BioCardia Receives FDA Breakthrough Device Designation for CardiAMP Cell Therapy System for Heart Failure
BioCardia, Inc. (Nasdaq: BCDA) announced that the FDA has granted Breakthrough Device Designation for its CardiAMP® Cell Therapy System aimed at treating heart failure. This designation marks it as the first cardiac cell therapy to receive such status. The therapy utilizes a patient's own bone marrow cells delivered minimally invasively, intending to enhance treatment efficacy and patient safety. Currently, the CardiAMP Heart Failure Trial is enrolling patients to assess the therapy's effectiveness, with promising past results indicating significant improvements in exercise tolerance and quality of life.
- FDA Breakthrough Device Designation received for CardiAMP Cell Therapy.
- First cardiac cell therapy to achieve Breakthrough Device status.
- Therapy aims to improve patient outcomes in heart failure, potentially addressing over 1.2 million patients in the U.S.
- No mortality reported at one year in prior clinical trials.
- Positive results in improving exercise tolerance and quality of life from earlier studies.
- None.
CardiAMP Cell Therapy uses a patient’s own (autologous) bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure. The therapy incorporates a pre-procedural screening assay to identify patients who may be likely responders, a first for a cardiac cell therapy and designed to enhance patient selection. Eligible patients receive a high dose of cells using an intramyocardial delivery system that has been shown in published literature to present the lowest risk to patients for biotherapeutic delivery1 and to be three to six times more efficient at delivering cells to the heart muscle than other methods.2 This approach allows the patient to be discharged from the hospital the morning after the procedure.
CardiAMP Cell Therapy is designed to potentially stimulate the body’s natural healing response, provoking a beneficial paracrine reaction to repair the heart. This is a different mechanism of action from other therapies that have sought to transform stem cells into new heart cells, a method that has presented patient risks, such as rhythm abnormalities and cell rejection.
“It is exciting for the field of cardiology that the FDA has recognized the potential of a cell therapy to improve the lives of patients struggling with heart failure. Getting this therapy fast-tracked and to patients more quickly than traditional methods would give us new options and a greater armamentarium to assist our patients in need. I am enthusiastic about completing the
The CardiAMP Cell Therapy Heart Failure Trial is a
The CardiAMP Cell Therapy System has shown no incidence of mortality at one year in its Phase II trial or in the 10-patient roll-in cohort from the Phase III trial that is currently enrolling. Earlier studies of the therapy have shown statistically significant improvement in exercise tolerance and quality of life.
“We thank the FDA for granting Breakthrough Device Designation to the CardiAMP Cell Therapy System and recognizing its potential to provide more effective treatment for heart failure, a major achievement for this unique therapy,” said
He continued, “Past trials of cell therapy delivered intramyocardially showed benefit in improving heart function, but they did not reach statistical significance. We learned from these earlier approaches and added three elements that we believe improve our probability of success: a pre-procedural diagnostic for patient selection, a higher target dosage of cells, and a proprietary delivery system that has been shown to be safer than other intramyocardial delivery systems and exponentially more successful in cell retention. It is our intention that CardiAMP Cell Therapy could complement and enhance new pharmaceutical approaches to bring greater benefit to patients upon FDA approval.”
The Breakthrough Devices Program is designed to expedite FDA approval of certain novel devices or device-led combination products (products that combine drugs, devices or biological products) that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
About Heart Failure
Heart Failure (HF) is a complex clinical syndrome that results from any structural or functional impairment of ventricular filling or ejection of blood. The cardinal manifestations of HF are dyspnea and fatigue, which may limit exercise tolerance, and fluid retention, which may lead to pulmonary congestion and/or peripheral edema. Projections show that the prevalence of HF in
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1 Duckers HJ, Raval A, Pepine CJ, et al. Performance of Helix transendocardial biotherapeutic delivery system after 300 cases. Poster Presentation at
2 Mitsutake, Y. Pyun WB, Rouy D, et al. Improvement of local cell delivery using Helix transendocardial delivery catheter in a porcine heart, Int. Heart J. 58 (2017) 435–440.
3 de la Fuente LM, Stertzer SH, Argentieri J, et al. Transendocardial autologous bone marrow in myocardial infarction induced heart failure, two-year follow-up in an open-label phase I safety study (the TABMMI study). EuroIntervention:
4 Heldman AW, DiFede DL, Fishman JE, et al. Transendocardial mesenchymal stem cells and mononuclear bone marrow cells for ischemic cardiomyopathy: the TAC-HFT randomized trial. JAMA. 2014;311:62-73.
5
6 Raval AN, Johnston PV, Duckers HJ, , et al. Point of care, bone marrow mononuclear cell therapy in ischemic heart failure patients personalized for cell potency: 12-month feasibility results from CardiAMP heart failure roll-in cohort. Int J Cardiol. 2021
7 Raval AN, Johnston P, Phillips J, , et al. High Doses of CD34+ Cells Delivered to Patients in the CardiAMP Cell Therapy Heart Failure Trial, presented at the
8 Heidenreich, PA, Albert, NM et al; on behalf of the American Heart Association Advocacy Coordinating Committee;
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FAQ
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