Pulmonx announced the presentation of clinical data from the AeriSeal CONVERT trial and five-year follow-up data from the LIBERATE study at the European Respiratory Society, or ERS, Congress in Vienna, Austria. Presented data from the CONVERT trial demonstrated that treatment with the AeriSeal System is safe and effective in occluding small airways and/or collateral air channels allowing patients with collateral ventilation to undergo and benefit from treatment with Zephyr Endobronchial Valves. Presented five-year follow-up data from the LIBERATE study showed patients treated with Zephyr Valves experience durable improvements in lung function out to at least five years. The reported data from the full 101-patient cohort in the CONVERT trial demonstrated 77.6% of patients with collateral ventilation treated with AeriSeal successfully experienced conversion. Furthermore, following conversion, patients treated with Zephyr Valves experienced clinically meaningful improvements over the baseline with: Improved lung function of 80mL or 10.2% over the baseline as measured by Forced Expiratory Volume in 1 second. Improvement of 6.3 points in quality of life measured by the St. George’s Respiratory Questionnaire. Mean treated lobe volume reduction of greater than one liter at 45 days. Overall, 89% of CV- converted patients achieved a TLVR equal to or greater than 350mL, the minimal clinical important difference, at six-months following valve implantation. These findings show that patients with collateral ventilation can successfully undergo bronchoscopic lung volume reduction with Zephyr Valves following closure of the fissure gap with the AeriSeal System. The five-year follow-up data for the Zephyr Valve treated patients from the LIBERATE study demonstrate durable improvements out to at least five years. More specifically, the data shows durable long-term benefits over the baseline with: Annual improvements in lung function measured by FEV1 ranging from 109 mL in Year 1 to 79 mL at Year 5, with an acceptable safety profile. FEV1 improvement over the baseline through year five is considered an advantage over maximal medical treatment alone given the known decline in lung function over time. Similar or lower incidence of respiratory adverse events or serious adverse advents through Year 2 to Year 5 compared to Year 1 post-procedure. No new types or increase in frequency of respiratory SAEs compared to prior years. Overall, 38% mortality over the 5-year period, below the mortality of 49% in historical medically managed control patients. The post-hoc analysis of the LIBERATE study data demonstrate that a TLVR of 50% or above, following treatment with Zephyr Valves, is correlated with significantly fewer severe COPD exacerbations requiring hospitalization compared to the medically managed control group over the long-term.
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