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SUMMARY
HeartWare Limited Product Pipeline Analysis
Summary
This report is an insightful source for data, analysis and strategic insights
into a HeartWare Limited's pipeline and investigational products. The report
also provides details on clinical trials covering trial phase, description,
investigator information, primary and secondary end-points and trial results
for products in development.
Scope
• Details of development stage by sector and equipment type. • Pipeline
products grouped by therapy area, development stage and trial phase. •
Detailed information on clinical trials covering trial phase, description,
investigator .nformation, primary and secondary end-points and trial
results. • Trial updates, trial start and end dates, patient numbers and
the trials primary outcome measures, secondary outcome measures. • Product
updates covering estimated approval dates and estimated launch dates. •
Descriptions of novel technologies relating to pipeline products of the
company. • Patents and patent applications covered for the product. •
News updates on key events relating to the product and its development.
Reasons to buy
• A single source to fulfill competitor information relating to products in
development. • Identify pipeline products that are potential competitor to
your product lines. Understand a company's strategic position by accessing
detailed independent intelligence on its product pipeline. • Access
clinical trial information to map trial results and plan targeted marketing
activities. • Take corrective measures on your own development programs
and R&D initiatives based on regulatory events of competitor product
pipelines. • Identification of potential investment opportunities. •
Build up knowledge base for potential distribution and marketing partners.
• Helps avoid patent infringement. • Timelines from concept to market lets
you keep track of market potential build for a new product. Assess a
company's future growth by determining its pipeline depth, for probable
acquisition opportunities.
TABLE OF CONTENTS
1 Table of Contents 3 1.1 List of Tables 6 1.2 List of Figures 7 2
Company Snapshot 8 2.1 Key Information 8 2.2 Company Overview 8
2.3 Financial Performance 8 2.4 Industry Outlook -- Cardiovascular Devices
8 3 Business Description 9 3.1 Business Overview 9 3.2 Major
Products and Services 9 3.2.1 Overview 9 4 History 10 5
Competitors 11 6 Key Employees 12 7 Key Employee Biographies 13 8
Company Statement 15 9 Locations And Subsidiaries 18 9.1 Head Office
18 9.2 Other Locations & Subsidiaries 18 10 Recent Developments 19
10.1 Strategy And Business Planning 19 10.1.1 Apr 18, 2008: HeartWare
Moves To New Manufacturing Facility In US 19 10.2 Financial Announcements
19 10.2.1 Apr 18, 2008: HeartWare Reports 2007 Results 19 10.2.2 Aug
31, 2007: HeartWare Reports H1 2007 Results 21 10.2.3 Feb 28, 2007:
HeartWare Reports 2006 Results 22 10.3 Corporate Communications 24
10.3.1 Apr 30, 2008: HeartWare Appoints New Board Member 24 10.3.2 Apr 29,
2008: HeartWare Appoints CMO 24 10.3.3 Sep 04, 2006: HeartWare Appoints
New CEO 25 10.4 Product News 25 10.4.1 May 05, 2008: HeartWare
Receives Conditional Approval Of IDE 25 10.4.2 Jul 13, 2007: Heartware
Announces Clinical Trial Update 26 10.4.3 Mar 09, 2007: Heartware Ltd To
Launch HVAD Heart Device In Europe 26 10.4.4 May 22, 2006: HeartWare
Receives Regulatory Approval For HVAD Implants In United Kingdom 27 10.5
Product Approvals 27 10.5.1 May 05, 2008: HeartWare Receives Conditional
Approval Of IDE 27 10.5.2 May 22, 2006: HeartWare Receives Regulatory
Approval For HVAD Implants In United Kingdom 28 10.6 Clinical Trials
28 10.6.1 Jul 13, 2007: Heartware Announces Clinical Trial Update 28
11 HeartWare Limited Pipeline Products 29 11.1 HeartWare Limited Product
Pipeline Analysis 29 11.1.1 HeartWare Limited Pipeline Products By
Equipment Type 29 11.1.2 HeartWare Limited Pipeline Products By
Development Stage 30 11.1.3 HeartWare Limited Pipeline Products By Therapy
Area 31 11.1.4 HeartWare Limited Pipeline Products By Clinical Trials
31 11.1.5 HeartWare Limited Pipeline Products By News Summary 32 11.2
HVAD System 32 11.2.1 Product Description 33 11.2.2 Product Status
33 11.2.3 Clinical Trials 33 11.2.4 Product Milestone 34 11.2.5
Product Patent Details 34 11.3 MVAD System 35 11.3.1 Product
Description 35 11.3.2 Product Status 36 11.3.3 Product Patent Details
36 11.4 HeartWare IV-VAD 37 11.4.1 Product Description 37 11.4.2
Product Status 37 11.4.3 Product Patent Details 37 11.5 PedVAD 38
11.5.1 Product Description 38 11.5.2 Product Status 38 11.6 TETS
Technology 39 11.6.1 Product Description 39 11.6.2 Product Status
39 12 Appendix 40 12.1 Methodology 40 12.1.1 Coverage 40
12.1.2 Secondary Research 41 12.1.3 Primary Research 41 12.1.4 Expert
Panel Validation 42 12.2 Contact Us 42 12.3 About Global Markets
Direct 42 12.4 Disclaimer 42 1.1 List of Tables Table 1:
HeartWare Limited,Key Facts 8 Table 2: HeartWare Limited, Key
Employees, 12 Table 3: HeartWare Limited, Other Locations 18
Table 4: HeartWare Limited Pipeline Products by Equipment Type 29
Table 5: HeartWare Limited Pipeline Products By Development Stage 30
Table 6: HeartWare Limited Pipeline Products By Therapy Area 31 Table
7: HeartWare Limited Pipeline Products By Clinical Trials 31 Table 8:
HeartWare Limited Pipeline Products By News Summaries 32 1.2
List of Figures Figure 1: HeartWare Limited Pipeline Products By
Development Stage 30 Figure 2: HeartWare Limited Pipeline Products By
News Summary 32 Figure 3: Global Markets Direct Methodology 40
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