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FDA Approves CardiAMP® Heart Failure II Protocol Amendment to Use Proprietary Cell Population Analysis Screening to Define Treatment
Patented personalized medicine approach for patient dosing for autologous cell therapyExpected to meaningfully enhance clinical experience and market
About this update from Biocardia, Inc.
[{"type":"text","content":"Patented personalized medicine approach for patient dosing for autologous cell therapyExpected to meaningfully enhance clinical experience and market opportunity SUNNYVALE, Calif., Aug. 21, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced today 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). The protocol amendment allows patients who would have previously been excluded from treatment to receive additional cell deliveries to achieve the same target minimum dosage utilizing a treatment plan informed by the preprocedural CardiAMP Cell Population Analysis. “This is a substantial advance in autologous cell therapy built on the analysis of clinical data from the 125 patients enrolled in our CardiAMP Heart Failure I Trial,” said Debby Holmes-Higgin, Vice President of Clinical at BioCardia. “This modification is expected to enable the same dosing result to be achieved for more patients and enhance the ease, efficiency, and experience for patients, physicians, and coordinators, in the CardiAMP Heart Failure II Trial.” The CardiAMP Cell Population Analysis approach was developed to select patients most likely to respond to therapy based on their therapeutic cell composition at screening. In the CardiAMP Heart Failure II Trial, available clinical results enabled both refinement of the algorithm and development of a personalized treatment plan for patients below the Cell Population Analysis acceptance criteria. Such treatment plans adjust the number of dosing aliquots for patients with lower concentrations of important specified cells. Combined, the algorithm modifications and development of the treatment plan approach are expected to considerably increase the number of patients eligible for the trial. About CardiAMP Cell Therapy Designated by the FDA as a Breakthrough Therapy, CardiAMP Cell Therapy uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response. CardiAMP Cell Therapy inc...