Biocardia, Inc. · NASDAQ:BCDA
Biocardia — Technical Presentation (April 2026)
36 slides from Biocardia's technical presentation, Apr 28, 2026
Slide 1: CardiAMP Cell Therapy for Ischemic HFrEF: Scientific Background
CardiAMP® Cell Therapy for Ischemic HFrEF Scientific Background 05141-C (MKT) Science of CardiAMP Cell Therapy 4/28/2026 1
Slide 2: Science of CardiAMP Cell Therapy for Ischemic HFrEF - Overview
Science of CardiAMP Cell Therapy for Ischemic HFrEF - Overview Mononuclear cell therapy – Preclinical and Clinical Experience o Rats: Paracrine stimulus study- reduces scar and leads to microvessel formation o Pigs: Dose dependent study- higher dose reduces scar and leads to increased microvessel
Slide 3: What is Marrow Derived Mononuclear Cell Therapy?
What is Marrow Derived Mononuclear Cell Therapy? • Stem cell therapies may offer the potential to treat diseases or conditions for which few treatments exist. • Sometimes called the body’s “master cells,” stem cells are the cells that develop into blood, brain, bones, and all of the body’s organs. •
Slide 4: Cardiac Cell Therapy: Mechanisms of Action to Enhance Microvascular Function
Cardiac Cell Therapy: Mechanisms of Action to Enhance Microvascular Function Cell therapies have been shown to provide paracrine mediators, which are released from the cells. These promote potentially valuable mechanisms of action. Significant compelling preclinical data sets using marrow derived
Slide 5: Marrow Mononuclear Cells – Preclinical Experience
Marrow Mononuclear Cells – Preclinical Experience Small (rats, mice) and large animal (swine, canine) studies support safety and efficacy of bone marrow cells. A few of these are provided. Takahashi et al. (2006): o Explored paracrine mechanism in rats o BMC media injected after overnight incuba
Slide 6: Marrow Mononuclear Cells – Preclinical Experience (Rat)
Marrow Mononuclear Cells – Preclinical Experience (Rat) Paracrine Stimulus: BMC Media (Normoxia and Hypoxia) led to reduced fibrotic scar and enhanced microvessel density in the infarcted rat myocardium 28 Days after treatment Reduced Fibrosis Increased Microvessel Density Takahashi, M. et al. (2006
Slide 7: Cardiac Function Enhanced After Marrow Cells or Medium Transplantation in Rats
Cardiac Function Enhanced After Marrow Cells or Marrow Cells Medium Transplantation in Rats Results of echocardiography showing more rapid loss of function and ventricular dilation in the control group [sham group, n = 6; medium group, n = 9; and bone marrow cell-transplanted (BMC) group, n = 9] Sun
Slide 8: Marrow Mononuclear Cells – Preclinical Experience (Pig)
Marrow Mononuclear Cells – Preclinical Experience (Pig) Dose Dependence: Higher dose of mononuclear cells led to less fibrosis and increased microvessel formation in infarcted pig myocardium 60 days after treatment Reduced Fibrosis >100 Million MMC resulted in less fibrosis Increased Capillary Densi
Slide 9: Enhancing Microvascular Function
Enhancing Microvascular Function Microvascular dysfunction is increasingly recognized as a common pathway in a variety of manifestations of cardiovascular disease, including chronic angina and acute coronary syndromes in patients both with and without epicardial coronary disease. Similarly, it is cr
Slide 10: Marrow Mononuclear Cells Clinical Experience
Marrow Mononuclear Cells Clinical Experience Relevant Conclusions: • Every 3% higher level of CD34 cells was associated with on average a 3.0% greater absolute unit increase in LVEF in multiple variable model that included age and treatment as predictor variables [95% CI, 0.14-5.98]; (P = 0.04) • An
Slide 11: Marrow Mononuclear Cells Clinical Experience: 2018 Meta Analysis Update
Marrow Mononuclear Cells Clinical Experience 2018 Meta Analysis Update - Highlights • Mortality rate in patients - with BM MNC therapy was significantly lower (15.4%; RR 0.38) on meta analysis of 21 randomized trials in 1010 pts) • Cell therapy was associated with a reduction in non-fatal MI (RR 0.4
Slide 12: CardiAMP Autologous Cell Therapy Overview
CardiAMP Autologous Cell Therapy Overview 05141-C (MKT) Science of CardiAMP Cell Therapy 4/28/2026 12
Slide 13: CardiAMP Autologous Cell Therapy: Pre-Procedure Cell Screening
CardiAMP Autologous Cell Therapy: Pre-Procedure Cell Screening Targets 88% anticipated to be most likely to respond based on therapeutic potential of their bone marrow Personalized approach to treatment using cell therapy with goal to treat the patients whose own cells, based on previous studies,
Slide 14: CardiAMP Autologous Cell Therapy Step 2: Cell Processing
CardiAMP Autologous Cell Therapy Step 2: Cell Processing Cell poor plasma Nucleated cell concentrate Red blood cells • Isolation and approx. 7-10x concentration of nucleated BM fraction at point-of-care • Isolation of 60 cc of BM aspirate able to create a target dose of 200 Mill BM MNC • Minimal pro
Slide 15: CardiAMP Autologous Cell Therapy Step 3: Delivery
CardiAMP Autologous Cell Therapy Step 3: Delivery • Cells are delivered transendocardially to 10 pre-specified target sites in myocardial wall surrounding the infarct zone • Pre-procedure echocardiography is used to target sites • Navigation using fluoroscopy, with biplane recommended but not requir
Slide 16: CardiAMP Autologous Cell Therapy Step 3: Delivery Targeting
CardiAMP Autologous Cell Therapy Step 3: Delivery Targeting To be enhanced by proprietary Heart3D Fusion Imaging Annotated anatomical overlays and echo wall motion / thickness bullseye targeting. 05141-C (MKT) Science of CardiAMP Cell Therapy 16 4/28/2026 16
Slide 17: Qualitative Assessment of CardiAMP Cell Delivery Approaches
Qualitative Assessment of CardiAMP Cell Delivery Approaches: Trans-endocardial (Helix), Trans-epicardial, and Coronary Artery Delivery . Trans-endocardial Helix Trans-epicardial Coronary Artery Surgical PET imaging of cells in swine model shows superior myocardial retention with Helix delivery. Circ
Slide 18: Quantitative Assessment of CardiAMP Cell Delivery Approaches
Quantitative Assessment of CardiAMP Cell Delivery Approaches Trans-endocardial (Helix), Trans-epicardial, and Coronary Artery Delivery 3x Increased Efficiency of Delivery Increases Effective Dosage Helical shaped needle in Helix/Morph delivery device results in superior myocardial retention and high
Slide 19: Phase 1 CardiAMP HF Trial: TABMMI Study NCT00507468
Phase 1 CardiAMP HF Trial : TABMMI Study NCT00507468 The Transendocardial Autologous Bone Marrow in Myocardial Infarction clinical study (TABMMI ClinicalTrials.gov Identifier NCT00507468) was an open label safety trial carried out in Argentina using autologous mononuclear cells prepared from the bon
Slide 20: CardiAMP HF Phase I Trial Design and Results
CardiAMP HF Phase I Trial Design and Results Trans-endocardial Autologous Bone Marrow in Myocardial Infarction (TABMMI) NCT00507468 Safety: No Treatment Emergent-MACE Exercise Tolerance Time Improvement at 12 & 24M: 20 Ischemic Heart Failure Patients ~ +125 sec, p=0.006 LVEF<40% NYHA Class I, II, an
Slide 21: Phase 2 CardiAMP HF Trial: TAC HFT Study NCT00768066
Phase 2 CardiAMP HF Trial : TAC HFT Study NCT00768066 The TAC-HFT study protocol, a phase 1 and 2, randomized, double-blind, placebo-controlled study to demonstrate the safety and efficacy of both mesenchymal stem cells and bone marrow mononuclear cells administered tranendocardially in patients wit
Slide 22: Phase 2 CardiAMP HF Trial: TAC HFT Study NCT00768066
Phase 2 CardiAMP HF Trial : TAC HFT Study NCT00768066 Transendocardial Autologous Cells in Heart Failure Trial (TAC-HFT), NCT00768066 Primary safety endpoint was met: no treatment-emergent MACE at 30 days pp; no death or MACE in BMC treatment group at one year follow-up All secondary efficacy endp
Slide 23: Phase 2 CardiAMP HF Trial: TAC HFT Study NCT00768066
Phase 2 CardiAMP HF Trial : TAC HFT Study NCT00768066 Primary safety endpoint met: no treatment emergent MACE at 30 days No death or MACE in BMC treatment group at one year follow-up All secondary efficacy endpoints at one year follow-up favor therapy (below) Multiple endpoints that are statisti
Slide 24: Phase 2 TAC HFT: Improvements Larger Than Other Pivotal Trials
Phase 2 CardiAMP HF Trial : TAC HFT Study NCT00768066 Improvements in Quality of Life and Six Minute Walk Larger Than Other Pivotal Trials for Established Therapies 1 CRT, Miracle-ICD, JAMA, 2003 2 Cells, REVASCOR, Circ Res 2005 CRT = Cardiac Resynchronization Therapy or 3 CRT, Contak CD, JACC, 20
Slide 25: Phase III: CardiAMP HF Study NCT02438306
Phase III: CardiAMP HF Study NCT02438306 Trial size: Breakthrough Device Designation granted by 125 Ischemic Heart Failure FDA based on results from three trials to Patients LVEF<40% date. NYHA Class II and III Key Eligibility Criteria • Chronic ischemic HFrEF with LVEF 20-40% Design: • NYHA II/III
Slide 26: Phase III: CardiAMP HF Study NCT02438306
Phase III: CardiAMP HF Study NCT02438306 Primary Outcome: Hierarchical composite ranking using Finkelstein Schoenfeld: Tier 1. All cause death, cardiac transplant, LVAD Tier 2. Non-fatal MACE (HF hospitalizations, MI, stroke) Tier 3. Change in 6MWD from baseline to last follow-up Pre-specified Secon
Slide 27: Phase III: CardiAMP HF Study NCT02438306
Phase III: CardiAMP HF Study NCT02438306 Baseline Periprocedural Safety • 3 pericardial effusions • No sustained arrhythmias 05141-C (MKT) Science of CardiAMP Cell Therapy 4/28/2026 27
Slide 28: Phase III: Primary and Key Secondary Outcomes
Phase III: CardiAMP HF Study NCT02438306 Primary and Key Secondary Outcomes A C A C Tier 3 6MWD MLHFQ +5.7m +27.1m 5.5 pts improvement WR = 0.99 WR = 1.42 (CI: 0.63-1.56) (CI: 0.91-2.22) p = 0.96 p = 0.14 05141-C (MKT) Science of CardiAMP Cell Therapy 4/28/2026 28
Slide 29: Phase III: LV Volume Indices-Full population
Phase III: CardiAMP HF Study NCT02438306 LV Volume Indices-Full population LVEDVi LVESVi p p= 0.06* p= 0.09* n=41 n=41 n=74 n=74 29
Slide 30: Phase III: Prespecified Subgroup Analysis
Phase III: CardiAMP HF Study NCT02438306 Prespecified Subgroup Analysis 05141-C (MKT) Science of CardiAMP Cell Therapy 4/28/2026 30
Slide 31: Phase III: Subgroup with NTproBNP/BNP >500 pg/ml
Phase III: CardiAMP HF Study NCT02438306 Subgroup with NTproBNP/BNP >500 pg/ml A C A C Tier 3 6MWD MLHFQ +14m +0m 9.9 pts improvement WR=1.61 WR=2.02 CI 0.84-3.08 CI 1.01- 4.03 p=0.15 p =0.04 05141-C (MKT) Science of CardiAMP Cell Therapy 4/28/2026 31
Slide 32: Phase III: Subgroup LV Volume Indices
Phase III: CardiAMP HF Study NCT02438306 Subgroup with NTproBNP/BNP >500 pg/ml LVEDVi LVESVi p= 0.02* p= 0.01* n=22 n=22 n=35 n=35 *Mixed Model for Repeated Measures 32
Slide 33: Phase III: CardiAMP HF Study Conclusions
Phase III: CardiAMP HF Study NCT02438306 Conclusions • Autologous MNC (CardiAMP) therapy for chronic ischemic HFrEF was safe, had less fatal & non-fatal MACE but the primary 3-tier composite outcome was neutral with six-minute walk in the third tier. • This is hypothesized as due to in six-minute wa
Slide 34: Phase IIIB: CardiAMP HF II Confirmatory Study NCT06258447
Phase IIIB: CardiAMP HF II Confirmatory Study NCT06258447 Trial size: Breakthrough Device Designation granted by 250 Ischemic Heart Failure Patients FDA based on results from three trials to date. LVEF<40% NYHA Class II and III Key Eligibility Criteria • Chronic ischemic HFrEF with LVEF 20-40% • NYH
Slide 35: Phase IIIB: CardiAMP HF II Confirmatory Study Status 2026
Phase IIIB: CardiAMP HF II Confirmatory Study NCT06258447 Status 2026: Actively enrolling at four US Centers 05141-C (MKT) Science of CardiAMP Cell Therapy 4/28/2026 35
Slide 36: Thank you
Thank you 05141-C (MKT) Science of CardiAMP Cell Therapy 4/28/2026 36