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2010 Bone Grafts and Bone Substitutes

The US biologics market monitored by Orthopedic Network News had virtually no change between 2009 and 2010. 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. This year, a new category "Cell-based matrices" was added to accommodate the stem-cell products of Nuvasive (Osteocel) and Orthofix (Trinity Evolution). 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 2009 and 2010 by 1.8% to $754 million leading to a decline in the overall segment. Although the sales of these products have declined, it is still about 50% of the biologics 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 machined bone, generally implanted in the spine for fusion. Data obtained from the HPD (Hospital Purchasing Database) provides a distribution of hospital purchases in the specific category of bone grafts and substitutes (GIC 61). This data, derived from over one hundred hospitals, indicates the ongoing shift from allograft bone and DBM products to bone substitutes, and more recently to cell-based matrices, which were formerly classified as allograft bone. According to the HPD, the percentage of bone grafts and substitutes that were classified as allograft bone declined to 13% of the dollar volume between 2009 and 2010; demineralized bone matrix products (DBMs) increased slightly to 21% of this group in 2010, while bone substitutes increased from 37% of sales to 41% of sales. The "Other" category accounted for 27% of sales in this group in 2009, but that declined to 10% in 2010--almost all of the sales were accounted for by Spineology's OptiMesh, a device used for containing bone graft, often used in kyphoplasty-like procedures. The newest category of cell-based matrices accounted for 17% of all sales in this group. Although biologics are touted as the next panacea for a variety of procedures, for the most part, bone grafts and substitutes are heavily concentrated in spinal fusions. About 84% of bone

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U.S. Sales of Biologicals, 2009-2010 2009 BMP/Growth Factors Platelet Concentrators Bone Substitutes Machined Bone Cell-Based Matrices Demineralized Bone Matrix (DBM) Allograft Bone Total $767.8 $3.7 $297.5 $228.7 $51.0 $203.6 $57.4 $1,609.7 2010 $754.0 $3.7 $297.3 $220.6 $59.0 $208.1 $54.3 $1,597.0 % Chg - 1.8% nc - 0.1% - 3.5% + 15.7% + 2.2% -5.4% -0.8%

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, 2004-2010

100% 27%

Cell Based Matrices 17% (CBM) 10% Other

75%

50%

37%

41% Bone Substitutes

25%

18% 18% 2004 2005 2006 2007 2008 2009

21% DBM 13% Allograft Bone 2010

0%

Source: HPD (Hospital Purchasing Database) 2004-2008, GIC 61. Allograft bone: Type1=Allo Bone, DBM: Type1=DBM, Bone substitutes: Type1=Bone Subs; Cell based matrices include Trinity and OsteoCel "Other" is OptiMesh . Note the decline in "other" from 27% in 2009 to 10% in 2010 represents a decline in the usage of Optimesh by one of the participating hospitals. Note the growth in CBMs represents the reclassification of OsteCel and Trinity Evolution in 2010 from Allograft Bone to Cell Based Matrix.

Trauma

Usage of Bone Grafts and Substitutes by Procedure Type % of Dollars for Bone Grafts By Procedure Type, 2010

Recon Trauma 10% 6%

50% 40% 30%

Other Spine

% of Procedures with Bone Graft and Bone Substitute

Spine Procedures 47%

Recon

Spine 84%

20% 10% 0%

99 00 01 02 03 04 05 06 07 08 09 10

Trauma 11% Recon 1%

Source: ORN (1999-2010). Cases with GIC61>0 assigned to constructs for cases assigned to segment "Recon", "Spine" or "Trauma".

© 2010 Mendenhall Associates, Inc.

Orthopedic Network News, Vol 21, No 4, October 2010

posted to www.OrthopedicNetworkNews.com on November 2, 2010 at 5:00 PM EST

grafts and substitutes were used in spinal procedures followed by 10% in trauma, and 6% in recon procedures. Of the spine procedures monitored about 48% received a bone graft or bone substitute which dwarves the number of trauma (10%), or recon (1%) procedures. The specific product lines and manufacturer leaders are displayed at the right. Allograft bone, which includes cancellous chips, and non-structural allograft, was led by the Musculoskeletal Transplant Foundation with 55% of the share in 2010. The market leader in DBM products was led by Osteotech and Isotis, both with a 20% share, followed by Sofamor Danek (14%), MTF/Synthes with 11% share, and Wright with 6%. Other manufacturers accounted for 29% of the market in 2010. The specific product lines in this group include Osteotech's Grafton, Isotis' Accell Evo 3, Synthes/MTF's DBX, Sofamor Danek's Progenix Plus, Altiva's Osteobridge. The bone substitute market in 2010 was led by Sofamor Danek with 37% share, Apatech with 14%, Orthovita and Wright, both with 10%, and NexGen with 8% share. "All other" accounted for 21% of the total of this subsegment group. The specific product lines include Sofamor Danek's Mastergraft, Apatech's Actifuse ABX, Orthovita's Vitoss, Wright's Pro-Dense, among others. There were a total of 50 different product lines for bone substitutes in the 2010 HPD. The new category of "cell based matrices" was created to recognize the difference between bone substitutes that use stem-cell or related technologies in their development. Thus far, the only two products in this group are NuVasive's OsteoCel and OsteoCel Plus, which they acquired from Osiris Therapeutics, and Trinity Evolution, marketed by Orthofix/Blackstone. In 2010, the OsteoCel products accounted for over 92% of the sales in this category. The distribution of the "machined bone" (GIC 58) is also included here. Machined bone is often allograft bone that has been manipulated so that it can be easily placed between cervical or lumbar vertebrae. This category was again led by Sofamor Danek and its related companies with a 23% share, followed by Depuy/Lifenet with 17%, MTF with 13%, and RTI with 8%. It should be noted that the history of the products in this segment is to be the "latest and greatest" until a newer product displaces it. This can be seen going back several years when Osteotech's Grafton was the product commanding share. In prior year's it was products manufactured from coral by Interpore Cross (now Biomet), then Orthovita. The latest iteration are the cell-based matrices which have cannibalized market share from bone substitutes.

© 2010 Mendenhall Associates, Inc.

posted to www.OrthopedicNetworkNews.com on November 2, 2010 at 5:00 PM EST

Market Share, Major Products by Subsegment, GIC 58, GIC 61

Allograft Bone

Lifenet DCI 6% 6% Others 14% Ostetech 19%

Major Product Lines MTF (All Products) Osteotech DCI Donor services ReadiGraft AlloSource Community Tissue Bank All Others

GIC=61 and type1=Allo Bone

2010q1-q2 Share 55% 19% 6% 5% 3% 3% 9%

MTF 55%

Demineralized Bone Matrix Products

Wright 6% MTF 11%

Product Lines

Sold by

2010q1-q2 Share 19% 17% 11% 9% 5% 4% 4% 2% 2% 2% 25%

Sofamor Danek 14%

Others 29% Osteotech 20%

Isotis 20%

Grafton Osteotech Accell Evo3 Isotis DBX Synthes/MTF Progenix Plus Sofamor Danek Osteobridge Altiva Allomatrix C Wright Osteosponge Bacterin InterGro Biomet Accell Connexus Isotis Allomatrix Wright All Others (37 Different)

GIC=61 and type1=DBM

Bone Substitutes

NexGen Wright 10% Orthovita 10% 8% Sofamor Danek 37%

Product Line

Sold by

2010q1-q2 Share 37% 12% 10% 9% 8% 3% 3% 2% 2% 1% 13%

Apatech 14% Others 21%

Mastergraft Sofamor Danek Actifuse ABX Apatech Vitoss Orthovita Pro-Dense Wright NexGraft NexGen OssiMend Collagen Matrix Healos Depuy Pro-Osteon Biomet Spine chronOS Synthes Hydroset Stryker Spine All Others (40 Other Products)

GIC=61 and type1=Bone Subs

Cell Based Matrices

Orthofix 8%

Product Line

Sold by

2010q1-q2 Share 90% 8% 2%

OsteoCel NuVasive Trinity Evolution Orthofix OsteoCel Plus NuVasive

GIC=61 and type1=CBM

NuVasive 92%

Machined Bone

RTI MTF 8% 13% Lifenet 17%

Product Lines

Sold by

2010q1-q2 Share 14% 12% 12% 11% 9% 4% 4% 3% 3% 2% 26%

Others 35%

Sofamor Danek 27%

Cornerstone L ASR Sofamor Danek MTF MTF Cornerstone SR Sofamor Danek VertiGraft 2 Lifenet Pioneer Surgical Pioneer Surgical AlloCraft Stryker Spine MD RTI ExtenSure H2 NuVasive Composite Cervical Biomet Spines Fortis Lanx All Others (50 Different)

GIC=58

Product line shares will not equal manufacture shares because some products are sold by multiple companies Source: Hospital Purchasing Data (HPD) 2010q1-q2

Orthopedic Network News, Vol 21, No 4, October 2010

17

2010 Bone Grafts and Bone Substitutes

Processor Price Date Part number

SOFAMOR DANEK 2010q1-q2 ASP

APATECH 2010q1-q2 ASP ActiFuse ABX Putty 10ml Putty 506005078052 $1993 5ml Putty 506005078051 $1014 2.5ml Putty 506005078050 $688 EZ fill Putty 20 ml 506005078058 $3569

WRIGHT MEDICAL GROUP January 1, 2010 Pro-Dense 4cc 87SR-0404 $1985 10cc 87SR-0410 $3995 15cc 87SR-CK15 $6055 20cc 87SR-0420 $6495 MIIG X3 15cc 84SS-0415 $3025 Osteoset BVF Bone Graft 25cc 8400-0311 $1195 5cc 8400-0611 $715 Osteoset 3.0 Pellets 5cc 8400-0305 $480 10cc 8400-0310 $720 20cc 8400-0101 $1085 Bead Kit 25cc 8400-0211 $1195

ORTHOVITA October 1, 2009 VitossTM Foam Pack 1.2cc 2102-1401 $260 2.5cc 2102-1402 $470 5cc 2102-1405 $920 10cc 2102-1410 $1830 Foam Strip 25x50x4 2102-1105 $1060 25x100x4 2102-1100 $1830 25x100x8mm 2102-1120 $3320 25x240x4mm 2102-1101 $3520 Bioactive Foam Pack 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

NEXGEN September 15, 2008 NexGraft 3 Strip Box NBF-3 2 Strip Box NBFS2-05

Collagen Matrix Pricing not available

Bone Substitutes

1

MasterGraft Matrix

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

7600320 $1059 7600310 $841 7600305 $438 7600709 $963 7600706 $586 7600703 $354 7800336 $3850 7800310 $1191 7800310 $2300

OssiMend Block bone graft $1750 matrix 10cc MCCB10 NA $1750

Putty

Price obtained on SpineMatrix 2009 price list

Strip

43cc 12cc 20cc

Demineralized Bone Matrix (DBM) Products

2

OSTEOTECH January 1, 2009

ISOTIS ORTHOBIOLOGICS 2010q1-q2 ASP Accell Evo3 DBM 10cc 02-5000-100 $1758 5cc 02-5000-050 $1006 2.5cc 02-5000-025 $638 Accell Connexus 10cc 02-3000-100 $1066 5cc 02-3000-050 $728 2.5cc 02-3000-025 $376 Accell Matrix

7cm 02-4000-760 NA

SOFAMOR DANEK 2010q1-q2 ASP Progenix Plus 10cc 006010 $1349 20cc 006020 $1810 5cc 006005 $884 10cc 006001 $206 2.5cc 006002 $381 Progenix DBM 5cc 005005 $589 10cc 005110 $991 1cc 005001 $194 0.5cc 000505 $113

MUSKULOSKELETAL TRANSPLANT FOUNDATION/SYNTHES WRIGHT MEDICAL GROUP January 1, 2010 January 1, 2009

Grafton ®

DBM Matrix 2.5x5 42210 $872 2.5x10 42200 $1407 Orthoblend 10cc 44150 $1500 5cc 44145 $1040 Paste 1cc 45001 $200 Strips 1x10cm 42275 $730 Gel 10cc 41150 $1220 Putty 5cc 43105 $800 2.5c 43103 $440 Crunch 15cc 44115 $1760

DBX®

AllomatrixTM

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

Orthoblast II Putty 5cc 02-2110-050 NA 10cc 02-2110-100 NA

OsteofilTM

Strip 50mm 002350 90mm 002390

NA NA

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

EXACTECH September 1, 2009

OpteFormTM

Disc 2.1cc 600-05-45 $1895 Allograft 2cc 606-01-02 $620 10cc 606-01-10 $2395 20cc 606-01-20 $3885 Optefil Allograft Syringe 1cc 616-01-01 $245 5cc 616-01-05 $1020 10cc 616-01-10 $1620 18

ORTHOFIX January 1, 2009 Origen DBM OpteCureTM 2cc 22-2002 $300 Allograft Jar $750 1cc 650-00-01 $285 5cc 22-2005 5cc 650-00-05 $1175 10cc 22-2010 $1350 10cc 650-00-10 $1870 with CCC Jar 1cc 652-00-01 $310 5cc 652-00-05 $1460 10cc 652-00-10 $2445

ALPHATECH SPINE August 15, 2009 AlphaGRAFT Gel 1cc 1001-010 $287 5cc 1001-050 NA Putty 2.5cc 1002-025 $542 5cc 1002-050 NA 10cc 1002-100 $1626 Alphagraft Profuse 13x11 67013-002 $1000

ZIMMER SPINE September 1, 2009 Puros DBM Putty 1cc

00-1105-010-01

STRYKER SPINE September 1, 2008

AlloCraft DBM $434 2cc 653002 5cc 653005 $1012 $1736 $310 10cc 653010

$940 $1660

5cc

00-1105-050-01

10cc

00-1105-100-01

© 2010 Mendenhall Associates, Inc.

Orthopedic Network News, Vol 21, No 4, October 2010

posted to www.OrthopedicNetworkNews.com on November 2, 2010 at 5:00 PM EST

BIOMET TRAUMA January 1, 2010

DEPUY SPINE January 1, 2010

SYNTHES November 1, 2009

STRYKER September 1, 2010 HydroSet Injectable HA Bone 3cc 397003 $1162 5cc 397005 $1860 10cc 397010 * $3444 15cc 397015 * $4944 Bonesave 20cc 6184-9-220 $1259 * Price in Sept 1 2009 price list

NUVASIVE April 29, 2009 FormaGraft Granules 5cc 5010005 $936 10cc 5010010 $1649 Strips 5cc 5010205 $891 10cc 5010200 $1650 Block XL 5010200 $2100

ZIMMER January 1, 2010

INTEGRA LIFE SCIENCES 2009 ASP Mozaik Strip, 15cc

CCM10256 $1343 NA NA NA NA

Pro-Osteon ® Pro

Healos® II

Osteon 500 (1) 5cc 5G05 $380 10cc 5G10 $730 15cc 5G15 $888 20cc 5G20 $1052 30cc 5G30 $1204 Pro Osteon 500R 5cc 5RG05 $379 10cc 5RG10 $730 15cc 5RG15 $888 20cc 5RG20 $1051 30cc 5RG30 $1203

Single Strip, 2.5cc

Granules 2761-60-002 $565 5cc 710.014.99S $415 Single Strip, 5cc 10cc 710.026.97S $800 2761-60-005 $990 20cc 710.021.99S $1145 Two Strips, 16cc Small Cylinder 2761-60-016 $1317 L sz9 710.935.99S $440 Single Strip 15cc chronOS beta TCP 2761-60-015 $2415 Granules Conduit 5cc 710.014.98S $415 Granules/Vial Block: 20x20x10 5cc 2761-01-005 $420 710.047.98S $750 10cc 2761-01-010 $775 Wedge: 25x35x10 15cc 2761-01-015 $935 20cc 710.050.98S $785 30cc 2761-01-030 $1510 Strip: 100x25x3 07.801.101.99S $1480 Strip: 100x25x6 07.801.111.99S $2530

chronOS

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 $355 5 00-1103-020-05 $870 10 00-1103-020-10 $1565 Cubes 60cc 00-1105-080-20 $902 ZIMMER SPINE September 1, 2010 Bone Void Filler, cc's: 1 07.00582.001 $365 5 07.00582.003 $895 10 07.00582.004 $1610

Putty

2.5cc 5cc 10cc 15cc 5cc 10cc 5cc 10cc PTY10125 PTY10155 PTY10210 PTY10256

Syn Flow

05-7100-050 NA 05-7100-100 NA 05-7000-050 NA 05-7000-100 NA

Syn Linx

CopiOs TM

ALTIVA Pricing not available

BACTERIN 2010q1-q2 ASP

LANX SPINE January 19, 2010 AlloFuse DBM Gel 5cc 9900-2005 $950 10cc 9900-2010 $1513 Putty 5cc 9900-1005 $950 10cc 9900-1010 $1513 AlloSponge Block 10mm 6051-5010 $782 AlloSponge strip 20x50x3-6mm 6061-5205 $1538

BIOMET TRAUMA January 1, 2010 InterGro Plus Putty 5cc DBMW05 $1016 10cc DBMW10 $1565 InterGro Paste 1cc DBM001 $210 5cc DBM005 $771 InterGro Putty 10cc DBM010 $1349

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

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

Osteosponge Osteobridge DBM $950 5cc 632-00-05 NA 10cc 109510 14mm 109614 $750 10cc 632-00-10 NA 12mm 109612 $700 Osteoselect putty 5cc 309050 $750

GLOBUS MEDICAL January 1, 2009

BIOMET Pricing not available

Orthofix January 1, 2009

NuVasive 2010q1-q2 ASP OsteoCel Plus 15cc 5013015 $4841 10cc 5013010 $3794 5cc 5013005 $2281 1cc 5013010 $472

NuBone DBM Bonus II Putty Putty 5cc 48-DBM5 NA $344 10cc 48-DBM10 NA 1cc 840.001 5cc 840.005 $1404 10cc 840.010 $2164

Cell-Based Matrices

3

Trinity Evolution $495 1cc 410101 5cc 410105 $2195 10cc 410110 $3995 15cc 410115 $4995

Pricing is from manufacturer list prices, where available. If manufacturer list prices are not available or not provided (e.g. Sofamor Danek), the average selling prices of the components most frequently found in the hospital-supplied data are displayed in descending sequence by frequency of use. These are designated with a price list date of 2010q1-q2 ASP. If fewer than 5 hospitals data contributed to an average selling price, the price is displayed as "NA."

© 2010 Mendenhall Associates, Inc.

posted to www.OrthopedicNetworkNews.com on November 2, 2010 at 5:00 PM EST

Orthopedic Network News, Vol 21, No 4, October 2010

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