AAOS, Arthroscopy - Orthoworld

FISCAL FITNESScontinued from page 25diverse places as South Korea and Valparaiso, Indiana. Exhibit 3 liststhese companies along with their newly-cleared products.Having traveled the more arduous IDE/PMA route to product clearancein the U.S., Synthes received FDA’s okay to market its ProDisc-Llumbar disc, while FDA’s Orthopedic and Rehabilitation Devices Panelrecommended for approval of Medtronic’s Prestige cervical disc andInfuse for craniomaxillofacial indications. Smith & Nephew’sBirmingham Hip Resurfacing System also received FDA clearance, asdid Aastrom Biosciences’ proprietary Tissue Repair Cells for use in treatmentof osteonecrosis, cleared through an Orphan Drug Designation. AnFDA panel will meet in first quarter 2007 to review Corin’s Cormetresurfacing hip for possible clearance in the U.S.ReGen Biologics failed in its attempts to gain FDA clearance for itscollagen scaffold and FDA cancelled a meeting in 2006 that may delayclearance for Stryker’s OP-1 putty. Millenium Biologix withdrew itsrequest for an IDE for Peptos bone graft product and OrthoLogic’s IDEfor Chrysalin was terminated due to lack of demonstrable benefits of theproduct in treatment of distal radius fractures.FDA’s Orthopaedic and Rehabilitation Devices Panel voted to opposereclassification (downclassification) of non-invasive bone growth stimulatorsand classified BioniCare’s pulsed electrical stimulator technologyas “Transcutaneous Electrical Stimulator for Arthritis,” as opposed to aExhibit 2.Strategic Alliances in Orthopaedics in 2006Company Providing Company Receiving Activityaap FAME MergerAastrom Biosciences Orthovita Agreement to develop orthopaedic products using Orthovita's Vitoss scaffolds + Aastrom's Tissue Repair CellsAffinergy Synthes Exclusive development/license agreement for coatings/medical devices in spinal, trauma and craniomaxillofacial areasAffinergy MTF Exclusive worldwide alliance for use of Affinergy's coating technology with MTF allograft productsAlloSource Osiris Provision of bone matrix for production of Osiris' bone regenerating productsAltiva Curasan Launch of Cerasorb M Ortho beta-tricalcium phosphate product for spinal indicationsArtimplant Arthrotek Distribution/launch in U.S. of Sportmesh rotator cuff patchBiorthexNitinol Device & Components (J&Jsubsidiary)Collaboration to develop Actipore-based (porous Nitinol) surface coating for orthopaedic implantsBlackstone Capital Encore Medical Merger (return to private status)Blackstone et al . private equity Biomet Acquisition (to close 10/07)Brasseler Zimmer U.S. distribution of Brasseler's large bone surgical power equipment system and other devicesCeraPedics BioD Collaborate on product development using CeraPedics' P-15 bone graft substitute technology and BioD's stem cell procurement procedureClearant Tissue Banks International Supply of Clearant Process sports medicine implantsCoolSystems VQ OrthoCare Distribution of Game Ready Accelerated Recovery System to podiatrists, pain management specialists and orthopaedic and spine surgeonsCorin Stryker Exclusive U.S. marketing/distribution of Corin's Uniglide mobile bearing unicondylar knee systemCorin Acrobot Acquisition of 7.5% stakeDePuy FMS, Hand Innovations AcquisitionEncelle Pioneer Surgical Technology Collaboration on product development (e.g. for bone graft extender in spine)Integra KMI, Miltex AcquisitionIntegra LifeSciences Miltex AcquisitionIntegra LifeSciences Kinetikos Medical AcquisitionIntelligent Orthopaedics BSN Medical Global rights to distribute STORM device (Staffordshire Orthopaedic Reduction Machine) for fracture reduction in tibia and distal femurIsoTis OrthoBiologics Alphatec Non-exclusive private label agreement for distribution of DynaGraft II DBMKyphon Disc-O-Tech, InnoSpine, St. Francis AcquisitionLifeNet Zimmer Rights and licenses to patents and intellectual property related to Allowash bone cleaning and sterilization technologyMedArtis Vertebron Worldwide distribution (U.S. exclusivity) of tricalcium phosphate and hydroxyapatite synthetic bone graft materialsMoog McKinley Acquisition of pain management businessOrthofix Blackstone AcquisitionOrthoLogic Quintiles Development/commercialization of synthetic peptide with potential application in fracture repairOssur Innovation Sports AcquisitionOsteobiologics Alphatec Exclusive U.S. marketing/distribution rights to PolyGraft for certain spine bone void filling applicationsOsteoMed Skeletal Kinetics AcquisitionOsteotech Bacterin Nonexclusive license to U.S. Patents. 5,284,655 and 5,290,558 relating to flowable DBM powder compositionsPortland Orthopaedics PLUS Orthopedics U.S. distribution of Portland's Revision Knee SystemRegeneration Technologies (RTI) Altiva Distribution of OsteoBridge line of DBM-based productsRegeneration Technologies (RTI) Pioneer Distribution of BioSet DBM pasteRTI Blackstone Manufacturing of BioCleanse-Sterilized Spinal AllograftsRTI Cryolife Exchange and service agreement for orthopaedic tissueSmith & Nephew Endoscopy Nexa Orthopedics Exclusive right to distribute certain PolyGraft products for forefoot surgerySummit Corporate Services Orthos Product importation, management of Orthos' distribution facility, inventory, billing, etc.Summit Corporate Services Accin Product support, inventory management, logistics, distribution, etc.TiGenix Hospital for Special Surgery Collaboration for further development of ChondroCelect cartilage repair productTranS1 ApaTech Exclusive U.K. and Ireland distribution of AxiaLIF lumbar fusion systemTutogen RTI Mutual sourcing agreements; RTI w/ 1st right of refusal to all soft tissue used in sports medicine surgeries recovered by Tutogen's partnersWarburg Pincus et al . Tornier Acquisition of majority interestcontinued on page 2726 Orthopaedic Product News • January/February 2007