Slide 1: CardiAMP Chronic Myocardial Ischemia (CMI) Trial for patients with refractory angina
CardiAMP Chronic Myocardial Ischemia (CMI) Trial for patients with refractory angina • Completion of Roll In Cohort Primary Endpoint • and Considerations for the Randomized Trial Physician Investigators KOL Physician Investigator KOL • Dr. Carl Pepine, Professor • Dr. Amish Raval, Professor of Medic
Slide 2: Problem: Chronic Myocardial Ischemia
Problem: Chronic Myocardial Ischemia Burden of Illness and Unmet Need Characterized by disabling chest pain, referred to as refractory angina (RA). Patients suffer from poor perceived health status and psychological distress, have impaired quality of life, and represent a burden to the healthcar
Slide 3: Problem: Chronic Myocardial Ischemia
Problem: Chronic Myocardial Ischemia • A large group of patients with angina remains un-revascularized • Quality of life for these patients is poor • Mortality is not necessarily high, given largely preserved EF, but resource use is extraordinary Modified from slide Courtesy of Thomas Povsic, MD, Du
Slide 4: Therapies for Refractory Angina: Considerable Room for Improvement
Therapies for Refractory Angina: Considerable Room for Improvement Cell Therapy Has Shown Great Promise Therapy Status/ Stage of Pros Cons Evidence Ranolazine FDA Approved No intervention Not well tolerated required. or impactful. Enhanced FDA Approved No invasive Inconvenient and External Counter i
Slide 5: CardiAMP Cell Therapy – A Potential Solution
CardiAMP Cell Therapy – A Potential Solution Solves the problem of high cost of autologous elected CD34 cell therapy and simplifies clinical logistics. Safety supported by multiple trials and hundreds of patients in CardiAMP Heart Failure program. Achieves high dosages of important CD34+ cells to tr
Slide 6: CardiAMP Cell Therapy Has High Effective CD34+ Cell Dosage
CardiAMP Cell Therapy Has High Effective CD34+ Cell Dosage Raval et al ESC 2021 from CardiAMP HF Cell dose compared favorably to the RENEW trial using GCSF mobilized CD34+ products delivered via a straight needle for patients with refractory angina. 4/30/2024 05905-A(MKT) THE CARDIAMP CMI TRIAL Copy
Slide 7: CardiAMP CMI Trial Design
CardiAMP Chronic Myocardial Ischemia (CMI) Trial for patients with refractory angina Trial Design: Open Label Roll-In 2 centers, 19 screened, 14 screen fails Six-month data available on four patients Randomized Controlled Trial Up to 40 centers, 333 patients With adaptive readout Primary endpoint is
Slide 8: Roll in Cohort Patient Demographics
Roll in Cohort Patient Demographics • All male, between 70 and 83 years old, who experienced angina with short walking distance or even while resting (Canadian Cardiovascular Score class III or IV) • All reported having 7 or more angina episodes a week (~once daily) – Angina occurred, despite taking
Slide 9: Diffuse coronary artery disease that is not treatable with stents or surgery
Diffuse coronary artery disease that is not treatable with stents or surgery 4/30/2024 05905-A(MKT) THE CARDIAMP CMI TRIAL Copyright © 2024 BioCardia. All Rights Reserved 8
Slide 10: Roll In Cohort Patients: Results
Roll In Cohort Patients: Results • 19 subjects; 14 screen failed – Plan to greatly reduce screen fails going forward • Angina Episodes (patient diary): – Screening/Baseline: average of 9-13 episodes / week – Month 6: reduced to average of 1-2 episodes / week • Angina episodes decreased by 8.4 per we
Slide 11: Numbers of Anginal Episodes Per Week
Change in Angina Episodes per Week 100% of patients responded in CardiAMP CMI 0 -1 Numbers of Anginal Episodes Per Week -2 -3 Change in -4 -5 -6 -7 -8 -9 ERICA CARISA EECP CD34-6 CD34-12 CardiAMP Month Month - 6 Month Angina/week -0.43 -0.8 -1.4 -3 -5.6 -8.4 Ranolazine Modified from slide Courtesy o
Slide 12: Change in Exercise Tolerance Time (Seconds)
Change in Exercise Tolerance Testing at 6 Months 75% of patients responded in CardiAMP CMI Change in Exercise Tolerance Time (Seconds) P=0.02 NS P=0.007 EECP EECP RENEW RENEW RENEW RENEW CardiAMP CardiAMP Treated Control CD34- Control CD34- CD 34 CMI 3M CMI 6M Treatment 3M Treatment Control 3M 6M 6M
Slide 13: Considerations for Randomized Pivotal Trial
Considerations for Randomized Pivotal Trial • Early results compelling for both improved ETT and Angina episode reduction which has only been shown with cell therapy. • Implementing changes to enhance speed of enrollment and eliminate screen fails • CMS reimbursement can support patient research cos