes allogeneic mesenchymal stem cells delivered through BioCardia's minimally invasive system, with the first Data Safety Monitoring Board review expected in March 2025. - The study incorporates precision medicine approaches and FDA-approved Morph DNA steerable guide technology, aiming to enhance therapeutic delivery and patient outcomes in heart failure treatment.
- The myocardial infarction therapeutics pipeline is robust, featuring over 45 companies developing more than 50 potential drugs. - Key companies like Boehringer Ingelheim and Idorsia Pharmaceuticals are advancing novel therapies to improve outcomes post-myocardial infarction. - Several promising therapies, including Selatogrel and FDY-5301, are in Phase III trials, showing potential for significant advancements. - Recent clinical trial activities, such as the commencement of the PERFECT study and completion of enrollment in the Iocyte AMI-3 trial, highlight ongoing research efforts.
- BioCardia has commercially launched its Morph DNA steerable introducer, designed for enhanced control in biotherapeutic delivery, particularly in cell-therapy clinical trials. - The Morph DNA introducer features bidirectional steering and a design intended to prevent catheter 'whip,' improving navigation within the vascular system. - BioCardia is focusing on organic sales to minimize costs and is prioritizing its CardiAMP Heart Failure I and II clinical trials, with results expected by Q1 2025. - The company's Morph DNA introducer has FDA breakthrough designation for its cell therapy product candidate to treat ischemic heart failure.
