BioCardia Inc - Product Pipeline Analysis, 2018 Update

Summary

BioCardia Inc (BioCardia) is a clinical-stage regenerative medicine company that develops novel therapeutics for cardiovascular diseases. The company develops biotherapeutic candidate, which include CardiAMP cell therapy system, an autologous minimally processed bone marrow cells; and CardiALLO cell therapy system, an allogeneic off the shelf mesenchymal stem cell product candidate for ischemic systolic heart failure. Its CardiAMP cell therapy system comprises cell potency screening test, a point of care cell processing platform, and a biotherapeutic delivery system. BioCardia also offers catheters for use in delivery of therapeutic agents directly to the heart, and of guiding catheters for use in peripheral and coronary vasculature and chambers of the heart. The company sells its products through a network of distributors across the US. BioCardia is headquartered in San Carlos, California, the US.

This report is a source for data, analysis, and actionable intelligence on the companys portfolio of pipeline products. The report provides key information about the company, its major products and brands.

The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage.

Scope:

- The report reviews detailed company profile with information on business description, key company facts, major products and services, key competitors, key employees, locations and subsidiaries and recent developments
- The report analyzes all pipeline products in development for the company BioCardia Inc
- The report provides pipeline analysis on all pipeline products of the company (by equipment type, by indication, by development stage, and by trial status)
- The report covers detailed information on each pipeline product with information on pipeline territory, stage of development, device class, regulatory path, indication(s), application(s) and estimated launch date
- The report provides detailed description of products in development, technical specification and functions
- The report also covers ongoing clinical trials (wherever applicable) with information on trial name, trial objective, sponsor, trial design , trial status and phase, estimated start and end date.

Reasons to Buy:

- Develop business strategies by understanding the trends and developments driving the medical devices pipeline and technology landscape
- Design and develop your product development, marketing and sales strategies by understanding the competitor portfolio
- To formulate effective Research & Development strategies
- Develop market-entry and market expansion strategies
- Exploit in-licensing and out-licensing opportunities by identifying products, most likely to ensure a robust return
- Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline
- Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage
- Develop competition strategies by identifying the status and likely launch of the competitors pipeline products through review of the clinical trials, stage and of development, etc
- Identify, understand and capitalize the next high-value products that your competitor would add in its portfolio



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 6
BioCardia Inc - Key Facts 6
BioCardia Inc - Major Products and Services 7
BioCardia Inc Pipeline Products by Development Stage 8
BioCardia Inc Ongoing Clinical Trials by Trial Status 10
BioCardia Inc Pipeline Products Overview 12
CardiAMP - Chronic Myocardial Ischemia 12
CardiAMP - Chronic Myocardial Ischemia Product Overview 12
CardiAMP - Chronic Myocardial Ischemia Clinical Trial 13
CardiAMP - Heart Failure 14
CardiAMP - Heart Failure Product Overview 14
CardiAMP - Heart Failure Clinical Trial 15
CardiAMP - Post Acute Infarction 16
CardiAMP - Post Acute Infarction Product Overview 16
Helix Transendocardial Delivery System 17
Helix Transendocardial Delivery System Product Overview 17
Helix Transendocardial Delivery System Clinical Trial 18
BioCardia Inc - Key Competitors 20
BioCardia Inc - Key Employees 21
BioCardia Inc - Locations And Subsidiaries 22
Head Office 22
Recent Developments 23
BioCardia Inc, Recent Developments 23
May 11, 2018: BioCardia Reports First Quarter 2018 Financial Results And Business Highlights 23
May 10, 2018: Centers for Medicare and Medicaid Services Approves Reimbursement for BioCardias CardiAMP Cell Therapy in Pivotal Clinical Trial Studying Second Indication in Chronic Myocardial Ischemia 23
Apr 25, 2018: BioCardia Receives New Potency Assay Patent, Providing Further Protection to Autologous Cell Therapy Programs in Heart Failure and Refractory Angina 24
Apr 16, 2018: St. Joseph Mercy Ann Arbor to perform clinical trial using stem cells to treat congestive heart failure 24
Apr 09, 2018: Phase III CardiAMP Heart Failure Trial Featured in American Heart Journal 25
Mar 21, 2018: BioCardia Announces Fourth Quarter 2017 Financial Results 25
Jan 29, 2018: CardiAMP Cell Therapy Receives FDA Approval for Pivotal Trial in Chronic Myocardial Ischemia 26
Jan 05, 2018: BioCardia Submits Clinical Trial to FDA for New Indication of Chronic Myocardial Ischemia for CardiAMP Cell Therapy 26
Nov 10, 2017: BioCardia Reports Third Quarter 2017 Financial Results and Business Highlights 27
Nov 07, 2017: Dr. Ian McNiece Appointed BioCardia Chief Scientific Officer 27
Appendix 29
Methodology 29
About GlobalData 32
Contact Us 32
Disclaimer 32

List Of Tables

List of Tables
BioCardia Inc Pipeline Products and Ongoing Clinical Trials Overview 4
BioCardia Inc Pipeline Products by Equipment Type 5
BioCardia Inc Pipeline Products by Indication 5
BioCardia Inc Ongoing Clinical Trials by Trial Status 5
BioCardia Inc, Key Facts 6
BioCardia Inc, Major Products and Services 7
BioCardia Inc Number of Pipeline Products by Development Stage 8
BioCardia Inc Pipeline Products Summary by Development Stage 9
BioCardia Inc Ongoing Clinical Trials by Trial Status 10
BioCardia Inc Ongoing Clinical Trials Summary 11
CardiAMP - Chronic Myocardial Ischemia - Product Status 12
CardiAMP - Chronic Myocardial Ischemia - Product Description 12
CardiAMP - Chronic Myocardial Ischemia - Randomized Controlled Pivotal Trial of Autologous Bone Marrow Cells Using the CardiAMP Cell Therapy System in Patients with Refractory Angina Pectoris and Chronic Myocardial Ischemia: CardiAMP CMI Trial 13
CardiAMP - Heart Failure - Product Status 14
CardiAMP - Heart Failure - Product Description 14
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 15
CardiAMP - Post Acute Infarction - Product Status 16
CardiAMP - Post Acute Infarction - Product Description 16
Helix Transendocardial Delivery System - Product Status 17
Helix Transendocardial Delivery System - Product Description 17
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 18
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 18
Helix Transendocardial Delivery System - Phase I Trial of Endocavitary Injection of Bone Marrow Derived CD133+ Cells in Ischemic Refractory Cardiomyopathy (RECARDIO Trial) 19
BioCardia Inc, Key Employees 21
Glossary 31

List Of Figures

List of Figures
BioCardia Inc Pipeline Products by Equipment Type 5
BioCardia Inc Pipeline Products by Development Stage 8
BioCardia Inc Ongoing Clinical Trials by Trial Status 10

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