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BioCardia Inc - Product Pipeline Analysis, 2018 Update

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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 company's 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.


- 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

Note: Some sections may be missing if data is unavailable for the company


Table Of Content


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 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 BioCardia's 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 Figure

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

List Of Table

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

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Products and Companies


BioCardia Inc, Product, Pipeline, Product Pipeline, Key Pipeline, Products by Equipment Type, Equipment Type, Therapy Area, Products by Therapy Area, Development Stage, Products by Development Stage, Milestone, Products by Milestone, Major Products, Brands, No of Products, Device Class, Market, Territory, Product Name, Therapy Name, Trial Name, Trial, Indication, Summary, Event Type, Clinical Trial, MileStone, Product Status, Product Description, Description, Patent, Patent Details, Competitors, Key Employees, Subsidiaries, Locations, News, Events, Developments, medical devices, business description, company facts, trial phase, approval, estimated, technology, product patent details, phase, trial status, trial objective, trial design, trial site, business strategies, trends, pipeline and technology, sales strategies


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