This section highlights FDA-related milestones and regulatory updates for drugs developed by BioCardia (BCDA).
Over the past two years, BioCardia has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
BCDA-01, BCDA-03, CardiALLO-HF, CardiAMP, CardiAMP, and Morph®. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
BCDA-01 FDA Regulatory Events
BCDA-01 is a drug developed by BioCardia for the following indication: For the treatment of ischemic heart failure of reduced ejection fraction (HFrEF).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BCDA-01
- Announced Date:
- December 4, 2024
- Indication:
- For the treatment of ischemic heart failure of reduced ejection fraction (HFrEF).
Announcement
BioCardia, Inc announced the successful completion of a consultation with Japan's Pharmaceutical and Medical Device Agency (PMDA) on the next steps for the submission for registration of its lead therapeutic asset, BCDA-01, for the treatment of ischemic heart failure of reduced ejection fraction (HFrEF).
AI Summary
BioCardia, Inc. announced that it successfully completed a consultation with Japan’s Pharmaceutical and Medical Device Agency (PMDA) regarding the next steps for registering its lead asset, BCDA-01. The therapy is intended to treat ischemic heart failure with reduced ejection fraction (HFrEF). During the meeting, the PMDA invited BioCardia for a follow-up consultation after the company submits its final clinical data, which includes a two-year follow-up. This data will help demonstrate the safety and efficacy of BCDA-01. In addition, the agency is considering evidence from the CardiAMP Heart Failure Trial as potentially sufficient for registering the CardiAMP Cell Therapy System for use in treating heart failure in Japan. BioCardia expects to lock data from its full trial enrollment soon, with final results anticipated by the first quarter of 2025.
Read Announcement
BCDA-03 FDA Regulatory Events
BCDA-03 is a drug developed by BioCardia for the following indication: For Treat Ischemic Heart Failure of Reduced Ejection Fraction (HFrEF).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BCDA-03
- Announced Date:
- February 13, 2025
- Indication:
- For Treat Ischemic Heart Failure of Reduced Ejection Fraction (HFrEF)
Announcement
BioCardia, announced today completion of enrollment and dosing in the low dose cohort in its CardiALLO™ Allogeneic Mesenchymal Cell Therapy Phase I/II trial.
AI Summary
BioCardia, Inc. announced that it has successfully completed enrollment and dosing in the low dose cohort of its CardiALLO™ Allogeneic Mesenchymal Cell Therapy Phase I/II trial. This trial targets patients with ischemic heart failure of reduced ejection fraction (HFrEF) who exhibit elevated markers of heart stress and systemic inflammation. It is considered the world's first prospective study using allogeneic mesenchymal stem cells (MSC) for such heart patients. The study employs an enhanced delivery system using the FDA-approved Morph DNA steerable guide, which improves physician control for precise cell delivery. This approach, along with dose escalation, aims to better identify the optimal dosing for patients who are most likely to benefit. The company is now looking forward to the initial independent safety review, eagerly anticipating further insights into the treatment’s safety and potential efficacy. BioCardia’s efforts mark a promising advancement in cell-based therapies for heart disease.
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CardiALLO-HF FDA Regulatory Events
CardiALLO-HF is a drug developed by BioCardia for the following indication: For Heart Failure.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CardiALLO-HF
- Announced Date:
- April 15, 2025
- Indication:
- For Heart Failure
Announcement
BioCardia, announced that the study's independent DSMB, which conducted a planned review of the 30-day safety data from the roll-in 20 million cell dosing cohort in the CardiALLO-HF trial, recommended that the study continue as designed.
AI Summary
BioCardia announced that the study’s independent Data Safety Monitoring Board (DSMB) has recommended that the CardiALLO-HF trial proceed as planned based on a planned review of 30-day safety data from the roll-in 20 million cell dosing cohort. The DSMB observed no major adverse cardiac events or clinical signs of immune reactions among the participants, indicating that the therapy shows a promising safety profile in its current low-dose group.
This positive recommendation is seen as a key step in furthering BioCardia’s allogeneic mesenchymal stromal/stem cell therapy for cardiovascular conditions. Following this review, the company intends to enroll 39 participants in the United States to continue the evaluation of the therapy. BioCardia believes this progress could help support further trial designs and attract funding and partnership opportunities in the future.
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CardiAMP FDA Regulatory Timeline and Events
CardiAMP is a drug developed by BioCardia for the following indication: Designed to be a comprehensive biotherapeutic heart failure solution.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CardiAMP
- Announced Date:
- July 16, 2025
- Indication:
- Designed to be a comprehensive biotherapeutic heart failure solution
Announcement
BioCardia, announced that Henry Ford Health in Detroit, Michigan is now enrolling patients with ischemic HFrEF in the Company's ongoing pivotal CardiAMP HF II trial.
AI Summary
BioCardia announced that Henry Ford Health in Detroit is now enrolling patients with ischemic HFrEF (heart failure with reduced ejection fraction) in its pivotal CardiAMP HF II trial. This trial is testing a new autologous cell therapy that uses patients’ own bone marrow cells to repair damaged heart tissue. During the treatment, cells are harvested, processed at the bedside, and injected directly into the heart using a minimally invasive catheter procedure. The approach is designed to promote microvascular repair, reduce fibrosis, and increase capillary density, aiming to improve heart function.
Dr. Gerald Koenig, the Principal Investigator at Henry Ford Health, stressed the importance of this study in bringing early access to innovative therapies for patients with ischemic heart failure. BioCardia is hopeful that confirming earlier promising results will lead to better treatment options and improved quality of life for these patients.
Read Announcement- Drug:
- CardiAMP
- Announced Date:
- February 27, 2025
- Indication:
- Designed to be a comprehensive biotherapeutic heart failure solution
Announcement
BioCardia, announced the completion of source data verification and freezing of primary outcomes data in the double-blind randomized placebo-controlled Phase 3 CardiAMP HF study of its autologous minimally invasive cell therapy for the treatment of ischemic heart failure of reduced ejection fraction (HFrEF).
AI Summary
BioCardia announced it has completed source data verification and frozen the primary outcomes data for its Phase 3 CardiAMP HF study. This double-blind, randomized, placebo-controlled trial evaluated an autologous, minimally invasive cell therapy for patients with ischemic heart failure with reduced ejection fraction (HFrEF). The trial enrolled 115 patients, whose data was recently transferred to a Statistical Data Analysis Center for further processing. The study stands out as it is the largest randomized trial of its kind, using a precision medicine approach to identify patients most likely to benefit from the therapy. BioCardia hopes that the analysis, expected to be presented at a major cardiology conference in March 2025, will show that this novel cell therapy offers meaningful benefit for heart failure patients who do not respond adequately to medication. The company aims to support future approvals based on this evidence of safety and effectiveness.
Read Announcement- Drug:
- CardiAMP
- Announced Date:
- August 21, 2024
- Indication:
- Designed to be a comprehensive biotherapeutic heart failure solution
Announcement
BioCardia, announced that the FDA has approved a protocol amendment for the CardiAMP Heart Failure II Trial, BioCardia's confirmatory Phase 3 trial of its autologous CardiAMP cell therapy product candidate for patients with ischemic heart failure of reduced ejection fraction (HFrEF).
AI Summary
BioCardia announced that the FDA has approved a protocol amendment for its CardiAMP Heart Failure II Trial. This confirmatory Phase 3 trial evaluates the autologous CardiAMP cell therapy candidate for patients with ischemic heart failure with reduced ejection fraction (HFrEF). The amendment allows patients who previously did not meet the criteria to receive extra cell deliveries to achieve the target minimum dose. The adjustment is based on the preprocedural CardiAMP Cell Population Analysis, which identifies patients most likely to benefit from the therapy and tailors the number of doses needed for those with lower therapeutic cell concentrations.
This change is expected to increase the number of eligible patients while improving the treatment process. According to BioCardia’s clinical team, this personalized dosing approach enhances the overall patient experience, efficiency for physicians, and coordination during the trial.
Read Announcement- Drug:
- CardiAMP
- Announced Date:
- July 25, 2024
- Indication:
- Designed to be a comprehensive biotherapeutic heart failure solution
Announcement
BioCardia, announced that hat the confirmatory Phase 3 trial of its autologous CardiAMP cell therapy product candidate for patients with ischemic heart failure of reduced ejection fraction (HFrEF) has commenced enrollment in the United States.
AI Summary
BioCardia recently announced that enrollment has begun in the United States for its confirmatory Phase 3 trial of the autologous CardiAMP cell therapy. This trial is designed for patients suffering from ischemic heart failure with reduced ejection fraction (HFrEF). The study will include 250 patients and is randomized and controlled, with each participant followed for a minimum of 12 months. Key outcomes being evaluated include all-cause death, the reduction of major adverse cardiovascular events, and improvements in quality of life. BioCardia is hopeful that this trial will confirm earlier trends of enhanced survival and better patient outcomes, potentially offering a safe and effective treatment option for those affected by this challenging condition. The commencement of enrollment marks an important step toward delivering a novel therapeutic solution for patients with HFrEF.
Read Announcement- Drug:
- CardiAMP
- Announced Date:
- May 1, 2024
- Indication:
- Designed to be a comprehensive biotherapeutic heart failure solution
Announcement
BioCardia announced the primary endpoint results of the open label roll-in cohort of the CardiAMP® Cell Therapy in Chronic Myocardial Ischemia Trial.
AI Summary
BioCardia announced positive primary endpoint results for its CardiAMP Cell Therapy in Chronic Myocardial Ischemia Trial. In the open label roll-in study cohort, patients with chronic myocardial ischemia and refractory angina showed significant improvement. After six months, patients experienced an average increase of 107 seconds in exercise tolerance and an 82% reduction in angina episodes compared to their condition before the therapy. Every patient in the study benefited from the treatment, showing enhanced exercise capacity and reduced chest pain symptoms.
These early findings support BioCardia's efforts to offer a cost-effective, minimally invasive, autologous cell therapy for patients with limited treatment options. The results suggest that CardiAMP may offer a promising alternative to current therapies for refractory angina. BioCardia presented these findings in an online webcast, highlighting the potential of the CardiAMP platform to improve patient outcomes and transform treatment approaches for cardiovascular disease.
Read Announcement
CardiAMP HF FDA Regulatory Timeline and Events
CardiAMP HF is a drug developed by BioCardia for the following indication: For Ischemic Heart Failure.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CardiAMP HF
- Announced Date:
- May 1, 2025
- Indication:
- For Ischemic Heart Failure
Announcement
BioCardia, Inc. announced the first patient enrolled in the Phase III randomized procedure placebo-controlled double-blind CardiAMP HF II clinical trial of the Company's lead autologous cell therapy program for the treatment of heart failure at BayCare Morton Plant Hospital in Clearwater, Florida.
AI Summary
BioCardia, Inc. has taken an important step in advancing heart failure treatment by enrolling the first patient in its Phase III CardiAMP HF II clinical trial at BayCare Morton Plant Hospital in Clearwater, Florida. This randomized, procedure placebo-controlled, double-blind study focuses on the Company's lead autologous cell therapy program. The therapy uses a patient’s own bone marrow cells, which are processed and delivered directly into the heart muscle using advanced, minimally invasive catheter systems. Medical experts, including Dr. Leslie Miller and Dr. Rakesh Sharma, are leading the effort to confirm whether this innovative treatment can enhance microvascular function and provide better clinical outcomes for patients with heart failure.
The trial represents a significant milestone in developing personalized treatments that preserve other therapeutic options and eliminate the need for immune suppression, offering hope for improved management of heart failure.
Read Announcement- Drug:
- CardiAMP HF
- Announced Date:
- March 31, 2025
- Indication:
- For Ischemic Heart Failure
Announcement
BioCardia, announced two-year outcomes from the double-blind randomized placebo-controlled Phase 3 CardiAMP-HF study of its CardiAMP autologous minimally invasive cell therapy for the treatment of ischemic heart failure in patients with reduced ejection fraction (HFrEF).
AI Summary
BioCardia, Inc. announced positive two-year outcomes from its Phase 3 CardiAMP-HF study, which evaluated the CardiAMP autologous minimally invasive cell therapy in patients suffering from ischemic heart failure with reduced ejection fraction (HFrEF). The study was a double-blind, randomized, placebo-controlled trial involving 115 patients across 18 centers in the United States and Canada. Patients received standard heart failure medication along with a single dose of CardiAMP therapy.
Results showed that, especially in patients with elevated NTproBNP biomarkers, the therapy significantly improved a composite outcome of survival, major adverse cardiac and cerebrovascular events (MACCE), and quality of life, when compared to medication alone. The findings suggest that CardiAMP therapy provides durable benefits by promoting healing in heart tissue, reducing fibrosis, and enhancing blood flow, offering a promising new treatment option for heart failure patients.
Read Announcement- Drug:
- CardiAMP HF
- Announced Date:
- January 27, 2025
- Indication:
- For Ischemic Heart Failure
Announcement
BioCardia, announced that the results of its double-blind randomized placebo-controlled CardiAMP HF Phase 3 study have been accepted for presentation in a late-breaking symposium at the American College of Cardiology 2025 Scientific Sessions, taking place in Chicago, March 29-31, 2025.
AI Summary
BioCardia announced that the results of its CardiAMP HF Phase 3 study have been accepted for a late-breaking symposium presentation at the American College of Cardiology 2025 Scientific Sessions in Chicago, scheduled for March 29-31, 2025. The study, a double-blind, randomized, placebo-controlled trial, focused on evaluating an autologous cell therapy designed to treat heart failure. This trial used patients’ own bone marrow cells, delivered via a minimally invasive procedure, to potentially boost heart repair by enhancing blood flow and reducing tissue scarring.
The upcoming presentation will offer key insights into how this innovative treatment works and its potential benefits for patients with heart failure. Experts from the cardiovascular field will have the chance to discuss these new findings, which could pave the way for improved care and new therapies for heart conditions.
Read Announcement
Morph® DNA™ FDA Regulatory Timeline and Events
Morph® DNA™ is a drug developed by BioCardia for the following indication: This product family is intended to provide a pathway through which medical instruments, such as balloon dilatation catheters, guidewires, or other therapeutic devices, may be introduced into the peripheral vasculature or chambers and coronary vasculature of the heart.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Morph® DNA™
- Announced Date:
- December 17, 2024
- Indication:
- This product family is intended to provide a pathway through which medical instruments, such as balloon dilatation catheters, guidewires, or other therapeutic devices, may be introduced into the peripheral vasculature or chambers and coronary vasculature of the heart.
Announcement
BioCardia announced today the commercial availability of its Morph DNA steerable introducer product family, currently utilized in the Company's ongoing cell-therapy clinical trials.
AI Summary
BioCardia announced the commercial availability of its Morph DNA steerable introducer product family. This innovative tool is now being used in the company's ongoing cell-therapy clinical trials, aiming to improve procedures aimed at treating cardiovascular diseases. The Morph DNA introducers are designed with features that include bidirectional steering, ergonomic actuation, an adjustable brake for fine control, and a swiveling side port to reduce tangling. These design elements, inspired by the double helix of DNA, allow for consistent performance and smooth navigation within the vascular system.
CEO Peter Altman, PhD, stated that the company is building a sales pipeline organically, without the extra costs of engaging direct sales teams or third-party partners. BioCardia looks forward to demonstrating the benefits of the Morph DNA product to physicians during various vascular procedures.
Read Announcement- Drug:
- Morph® DNA™
- Announced Date:
- August 29, 2024
- Indication:
- This product family is intended to provide a pathway through which medical instruments, such as balloon dilatation catheters, guidewires, or other therapeutic devices, may be introduced into the peripheral vasculature or chambers and coronary vasculature of the heart.
Announcement
BioCardia, that the Food and Drug Administration (FDA) has cleared BioCardia to market the Morph DNA Steerable Introducer product family, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act.
AI Summary
BioCardia, Inc. recently announced that the Food and Drug Administration (FDA) has granted clearance for its Morph DNA Steerable Introducer product family. This clearance, issued under the general controls provisions of the Federal Food, Drug, and Cosmetic Act, allows the company to market its innovative introducers designed to help guide medical devices into peripheral vessels and heart chambers.
The Morph DNA product family features advanced design elements like bidirectional steering, ergonomic actuation, and an adjustable brake for enhanced control. These features are expected to improve the accuracy and safety of procedures in interventional cardiology, radiology, cardiac electrophysiology, and vascular surgery. With multiple sizes available, the product family provides physicians with an effective tool to navigate complex anatomies, potentially reducing procedure times and improving patient outcomes.
Read Announcement- Drug:
- Morph® DNA™
- Announced Date:
- July 30, 2024
- Indication:
- This product family is intended to provide a pathway through which medical instruments, such as balloon dilatation catheters, guidewires, or other therapeutic devices, may be introduced into the peripheral vasculature or chambers and coronary vasculature of the heart.
Announcement
BioCardia, reported it has submitted a 510(k) for approval of its patented Morph® DNA™ Steerable Introducer Sheath.
AI Summary
BioCardia, a company focused on therapies for heart and lung diseases, has submitted a 510(k) application to the FDA for its patented Morph® DNA™ Steerable Introducer Sheath. This special medical device is designed to help guide instruments like balloon catheters and guidewires into the heart and peripheral blood vessels safely and reliably. The introducer sheath uses a unique double helix design where its tensioning elements rotate around the catheter shaft. This design ensures smooth navigation and consistent performance in any direction, helping to prevent sudden shifts or “whip” during procedures. By applying this technology, BioCardia hopes to expand the tool’s use across many complex cardiovascular and peripheral interventions, further supporting advancements in treating conditions such as heart failure and refractory angina.
Read Announcement
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