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Emerging Technologies in Spinal Motion Preservation

Published by: Espicom Healthcare Intelligence

Published: Oct. 3, 2006 - 180 Pages


Table of Contents


OVERVIEW

Orthopaedic Market overview


Table 1 - 2005 Worldwide Orthopaedic Market by Product (Market Size US$26 billion)


SPINAL MARKET


Overview


Fig.1: Global Spinal Market Shares, 2005

Table 2: Leading Spinal Companies - 2005 Spinal Sales, US$ million

Fig. 2: Worldwide Spinal Device Market 2006-2011 (CAGR = 16%)

Fig. 3: Worldwide Spinal Device Market Scenarios 2011


The Spine

Spinal Disorders


Herniated Disc

Degenerative Disc Disease

Facet Joint Arthritis

Stenosis

Spondylolisthesis

Spondylolysis

Scoliosis

Trauma

Tumours


Back Pain

Traditional Surgical Treatments


Spinal Fusion

Spine Surgery Instrumentation

Bone Grafts

Demineralised Bone Matrix

Synthetic Substitutes

Bone Morphogenetic Protein (BMP)

Electrical Stimulation Units

IntraDiscal ElectroThermal (IDET) Therapy


Market Dynamics


Favourable Demographics

Development of new implants for younger patients

Increased use of implants

Increased use of minimally-invasive procedures

Orthobiologics/Osteobiologics

Gene Therapy

Switch from fusion to motion-preserving devices



MOTION PRESERVATION/NON-FUSION Market


Table 3: Projected Worldwide Spinal Fusion/Motion Preservation Device Revenues 2006-2011

Table 4: Projected Worldwide Spinal Motion Preservation Device Revenues 2006-2011


TOTAL DISC REPLACEMENTS


Table 5: Criteria to Determine Candidacy for TDR


LUMBAR DISCS




Table 6: Select Lumbar Discs - Design Comparison


DePuy Spine - Charité Artificial Lumbar Disc


Charité Clinical Trial Results



Synthes


ProDisc-L

Charité vs ProDisc


Medtronic Sofamor Danek.(MSD)


Maverick Artificial Lumbar Disc


US Clinical Trial



Stryker Spine


FlexiCore Artificial Lumbar Disc


B..Braun/Aesculap


activL


SpinalMotion


Kineflex Lumbar Disc


LDR


Mobidisc


Vertebron


Lumbar Motion Preservation (LMP)


Theken Disc


eDisc


Ranier Technology


CAdisc


AxioMed


Freedom Lumbar Disc


TranS1


Percutaneous Disc Reconstruction (PDR)


NuVasive

SpineMedica


SaluDisc


Biomet./.EBI


Rescue Total Disc Replacement

Min T Total Disc Replacement


Amedica


Altia Spinal Disc


Nexgen Spine


Physio-L


US Spine


Spartacus


Zimmer


Dynardi Artificial Lumbar Disc


Disc Motion Technologies


Total Spinal Motion Segment System (TSMS)


Table 7: Lumbar Total Disc Replacement Devices - Competitive Landscape




CERVICAL DISCS


Medtronic Sofamor Danek


Prestige ST Cervical Disc


Prestige ST - US Clinical Trial Results


Prestige LP Cervical Disc


Prestige LP - US Clinical Trial


Bryan Cervical Disc System


Bryan and Prestige ST - US Clinical Trials



Synthes


ProDisc-C


Cervitech


PCM (Porous Coated Motion) Cervical Disc System


US Clinical Trial



LDR Spine


Mobi-C


SpinalMotion


Kineflex/C Cervical Disc


Stryker Spine


CerviCore Artificial Cervical Disc


Globus Medical


Secure-C Cervical Artificial Disc


Scient’x


Discocerv

NuVasive


CerPass

NeoDisc


DePuy Spine


Discover Artificial Cervical Disc



Vertebron


Cervical Motion Preservation Device (CMP)

Blackstone Medical


Advent Cervical Disc


Table 8: Cervical Total Disc Replacement Products - Competitive Landscape




Market Outlook.-.Total Disc Replacements


Table 9: Projected Worldwide TDR Revenues 2006-2011

Table 10: Projected Worldwide TDR Market, 2011



NUCLEUS REPLACEMENT DEVICES


Raymedica


HydraFlex Nucleus Arthroplasty System

PDN-Solo and PDN-Solo XL


PDN-Solo, 24-Month Preliminary Results of International Multi-centre Study

PDN Study - 10-Year Results with 1st Generation PDN Disc



Spine Wave


NuCore Injectable Nucleus


IDE Clinical Trial

First arm study findings



Pioneer Surgical Technology


Nubac Disc Arthroplasty System


Disc Dynamics Inc


Dascor Disc Arthroplasty System


CryoLife


BioDisc


BioDisc Study



Biomet/EBI


Regain Lumbar Nucleus Replacement


TranS1


PNR


Arthro Kinetics


NuCell


Zimmer


Injectable Hyrodgel Nucleus Device


Synthes Spine


Hydrafil


Replication Medical


NeuDisc


Gentis


DiscCell


Progress Update


Table 11: Nucleus Replacement Devices - Competitive Landscape




Market Outlook.-.Nucleus Replacement Devices


Table 12: Projected Worldwide Partial Replacement Device Revenues 2006-2011



DYNAMIC STABILISATION systems


Pedicle Screw-Based Systems


Zimmer


Dynesys


SpineVision (FlexSpine)


FlexPLUS


Applied Spine Technologies


Stabilimax NZ


Scient’x


Isobar TTL


N Spine


N Flex


Globus Medical


Posterior Dynamic Stabilisation System


Alphatec Spine

Mekanika


Modulus 60C


Innovative Spinal Technologies (IST)


Interspinous Spacer Systems


St. Francis Medical Technologies


X Stop Interspinous Process Decompression (IPD) System

X Stop PK

X Stop Clinical Trial Data


Abbott Spine


Wallis Stabilisation System

US Clinical Trial


Medtronic Sofamor Danek


DIAM Spinal Stabilisation System


Paradigm Spine


coflex



Fixano


Interspinous U

NuVasive


ExtenSure


Biomet


Interspinous System (ISS)


Biorthex


Actipore Vertebral Body Replacement System


GM Reis


Dynafix



Facet Joint Replacement Devices


Archus Orthopedics


Total Facet Arthroplasty System (TFAS)


Facet Solutions


Anatomic Facet Replacement System


Impliant


TOPS Motion Preservation System


Spinal Elements (formerly Quantum Orthopedics)


Zyre Facet Arthroplasty System



Market Outlook.-.Dynamic Stabilisation Ssystems


Table 13: Dynamic Stabilisation Systems - Competitive Landscape

Table 14: Projected Worldwide Dynamic Stablisation Device Revenues 2006-2011



ANNULAR REPAIR


Anulex Technologies


Inclose Surgical Mesh System


Intrinsic Therapeutics


NUCLEUS REMOVAL DEVICES


CoreSpine Technologies


Complete Nucleus Removal (CNR) Device



ORTHOBIOLOGICS


Medtronic


InFUSE Bone Graft


Stryker Biotech


OP-1



CELL THERAPY


co-don


co don chondrotransplant DISC


EuroDISC Study




STEM CELL THERAPY


Blackstone Medical/Osiris


Trinity Matrix/Osteocel


Aastrom Biosciences


Tissue Repair Cell (TRC)



GENE-bASED DIAGNOSTIC TESTING


Axial Biotech


MINIMALLY-INVASIVE SPINAL SYSTEMS


Endius


Atavi Atraumatic Spine Surgery System


Medtronic Sofamor Danek


MAST


CD Horizon Sextant Rod Insertion System


CD Horizon Eclipse

METRx System

X-Tube


Arthro Kinetics


KISS

Globus Medical


Pivot MIS System



DePuy Spine


Pipeline, Concorde and Viper

Aperture Spinal Access System


Abbott Spine


PathFinder

TraXis

Harmony


NuVasive

Zimmer


VuePASS Portal Access Surgical System


US Spine


Facet Fixation System


Mazor Surgical Technologies’


SpineAssist

DiscAssist



REGIONAL MARKETS



Fig. 4: Projected Motion Preservation Market by Region, 2006-2011

Table 15: Projected Motion Preservation Market by Region, 2006-2011


US


Table 16: Back-related Diagnoses in the US in 2003

Table 17: Spine Procedures in the US in 2003


Europe

Asia Pacific

Latin America


MOTION PRESERVATION - CONCLUSIONS

MANUFACTURERS


Aastrom Biosciences


Agreements


Orthovita



Abbott Spine


Acquisitions


Spinal Concepts

Spine Next SA


Agreements


Invibio

AlloSource

curasan



Alphatec Spine


Acquisitions


Cortek


Agreements


IsoTis

Hansen A Yuan


Financials


Amedica


Patent Portfolio


Metal-on-Ceramic Bearings Patent

Spine Graft Patent


Agreements

Funding


Anulex Technologies


Annular Repair

Funding


Applied Spine Technologies


Funding


Archus Orthopedics


Series C Financing


Arthro Kinetics


Joint Venture


Australian Biotechnologies Pty Ltd



Axial Biotech


Funding


AxioMed Spine


Financials


Biomet

Motion Preservation Products


Financials - Spinal Products


US Spinal Products Market,.2005-2006

Biorthex


Agreements


Nitinol Device & Components



Blackstone Medical


Proposed Acquisition by Orthofix International


B..Braun/Aesculap

Cervitech


Funding


co don

CoreSpine Technologies

Corin


Financials


CryoLife


Financials


DePuy Spine


Acquisitions


Bright Group’s Minimally-invasive Spinal Technology

Link Spine Group


Financials


Disc Dynamics


Funding


Disc Motion Technologies

Dynamic Spine

Endius

Facet Solutions


Funding


Fixano

GM Reis

Gentis


Funding


Genzyme


Synvisc Clinical Trial Data


Additional Study Findings



Globus Medical


Financials


Impliant


Financials


Innovative Spinal Technologies


Financials

Agreements


GE Healthcare Technologies



Intrinsic Therapeutics


Funding


K2M


Funding


LDR


Funding


Life Spine

Mazor Surgical Technologies


Funding


Medtronic Sofamor Danek


Non-Fusion Acquisitions


Spinal Dynamics Corporation


Agreements


Wyeth and Yamanouchi Pharmaceutical


Financials


Mekanika

N Spine


Funding


Nexgen Spine

NuVasive


Acquisitions


NeoDisc Technology

ExtenSure


Financials


Orthofix


Agreement to acquire Blackstone Medical

Financials


Orthonics

Osiris Therapeutics


Osteocel

Financials


Paradigm Spine


Adolescent Idiopathic Scoliosis - Canadian Study


Pioneer Surgical Technology

Ranier Technology


Funding


Raymedica


Funding


Replication Medical


Funding


Scient’x


Agreements


Encore Medical



SeaSpine

Spinal Elements.(formerly Quantum Orthopedics)

SpinalMotion

Spine Wave


Funding


SpineVision

SpineMedica


Agreements


SaluMedica



Spinal Restoration

St..Francis Medical Technologies


X Stop Interspinous Process Decompression (IPD) System


Stryker Spine


Stryker Biotech - Orthobiologics

Financials


Synthes


Acquisitions


Gelifex

Spine Solutions


Minority Investments


Innovative Spinal Technologies


Financials


Theken Disc


Funding


TranS1


Funding


US Spine


Funding


Verterbron


Agreements


medArtis International

Innovasis

US Tissue and Cell

Musculoskeletal Transplant Foundation


Acquisitions


Intellectual Property


Funding


X-spine


Financials


Zimmer Spine


Agreements


ISTO Technologies


Revivicor

Tutogen Medical

Massachusetts General Hospital and Cambridge Polymer Group

Financials


Table 18: Zimmer Spine Sales by Geographic Region, 2004-2005 (US$ million)

Table 19: Zimmer’s Global Orthopaedic Market Estimates



References




Index of tables


Table 1 - 2005 Worldwide Orthopaedic Market by Product (Market Size US$26 billion)

Fig.1: Global Spinal Market Shares, 2005

Table 2: Leading Spinal Companies - 2005 Spinal Sales, US$ million

Table 3: Projected Worldwide Spinal Fusion/Motion Preservation Device Revenues 2006-2011

Table 4: Projected Worldwide Spinal Motion Preservation Device Revenues 2006-2011

Table 5: Criteria to Determine Candidacy for TDR

Table 6: Select Lumbar Discs - Design Comparison

Table 7: Lumbar Total Disc Replacement Devices - Competitive Landscape

Table 8: Cervical Total Disc Replacement Products - Competitive Landscape

Table 9: Projected Worldwide TDR Revenues 2006-2011

Table 10: Projected Worldwide TDR Market, 2011

Table 11: Nucleus Replacement Devices - Competitive Landscape

Table 12: Projected Worldwide Partial Replacement Device Revenues 2006-2011

Table 13: Dynamic Stabilisation Systems - Competitive Landscape

Table 14: Projected Worldwide Dynamic Stablisation Device Revenues 2006-2011

Table 15: Projected Motion Preservation Market by Region, 2006-2011

Table 16: Back-related Diagnoses in the US in 2003

Table 17: Spine Procedures in the US in 2003

Table 18: Zimmer Spine Sales by Geographic Region, 2004-2005 (US$ million)

Table 19: Zimmer’s Global Orthopaedic Market Estimates


Abstract

"By 2011, motion preservation technologies will achieve revenues of US$5.1 billion and account for 50% of the market"

Motion preservation is the hottest topic around in spinal orthopaedics - a sector forecast to achieve 16% growth per year till 2011.

The concept of motion preservation in the spine is an intriguing one and the array of non-fusion technologies being introduced to the market offer a great deal of promise for spinal surgery patients.

However, despite the fact that some of these technologies have been in use in Europe and other international markets for many years, the clinical outcomes data available are extremely limited in proportion to the tens of thousands of procedures performed. While this has apparently not inhibited international growth, regulatory clearance criteria in the US are by far the most rigorous in the world. As such, the paucity of well-designed studies to prove the safety and effectiveness of artificial discs may hinder growth in the US.

Despite the lack of evidence, patient demand has not been dampened. A recent industry study of 461 prospective spine fusion patients, found that 49% would rather wait for a motion preserving implant than undergo a fusion procedure. A further 26% are still weighing the pros and cons of the two surgeries. Only 26% opted for the fusion procedure. Of course, owing to the many contradictions for total disc replacement, not all patients will be suitable candidates for the procedure.

What has become clear is that for optimal results, patient selection is critical with poor selection too often resulting in poor outcome. For certain segments of the patient population, traditional fusion will remain the appropriate therapy.

What’s it all about?

Spinal fusion has become the standard surgical care for numerous pathologic conditions of the spine. Spinal fusion surgery is frequently performed to treat spinal disorders such as spondylolisthesis, scoliosis, degenerative disc disease (DDD), instability of the spine or spinal fractures.

An alternative to spinal fusion in the treatment of DDD, is an artificial intervertebral disc. Unlike spinal fusion which achieves pain relief through immobilisation, artificial discs maintain motion at the operative level once the damaged disc has been removed. By preserving normal physiological motion, it is thought this may also reduce or prevent the development of adjacent segment degeneration. In addition, a bone graft is not required for an artificial disc replacement and this alleviates complications such as bone graft donor site pain and pseudo-arthritis. Furthermore, artificial disc replacements provide a more rapid return to activity than fusion surgery which requires time for the bone graft to grow into a solid mass.

This report provides real insights:

For executives working in industry and commerce, the need to understand the issues, players and products in this sector of high growth potential is essential. That is why Espicom, for 25 years a leading publisher of strategic business information for the medical device community, has published this extensive report.

In over 175-pages, the report examines the background to market, provides key figures and estimates for market growth and examines in-depth the companies and innovative products that are driving change.

This report answers key business questions:
  • What % of the market may be taken by the fledgling disc nucleus replacement market if it can overcome regulatory obstacles in the USA?
  • What competitive impact will Medtronic’s breakthrough have in the US cervical TDR market?
  • What % of the global market will Dynamic Stabilisation Systems command in 2011?
  • What is the potential for minimally-invasive spinal technology?
  • Which development companies have the most promising and innovative technology and present the most attractive acquisition targets?
  • To what degree will gene-based diagnostic testing affect the market in the future?
Providing:
  • Comprehensive market forecasts of technology and application sectors to 2011
  • A thorough review of the spinal orthopaedic market worldwide
An examination of key products that are currently in development:
  • Total Disc Replacement
  • Dynamic Stabilisation Devices
  • Disc Nucleus Replacement
A competitive review of 63 companies actively developing spinal preservation products

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