The LIBERATE Study
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Published in THE AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE The LIBERATE Study A multicenter, multinational randomized controlled trial of Zephyr® Endobronchial Valves in patients with heterogenous emphysema and little or no collateral ventilation ts are comparable to those “ The benefiin post-procedure morbidity.seen with LVRS but with a reduction ” Criner G et al Am J Resp Crit Care Med 2018, in press METHODS & ENDPOINTS • First multicenter RCT to evaluate effectiveness and safety of Zephyr® Endobronchial Valves in patients with little or no collateral ventilation (CV) out to 12 months. • 190 subjects with hyperinflation (RV, 225% pred.; FEV1, 27% pred.; DLCO, 34% pred.) randomized 2:1 (128 Zephyr EBV: 62 SoC). STUDY DESIGN 909 Subjects consented - 2 Withdrew consent - 4 Died - 1 Excluded for medical reasons 121 Active subjects at 45 days 719 Subjects excluded • 13 Withdrew consent • 706 Screen failures - 65 No eligible CV-lobe - 280 Heterogeneity /destruction score - 156 PFTs/lung volumes - 145 Medical history, age, BMI, smoking history - 49 Blood chemistry - 11 Other 62 Active subjects at 45 days - 1 Died - 2 Excluded for medical reasons - 1 Died 120 Active subjects at 6 months 59 Active subjects at 6 months 59 Active subjects at 12 months - 1 Unwiling to return for follow-up visits 119 Active subjects at 12 months - 2 Missed 12-month visit - 2 Not evaluated because of ongoing AEs – both subsequently died in Year 2 SOURCE: Criner G et al Am J Resp Crit Care Med 2018, in press 43 Active crossover subjects - 8 Pending crossover procedures - 7 Excluded for medical

Primary Endpoint Responder Analysis Other Responder Analysis Percent of Subjects with FEV1 Change of ≥ 15% Proportion of Patients Achieving MCID EBV group from Baseline Control group from Baseline Six-Minute Walk Distance (meters) EBV group from Baseline Between-group difference Control group from Baseline EBV group from Baseline Between-group difference Control group from Baseline Change in SGRQ scope (points) St. George’s Resp Questionnaire (points) EBV group from Baseline Between-group difference Control group from Baseline Safety: Pulmonary Serious Adverse Events Occurring in at Least...