Table of Contents
Table of Contents 2
List of Tables 3
List of Figures 3
BioCardia Inc Company Overview 4
BioCardia Inc Company Snapshot 4
BioCardia Inc Pipeline Products and Ongoing Clinical Trials Overview 4
BioCardia Inc – Pipeline Analysis Overview 7
BioCardia Inc – Key Facts 7
BioCardia Inc – Major Products and Services 8
BioCardia Inc Pipeline Products by Development Stage 9
BioCardia Inc Ongoing Clinical Trials by Trial Status 11
BioCardia Inc Pipeline Products Overview 13
CardiAMP – Heart Failure 13
CardiAMP – Heart Failure Product Overview 13
CardiAMP – Heart Failure Clinical Trial 14
CardiAMP – Post Acute Infarction 15
CardiAMP – Post Acute Infarction Product Overview 15
Helix Transendocardial Delivery System 16
Helix Transendocardial Delivery System Product Overview 16
Helix Transendocardial Delivery System Clinical Trial 17
BioCardia Inc – Key Competitors 19
BioCardia Inc – Key Employees 20
BioCardia Inc – Locations And Subsidiaries 21
Head Office 21
Recent Developments 22
BioCardia Inc, Recent Developments 22
Nov 10, 2017: BioCardia Reports Third Quarter 2017 Financial Results and Business Highlights 22
Nov 07, 2017: Dr. Ian McNiece Appointed BioCardia Chief Scientific Officer 22
Oct 04, 2017: BioCardia Receives U.S. Patent Covering Morph Product Family Design 23
Sep 27, 2017: BioCardia Announces Successful Interim Safety Analysis in Its Phase 3 Clinical Trial of CardiAMP Stem Cell Therapy for Heart Failure 23
Sep 19, 2017: BioCardia Announces Publication of 12-Month Results from Phase II TRIDENT Clinical Trial that Shows Positive Safety Profile for Allogeneic Bone Marrow Stem Cells Delivered with Helix Transendocardial Delivery System 24
Sep 15, 2017: BioCardia’s CardiAMP Heart Failure Trial Design to be Presented at Texas Heart Institute International Symposium on Cardiovascular Regenerative Medicine 24
Jul 26, 2017: BioCardia Completes Roll-in Cohort in Pivotal Phase III CardiAMP Heart Failure Trial 25
May 24, 2017: Study Shows Helix Transendocardial Delivery System Enables Greater Myocardial Retention of Stem Cell Therapy 26
Feb 28, 2017: Johns Hopkins Medicine, Maryland Stem Cell Research Fund and BioCardia Announce First Patient Treated with CardiAMP Cell Therapy for Ischemic Heart Failure in Phase III Clinical Trial 26
Dec 29, 2016: CardiAMP Pivotal Heart Failure Trial Initiated at Two US Centers 27
Appendix 28
Methodology 28
About GlobalData 30
Contact Us 30
Disclaimer 31
BioCardia Inc Pipeline Products and Ongoing Clinical Trials Overview 4
BioCardia Inc Pipeline Products by Equipment Type 5
BioCardia Inc Pipeline Products by Indication 6
BioCardia Inc Ongoing Clinical Trials by Trial Status 6
BioCardia Inc, Key Facts 7
BioCardia Inc, Major Products and Services 8
BioCardia Inc Number of Pipeline Products by Development Stage 9
BioCardia Inc Pipeline Products Summary by Development Stage 10
BioCardia Inc Ongoing Clinical Trials by Trial Status 11
BioCardia Inc Ongoing Clinical Trials Summary 12
CardiAMP - Heart Failure - Product Status 13
CardiAMP - Heart Failure - Product Description 13
CardiAMP - Heart Failure - Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy in Patients with Post Myocardial Infarction Heart Failure: CardiAMP Heart Failure Trial 14
CardiAMP - Post Acute Infarction - Product Status 15
CardiAMP - Post Acute Infarction - Product Description 15
Helix Transendocardial Delivery System - Product Status 16
Helix Transendocardial Delivery System - Product Description 16
Helix Transendocardial Delivery System - A Multicentric Controlled Phase I / IIb Study Evaluating the Safety and the Efficacy of in Vitro Expanded Peripheral Blood CD34+ Stem Cells Output by the StemXpand Automated Process, and Injected in Patients with an Acute Myocardial Infarction and a Left Ventricle Ejection Fraction (LVEF) Remaining Below or Equal to 45% after PTCA and Stent(s) Implantation Versus Standard of Care 17
Helix Transendocardial Delivery System - A Phase II, Randomized, Blinded, Study of the Safety and Efficacy of Transendocardial Injection of Allogeneic Human Mesenchymal Stem Cells (hMSCs) (20 Million or 100 Million Total MSCs) in Patients with Chronic Ischemic Left Ventricular Dysfunction Secondary to Myocardial Infarction 17
Helix Transendocardial Delivery System - Phase I Trial of Endocavitary Injection of Bone Marrow Derived CD133+ Cells in Ischemic Refractory Cardiomyopathy (RECARDIO Trial) 18
BioCardia Inc, Key Employees 20
Glossary 29