BioCardia Announces FDA and PMDA Regulatory Timeline for CardiAMP® Cell Therapy and Helix™ Catheter
BioCardia, Inc. announced its anticipated timeline for seeking FDA and Japan PMDA approvals for its CardiAMP® Cell Therapy System and Helix™ Transendo...
Breakthrough Clinical Results
BioCardia, Inc. announced its anticipated timeline for seeking FDA and Japan PMDA approvals for its CardiAMP® Cell Therapy System and Helix™ Transendocardial Delivery Catheter. The company plans to submit a DeNovo 510(k) application for Helix to the FDA in Q3 2025, followed by a submission and meeting request for CardiAMP Cell Therapy for ischemic heart failure in Q4 2025. A clinical consultation meeting with the Japan PMDA is also expected in Q4 2025. The CardiAMP therapy uses a patient's own bone marrow cells delivered to the heart to treat microvascular dysfunction, and positive results from previous clinical trials (NCT06258447, NCT02438306, NCT00768066, NCT00507468) support the application. The therapy is currently in Phase IIIB clinical trials.
Key Highlights
- Planned Q3 2025 FDA DeNovo 510(k) submission for Helix Transendocardial Delivery System.
- Anticipated Q4 2025 FDA submission and meeting request for CardiAMP Cell Therapy for ischemic heart failure.
- Expected Q4 2025 clinical consultation meeting with Japan PMDA for CardiAMP Cell Therapy.
- CardiAMP HF II trial (NCT06258447) actively enrolling in the US.
Incidence and Prevalence
Global Estimates of Heart Failure Incidence and Prevalence
Heart failure represents a continuing global burden, with cardiovascular disease (CVD) constituting 50% of all deaths worldwide despite advances in treatment. It is a global problem with an estimated prevalence of 38 million patients worldwide, a number that is increasing with the ageing of the population.
The prevalence of heart failure ranges from 3-20 per 1,000 and increases steeply with age. In the United States, there has been a tremendous increase in both the incidence and prevalence of heart failure. Recent statistical data (2022) estimate that 5.7 million Americans over 20 years of age have congestive heart failure (CHF), with projections indicating an increase of approximately 46.0% between 2012 and 2030.
In Brazil, while specific epidemiological studies on heart failure incidence are lacking, estimates suggest up to 6.4 million Brazilians suffer from this syndrome.
A German population-based study (2009) of 1,779 subjects aged 45-83 years found the overall age-standardized prevalence of symptomatic CHF was 7.7% (95%CI 6.0-9.8) for men and 9.0% (95%CI 7.0-11.5) for women. The prevalence strongly increased with age from 3.0% among 45-54-year-olds to 22.0% among 75-83-year-olds.
In terms of heart failure types, symptomatic HFREF (heart failure with reduced ejection fraction) was found in 48% of subjects with CHF, while symptomatic HFNEF (heart failure with normal ejection fraction) was found in 52%. The age-standardized prevalence of HFREF was 3.8% for women and 4.6% for men, while HFNEF prevalence was 5.1% for women and 3.0% for men.
The INTERnational Congestive Heart Failure Study, a cohort study of 5,813 HF patients from 108 centers in 16 low-income and middle-income countries, revealed that the mean age of HF patients was 59 ± 15 years, 40% were female, 62% had hypertension, 30% had diabetes, and 21% had prior myocardial infarction. Additionally, 29% had HF with preserved left ventricular ejection fraction.
Coronary heart disease is the underlying cause in 50% of heart failure cases, while idiopathic cardiomyopathy accounts for 20%. In developing countries with limited HAART availability and significant nutritional factors, a 32% increase was observed in the prevalence of cardiomyopathy and related high mortality from congestive heart failure.
The prognosis remains poor, with survival at 5 years after heart failure onset being only 25% in men and 38% in women according to the Framingham study. Mortality rates have increased 40%-50% in advanced cardiac failure and 15%-25% in mild to moderate cardiac failure within one year of diagnosis.
The economic burden is substantial, with the cost of managing heart failure in the US reaching $56 billion annually, 70% of which is attributed to hospitalization.
Key Unmet Needs and Target Populations for Heart Failure
Recent publications highlight several unmet needs and underserved populations in heart failure management:
Economic and Healthcare System Challenges
- Hospital readmission rates represent a significant economic challenge for the United States healthcare system
- Congestive heart failure has a 30-day readmission rate of 23.2%
- There is a need for more cost data and patient satisfaction metrics to evaluate intervention effectiveness
Underserved Populations
- Indigenous populations face disproportionate heart failure challenges
- In New Zealand, atrial fibrillation was more prevalent in indigenous Māori octogenarians (26% at baseline, increasing to 50% over 5 years) compared to non-Māori (18% at baseline, increasing to 33%)
- AF incidence for Māori was twice that of non-Māori, highlighting significant ethnic disparities
- Octogenarians represent an underserved population, with "little known about AF in octogenarians" despite its significant healthcare burden
- Rural communities require specialized approaches to heart failure management
Treatment Gaps
- Standard therapy for chronic heart failure has limitations, prompting exploration of alternative treatments
- Recombinant human brain natriuretic peptide (BNP) has emerged as a potential therapy
- The relationship between atrial fibrillation and mortality remains controversial in heart failure patients
- In nonischemic cardiomyopathy, there is not a strong correlation between ventricular arrhythmias and sudden death risk, suggesting gaps in risk stratification
- SGLT2 inhibitors have demonstrated a 19% risk reduction in congestive heart failure beyond traditional risk factors control
Intervention and Research Needs
- Mobile integrated health care (MIH) programs show promise but have mixed results
- A study of a rural Pennsylvania health system MIH program showed reduced emergency department utilization but no significant change in all-cause inpatient utilization
- For CHF-only encounters, there was no significant change in utilization between cases and controls
- There is a lack of published data on MIH program outcomes
- Ethnic-specific research is needed to understand the "impact and risks and benefits of treating AF in octogenarians"
- Prospective studies are needed to better assess effects on inpatient utilization
- Further research is required to determine the efficacy and safety of lyophilized recombinant human BNP in CHF patients
- Research is needed on BNP's impact on microinflammatory status in heart failure patients
These findings underscore the need for targeted interventions for specific populations and continued research into novel therapeutic approaches to address the persistent challenges in heart failure management.
CardiAMP Cell Therapy Indications and Intervention Models
There is insufficient information available to provide details about CardiAMP Cell Therapy trials for indications other than heart failure. The current data does not contain specific information about:
- Additional clinical indications beyond cardiac applications
- Intervention models used in these trials
- Dosing regimens for non-cardiac applications
- Administration methodologies for CardiAMP therapy
- Trial protocols for alternative indications
CardiAMP Cell Therapy utilizes autologous bone marrow-derived cells, but further details about its applications beyond heart failure cannot be determined from the available information.
For comprehensive information about CardiAMP Cell Therapy trials for other indications, consulting clinical trial registries such as ClinicalTrials.gov or reaching out directly to the therapy's developer would be recommended.
