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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10 BONEZONE • December 2016 T he correlation among clinical outcomes data, product reimbursement and surgeon adoption is a statement that, frankly, we feel we've exhausted. Recent conver- sations with surgeons and industry experts, though, have revealed that the message bears repeating. Your surgeon and hospital customers will continue to demand clinical and economic data, no matter the type of implant or the size of your company; this is evidenced by the studies summarized below. Gathering this data takes time and money, two barriers that we know you face during collection. Not being armed with important information to make the final sale, though, undermines resources put into R&D, manufacturing, etc. Wherever your responsibilities lie within your company, it's important to consider how your work contributes to better patient outcomes, and know how your competition claims product success. With that in mind, we highlight select clinical trial and study announcements made in 2H16. • Interim results from a U.S. 300+ patient multi-center prospective study of ConforMIS' iTotal® CR total knee indicate that 92% of patients were satisfied, on average, at one year. The new analysis corroborates a previously- published study demonstrating statistically significantly higher satisfaction rates with iTotal CR vs. off-the-shelf implants in 35 matched pairs of subjects. At one year, 94% of iTotal patients vs. 74% of off-the-shelf patients reported satisfaction with their procedure. • DePuy Synthes announced new clinical evidence sug- gesting positive performance of the ATTUNE® Knee System. Implant survivorship data from the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man has demonstrated results for the performance of ATTUNE that compare favorably to the class of cemented total knees. Further, analysis of a large U.S. hospital admin database indicates that ATTUNE patients had 39% lower adjusted odds of discharge to a skilled nursing facility vs. those receiv- ing a competitor's total knee. • Study results support the biocompatibility of Rotation Medical's collagen-based bioinductive implant and its ability to promote new connective tissue with the appearance of tendon. (Results are published in the journal Arthroscopy.) The retrospective study included biopsies from seven patients undergoing a subsequent arthroscopic procedure for issues unrelated to the implant at various time points (five weeks to six months) following arthroscopic rotator cuff repair with the bioinductive implant. At six months, newly- generated tissue was observed with histologic appear- ance of a tendon, suggesting functional loading of the newly-generated host tissue. • Randomized study results indicate that Safe Ortho- paedics' single-use spine surgical instruments yielded an 80% decrease in pre- and post-operative times. The study assessed 40 surgeries comparing traditional renewable instruments to Safe Orthopaedics' single- use instruments (1:1) in lumbar fusion. The study showed a reduction of 81% in average logistics times, from 176 to 33 minutes on average, by switching to single-use instruments and eliminating transport, labor and sterilization. No logistical incidents were observed with Safe Orthopaedics' instruments, vs.15% with the comparison group (e.g., unavailability of instrument set, lack of screws and sterilization problems). • A study of Silver Bullet Therapeutics' OrthoFuzIon® Antimicrobial Bone Screw, one of the first antimicro- bial implantable medical devices designed specifically for orthopaedics, shows that the screw was able to significantly disrupt the development of biofilms com- pared to traditional, uncoated titanium screws. The study was designed to test "Time Kill" and "Adher- ence" effectiveness of OrthoFuzIon against the top six antibiotic resistant superbugs as identified by the CDC. The implant received CE Mark approval in early 2015 and is amassing a portfolio of patents in the U.S. • Vertera Spine announced initial successful outcomes for its COHERE® Cervical Interbody Fusion Device, reportedly the first device in clinical use to be manu- factured entirely from PEEK and contain porosity. COHERE features Scoria® biomaterial that seamlessly integrates with the bulk PEEK implant to support bony tissue ingrowth while retaining mechanical and imaging properties of traditional PEEK implants. Surgeons have reported early signs of fusion with significant bony bridging. • A seven-year outcomes study demonstrated statistical superiority of Zimmer Biomet's Mobi-C Cervical Disc Prosthesis vs. 2-level anterior cervical discectomy and fusion in overall success. The prospective, ran- domized, controlled trial was conducted as an FDA- regulated Investigational Device Exemption clinical trial. Overall success required improvement in Neck Disability Index, no secondary surgical interventions at index levels and absence of major complications (e.g., radiographic failure, neurological failure or adverse events). CLINICAL DATA 2H16 Study Results Announced Rise in need for outcomes data requires knowing competitors' success. INDUSTRY UPDATE

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