1. : Intermittent Neurogenic Claudication Aperius ® Percutaneous Interspinous Spacer F. Collignon, P. Fransen, D Morelli, N. Craig, J. Van Meirhaeghe For the INCA-study investigator group Disclosure information Patrick Fransen

2. STUDY DESIGNInternational, multi-center, single arm trial N° PATIENTS162 patients consented, 157 patients treated CLINICAL SITES12 European: 6 in Belgium, 5 in Germany, 1 in United Kingdom FOLLOW-UP48 hours, 7 days, 6 weeks, 6 months and 12 months ENDPOINTSPrimary  Safety: procedural or device related SAE < 7 days  Effectiveness: ZCQ-Symptom Severity at 6 weeks Secondary  Safety: procedural or device related SAE in follow-up Effectiveness: ZCQ Symptom Severity  ZCQ Physical Function and EQ-5D Radiological  Implant status & positioning, change in lordosis, p-MRI, maintenance of distraction PURPOSEEvaluate safety of the procedure and the safety and effectiveness of Aperius ® Percutaneous Interspinous Spacer Study design

3. Sex 50.3% Male 49.7% Female Mean age64,9 years ± 11,9 Mean complaint duration 40.0 months ± 60,4 Treatment history Pain medication : 85,4 % Physical therapy : 66,2 % Epidural infiltration : 59,2 % N° of stenotic levels1 level : 69 patients 2 levels : 78 patients 3 levels : 10 patients Treated levelsL1-L2 : 0.4 % L2-L3 : 5.9 % L3-L4 : 35.5 % L4-L5 : 58.2 % Device size used (n=250)8mm : 6.4 % 10mm : 24.8 % 12mm : 39.2 % 14mm : 29.6 % Mean estimated procedure time (skin to skin) One level : 15.5 min ± 9.1 Two levels : 24.6 min ± 8.6 Three levels : 39.1 min ± 8.9 Patient Demographics & Surgical Procedure Information

4. * * * * Primary Effectiveness Endpoint Zurich Claudication Questionnaire on Symptom Severity Primary endpoint At 6 weeks the mean ZCQ Symptom Severity was reduced by 29.7%. This statistical significant improvement (*p<0.001) was maintained at 6 and 12 months

5. Secondary Effectiveness Endpoints VAS Pain Scores Pain medication Walking distance ZCQ-Physical Function Max. improvement (0.7 points in ZCQ PF) reached at 6 weeks (*paired t-test p<0.001) The use and strenght of pain medication used decreased over time Walking distance improved overall and was maintained over total follow-up period * ** Immediate significant pain reduction and at all timepoints compared to baseline (*p<0.001) * * * *

6. Primary safety endpoint - First 7 days post-operatively 6 serious adverse device related effects (SADE) were observed One patient with a spinous process fracture Three patients suffering from back pain One hematoma One patient experiencing pain in the lower extremities Safety Overall safety assessment - Up to 12 months 11 patients experienced an SADE, mainly reporting back pain and recurrence of NIC symptoms 52 patients experienced an ADE of which 26 reported as back pain and 10 recurrent NIC symptoms. 14 explant procedures were performed while 90.7% of the population had their device still in place Nine confirmed cases of spinous process fracture were observed during the study, 3 spontaneously reported cases and 6 cases confirmed following central reading of X-rays. The clinical outcome of all nine patients was analysed but no correlation was found.

7. 1.The procedure was shown to be generally safe and well tolerated 11 patients experienced SADEs during the total follow-up period No unexpected ADEs or SADEs were identified 2.The device was effective for up to 12 months post ‑ operatively when used for the relief of NIC complaints in patients with symptomatic DLSS Statistical significant improvement from baseline was shown in: both symptom severity and physical function (ZCQ) leg, back and buttock/groin pain assessed by VAS Quality of life assessed by EQ5D A reduced use of pain medication was reported. Significant improvement in walking distance was observed. 3.The APERIUS® device offers advantages due to the percutaneous approach Short operation time Potential use of local anesthesia Minimal/negligible blood loss Short recovery and rehabilitation period Conclusion