Exalenz Bioscience Ltd. (EXEN) - Product Pipeline Analysis, 2016 Update

Report code: GDME17842PD

Publisher: GlobalData

Formats: PDF

Published: July 05, 2016

Number of pages: 39

Exalenz Bioscience Ltd. (Exalenz) carries out the development and commercialization of advanced medical systems for a range of gastrointestinal tract and liver disorders. The company harnesses its BreathID technology platform for assessment and monitoring of functional diseases. Its flagship product, BreathID Hp is a urea breath test for diagnosing, monitoring and managing gastric Helicobacter pylori (H. pylori) bacteria infection in adults. The BreathID Hp obtained the US FDA approval and European CE mark. The company offers products for detection of peptic ulcer disease, gastric adenocarcinoma, and mucosa associated lymphoid tissue lymphoma. It works in collaboration with various clinical and industrial partners in the US, Europe, Asia, and Israel. Exalenz is headquartered in Modiin, Israel.

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 Exalenz Bioscience Ltd.

- 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.

Reason 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

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 4

List of Figures 5

Exalenz Bioscience Ltd. Company Snapshot 6

Exalenz Bioscience Ltd. Company Overview 6

Exalenz Bioscience Ltd. Pipeline Products and Clinical Trials Overview 7

Exalenz Bioscience Ltd. – Pipeline Analysis Overview 9

Business Description 9

Key Facts 9

Exalenz Bioscience Ltd. - Major Products and Services 10

Exalenz Bioscience Ltd. Pipeline Products by Development Stage 11

Exalenz Bioscience Ltd. Clinical Trials by Trial Status 13

Exalenz Bioscience Ltd. Pipeline Products Overview 15

BreathID MBT Device 15

BreathID MBT Device Product Overview 15

BreathID MBT Device Clinical Trial 16

BreathID System - Pancreatitis 18

BreathID System - Pancreatitis Product Overview 18

BreathID Test - Chronic Liver Disease 19

BreathID Test - Chronic Liver Disease Product Overview 19

BreathID Test - Chronic Liver Disease Clinical Trial 20

BreathID Test - Hepatocellular Carcinoma 21

BreathID Test - Hepatocellular Carcinoma Product Overview 21

BreathID Test - Hepatocellular Carcinoma Clinical Trial 22

BreathID Test - Nonalcoholic Steatohepatitis 23

BreathID Test - Nonalcoholic Steatohepatitis Product Overview 23

BreathID Test - Nonalcoholic Steatohepatitis Clinical Trial 24

BreathID Test - Portal Hypertension 25

BreathID Test - Portal Hypertension Product Overview 25

Methacetin Breath Test - Acute Liver Failure 26

Methacetin Breath Test - Acute Liver Failure Product Overview 26

Methacetin Breath Test - Acute Liver Failure Clinical Trial 27

Exalenz Bioscience Ltd. - Key Competitors 28

Exalenz Bioscience Ltd. - Key Employees 29

Exalenz Bioscience Ltd. - Key Employee Biographies 30

Exalenz Bioscience Ltd. - Locations And Subsidiaries 31

Head Office 31

Other Locations & Subsidiaries 31

Recent Developments 32

Exalenz Bioscience Ltd., Recent Developments 32

Mar 14, 2016: Exalenz Biosciences Announces Collaboration with ALF Study Group to use BreathID to Monitor Patients with Acute Liver Failure 32

Aug 03, 2015: Exalenz Bioscience Announces Collaboration with Galectin Therapeutics to use BreathID to Monitor Patients with Cirrhosis Associated with NASH 32

Jun 04, 2015: Exalenz Bioscience Launches Clinical Study for Breath-Based Detection of Primary Liver Cancer (HCC) 33

May 06, 2015: Exalenz Launches Clinical Study Of BreathID Test For Hepatocellular Carcinoma 34

Apr 13, 2015: Exalenz Bioscience Announces New Published Data Confirming the Clinical Utility of its BreathID Test for Detecting H. Pylori in an Emergency Department Setting 34

Oct 21, 2014: Exalenz Bioscience Launches Pivotal Study of World’s First Breath-Based Test to Diagnose Clinically Significant Portal Hypertension 35

Sep 22, 2014: Deloitte Names EXALENZ as One of Israel's Companies-to-Watch in the 2014 Deloitte Technology Fast 50 Awards 36

Aug 21, 2013: Exalenz Granted US Patent for Liver Application of Company’s BreathID Platform Technology 36

Jul 15, 2013: Exalenz Bioscience Announces the Global Market Launch of the New BreathID Hp for Detection and Management of H. pylori 36

May 26, 2013: Exalenz Gets FDA Clearance To Market Next Generation Of BreathID Technology 37

Appendix 39

Methodology 39

About GlobalData 39

Contact Us 39

Disclaimer 39

List of Tables

List of Tables

Exalenz Bioscience Ltd. Pipeline Products and Clinical Trials Overview 7

Exalenz Bioscience Ltd. Pipeline Products by Equipment Type 7

Exalenz Bioscience Ltd. Pipeline Products by Indication 8

Exalenz Bioscience Ltd. Clinical Trials by Trial Status 8

Exalenz Bioscience Ltd., Key Facts 9

Exalenz Bioscience Ltd., Major Products and Services 10

Exalenz Bioscience Ltd. Number of Pipeline Products by Development Stage 11

Exalenz Bioscience Ltd. Pipeline Products Summary by Development Stage 12

Exalenz Bioscience Ltd. Clinical Trials by Trial Status 13

Exalenz Bioscience Ltd. Clinical Trials Summary 14

BreathID MBT Device - Product Status 15

BreathID MBT Device - Product Description 15

BreathID MBT Device - Assessment of the BreathID Methacetin Breath Test (MBT) Ability to Predict Patient Outcome in Acute Liver Failure (ALF) 16

BreathID MBT Device - Clinical Study of the BreathID LF System to Train the Algorithm for the ¹³C-Methacetin Breath Test (MBT) in Assessment of Portal Hypertension in Patients With Compensated Liver Cirrhosis 16

BreathID MBT Device - The Prediction Value of the BreathID 13C-Methacetin Breath Test for Hepatic Decompensation; a Retrospective Analysis 17

BreathID System - Pancreatitis - Product Status 18

BreathID System - Pancreatitis - Product Description 18

BreathID Test - Chronic Liver Disease - Product Status 19

BreathID Test - Chronic Liver Disease - Product Description 19

BreathID Test - Chronic Liver Disease - 13C-Methacetin Breath Test for the Prediction of Outcome in Acute Liver Failure 20

BreathID Test - Hepatocellular Carcinoma - Product Status 21

BreathID Test - Hepatocellular Carcinoma - Product Description 21

BreathID Test - Hepatocellular Carcinoma - Evaluation of the Capability of the ¹³C-Octanoate Breath Test (OBT) Measurement to Differentiate Between Presence and Absence of HCC Determined by MRI in Patients with Chronic Liver Disease 22

BreathID Test - Nonalcoholic Steatohepatitis - Product Status 23

BreathID Test - Nonalcoholic Steatohepatitis - Product Description 23

BreathID Test - Nonalcoholic Steatohepatitis - Clinical Study of Breath-based Diagnostic Test in Subjects with Nonalcoholic Steatohepatitis 24

BreathID Test - Portal Hypertension - Product Status 25

BreathID Test - Portal Hypertension - Product Description 25

Methacetin Breath Test - Acute Liver Failure - Product Status 26

Methacetin Breath Test - Acute Liver Failure - Product Description 26

Methacetin Breath Test - Acute Liver Failure - 13C-Methacetin Breath Test for the Prediction of Outcome in Acute Liver Failure 27

Exalenz Bioscience Ltd., Key Employees 29

Exalenz Bioscience Ltd., Key Employee Biographies 30

Exalenz Bioscience Ltd., Subsidiaries 31

List of Figures

List of Figures

Exalenz Bioscience Ltd. Pipeline Products by Equipment Type 8

Exalenz Bioscience Ltd. Pipeline Products by Development Stage 11

Exalenz Bioscience Ltd. Clinical Trials by Trial Status 13

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