Hip & Knee Surgery - Orthoworld

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FUTURETECHEmerging Orthopaedic Technologies & TreatmentsRecent FDA ClearancesAugust and September 2009AngleFix T Locking Plate (ANGLEFIX TECH)Osteoselect Demineralized Bone MatrixPutty(BACTERIN)Spinal Foraminoscope(BLAZEJEWSKI MEDI-TECH)Anterior Cervical Plate (CARDO MEDICAL)Regent Anterior Cervical Plate(CUSTOM SPINE)Equivabone Osteoinductive Bone GraftSubstitute(ETEX)Truss Thoracolumbar Plate(GLOBUS MEDICAL)PCT Spinal System(GOLD STANDARD ORTHOPAEDICS)Michelangelo Bunion System (INSTRATEK)Sentinel Spinal System(LIFE SPINE)Robotic Arm Interactive Orthopedic System(MAKO SURGICAL)Freedom Total Knee Cruciate Retaining FemoralComponent (MAXX ORTHOPEDICS)Aptus K-Wire System(MEDARTIS)Asfora Bullet Cage System(MEDICAL DESIGNS)KneeAlign SystemArthroscope(ORTHALIGN)(ORTHOPEDIC SCIENCES)PEEK CF Interference Screw and V-LoxPEEK Suture Anchor (PARCUS MEDICAL)Monopoly Pedicle Screw (SIGNUS MEDICAL)WavEon WRx Bone Fixation System(SONOMA ORTHOPEDIC PRODUCTS)Tryptik CA Anterior Intersomatic CervicalCage(SPINEART)Dorado Wide Intervertebral Body Cage(SPINEFRONTIER)SIGN Hip Construct(SURGICALIMPLANT GENERATION NETWORK)FDA 510(k) Releasable Database, 8/09 and 9/09The National Institutes of Health will award 15 grants to support the Patient ReportedOutcomes Measurement Information System (PROMIS), an initiative that usescomputer technology and measurement theory to assess pain, fatigue and otheraspects of quality of life in a standardized manner. PROMIS is managed by theNational Institute of Arthritis and Musculoskeletal and Skin Diseases.(NIH/National Institute of Arthritis and Musculoskeletal and Skin Diseases, 10/19/09)Studies indicate that direct injections of recombinant human lubricin significantlyreduced cartilage degeneration in a rat model of post-traumatic osteoarthritis. Lubrisis developing the product for orthopaedic and other indications.(Biomodels LLC,10/19/09)RSB Spine received FDA clearance of its InterPlate® C-Ti for a new indication. Thedevice is now reportedly the 1st interbody fusion device to be cleared as an anteriorcervical plate. (RSB Spine, LLC, 10/12/09)Pre-clinical research revealed that SANUWAVE's Pulsed Acoustic Cellular Expression(PACE) technology can stimulate proliferation and thickening of osteoprogenitorstem cells for harvest and re-transplantation in bone tissue engineering applications.(SANUWAVE, Inc., 10/13/09)Impliant has conducted the first 2 implantations using its TOPS VersaLink, abilateral titanium lumbar fusion system. (Impliant, Inc., 10/9/09)OrthAlign received FDA 510(k) clearance to market the KneeAlign disposablecomputer-assisted surgical navigation system for total knee arthroplasty.(OrthAlign, Inc., 10/7/09)Suspension Orthopaedic Solutions raised US $2.3MM which will supportdevelopment of shoulder and knee implants (for example, the Suspension FractureFixation System). The company anticipates bringing product to market by mid-2010.(Baltimore Business Journal, 10/6/09)Studies suggest that early outcomes appear to be promising from the use of plateletrichplasma as an alternative treatment for orthopaedic-related sports medicineconditions, though larger clinical studies are needed to determine the benefits of its use.(American Academy of Orthopaedic Surgeons, 10/1/09)Studies suggest that supervised exercise may result in better outcomes thanshockwave treatment for relieving chronic shoulder pain. After 18 weeks, 64% ofpatients in the exercise group had reduced pain and disability, vs. 36% of thosereceiving shockwave therapy. (HealthDay News, 9/16/09)Studies suggest that people who have suffered a torn anterior cruciate ligament maybe more likely to have a smaller ligament than similarly-sized people who have neverinjured a knee. (Ohio State University, 9/14/09)A research team at Virginia Tech won a US $0.3MM grant to study knee ligamentsprains at the micro-mechanical level. The findings could support the creation ofreplacement grafts and biological scaffolds for damaged ligaments, as well as guidethe design of braces or stretching routines. (Virginia Tech, 9/10/09)Kapstone Medical acquired from Spherofix the exclusive rights to a suite of fixationtechnology. Kapstone is pursuing the development of multiple projects involvingspinal products. (Kapstone Medical, LLC, 9/10/09)FDA has cleared Covidien's DuraSeal spine sealant for use as an adjunct tosuturing for intra-operative dural sealing. (Covidien, 9/8/09)28 ORTHOPAEDIC PRODUCT NEWS • November/December 2009
ORTHOINVESTOR UPDATETicker Track (Based on close of business, 9/30/09)Ticker 52-Wk 52-Wk Chg vs. Chg vs.Company Symbol High Low Close Prior Mo. Prior Yr.aap † AAQ 3.18 1.33 1.74 -4.4% -33.1%Alphatec Holdings ATEC 5.51 1.10 4.60 0.4% 0.0%ArthroCare ARTC.PK 31.00 2.89 20.39 15.9% -26.4%BioMimetic Therapeutics BMTI 13.56 4.69 12.21 3.7% 10.4%co.don AG † CNW 1.31 0.55 0.74 -6.3% 20.4%ConMed CNMD 31.63 11.56 19.17 7.5% -40.1%Corin Group †† CRG.L 1.97 0.52 1.08 2.9% -49.1%curasan † CUR 5.17 1.78 4.20 1.9% 51.1%Exactech EXAC 21.10 10.74 15.74 5.8% -29.2%Inion †† IIN.L 0.19 0.00 0.01 0.0% -92.9%Japan MDM § 7600 4.13 1.36 3.17 37.8% 28.3%MAKO Surgical MAKO 10.00 5.23 8.76 2.5% 20.8%NuVasive NUVA 51.17 24.17 41.76 4.2% -15.3%Orthofix OFIX 30.47 8.65 29.39 7.4% 57.8%Orthovita VITA 6.91 1.49 4.39 4.0% 68.8%Osteotech OSTE 5.04 1.31 4.45 3.0% 4.5%ReGen Biologics RGBO.OB 5.90 0.00 0.93 -48.3% -69.0%RTI Biologics RTIX 9.38 1.30 4.35 -4.4% -53.5%Smith & Nephew SNN 49.39 30.01 45.03 6.6% -15.1%Stryker SYK 62.92 30.82 45.43 9.6% -27.1%Symmetry Medical SMA 17.83 3.90 10.37 -5.9% -44.1%Synthes ‡ SYST 149.07 99.44 116.70 -1.6% -15.2%TiGenix † TIG 8.08 3.15 6.50 2.8% 56.3%TranS1 TSON 10.03 4.08 4.81 2.1% -51.4%Company Financials †2Q09 vs. 2Q08Company Sales vs.($MM) PriorALPHATEC $32.3 +35%U.S. $26.4 +36%Asia $5.5 +21%Europe $0.4MAKO Surgical $14.9ORTHOVITA $24.5 +27%SYMMETRY $101.0 -8%Instruments $46.9 +4%Implants $29.9 -4%Cases $18.9 -19%WRIGHT MEDICAL $118.9 +3%Hips $41.0 +2%Knees $30.2 -1%Biologics $19.5 -4%Extremities $25.6 +19%Other $2.5 -36%OTHER FINANCIAL PERIODSCompany Sales vs.($MM) PriorCORIN 1st Half $32.9 †† -25%Hips $15.8 -45%Knees $8.5 -7%Other Products $8.5 +37%MEDTRONIC1st Quarter Fiscal 2010, ended 7/31/09Spinal $915.0 +8%Core Spinal $696.0 +11%Biologics $219.0 flat(Company news releases, 8/09)†Orthopaedic product sales only.††£20.1MMWright Medical Group WMGI 28.99 11.17 17.86 10.0% -41.3%Zimmer Holdings ZMH 62.40 30.67 53.45 12.9% -17.2%†Converted from Euro to USD; 1€ = 1.4654 USD.††Converted from British Pound to USD; 1£ = 1.5941USD.‡Converted from Swiss Franc to USD, 1CHF = 0.9693 USD.§Converted from Yen to USD, 1¥ = 0.0112 USD.In order for a company to qualify for inclusion in the Orthoinvestor Update, orthopaedics must representat least 60% of its revenues.November/December 2009 • ORTHOPAEDIC PRODUCT NEWS 29
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