BioCardia Inc:製品パイプライン分析

◆英語タイトル:BioCardia Inc - Product Pipeline Analysis, 2017 Update
◆商品コード:DATA8010088
◆発行会社(調査会社):GlobalData
◆発行日:2017年12月27日
◆ページ数:31
◆レポート言語:英語
◆レポート形式:PDF
◆納品方法:Eメール
◆対象地域:アメリカ
◆産業分野:医療機器
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【レポートの概要】

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 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.

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

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

【レポートの目次】

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

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 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

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