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2009 Bone Grafts and Bone Substitutes

The US bone and bone substitute market shrank about 2% between 2008 and 2009 according to data estimated by Orthopedic Network News. The segments include traditional allograft (bone wedges and cancellous and cortical bone chips), demineralized bone matrix (DBM) products, machined bone, bone substitutes, platelet concentrators, and bone morphogenic protein. Excluded are allograft tissue, tissue substitutes, hyaluronic acid viscosupplementation (Synvisc, Hylan), surgical hemostats (e.g. Vitagel), and cartilage repair products. The largest subsegment of this market continues to be bone morphogenic protein, the products sold by Medtronic and Stryker Bio-Tech. The sales of these products declined between 2008 and 2009 by 7.8% to $768 million leading to a decline in the overall segment. Although this market has declined, it is still about 50% of the total bone graft and bone substitute market. Following BMP, the allograft bone, demineralized bone matrix, and bone substitutes products accounted for the next largest group of the $1.5 billion in sales, and is the subject of most of the rest of this report. Smaller segments were reported for platelet concentrators and machine bone, generally implanted in the spine for fusion. Data obtained from the HPD (Hospital Purchasing Database) provides a distribution of purchases over the last five years. This data, derived from several hundred hospitals, indicates the ongoing shift from allograft bone and DBM products to bone substitutes. According to the HPD, the percentage of bone grafts and substitutes that were classified as allograft bone stayed at 15% of the dollar volume between 2007 and 2008; DBM continued its decline from 33% of the sales to 24% in 2008, while bone substitutes increased from 52% of sales to 54% of sales. The new category of "other" accounted for 8% of sales and was filled by Spineology's OptiMesh, a device used for containing bone graft, often used in kyphoplasty-like procedures. Data obtained from the ORN indicates how bone grafts and substitutes are being deployed: of the 42,000 plus cases reported in 2009, spinal procedures accounted for 83% of the bone grafts and substitutes used, followed by "Other" (generally trauma procedures), and hips and knees with 4% of the dollar total. The other graphic reports what percentage of hip or knee replacement, spine or other procedures received a bone graft or substitute according to the data from the ORN. About 50% of all spinal procedures received a bone graft or substitute, compared to 7% of "other" procedures, 2% of hip replacements, and 1% of knee replacements.

16

U.S. Sales of Bone Grafts and Bone Substitutes, 2008-2009 2008 BMP/Growth Factors Platelet Concentrators Bone Substitutes Machined Bone Demineralized Bone Matrix (DBM) Allograft Bone Total $832.7 $3.7 $257.8 $183 $205.2 $61.1 $1,543.6 2009 $767.8 $3.7 $297.5 $171 $203.6 $63.0 $1,506.6 % Chg - 7.8% nc + 15.4% - 6.6% - 0.8% + 3.1% - 2.4%

Source: Orthopedic Network News estimates based on analysis of company reports and data from the HPD. Company reports reviewed include Stryker, Medtronic, Alphatec Spine, RTI, Osteotech, MTF, Orthofix, and others.

Changes in Bone Grafts and Substitutes, 2004-2008

100% 7% Other

75% 52% 50% 33% 25% 15% 2004 2005 2006 2007 15% 2008 Allograft bone 24% DBM 54% Bone substitutes

0%

Source: HPD (Hospital Purchasing Database) 2004-2008, GIC 61. Allograft bone: Type1=Allo Bone, DBM: Type1=DBM, Bone substitutes: Type1=Bone Subs; "Other" is OptiMesh

Ot her

Usage of Bone Grafts and Substitutes by Procedure Type % of Dollars for Bone Grafts By Procedure Type, 2009

Knees 4% Hips 4% Other 9%

40% 30% 20% 50%

Spi ne Knees

% of Procedures with Bone Graft and Bone Substitute

Spine Procedures 50%

Hi ps

Spine 83%

10%

Other Procedures

7%

0% 99 00 01 02 03 04 05

06 07 08 09

Hips 2% Knees 1%

Source: www.ImplantData.com data for 2009. Cases with GIC61>0 assigned to constructs for primary hips and knees, or spinal fusion cases.

© 2009 Mendenhall Associates, Inc.

Orthopedic Network News, Vol 20, No 4, October 2009

Posted to OrthopedicNetworkNews.com on November 15, 2009 at 2:00 pm

Market Share, Major Products by Subsegment, GIC 61

The specific product lines and manufacturer leaders are displayed at the right. Allograft bone, which includes cancellous chips, and non-structural allograft, was dominated by the Musculoskeletal Transplant Foundation with 78% of the share in 2008. The market leader in DBM products was led by MTF/ Synthes with 34% share, Wright with 15%, Sofamor Danek with 13%, Isotis with 7%, and Osteotech with 6%. Other manufacturers accounted for 25% of the market in 2008. The specific product lines in this group included MTF's DBX bone products, which are also marketed by Synthes, followed by Osteotech's Grafton, Sofamor Danek's Progenix DBM, Wright Medical's Allomatrix C, Lanx's AlloFuse, Sofamor Danek's Osteofil RT, among others. There were a total of 71 different product lines for DBM products. The bone substitute market was led by Orthovita with a 28% share, followed by Wright and Sofamor Danek with a 20% share, Apatech with 7%, and NexGen (NexGraft) at 5%. "Other" manufacturers accounted for 20% of this subsegment. The specific product lines include Orthovita's Vitoss, Sofamor Danek's Mastergraft, Wright's Pro-Dense, Apatech's Actifuse ABX, among others. There were a total of 63 different product lines for bone substitutes in the 2008 HPD. An analysis of the actual dosages in the HPD demonstrates for DBM products, most were less than 15ccs, with an overall average of about 7ccs. However, with increased sizes, the average selling price rose to almost $2,000 a dose. Bone substitutes demonstrated a somewhat different dynamic with larger doses much more prevalent (overall average 12.7ccs), and selling prices which varied based on the product's preferred size rather than the amount of the dose. What makes tracking any of this data difficult is the profusion of companies that market and remarket the same product, often for different prices. For example, the DBM product AlloFuse is attributed to Allosource, but is marketed by both Lanx and Abbott Spine (now Zimmer Spine). NexGraft, a material which may be attributed to NexGen is marketed by Allez Spine and SpineMatrix. Grafton is sold by Osteotech and MTF, and occasionally regional offices of the American Red Cross.

Allograft Bone

Allosource 3% Lifenet 5% Others 6% DCI 8% MTF 78%

Major Product Lines MTF (All Products) DCI Donor Services LifeNet Allosource All Others

GIC=61 and type1=Allo Bone

2008 Share 78% 8% 5% 3% 6%

Demineralized Bone Matrix Products

Isotis Sofamor Danek Osteotech 6% MTF 34% 7% 13%

Product Lines

Sold by

2008 Share 28% 11% 8% 8% 7% 5% 4% 3% 3% 3% 3% 2% 2% 11%

Wright 15% Others 25%

Source: Hospital Purchasing Data (HPD) 2008

DBX Synthes/MTF Grafton Osteotech Progenix DBM Sofamor Danek Allomatrix C Wright AlloFuse Lanx Spine Osteofil RT Sofamor Danek Allomatrix Wright Accell Connexus Isotis Viagraf Smith/Nephew Osteobridge Altiva Bonus Biomet Accell Matrix Isotis Xpanse Osteotech All Others (58 Different)

GIC=61 and type1=DBM

Bone Substitutes

Apatech NexGen 5% Orthovita 28% Wright 20%

7% Sofamor Danek 20%

Others 20%

Source: Hospital Purchasing Data (HPD) 2008

GIC=61 and type1=Bone Subs Source: www.ImplantData.com data, procedures assigned to constructs for hip and knee replacements. Bone grafts and substitutes are components assigned to GIC 61. Product line shares will not equal manufacture shares because some products are sold by multiple companies

Product Line Sold by 2008 Share Vitoss Orthovita 28% Mastergraft Sofamor Danek 20% Pro-Dense Wright 16% Actifuse ABX Apatech 7% NexGraft NexGen 5% FormaGraft NuVasive 4% Hydroset Stryker Spine 4% Osteoset Wright 3% Healos Depuy 3% Pro-Osteon Biomet Spine 2% CopiOs Zimmer Spine 2% MIIG Wright 1% All others (51 other products) 5%

Number of Doses by Size and Average Selling Price Average DBM Products

Cases

1500 1,382 1200 900 600 300 30 895 1,091

Selling price $2000 $1500 $1000 $500

Average Dose Size: 7.0 ccs

91

$0

0 LT 5cc

Cases

10-14cc 20+cc 5-9cc 15-19cc

Bone Substitutes

2000 1500

$1,490 Average $1500 Selling price

1593

$1200

1000 851 500

792

1432

$900

Average Dose Size: 12.7 ccs

Source: HPD 2008

128 0 LT 5cc 10-14cc 20+cc 5-9cc 15-19cc

$600

© 2009 Mendenhall Associates, Inc.

Posted to OrthopedicNetworkNews.com on November 15, 2009 at 2:00 pm

Orthopedic Network News, Vol 20, No 4, October 2009

17

2009 Bone Grafts and Bone Substitutes

Processor Price Date Part number

MUSKULOSKELETAL TRANSPLANT FOUNDATION/SYNTHES WRIGHT MEDICAL GROUP January 1, 2009 January 1, 2009

SOFAMOR DANEK June 1, 2008 Progenix DBM 0.5cc 000505 1cc 005001 5cc 005005 10cc 005110

$105 $170 $595 $990

ISOTIS ORTHOBIOLOGICS January 1, 2008 RT Paste 1cc 004601 5cc 004605 10cc 004610 IC Syringe 5cc 002705 10cc 002710 20cc 002720

$176 $746 $1092 $1009 $1732 $2912

Demineralized Bone Matrix (DBM) Products

1

DBX®

AllomatrixTM

$220 $880 $1350 $220 $880 $1350 $590 $1070 $1680

DBX Paste 1cc 028010 5cc 028050 10cc 028100 DBX Putty 1cc 038010 5cc 038050 10cc 038100 DBX Mix 2.5cc 058025 5cc 058050 10cc 058100

Putty 1cc 8600-0100 $275 5cc 8600-0500 $920 10cc 8600-1000 $1420 20cc 8600-2000 $2575 Allomatrix-C 5cc 860C-0500 $1015 10cc 860C-1000 $1495 20cc 860C-2000 $2565 Allomatrix RCS 7cc 86CP-0700 $990 12cc 86CP-1200 $1375 Allomatrix DR DR 3cc 86DR-0300 $795

Osteoset 2 DBM 3.0mm 5cc 8600-3005 $950 10cc 8600-3010 $1635 50cc 8600-3050 NA 4.8mm 10cc 8600-4810 $1585 20cc 8600-4820 $2995

OsteofilTM

Paste 1cc 002401 $189 5cc 002405 $821 10cc 002410 $1200 ICM Moldable Strip 50mm 002350 $1456 90mm 002390 $2495

Accell Connexus 1cc 02-3000-010 $275 5cc 02-3000-050 $825 10cc 02-3000-100 $1485 Accell Matrix 5x2x.5 02-4000-520$1060 5x5x.5 02-4000-550 $2235 Accell DBM 100 1cc 02-1000-010 $335 5cc 02-1000-050 $940 10cc 02-1000-100 $1745 OrthoBlast II Putty 5cc 02-2110-050 $695 10cc 02-2110-100 $1220 OrthoBlast II Paste 3cc 02-2100-030 $440 8cc 02-2100-080 $1005

LANX SPINE April 15, 2008 AlloFuse DBM Gel 1cc 9900-1001 $198 5cc 9900-1005 $911 10cc 9900-1010 $1451 Putty 1cc 9900-2001 $225 5cc 9900-2005 $911 10cc 9900-2010 $1451 Osteosponge Block 6mm 9900-3006 NA

EXACTECH September 1, 2008

AESCULAP December 1, 2008

OpteFormTM

Disc 2.1cc 600-05-45 $1720 Allograft 2cc 606-01-02 $560 10cc 606-01-10 $2175 20cc 606-01-20 $3530 Optefil Allograft Syringe 1cc 616-01-01 $220 5cc 616-01-05 $925 10cc 616-01-10 $1470

OpteCureTM

Allograft Jar 1cc 650-00-01 $255 5cc 650-00-05 $1065 10cc 650-00-10 $1700 with CCC Jar 1cc 652-00-01 $280 5cc 652-00-05 $1325 10cc 652-00-10 $2220

ZIMMER SPINE ORTHOFIX September 1, 2009 January 1, 2009 Puros DBM Origen DBM Prospace DBM 2cc 22-2002 $300 Putty Gel $750 1cc 1cc ME602 $210 5cc 22-2005 $310 5cc ME601 $856 10cc 22-2010 $1350 00-1105-005-01 5cc Putty 00-1105-050-01 $940 1cc ME605 $476 10cc 5cc ME604 $856 00-1105-100-01 $1660 10cc ME603 $1345

Bone Substitutes

2

ORTHOVITA October 1, 2009 VitossTM Foam Pack 1.2cc

WRIGHT MEDICAL GROUP January 1, 2009

SOFAMOR DANEK June 1, 2008

APATECH July 1, 2008 ActiFuse ABX 2.5ml Putty 506005078050 $1100 5ml Putty 506005078051 $1850 10ml Putty 506005078052 $3000 ActiFuse MIS Applicator & Cartridge 506005078070 $3995 Refill and Cartridge 506005078072 $2950

NEXGEN January 1, 2008 NexGraft 3 Strip Box NBF-3 2 Strip Box NBFS2-05

NUVASIVE April 29, 2009

Pro-Dense 4cc 87SR-0404 $1985 2102-1401 $260 10cc 87SR-0410 $3875 2.5cc 2102-1402 $470 20cc 87SR-0420 $6295 5cc 2102-1405 $920 Osteoset 10cc 2102-1410 $1830 BVF Bone Graft 25cc 8400-0311 $1140 Foam Strip 25x50x4 5cc 8400-0611 $685 2102-1105 $1060 Osteoset 3.0 Pellets 25x100x4 2102-1100 $1830 5cc 8400-0305 $455 10cc 8400-0310 $685 25x100x8mm 2102-1120 $3320 20cc 8400-0101 $1035 25x240x4mm Bead Kit 2102-1101 $3520 Bioactive Foam Pack 25cc 8400-0211 $1140 1.2cc 2102-1601 $310 2.5cc 2102-1602 $605 5cc 2102-1605 $1130 10cc 2102-1610 $2085 Bioactive Foam Strip 25x100x4 2102-1500 $2085 25x50x4 2102-1505 $1270 25x50x8 2102-1510 $2085 25x100x8mm 2102-1520 $3790 18

MasterGraft Matrix

5cc 10cc 20cc 3cc 6cc 9cc

7600305 $475 7600310 $900 7600320 $1200 7600703 $365 7600706 $685 7600709 $1050

Putty

FormaGraft Granules $1750 5cc 5010005 10cc 5010010 $1750 Strips 5cc 5010205 Prices are 2008 ASPs of product sold by Allez Spine 10cc 5010200 Osteocel 1cc 5013001 5cc 5013005 10cc 5013010 15cc 5013015

$936 $1649 $891 $1650

$575 $2650 $4400 $5400

© 2009 Mendenhall Associates, Inc.

Orthopedic Network News, Vol 20, No 4, October 2009

Posted to OrthopedicNetworkNews.com on November 15, 2009 at 2:00 pm

OSTEOTECH January 1, 2009

a

indicates ASP for 2008 from HPD

ALLOSOURCE January 1, 2008 AlloFuse® DBM Putty 1cc 90038001 $165 5cc 90038005 $625 10cc 90038010 $1095 Gel 1cc 90138001 $165 5cc 90138005 $625 10cc 90138010 $1095 Osteocel 1cc 90103 $450 5cc 90081 $2125 10cc 90080 $4000 15cc 90055 $5350

Note: AlloFuse sold also by Lanx in 2008

SMITH & NEPHEW February 1, 2009

ALTIVA

a

BIOMET SPINE January 1, 2009

a

indicates ASP for 2008 from HPD

indicates ASP for 2008 from HPD

LIFENET January 1, 2009 I/C Graft 5cc GDS005 10cc GDS010 15cc GDS015 Optium Gel 1cc TGEL01 5cc TGEL05 10cc TGEL10 Optium Putty 1cc TPUT01 5cc TPUT05 Cellect

25c CEL25 $560 $1045 $1570 $200 $800 $1220 $200 $800 $1945

Grafton ®

DBM Matrix 2.5x5 42210 $872 2.5x10 42200 $1407 Matrix (qty = 2) 2.5x5 122210 $1659a 2.5x10 522200 $2127a Gel 1cc 521120 $189a 10cc 521150 $1155a Putty 1cc 43102 $200 5cc 523105 $767a 10cc 523110 $1165a Xpanse SML 60010 $1500 MED 60020 $1500 LRG 60030 $1500 STRYKER SPINE September 1, 2008

Viagraf DBM Osteobridge DBM Paste 5cc 632-00-05 $1103 a 1cc 717906 $185 10cc 632-00-10 $2495 a 5cc 717907 $750 10cc 717908 $1140 Canc Crunch 5cc 717914 $998 15cc 717915 $1690 Flex 5x2.5cm 717917 $960 10x2.5cm 717918 $1462

InterGro Plus Putty 5cc DBMW05 $968 10cc DBMW10 $1491 InterGro Paste 1cc DBM001 $200 5cc DBM005 $735 InterGro Putty 10cc DBM010 $1286 Bonus DBM 5cc 48-DBM1 $729 a 10cc 48-DBM2 $1411 a

ALPHATECH SPINE August 15, 2009 AlphaGRAFT AlloCraft DBM 2cc 653002 $434 Gel 5cc 653005 $1012 1cc 1001-010 $287 10cc 653010 $1736 5cc 1001-050 NA Putty 2.5cc 1002-025 $542 5cc 1002-050 NA 10cc 1002-100 $1626

GLOBUS MEDICAL January 1, 2009 NuBone DBM Putty 1cc 840.001 $344 5cc 840.005 $1404 10cc 840.010 $2164

Suppliers of Bone DePuy Spine and Bone Substitutes www.depuyspine.com Aesculap Exactech

www.aesculapusa.com www.exac.com

LifeNet

www.lifenet.org MTF www.mtf.org

Sofamor Danek Stryker

www.sofamordanek.com www.stryker.com

Allosource

Globus Medical

NuVasive Orthofix

www.allosource.org

Alphatec Spine Altiva

www.globusmedical. com

www.nuvasive.com www.orthofix.com

Synthes Theken

www.synthes.com www.theken.com

www.alphatecspine.com Integra Life Sciences www.integra-ls.com www.altivacorp.com Apatech www.apatech.com

Isotis Orthobiologics

www.isotis.com

Orthovita

www.orthovita.com

Wright Medical Technologies

www.wmt.com

Lanx Spine

Osteotech

Biomet Spine

www.lanxspine.com

www.osteotech.com

Zimmer Spine

Smith & Nephew

www.zimmerspine.com

www.ebimedical.com

www.smithnephew.com

STRYKER September 1, 2009 HydroSet Injectable HA Bone 3cc 397003 $1116 5cc 397005 $1788 10cc 397010 $3444 15cc 397015 $4944 Bonesave 20cc 6184-9-220 $1210 Calstrux TCP Bone Void Filler 15cc 400-15 NA

DEPUY SPINE January 1, 2009

BIOMET SPINE January 1, 2009

ZIMMER January 1, 2009

INTEGRA LIFE SCIENCES 2008 ASP Mozaik Strip, 15cc

CCM10256

SYNTHES November 1, 2008 $1435

$1348

THEKEN January 1, 2007

Healos® II

2761-60-002

Pro-Osteon ® Pro

$550 $960 $1280 $2345

Single Strip, 2.5cc Single Strip, 5cc

2761-60-005

Two Strips, 16cc

2761-60-016 2761-60-015

Single Strip 15cc

Conduit

Granules/Vial 5cc 2761-01-005 $395 10cc 2761-01-010 $730 15cc 2761-01-015 $880 30cc 2761-01-030 $1420 DePuy October 1, 2008 a-BSM 2.5cc 1980-90-025 $390 5cc 1980-90-050 $690 10cc 1980-90-100$1330

Osteon 500 (1) 5cc 5G05 $334 10cc 5G10 $634 15cc 5G15 $768 20cc 5G20 $913 30cc 5G30 $1041 Pro Osteon 500R 5cc 5RG05 $362 10cc 5RG10 $696 15cc 5RG15 $846 20cc 5RG20 $1002 30cc 5RG30 $1146

CopiOs TM

Sponge cc's: 1 00-1103-010-01 $355 5 00-1103-010-05 $870 10 00-1103-010-10 $1565 Paste (cc's) 1 00-1103-020-01 $345 5 00-1103-020-05 $845 10 00-1103-020-10 $1520 ZIMMER SPINE September 1, 2009

chronOS

Putty

2.5cc 5cc 10cc 15cc PTY10125 NA PTY10155 NA PTY10210 $1123 PTY10256 NA

Granules 5cc 710.014.99S $395 10cc 710.026.97S $760 20cc 710.021.99S $1090 Small Cylinder L sz9 710.935.99S $420

FormPutty

1cc 50-07-0010 $250 5cc 50-07-0050 $800 10cc 50-07-0100 $1200

xLink

chronOS beta TCP

CopiOs TM

Bone Void Filler, cc's: 1 07.00582.001 $355 5 07.00582.003 $870 10 07.00582.004 $1565

Granules 5cc 710.014.98S $395 Block: 20x20x10 710.047.98S $750 Wedge: 25x35x10 20cc 710.050.98S $760

5mm 50-01-0005 $795 10mm 50-02-0010 $995 20mm 50-02-0020 $1195

© 2009 Mendenhall Associates, Inc.

Posted to OrthopedicNetworkNews.com on November 15, 2009 at 2:00 pm

Orthopedic Network News, Vol 20, No 4, October 2009

19

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