BONEZONE

DEC 2016

Published by ORTHOWORLD Inc., BONEZONE delivers strategic sourcing & product commercialization solutions to orthopaedic device company decision makers and their partners.

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14 BONEZONE • December 2016 I n 2015, it was interbody cages, sacroiliac joints, artificial discs and robotics. This year, surgical assistance technolo- gies of all kinds generated the most pre- and post-event buzz. Implants made with 3D printing technologies were highlighted, too, as were companies' responses to changes in healthcare delivery. Below, we share extended detail on these three topics from news captured during NASS week. (A comprehensive list of NASS news can be found at BONEZONEpub.com.) Enabling Technologies These span systems that assist in pre-surgical planning, surgi- cal navigation, alignment, etc. DePuy Synthes Spine launched the KICK portable 2D spine imaging system with a FluoroEx- press Software Module, created through a partnership with Brain- lab. Working with a hospital's existing x-ray equipment, KICK is designed to provide access to affordable advanced imaging tech- nology with real-time navigation for pedicle screw placement. (KICK was one of seven spine products noted in JNJ's pipeline out through 2018, shared during the company's 2016 Business Review Day.) KB Medical announced a raise of CHF 2.5MM (~US $2.51MM) in Series B Financing. Funds will sup- port FDA clearance for the AQrate Robotic Assistance System V 1.2 for spinal surgery. The product pres- ently has CE Mark approval, and limited launch will begin in 2017. AQrate comprises hardware and software to support intra-op haptic steering. While its first iteration is focused on the spine, the company has noted potential application in orthopaedics from head to toe. Mazor Robotics commenced commercial launch of the Mazor X surgical assistance platform, which hit the market with 6 pre- orders and a purchase order from Medtronic for 15 systems, four of which were delivered in 3Q16. Mazor X differs from the com- pany's Renaissance product in a number of ways, not the least of which is intra-op guidance via a robotic arm that is bed-attached and bone-mounted to guide surgical tools and implants per pre-op analytic information. Real-time 3D veri- fication confirms execution and reconciliation of the surgical plan. The promotion and development of Mazor X is supported by a partnership with Medtronic, including an equity invest- ment from the leader in spine. Medacta completed initial U.S. surgeries using its proprietary MySpine patient-matched, low profile, 3D-printed surgical planning guide, following FDA clearance at the end of 2Q16. The guide is intended to help identify pedicle entry points, screw trajectories and implant specifications to potentially increase accuracy and outcomes. NuVasive introduced an Integrated Global Alignment (iGA) platform that is expanded to support cervical alignment. The new launch also includes Bendini OCT, a computer-assisted rod bending system with new application in occipito-cervico- thoracic cases, for use with NuvaPlanning software and NuvaMap O.R. real-time intra-op assessment of correction. Spinal Elements and Mighty Oak Medical partnered to co- market the FIREFLY surgical guidance system, comprising patient-matched bone models and intra-op pedicle screw guides created via 3D printing. FIREFLY Pedicle Screw Navi- gation received FDA clearance in late 2015, requires no capital equipment and may reduce intra-op imaging and radiation exposure. A second FDA clearance extends compatibility to essentially all currently cleared pedicle screw systems and indications to include the T1-S2/ilium region. Synaptive Medical attended NASS for the first time and showcased BrightMatter robotic arm/visualization Highlights from NASS 2016 Julie A. Vetalice ORTHOWORLD DePuy Synthes' KICK Mazor Robotics' Mazor X KB Medical's AQrate Images courtesy of manufacturers PRODUCT LAUNCH

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