August 6, 2007

For Immediate Release

Executive Summary

Introduction

Demographic trends

Consumer Driven Product Selection

Mechanisms of Tissue Repair

Commercial Imperatives

Industry Consolidation

Clinical Caseload

Market Segmentation and Dynamics

New Surgical Techniques Drive Market Opportunity

The Uses of Adjunctive Surgical Closure and Securement Products

Product Development History

Evolution of Commercial Markets for Sealants and Adhesives

Company Strategies — Overview

Section 1:        CLINICAL NEED, CASELOAD, AND PROCEDURE VOLUME

 

1.1       Anatomy and Physiology of Tissue Repair

1.2       The Skin

1.3       Internal Tissues and Organs

1.4       Wound Classification and Types

1.4.1          Classification by Morphology and Severity

1.4.2          Wound Classification by Cause

1.4.3          Surgical Wounds

1.5       Caseload

1.5.1          Cardiovascular

1.5.1.1       Coronary Heart Disease

1.5.1.2       Dysfunctional Heart Valves

1.5.1.3       Peripheral Vascular Disorders

1.5.1.4       Abnormal Aortic Aneurysms

1.5.1.5       Drivers of Caseloads for Cardiac Surgery

1.5.2          Neurological

1.5.2.1       Stroke

1.5.2.2       Parkinson’s Disease

1.5.2.3       Epilepsy

1.5.2.4       Traumatic Injury

1.5.2.5       Peripheral Nerve Treatment

1.5.2.6       Neurology Drivers

1.5.3          Orthopaedic

1.5.3.1       Hip Replacements

1.5.3.2       Knee Replacements

1.5.3.3       Cartilage Repair

1.5.3.4       Ligament Damage

1.5.3.5       Bone Grafting

1.5.3.6       Vertebral Disc Repair

1.5.3.7       Drivers of Orthopedic Surgery

1.5.4          Urological

1.5.4.1       Incontinence

1.5.4.2       Drivers of Urological Surgery

1.5.5          Skin

1.5.5.1       Burns

1.5.5.2       Pressure Ulcers

1.5.5.3       Diabetic Ulcers

1.5.5.4       Venous Ulcers

1.5.5.5       Plastic Surgery

1.6       The Role of Modern Sealant, Securement and Hemostatic Products in Surgery

1.6.1          Fibrin Sealants

1.6.2          High Strength Glues

Section 2:        SCIENCE, TECHNOLOGY, DEVELOPMENT, CLINICAL AND REGULATORY CHALLENGES

 

2.1       Tissue Healing

2.1.1          Hemostasis

2.1.2          Proliferation and Maturation

2.1.3          Factors that affect healing

2.2       Product Development

2.3       Development Timelines

2.3.1          Collagen and thrombin combination

2.3.2          Polyethylene glycol polymer (PEG)

2.3.3          Albumin cross-linked with glutaraldehyde

2.3.4          Delivery Systems

2.4       Cost Effectiveness

2.5       Regulatory challenges

2.5.1          Approval Processes

2.5.2          History of Product Development

2.5.3          Regulatory Aspects

Section 3:        PRODUCTS, TECHNOLOGIES, AND FORECAST OPPORTUNITY

 

3.1       Overview

3.2       Development Timeline

3.3       Sutures and Staples

3.3.1          Competitors and Products

3.3.2          Suppliers

3.4.3          Product Development

3.4.4          Market Analysis and Forecast

3.4       Tapes

3.4.1          Competitors and Products

3.4.2          Products in Development

3.4.3          Market Analysis and Forecast

3.5       Hemostats

3.5.1          Competitors and Products

3.5.2          Products in Development

3.5.3          Market Analysis and Forecasts

3.6       Fibrin and other Sealant Products

3.6.1          Competitors and Products

3.6.2          Products in Development

3.6.3          Fibrin and Sealant Market and Competitive Activity

3.6.4          High-Strength Medical Adhesives

3.6.5          Competitors and Products

3.6.6          Products in Development

3.6.7          Market Analysis and Forecasts

3.7       Post-Surgical Adhesion Prevention

3.7.1          Competitors and Products

3.7.2          Products in Development

3.7.3          Market Analysis and Forecasts

3.8       Wound Closure and Securement Markets: Global and Regional Analysis

3.8.1          Americas

3.8.1.1       USA

3.8.1.2       Latin America

3.8.2          Japan

3.8.3          Europe

3.8.4          Rest of World

3.9     Worldwide Markets By Country and Segment

 

Section 4:        Company Profiles

 

4.1       Advanced Medical Solutions plc

4.2       Angiotech Pharmaceuticals Inc

4.3       Anika Therapeutics Inc.

4.4       ARC Pharmaceuticals

4.5       Baxter International Inc.

4.6       Berlin Heart AG

4.7       Biocoral Inc.

4.8       Biovascular

4.9       Biomet Inc.

4.10     B. Braun Melsungen AG

4.11     Chemence Limited

4.12     Closure Medical Corporation

4.13     Collagen Matrix Inc.

4.14     Confluent Surgical Inc.

4.15     CryoLife Inc.

4.16     Consortium Service Management Group (CSMG)

4.17     CuraMedical BV

4.18     Ethicon (Johnson & Johnson)

4.19     Ethicon

4.20     FibroGen, Inc.

4.21     Fidia Advanced Biopolymers

4.22     Focal Inc. (Genzyme Biosurgery)

4.23     FzioMed Inc.

4.24     GEM srl

4.25     Genzyme Biosurgery Inc.

4.26     Glustitch Inc.

4.27     Haemacure Corporation

4.28     Harvest Technologies Corporation

4.29     HemCon, Inc.

4.30     Incisive Surgical, Inc.

4.31     Integra Life Sciences Holdings Corp.

4.32     Kensey Nash Corporation

4.33     King Pharmaceuticals

4.34     Lifecore Biomedical, Inc.

4.35     Marine Polymer Technologies

4.36     Medafor, Inc.

4.37     Nycomed Pharma

4.38     Omrix Biopharmaceuticals Inc.

4.39     Organogenesis Inc.

4.40     Ortec

4.41     Pharming Group NV

4.42     PlasmaSeal

4.43     Polyganics

4.44     Smith & Nephew plc

4.45     Spiration Inc.

4.46     Synovis Life Technologies

4.47     Thermogenesis Corporation

4.48     Tissuemed Ltd

4.49     Tyco International Inc.

4.50     US Surgical Corp.

4.51     Vivolution

4.52     ZLB Behring

 

APPENDIX: LIST OF COMPANIES

 

List of Exhibits

 

Exhibit ES-1: Recent Acquisitions in the Securement Segment

Exhibit ES-2: Introduction of New Securement Technologies to the U.S. Market

Exhibit ES-3: Definition of Surgical Closure and Securement Products

Exhibit ES-4:  Incidence of Two Example Surgical Procedures with High Requirement for Adjunctive Products for Surgical Closure and Securement

Exhibit ES-5: U.S. FDA Approved Uses of Sealants, Glues, and Hemostats

Exhibit ES-6:  Synthetic and Biological Sealant Competitors (Non-Fibrin Sealants)

Exhibit ES-7: Selected High Strength Adhesive Companies and Their Strategies

Exhibit ES-8:  Selected Sealant Product Companies and Their Strategies

Exhibit ES-9: Worldwide Growth in the Securement and Closure Market, 2006-2011

 

Exhibit 1-1:  Skin Structure Illustrating Major Organelles and Skin Layers

Exhibit 1-2:  Classification of Wounds by Morphology

Exhibit 1-3:  Severity Classification of Wounds

Exhibit 1-4:  Wound classification by Etiology

Exhibit 1-5:  Incidence of Different Wound Types

Exhibit 1-6: Criteria for Adjunctive Use of Hemostats, Sealants, Glues and Adhesion Prevention Products in Surgery

Exhibit 1-7: Surgical Procedures with Potential for the Use of Hemostats, Sealants, Glues and Adhesion Prevention Products

Exhibit 1-8: Potential for Cardiovascular Applications, Incidences of Applicable Surgical Disorders, 2006

Exhibit 1-9: Potential for Neurological Applications, Incidences of Applicable Disorders (000s), 2006

Exhibit 1-10:  Potential for Orthopedic Applications, Numbers of Major Surgical Interventions, 2006

Exhibit 1-11:  Potential for Urological Applications, Incidence of Applicable Disorders, 2006

Exhibit 1-12:  Potential for Dermal Repair, Incidence of Applicable Disorders

Exhibit 1-13:  Applications of Fibrin and Other Sealants

Exhibit 1-14:  Surgical Procedures Using Fibrin and Other Sealant Products (2006-2011)

Exhibit 1-15:  Surgical Indications for High Strength Glues (Europe - 2006)

Exhibit 2-1:  Factors That Affect Wound Healing

Exhibit 2-2: Timescales for Development of Closure and Sealant Products

Exhibit 2-3:  Variables Associated With Clinical Evaluation of Closure and Securement, and Related Products

 

Exhibit 3-1:  Companies Commercializing Technologies in the Surgical Suture and Staples Category

Exhibit 3-2: Worldwide Sutures and Staples, Market Forecast, 2006-2011

Exhibit 3-3:  Worldwide Suture and Staples Market 2006, Share by Supplier

Exhibit 3-4:  Companies Commercializing First Aid Technologies Often Used as Tapes for Closure

Exhibit 3-5:  Worldwide Tapes Market Forecast, 2006-2011

Exhibit 3-6:  Worldwide Tapes for Closure Market Share, 2006, by Supplier

Exhibit 3-7: Companies Commercializing Technologies in the Hemostat Category

Exhibit 3-8:  Worldwide Hemostats Market Forecast, 2006-2011

Exhibit 3-9:  Worldwide Hemostats Market Share, 2006, by Supplier

Exhibit 3-10:  Companies Commercializing Technologies in the Sealants Category

Exhibit 3-11:  Worldwide Sealants Market Forecast, 2006-2011

Exhibit 3-12: Worldwide Sealants Market Share, 2006, by Supplier

Exhibit 3-13:  Companies Commercializing Cyanoacrylate-based High Strength Medical Adhesives

Exhibit 3-14:  Worldwide High Strength Glues Market Forecast, 2006-2011

Exhibit 3-15:  Worldwide High Strength Glues Market Share 2006, by Supplier

Exhibit 3-16:  Regulatory Status of Surgical Sealant Products

Exhibit 3-17:  Companies Commercializing Technologies in the Post-Operative Adhesion Category

Exhibit 3-18:  Worldwide Post Operative Adhesion Prevention Market Forecast, 2006-2011

Exhibit 3-19:  Worldwide Post Operative Adhesion Prevention Market Share, 2006, by Supplier

Exhibit 3-20:  Size and Growth of Wound Closure and Securement Market, World and Selected Countries, 2006

Exhibit 3-21:  Wound Closure Market 2006, by Product Segments: The Major American Countries

Exhibit 3-22:  Wound Closure Market 2006, by Product Segments: Japan

Exhibit 3-23:  Wound Closure Market 2006, by Product Segments: Major European Countries

Exhibit 3-24: Growth Forecast for Closure and Securement Market, 2006-2011

 

Exhibit 4-1:  Advanced Medical Solutions, selected financial data for 12 months to December 31 2005 and 2004

Exhibit 4-2:  Angiotech Pharmaceuticals financial data for the quarter ending September 30th

Exhibit 4-3:  Anika Therapeutics selected financial data

Exhibit 4-4:  Baxter financial data, $millions

Exhibit 4-5:  B Braun financial data, €millions

Exhibit 4-6:  CryoLife financial results, 2005

Exhibit 4-7:  Johnson & Johnson key financial data; $ millions

Exhibit 4-9:  LifeCore Biomedical financial data

Exhibit 4-10:  Nycomed topline financial data; € millions

Exhibit 4-11:  Omrix topline financial data; $ millions

Exhibit 4-12:  Pharming financial data €000s