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
CardiAMP, Helix, CardiAMP, CardiALLO-HF, BCDA-03, Morph®, and BCDA-01. 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.
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:
- April 2, 2026
- Indication:
- Designed to be a comprehensive biotherapeutic heart failure solution
Announcement
BioCardia®, Inc reported submission to United States Food and Drug Administration (FDA) of the CardiAMP HF clinical study data and on its plans to meet with the FDA to discuss the accelerated approval pathway for the CardiAMP® System for ischemic chronic heart failure with reduced ejection fraction (HFrEF).
AI Summary
BioCardia reported that it submitted the CardiAMP HF clinical study data to the U.S. Food and Drug Administration and plans to meet with the FDA this quarter to discuss an accelerated approval pathway for the CardiAMP System to treat ischemic chronic heart failure with reduced ejection fraction (HFrEF). The company said the meeting’s main goals are to get FDA feedback on whether the proposed submission is acceptable for approval based on the safety data from the CardiAMP HF trial, the clinical response data from the 125 ischemic HFrEF patients enrolled, and the favorable risk‑benefit profile seen in the trial subgroup with elevated biomarkers of heart stress.
BioCardia noted these are forward‑looking plans and are subject to risks and uncertainties, so outcomes and timing are not guaranteed.
Read Announcement- Drug:
- CardiAMP
- Announced Date:
- December 16, 2025
- Indication:
- Designed to be a comprehensive biotherapeutic heart failure solution
Announcement
BioCardia®, Inc. announces it has completed a third preliminary clinical consultation with Japan's Pharmaceutical and Medical Device Agency (PMDA) on our CardiAMP Cell Therapy intended for treatment of Heart Failure with Reduced Ejection Fraction (HFrEF).
AI Summary
BioCardia announced it has completed a third preliminary clinical consultation with Japan’s Pharmaceutical and Medical Device Agency (PMDA) for CardiAMP Cell Therapy, its autologous treatment for Heart Failure with Reduced Ejection Fraction (HFrEF). The meeting prepared the company for a formal clinical consultation to determine whether the existing clinical data are acceptable for a regulatory submission. Based on the latest discussions, PMDA said BioCardia may advance to formal consultation. If PMDA agrees the available data show sufficient safety and efficacy, BioCardia could file for approval in Japan.
CardiAMP is a minimally invasive, catheter-delivered therapy using a patient’s own bone marrow cells aimed at repairing microvascular damage in ischemic heart failure. BioCardia says pooled results from three completed Phase I–III studies support positive outcomes — including improved survival, fewer major adverse cardiac events, better heart function, and improved quality of life — and indicate a favorable benefit‑risk profile as regulatory review continues in Japan.
Read Announcement- Drug:
- CardiAMP
- Announced Date:
- September 22, 2025
- Indication:
- Designed to be a comprehensive biotherapeutic heart failure solution
Announcement
BioCardia®, Inc. , announces it has had a positive preliminary clinical consultation with Japan's Pharmaceutical and Medical Device Agency (PMDA) on the CardiAMP Heart Failure Trial results previously provided to the agency.
AI Summary
BioCardia announced a positive preliminary clinical consultation with Japan’s Pharmaceutical and Medical Device Agency (PMDA) on the results of its CardiAMP Heart Failure Trial. The meeting prepared both sides for a formal review of the clinical data needed to apply for approval.
During the session, PMDA requested details on how the prespecified composite endpoints were positioned, the statistical power behind the study, the clinical rationale for the NT-proBNP patient subgroup, their risk-benefit profile, the anticipated number of patients in Japan, and the trial’s status in the United States. BioCardia is finalizing its responses and expects a formal consultation by year’s end.
CEO Peter Altman said the company looks forward to working with PMDA on three completed trials involving 178 ischemic heart failure patients. Their goal is to extend this therapy to patients who currently have few treatment options.
The CardiAMP therapy is an autologous, minimally invasive cell treatment that showed significant benefits in ischemic heart failure patients. BioCardia aims to give patients with limited options access to this new therapy.
Read Announcement- Drug:
- CardiAMP
- Announced Date:
- August 4, 2025
- Indication:
- Designed to be a comprehensive biotherapeutic heart failure solution
Announcement
BioCardia®, today provides the anticipated timing of regulatory activities seeking FDA and Japan PMDA approvals of its CardiAMP® Cell Therapy System and Helix Transendocardial Delivery Catheter.
AI Summary
BioCardia today announced the timing of its next regulatory steps for the CardiAMP® Cell Therapy System and Helix Transendocardial Delivery Catheter. In Q3 2025, the company plans to submit the Helix catheter to the FDA as a De Novo 510(k) application. This submission will draw on safety and performance data from over 4,000 intramyocardial deliveries, and will highlight improved therapeutic agent retention in the heart.
In Q4 2025, BioCardia expects to file its CardiAMP Cell Therapy for the treatment of ischemic heart failure and request a meeting with the FDA to discuss the approval pathway. The company will present its clinical data to support safety and potential patient benefits.
Also in Q4 2025, BioCardia will hold an in-person clinical consultation with Japan’s PMDA. If aligned, this meeting could pave the way for a CardiAMP market submission in Japan under the adaptive framework for regenerative medical products.
Read Announcement- Drug:
- CardiAMP
- Announced Date:
- July 24, 2025
- Indication:
- Designed to be a comprehensive biotherapeutic heart failure solution
Announcement
BioCardia®, Inc announced that it submitted its CardiAMP autologous cell therapy investigational heart failure treatment for clinical consultation with Japan's Pharmaceuticals and Medical Devices Agency (PMDA).
AI Summary
BioCardia, Inc. announced it submitted its CardiAMP autologous cell therapy for heart failure to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for clinical consultation. This step is key for possible approval in Japan, a major market for advanced heart therapies.
The submission included the full CardiAMP HF Trial data and the main section of the Summary Technical Documentation. This document shows that the CardiAMP System meets safety and performance requirements. The PMDA will review the clinical data, the proposed patient groups, and how the therapy fits into Japanese care for heart failure.
Getting PMDA feedback will help BioCardia shape its regulatory plans. The company expects to use agency insights to strengthen its application and may begin a post-marketing study in Japan next year. BioCardia is also seeking local partners to support this effort.
Read Announcement- 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
Helix Transendocardial Delivery Catheter FDA Regulatory Events
Helix Transendocardial Delivery Catheter is a drug developed by BioCardia for the following indication: intramyocardial therapeutic and diagnostic agent delivery.
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:
- Helix Transendocardial Delivery Catheter
- Announced Date:
- March 17, 2026
- Indication:
- intramyocardial therapeutic and diagnostic agent delivery.
Announcement
BioCardia®, Inc. announced the FDA has accepted its pre-submission package for the approval of its Helix Transendocardial Delivery Catheter ("Helix") intended for intramyocardial therapeutic and diagnostic agent delivery.
AI Summary
BioCardia, Inc. announced the U.S. Food and Drug Administration has accepted its pre-submission package for the Helix Transendocardial Delivery Catheter. The Helix is designed to deliver therapeutic and diagnostic agents directly into heart muscle (intramyocardial delivery), targeting precise placement of treatments and samples within the myocardium.
Acceptance of a pre-submission package starts a formal interaction with the FDA, allowing the agency to review BioCardia’s plans and give feedback before a full approval application. This step helps clarify what clinical data, testing and safety information the company will need and can streamline later review. BioCardia will use FDA input to refine study and device plans as it moves toward formal submissions and clinical evaluation. The acceptance is a key regulatory milestone for advancing the Helix as a platform for targeted heart therapies.
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:
- March 3, 2026
- Indication:
- For Ischemic Heart Failure
Announcement
BioCardia, today reported late breaking echocardiography results from its Phase III clinical trial for ischemic heart failure of reduced ejection fraction (HFrEF), which affects millions of patients in the United States.
AI Summary
BioCardia today reported late-breaking echocardiography results from its Phase III trial of CardiAMP cell therapy in ischemic heart failure with reduced ejection fraction (HFrEF), a condition that affects millions in the United States. In patients with elevated baseline NT‑proBNP, a marker of heart stress, CardiAMP was associated with less adverse cardiac remodeling based on core‑lab measured left ventricular volumes.
Investigators noted reduced ventricular size, which is linked to better long‑term outcomes for heart failure patients. Cleveland Clinic’s Dr. Wilson Tang said the treatment showed less remodeling in the high NT‑proBNP subgroup, and Dr. Carl Pepine emphasized the growing burden of ischemic heart failure and the limited impact of current drugs, highlighting the promise of targeting specific patient subgroups.
BioCardia views the findings as additional evidence supporting CardiAMP’s potential benefit for ischemic HFrEF. The full presentation is available on BioCardia’s website.Read Announcement
- Drug:
- CardiAMP HF
- Announced Date:
- February 3, 2026
- Indication:
- For Ischemic Heart Failure
Announcement
BioCardia®, Inc. announced echocardiography data for the CardiAMP Cell Therapy for the treatment of heart failure has been accepted for Late Breaking Clinical Trial Oral Presentation at the Technology and Heart Failure Therapeutics (THT) Meeting, which takes place March 2-4 in Boston, Massachusetts.
AI Summary
BioCardia, Inc. announced that echocardiography data for its CardiAMP Cell Therapy, a treatment for heart failure, has been accepted for a Late Breaking Clinical Trial Oral Presentation at the Technology and Heart Failure Therapeutics (THT) Meeting, March 2–4 in Boston. The data come from the CardiAMP HF trial and focus on autologous cell therapy — using a patient’s own cells — to treat chronic ischemic heart failure with reduced ejection fraction (HFrEF).
On behalf of the CardiAMP HF investigators, Dr. Amish Raval, M.D., Professor of Medicine at the University of Wisconsin School of Medicine and Public Health and National Co-Principal Investigator, will present the findings. The presentation, titled "Autologous Cell Therapy May Curb Pathological Ventricular Remodeling in Chronic Ischemic HFrEF Patients Selected for Favorable Cell Characteristics - Late Breaking Echocardiography Results from the CardiAMP HF trial," is scheduled for March 2 at 2:00 PM EST during the THT Late Breaking session. The acceptance highlights clinical interest in the trial’s echo results.Read Announcement
- Drug:
- CardiAMP HF
- Announced Date:
- November 10, 2025
- Indication:
- For Ischemic Heart Failure
Announcement
BioCardia, Inc. announced the first patient enrolled at Henry Ford Health in its ongoing Phase 3 CardiAMP® HF II clinical trial for patients with ischemic heart failure of reduced ejection fraction ("HFrEF").
AI Summary
BioCardia announced the first patient has been enrolled at Henry Ford Health in its ongoing Phase 3 CardiAMP® HF II clinical trial for patients with ischemic heart failure with reduced ejection fraction (HFrEF). The trial tests a one-time autologous cell therapy delivered via a minimally invasive catheter-based procedure aimed at improving microvascular function and patient outcomes.
CardiAMP HF II is a 250-patient, randomized, multicenter, procedure placebo-controlled study enrolling patients on guideline-directed medical therapy who have elevated NT‑proBNP. The study’s primary composite outcome includes all-cause death, nonfatal major adverse cardiac events, and a validated quality-of-life measure. The trial seeks to confirm safety and efficacy signals seen previously in a focused patient group.
Dr. Gerald Koenig and the Henry Ford team are recruiting patients to this confirmatory study. BioCardia’s leadership says the results so far suggest the therapy could help a large group of ischemic HFrEF patients who have limited treatment options.Read Announcement
- Drug:
- CardiAMP HF
- Announced Date:
- October 30, 2025
- Indication:
- For Ischemic Heart Failure
Announcement
BioCardia, Inc. announced the first patient enrolled at University of Wisconsin School of Medicine and Public Health in its ongoing Phase 3 CardiAMP HF II clinical trial.
AI Summary
BioCardia, Inc. announced the first patient enrolled at the University of Wisconsin School of Medicine and Public Health in its ongoing Phase 3 CardiAMP HF II clinical trial. CardiAMP cell therapy uses a patient’s own bone marrow cells delivered via a minimally invasive catheter to strengthen heart function in ischemic heart failure patients who remain at risk despite guideline medical therapy and elevated NT-proBNP levels.
Dr. Amish Raval, National Co-Principal Investigator, said early evidence of benefit makes this study important for advancing treatment options and offering patients access to a promising therapy. Peter Altman, BioCardia’s CEO, praised UW’s leadership, noting that its involvement strengthens this multicenter trial and aligns with the goal of translating specialized medicine into personalized care to improve outcomes.
CardiAMP HF II is a randomized, placebo-controlled study of 250 patients evaluating safety and efficacy through a composite endpoint of all-cause death, major cardiac events, and quality of life measures. The trial aims to confirm earlier positive results and support broader use of this novel cell therapy for heart failure.
Read Announcement- 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
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.
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.
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
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
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