The evidence is in...

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Asher Thomas
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1 The evidence is in... Controlled ablation Proven outcomes2,3 WEREWOLF System Supporting healthcare professionals Faster* patient recovery1 RX Better* patient outcomes2,3 RX RX Safe for use on all joint soft tissue4 10 Lower* RX total costs11 14 *Compared with mechanical debridement.

2 Chondral defects in the knee are common 15 and can cause significant morbidity 16 In a review of over 31,000 knee arthroscopy cases, 15 chondral lesions were observed in 63% of cases. Average of 2.7 lesions per knee Untreated lesions can lead to a variety of complications: 63% Patients with lesions were relatively young: 43 years old (average age) Pain, swelling, reduced function, increased disability 17 Worse outcomes following repair of anterior cruciate ligament tears 18 Osteoarthritis, 16 which may require a total knee replacement Treating chondral lesions with mechanical debridement has been associated with: A tearing effect on the cartilage, that can lead to further lesion propagation 19 Inadvertent removal of adjacent healthy cartilage 19 Failure to improve clinical outcomes compared with observation alone 20 Technology provides a clinically proven alternative to mechanical debridement Using Technology for knee procedures delivers: Faster patient recovery* 1 Better patient outcomes* 2,3 Safe for use on all joint soft tissue 4 10 Lower total costs* XR *Compared with mechanical debridement

3 Faster patient recovery* 1 Significantly less post-operative knee pain at all follow-up points (6 hours to 1 year) 1 91% reduction in relative risk of taking NSAIDs for knee pain at 1 year 1 24% faster return to work 1 A randomised controlled trial of 60 patients undergoing medial meniscectomy with idiopathic grade III medial-femoral cartilage defects. Patients were randomised into two groups; chondroplasty (n=30) or chondroplasty using mechanical debridement (n=30). At 1 year follow-up patients in the group experienced: 1 Significantly less knee pain at all follow-up points up to a year after surgery 10 8 Mechanical debridement Pain (VAS) scores 6 4 p=0.329 p<0.001 p<0.001 p< p= Pre-op 6 hours 24 hours 6 weeks 1 year 91% reduced relative risk of taking NSAIDs at 1 year were still taking an NSAID (p=0.026) 2% Mechanical debridement 23% Significantly less post-operative bleeding (p<0.001) 70% relative reduction 20.8ml 70.0ml Mechanical debridement 24% faster 16.4 days : return 16.4 days to Mechanical debridement work 21.7 days (p=0.002, mean values presented) 35% Less physical therapy : 6.4 sessions Mechanical debridement: 9.8 sessions (p=0.04) *Compared with mechanical debridement. NSAIDs = non-steroidal anti-inflammatory drug ; VAS = visual analogue scale

4 Better patient outcomes* 2,3 Significantly better KOOS and Tegner scores at 4 years 2 88% reduction in the relative risk of joint replacement surgery at 4 years 2 Significantly extends average time to revision surgery by 2.6 years 3 Patients from this randomised controlled trial were then followed at 4 years 2 and 10 years. 3 At these medium- and long-term follow-up points, was superior to mechanical debridement in several outcomes. Improved clinical outcomes Among patients not requiring revision or replacement surgery (n=40), those treated with had statistically significant improvements in clinical outcomes compared with mechanical debridement at 4 years 2 KOOS Tegner Score Pre-op 4 years Pre-op 4 years p<0.001 p= Mechanical debridement Slower varus angle progression Varus angle increases were smaller with vs the mechanical debridement group (2.3 vs 4.0 ; p<0.001) at 4 years % increase Mechanical debridement 167% increase Varus angle progression is an indirect sign of articular cartilage layer quality as well as of osteoarthritis progression.² *Compared with mechanical debridement. KOOS = Knee Osteoarthritis Outcome Score

Reduced revision At 4 years, a significantly lower proportion of revision procedures for persistent knee problems occurred in the group than the mechanical debridement group (p<0.

5 Reduced revision At 4 years, a significantly lower proportion of revision procedures for persistent knee problems occurred in the group than the mechanical debridement group (p<0.01) 2 (n=30) 1 Replacement 2 Osteotomies 1 Revision arthroscopy Mechanical debridement (n=30) 88% reduction in relative risk of joint replacement surgery (3% vs 27%; p= ,21 *) 71% reduction in relative risk of revision² (13% vs 47%; p=0.006) 8 Replacements 4 Osteotomies 2 Revision arthroscopies At 10 years, revision rates remained significantly lower in the group compared with the mechanical debridement group (p=0.061) 3 61% reduction in relative risk of revision surgery³ (23% vs 60%; p=0.061) A significantly longer mean time to revision 2.6 years extended average time to revision Mechanical debridement Mean time to revision (years) 95% confidence interval p=0.022 *Chi-square analysis based on data from Spahn et al.²

6 Safe for use on all joint soft tissue 4 10 Demonstrated safety for chondroplasty in a study with 824 patients 4 No cases of osteonecrosis or chondrolysis reported 4 is indicated for use in the knee on all soft tissue types Established clinical safety Low rates of complications and re-operations... 0 cases of osteonecrosis or chondrolysis reported in a retrospective study of 840 chondroplasty procedures using technology 4 2.2% Post-op complications within 6 months 2.7% Re-operations within 6 months... with zero complications or additional surgeries linked to the use of...with the potential to stabilise and fill partial cartilage lesions 22 Reduced Lesion Size All lesions (n=25) Mean lesion size (mm 2 ) Second-look arthroscopy Initial procedure Tibiofemoral joint lesions (n=14) Mean lesion size (mm 2 ) Second-look arthroscopy Initial procedure In a second-look arthroscopy study of 25 lesions in 15 patients treated with (mean follow-up 10.4 months) 22 88% of lesions showed no signs of progression 56% of cartilage defects demonstrated to have partial or complete filling of lesion has been used in over 1.5 million knee procedures* * Figure calculated by capturing the number of wands sold from July 2008 to May 2016

7 Lower total costs* Substantial cost savings at 4 years compared with mechanical debridement 2,11 14 Proven value shown in analyses of multiple national payer systems compared with mechanical debridement demonstrates meaningful reductions in physical therapy service use at 6 weeks 1 and overall revision rates at 4 years 2 2,073 Spain 11 Based on the 2016 Spanish Health Costs database Using these data, economic analyses for multiple national payer systems was performed comparing and mechanical debridement. In patients with chronic pain due to medial meniscus tear and an International Cartilage Research Society (ICRS) grade III focal chondral lesion, projected 4-year post-surgery total cost savings per patient were: 2,310 Germany 12 Based on the 2016 German Health Costs database 1,780 UK 13 Based on 2017/2018 UK NHS National Tariff Payment System $3,237 USA 14 Based on 2017 National Medicare Fee-for-Service Payment data *Compared with mechanical debridement.

WEREWOLF System with FLOW~IQ Technology FLOW~IQ Technology Automatically regulates saline outflow with energy to optimise performance across all tissue types.

FLOW 50 Wand Removes tissue approximately 4 times faster than our market leading 50 degree wand* 23 Removes tissue at lower temperatures than our market leading 50 degree wand* 23 Curved shaft and

8 WEREWOLF System with FLOW~IQ Technology FLOW~IQ Technology Automatically regulates saline outflow with energy to optimise performance across all tissue types. The only platform to control energy output and outflow suction. Enables VAC mode to rinse the joint and clear debris with a simple push of a button. FLOW 50 Wand Removes tissue approximately 4 times faster than our market leading 50 degree wand* 23 Removes tissue at lower temperatures than our market leading 50 degree wand* 23 Curved shaft and small tip allow good access. 5 modes addresses multiple tissue types and minimises instrument exchanges. Technology SCOPE-SENSING Technology AMBIENT Technology The controlled plasma field produced by allows for precise removal of soft tissue with minimal thermal damage ( μm) evident in untargeted cartilage tissue. 24 Proprietary circuits detect when a wand is in close proximity to metal and will automatically suspend energy delivery. When a safe distance is achieved, energy will automatically resume. First and only system offering two-zone real-time temperature monitoring of intra-articular fluid. New two-zone monitoring measures both the intra-articular fluid temperature and outflow temperatures within the hand piece. * Compares AMBIENT SUPERMULTIVAC 50 (set point 9) to WEREWOLF FLOW 50 Wand (Vac Mode). The results of the in vitro simulation testing have not been proven to predict clinical performance.

9 References 1. Spahn G, Kahl E, Mückley T, Hofmann GO, Klinger HM. Arthroscopic knee chondroplasty using a bipolar radiofrequency-based device compared to mechanical shaver: results of a prospective, randomized, controlled study. Knee Surg Sports Traumatol Arthrosc. 2008;16: Spahn G, Klinger HM, Muckley T, Hofmann GO. Four-year results from a randomized controlled study of knee chondroplasty with concomitant medial meniscectomy: mechanical debridement versus radiofrequency chondroplasty. Arthroscopy. 2010;26:S73 S Spahn G, Hofmann GO, von Engelhardt LV. Mechanical debridement versus radiofrequency in knee chondroplasty with concomitant medial meniscectomy: 10-year results from a randomized controlled study. Knee Surg Sports Traumatol Arthrosc. 2016;24: Gharaibeh M, Szomor A, Chen DB, MacDessi SJ. A retrospective study assessing safety and efficacy of bipolar radiofrequency ablation for knee chondral lesions. Cartilage. 2018;9: Barker SL, Johnstone AJ, Kumar K. In vivo temperature measurement in the subacromial bursa during arthroscopic subacromial decompression. J Shoulder Elbow Surg. 2011;21(6): Sean NYC, Singh I, Wai CK. Radiofrequency microtenotomy for the treatment of plantar fasciitis shows good early results. Foot Ankle Surg. 2010;16(4): Wei M, Liu Y, Li Z, Wang Z. Short-term effects of radiofrequency shrinkage treatment for anterior cruciate ligament relaxation on proprioception. J Int Med Res. 2013;41(5): Taverna E, Battistella F, Sansone V, Perfetti C, Tasto JP. Radiofrequency-based plasma microtenotomy compared with arthroscopic subacromial decompression yields equivalent outcomes for rotator cuff tendinosis. Arthroscopy. 2007;23(10): Zini R, Munegato D, De Benedetto M, Carraro A, Bigoni M. Endoscopic iliotibial band release in snapping hip. Hip Int. 2013;23(2): Liu YJ, Wang Y, Xue J, Lui PP, Chan KM. Arthroscopic gluteal muscle contracture release with radiofrequency energy. Clin Orthop Relat Res. 2009;467(3): Adeyemi A, Nherera L, Trueman P, Cano J. Cost-effectiveness analysis of technology vs. mechanical debridement with a shaver in the treatment of knee cartilage lesions - A Spanish payer perspective. Poster presented at: International Society For Pharmacoeconomics and Outcomes Research; November 4 8, 2017; Glasgow, UK. 12. Adeyemi A, Leo N, Trueman P, Emmermann A. Cost-effectiveness analysis of the use of knee chondroplasty versus mechanical debridement in German patients. Poster presented at: International Conference on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases; May 25 26, 2017; London, UK. 13. Adeyemi A, Nherera L, Trueman P. Cost-Effectiveness analysis of versus mechanical debridement in knee chondroplasty - A UK National Health Service perspective. Poster presented at: International Society For Pharmacoeconomics and Outcomes Research; May 19 23, 2018; Baltimore, MD, USA. 14. Adeyemi A, Nherera L, Trueman P, Delhougne G. Comparing costs and outcomes between and mechanical debridement in the treatment of knee cartilage lesions - A cost-effectiveness analysis from a US payer perspective. Poster presented at: International Society For Pharmacoeconomics and Outcomes Research; November 4 8, 2017; Glasgow, UK. 15. Curl WW, Krome J, Gordon ES, Rushing J, Smith BP, Poehling GG. Cartilage injuries: a review of 31,516 knee arthroscopies. Arthroscopy. 1997;13: Prakash D, Learmonth D. Natural progression of osteo-chondral defect in the femoral condyle. Knee. 2002;9: Sellards RA, Nho SJ, Cole BJ. Chondral injuries. Curr Opin Rheumatol. 2002;14: Cinque ME, Chahla J, Mitchell JJ, et al. Influence of meniscal and chondral lesions on patient-reported outcomes after primary anterior cruciate ligament reconstruction at 2-year follow-up. Orthop J Sports Med. 2018;6: Kosy JD, Schranz PJ, Toms AD, Eyres KS, Mandalia VI. The use of radiofrequency energy for arthroscopic chondroplasty in the knee. Arthroscopy. 2011;27,5: Bisson LJ, Kluczynski MA, Wind WM, et al. Patient outcomes after observation versus debridement of unstable chondral lesions during partial meniscectomy: The Chondral Lesions And Meniscus Procedures (ChAMP) randomized controlled trial. J Bone Joint Surg Am. 2017;99: Smith & Nephew. Data on file. EO.SPM.PCSgen.001.v Voloshin I, Morse KR, Allred CD, Bissell SA, Maloney MD, DeHaven KE. Arthroscopic evaluation of radiofrequency chondroplasty of the knee. Am J Sports Med. 2007;35: Smith & Nephew. Data on file. ArthroCare Flow 50 Wand Vac Mode Comparative Bench-Top Study Report. P/N _A. 24. Amiel D, Ball ST, Tasto JP. Chondrocyte viability and metabolic activity after treatment of bovine articular cartilage with bipolar radiofrequency: an in vitro study. Arthroscopy. 2004; 20(5):

10 Manufactured by: ArthroCare Corporation 7000 West William Cannon Drive, Austin, TX 78735, USA Distributed by: Smith & Nephew Inc. 150 Minuteman Road, Andover, MA, 01810, USA Trademark of Smith & Nephew Smith & Nephew. All rights reserved en V Supporting healthcare professionals for over 150 years

Bone&JointAppraisal Vol

Bone&JointAppraisal Vol 01 No 03 December 2016 COBLATION Chondroplasty Versus Mechanical Debridement: Randomized Controlled Trial with 10-Year Outcomes -Year Four-Year Ten-Year Group A COBLATION technology