Keywords : Orthopaedic, artificial joint
The orthopaedic market has not been immune to the economic downturn that has plagued world economies in recent times. Some of the smaller companies, particularly those at the cutting edge of the market, found themselves short of cash and with little in the way of white knights to help make up the shortfall. Now things are slowly changing. Private equity has returned to the industry and some of those calls for cash are finally getting answe...
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The orthopaedic market has not been immune to the economic downturn that has plagued world economies in recent times. Some of the smaller companies, particularly those at the cutting edge of the market, found themselves short of cash and with little in the way of white knights to help make up the shortfall.
Now things are slowly changing. Private equity has returned to the industry and some of those calls for cash are finally getting answered by investors. It has become noticeable that a number of these investors have been able to successfully sell some of their business holdings with their pride relatively intact. And the reasons why we need these devices are growing ever more present.
The strength of the orthopaedics sector is that the fundamentals remain strong. It is one of the fastest growing sectors in the industry, thanks to the impact of an expanding elderly population and the associated steady rise and diagnosis in musculoskeletal disorders.
Use this new report to easily answer key business questions such as:
What developments will underpin the 2012-17 CAGR of 8.2% in the artificial joint sector?
What new products and services has Integra LifeSciences introduced in 2012?
What is the product and service line of the newly merged DePuy Synthes?
What are the latest developments in worldwide regulation and how are they affecting the orthopaedic sector?
Does ConforMIS patented i-fit technology signal progression on the development of bespoke, patient specific implants?
Which company posted flat sales in the US but grew revenues in Europe and Asia by 10% and 16% respectively in 2011?
Who is active in the foot and ankle ortho sector and what are their competing products?
A complete analysis packed with facts, forecasts and
detailed company evaluations
Regulation: First Approval – why some companies prefer Europe over the USA
There is increasing concern from manufacturers that access to the world’s largest orthopaedic market is being frustrated by the FDA’s lengthy and costly approval process. Some companies have made conscious efforts to avoid the US market, citing the expense and uncertainty of the FDA process as the reasons. Indeed, it is often seen as a preferred option for US start-ups to find their feet - and their revenues - in the European market. Faced without the possibility of much needed revenue, a massive regulatory bill and a nervy team of investors, companies eyeing the US market are required to sit tight as the FDA goes through its safety and efficacy review processes.
Study shows the contrasts
The contrast in regulatory approaches in Europe could not be clearer. According to a 2010 Stanford University study in the US, entitled “FDA Impact on US Medical Technology Innovation, for a PMAtype product, the time span from the initial contact with the regulatory authority until market launch amounted to 54 months in the US, compared with 11 months in Europe. On average, a market launch in Europe can be realised three years earlier, with significantly lower costs. Financially, it can take a device manufacturer three to five years to get a medical device approved in Japan and China, at a cost of US$3 million or less in each market. In Europe, the time can range from six months to two years and cost around US$2 million. In contrast, getting approval in the US for a medical device can take between two and seven years and cost between US$50 to US$100 million. Time frames differ for those pursuing the 510(k) route to approval, but even here the FDA’s anxieties can be seen in requests for further information after first review: 3 out of 4 applications will now be referred back to the company. The trend, illustrated in the chart below, shows that this is long established.
Percentage of 510(k)s with additional information request on the first FDA review
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Global Orthopedic Industry
Contents
INTRODUCTION 1
AN OveRvIew Of RegUlATORy IssUes INThe Us, eUROpe AND beyOND 3
ORThOpAeDIC COMpANIes fIve-yeAR sAles RevIew 23
AAp IMplANTATe 25
KEY PERSONNEL 25
COMPANY OVERVIEW .25
KEY MILESTONES 25
AGREEMENTS .26
TECHNOLOGIES/PRODUCTS 27
KEY FINANCIAL DATA 30
AlphATeCspINe .31
KEY PERSONNEL 31
COMPANY OVERVIEW .31
KEY COMPETITORS 31
KEY MILESTONES 31
AGREEMENTS .32
TECHNOLOGIES/PRODUCTS 34
KEY FINANCIAL DATA 41
AMeDICA 43
KEY PERSONNEL 43
COMPANY OVERVIEW .43
KEY MILESTONES 43
AGREEMENTS 44
TECHNOLOGIES/PRODUCTS 45
KEY FINANCIAL DATA 47
ANIkA TheRApeUTICs 49
KEY PERSONNEL 49
COMPANY OVERVIEW .49
KEY COMPETITORS 49
KEY MILESTONES 49
AGREEMENTS .50
R&D MILESTONES 50
TECHNOLOGIES/PRODUCTS 50
KEY FINANCIAL DATA 51
ARThROCARe 53
KEY PERSONNEL 53
COMPANY OVERVIEW .53
KEY COMPETITORS 53
KEY MILESTONES 53
AGREEMENTS .54
R&D MILESTONES 54
TECHNOLOGIES/PRODUCTS 55
KEY FINANCIAL DATA 63
ARTIMplANT 65
KEY PERSONNEL .65
COMPANY OVERVIEW 65
KEY MILESTONES 65
AGREEMENTS 65
R&D MILESTONES .66
TECHNOLOGIES/PRODUCTS 67
KEY FINANCIAL DATA 67
bACTeRIN INTeRNATIONAl 69
KEY PERSONNEL .69
COMPANY OVERVIEW 69
KEY COMPETITORS 69
KEY MILESTONES 69
AGREEMENTS 70
R&D MILESTONES .70
TECHNOLOGIES/PRODUCTS 71
KEY FINANCIAL DATA 71
bIOMeT .73
KEY PERSONNEL .73
COMPANY OVERVIEW 73
KEY COMPETITORS 73
KEY MILESTONES 74
AGREEMENTS 74
R&D MILESTONES .75
TECHNOLOGIES/PRODUCTS 76
Subsidiaries 81
KEY FINANCIAL DATA 88
bIOMIMeTIC TheRApeUTICs 89
KEY PERSONNEL .89
COMPANY OVERVIEW 89
KEY COMPETITORS 89
KEY MILESTONES 89
AGREEMENTS 91
R&D MILESTONES .91
TECHNOLOGIES/PRODUCTS 93
KEY FINANCIAL DATA 94
bONesUppORT 95
KEY PERSONNEL .95
COMPANY OVERVIEW 95
KEY COMPETITORS 95
KEY MILESTONES 95
AGREEMENTS 95
TECHNOLOGIES/PRODUCTS 96
KEY FINANCIAL DATA 97
CAyeNNe MeDICAl .99
KEY PERSONNEL .99
COMPANY OVERVIEW 99
KEY MILESTONES 99
AGREEMENTS 99
R&D MILESTONES 100
PRODUCTS 100
KEY FINANCIAL DATA 101
CO.DON . 103
KEY PERSONNEL 103
COMPANY OVERVIEW .103
KEY COMPETITORS 103
AGREEMENTS .103
R&D MILESTONES 104
TECHNOLOGIES/PRODUCTS 104
KEY FINANCIAL DATA 104
CONfORMIs 105
KEY PERSONNEL 105
COMPANY OVERVIEW .105
KEY MILESTONES 105
AGREEMENTS .106
TECHNOLOGIES/PRODUCTS 106
KEY FINANCIAL DATA 106
CORIN 107
KEY PERSONNEL 107
COMPANY OVERVIEW .107
KEY MILESTONES 107
AGREEMENTS .107
R&D MILESTONES 108
TECHNOLOGIES/PRODUCTS 108
KEY FINANCIAL DATA .111
DepUy syNThes .113
KEY PERSONNEL 113
COMPANY OVERVIEW 113
KEY COMPETITORS .114
KEY MILESTONES .115
AGREEMENTS 116
TECHNOLOGIES/PRODUCTS .117
KEY FINANCIAL DATA 134
DJO glObAl 135
KEY PERSONNEL 135
COMPANY OVERVIEW .135
KEY COMPETITORS 135
KEY MILESTONES 135
AGREEMENTS 136
R&D MILESTONES 137
TECHNOLOGIES/PRODUCTS 137
KEY FINANCIAL DATA 147
exACTeCh .149
KEY PERSONNEL 149
COMPANY OVERVIEW .149
KEY COMPETITORS 149
KEY MILESTONES 149
AGREEMENTS .150
R&D MILESTONES 151
TECHNOLOGIES/PRODUCTS 151
KEY FINANCIAL DATA 157
glObUs MeDICAl 159
KEY PERSONNEL 159
COMPANY OVERVIEW .159
KEY COMPETITORS 159
KEY MILESTONES 159
R&D MILESTONES 160
TECHNOLOGIES/PRODUCTS 161
KEY FINANCIAL DATA 165
hANgeR .167
KEY PERSONNEL 167
COMPANY OVERVIEW .167
KEY COMPETITORS 167
KEY MILESTONES 167
AGREEMENTS .168
R&D MILESTONES 168
TECHNOLOGIES/PRODUCTS 169
KEY FINANCIAL DATA 171
INION 173
KEY PERSONNEL 173
COMPANY OVERVIEW .173
KEY MILESTONES 173
AGREEMENTS .173
R&D MILESTONES 174
TECHNOLOGIES/PRODUCTS .174
KEY FINANCIAL DATA 176
INTegRAlIfesCIeNCes 177
KEY PERSONNEL 177
COMPANY OVERVIEW .177
KEY COMPETITORS 177
KEY MILESTONES 177
AGREEMENTS .181
TECHNOLOGIES/PRODUCTS 181
KEY FINANCIAL DATA 191
k2M 193
KEY PERSONNEL 193
COMPANY OVERVIEW .193
KEY MILESTONES 193
AGREEMENTS .195
TECHNOLOGIES/PRODUCTS 195
KEY FINANCIAL DATA 197
kANghUI MeDICAl .199
KEY PERSONNEL 199
COMPANY OVERVIEW .199
KEY COMPETITORS 199
KEY MILESTONES 199
AGREEMENTS .200
TECHNOLOGIES /PRODUCTS 200
KEY FINANCIAL DATA 202
kfx MeDICAl .203
KEY PERSONNEL 203
COMPANY OVERVIEW .203
KEY COMPETITORS 203
KEY MILESTONES 203
TECHNOLOGIES/PRODUCTS 204
KEY FINANCIAL DATA 204
kUROs bIOsURgeRy 205
KEY PERSONNEL 205
COMPANY OVERVIEW .205
KEY MILESTONES 205
AGREEMENTS .205
R&D MILESTONES 206
TECHNOLOGIES/PRODUCTS 207
KEY FINANCIAL DATA 208
lANx 209
KEY PERSONNEL 209
COMPANY OVERVIEW .209
KEY MILESTONES 209
AGREEMENTS .209
R&D MILESTONES 210
TECHNOLOGIES/PRODUCTS 210
KEY FINANCIAL DATA .211
lDR spINe .213
KEY PERSONNEL 213
COMPANY OVERVIEW .213
KEY COMPETITORS 213
KEY MILESTONES 213
R&D MILESTONES 214
TECHNOLOGIES/PRODUCTS 215
KEY FINANCIAL DATA 217
lIfe spINe .219
KEY PERSONNEL 219
COMPANY OVERVIEW .219
KEY MILESTONES 219
AGREEMENTS .220
TECHNOLOGIES/PRODUCTS 220
KEY FINANCIAL DATA 222
MAkOsURgICAl 223
KEY PERSONNEL 223
COMPANY OVERVIEW .223
KEY COMPETITORS 223
KEY MILESTONES 223
AGREEMENTS .224
R&D MILESTONES 224
TECHNOLOGIES/PRODUCTS 224
KEY FINANCIAL DATA 226
MAzOR RObOTICs 227
KEY PERSONNEL 227
COMPANY OVERVIEW .227
KEY MILESTONES 227
AGREEMENTS .228
R&D MILESTONES 228
TECHNOLOGIES/PRODUCTS 229
KEY FINANCIAL DATA 230
MeDICReA INTeRNATIONAl 231
KEY PERSONNEL 231
COMPANY OVERVIEW .231
KEY MILESTONES 231
AGREEMENTS .231
R&D MILESTONES 232
TECHNOLOGIES/PRODUCTS 232
KEY FINANCIAL DATA 233
MeDTRONIC 235
KEY PERSONNEL 235
COMPANY OVERVIEW .235
KEY COMPETITORS 235
KEY MILESTONES 236
AGREEMENTS .238
R&D MILESTONES 239
TECHNOLOGIES/PRODUCTS 240
KEY FINANCIAL DATA 248
NUvAsIve 249
KEY PERSONNEL 249
COMPANY OVERVIEW .249
KEY COMPETITORS 249
KEY MILESTONES 250
AGREEMENTS .251
R&D MILESTONES 251
TECHNOLOGIES/PRODUCTS 252
KEY FINANCIAL DATA 254
ORThOfIx INTeRNATIONAl 255
KEY PERSONNEL 255
COMPANY OVERVIEW .255
KEY COMPETITORS 255
KEY MILESTONES 256
AGREEMENTS .257
TECHNOLOGIES/PRODUCTS 258
KEY FINANCIAL DATA 264
pIONeeRsURgICAl TeChNOlOgy 265
KEY PERSONNEL 265
COMPANY OVERVIEW .265
KEY MILESTONES 265
AGREEMENTS .266
R&D MILESTONES 267
TECHNOLOGIES/PRODUCTS 267
KEY FINANCIAL DATA 270
RTI bIOlOgICs 271
KEY PERSONNEL 271
COMPANY OVERVIEW .271
KEY MILESTONES 271
AGREEMENTS .272
R&D MILESTONES 272
TECHNOLOGIES/PRODUCTS 273
KEY FINANCIAL DATA 276
sI-bONe .277
KEY PERSONNEL 277
COMPANY OVERVIEW .277
KEY COMPETITORS 277
KEY MILESTONES 277
R&D MILESTONES 278
TECHNOLOGIES/PRODUCTS 278
KEY FINANCIAL DATA 278
sMAll bONe INNOvATIONs 279
KEY PERSONNEL 279
COMPANY OVERVIEW .279
KEY COMPETITORS 279
KEY MILESTONES 279
AGREEMENTS .280
R&D MILESTONES 281
TECHNOLOGIES/PRODUCTS 281
KEY FINANCIAL DATA 284
sMITh & Nephew .285
KEY PERSONNEL 285
COMPANY OVERVIEW .285
KEY COMPETITORS 285
KEY MILESTONES 286
AGREEMENTS 287
R&D MILESTONES 288
TECHNOLOGIES/PRODUCTS 289
KEY FINANCIAL DATA 292
spINAl eleMeNTs 295
KEY PERSONNEL 295
COMPANY OVERVIEW .295
KEY COMPETITORS 295
KEY MILESTONES 295
AGREEMENTS 295
R&D MILESTONES 296
TECHNOLOGIES/PRODUCTS 296
KEY FINANCIAL DATA 297
spINAlMOTION 299
KEY PERSONNEL 299
COMPANY OVERVIEW .299
KEY MILESTONES 299
R&D MILESTONES 299
TECHNOLOGIES/PRODUCTS 300
KEY FINANCIAL DATA 300
spINesMITh 301
KEY PERSONNEL 301
COMPANY OVERVIEW .301
KEY MILESTONES 301
AGREEMENTS .301
R&D MILESTONES 302
TECHNOLOGIES/PRODUCTS 302
KEY FINANCIAL DATA 303
sTANMORe IMplANTs 305
KEY PERSONNEL 305
COMPANY OVERVIEW .305
KEY MILESTONES 305
AGREEMENTS .305
TECHNOLOGIES/PRODUCTS 306
KEY FINANCIAL DATA 308
sTRykeR 309
KEY PERSONNEL 309
COMPANY OVERVIEW .309
KEY COMPETITORS 309
KEY MILESTONES 310
AGREEMENTS 311
R&D MILESTONES 311
TECHNOLOGIES/PRODUCTS 312
KEY FINANCIAL DATA 320
syMMeTRy MeDICAl 321
KEY PERSONNEL 321
COMPANY OVERVIEW .321
KEY COMPETITORS 321
KEY MILESTONES 321
AGREEMENTS 322
TECHNOLOGIES/PRODUCTS 323
KEY FINANCIAL DATA 325
TORNIeR 327
KEY PERSONNEL 327
COMPANY OVERVIEW .327
KEY MILESTONES 327
AGREEMENTS .328
R&D MILESTONES 328
TECHNOLOGIES/PRODUCTS 329
KEY FINANCIAL DATA 333
TRANs1 335
KEY PERSONNEL 335
COMPANY OVERVIEW .335
KEY COMPETITORS 335
KEY MILESTONES 335
AGREEMENTS .336
TECHNOLOGIES/PRODUCTS 336
KEY FINANCIAL DATA 337
wRIghT MeDICAl gROUp 339
KEY PERSONNEL 339
COMPANY OVERVIEW .339
KEY COMPETITORS 339
KEY MILESTONES 339
AGREEMENTS .341
R&D MILESTONES 341
TECHNOLOGIES/PRODUCTS 342
KEY FINANCIAL DATA 349
x-spINe sysTeMs 351
KEY PERSONNEL 351
COMPANY OVERVIEW .351
KEY MILESTONES 351
AGREEMENTS .351
TECHNOLOGIES/PRODUCTS 352
KEY FINANCIAL DATA 353
zIMMeR .355
KEY PERSONNEL 355
COMPANY OVERVIEW .355
KEY COMPETITORS 355
KEY MILESTONES 355
AGREEMENTS .357
R&D MILESTONES 358
TECHNOLOGIES/PRODUCTS 359
KEY FINANCIAL DATA 368
