Pulmonx Announces Treatment of the First Patient with the AeriSeal System in CONVERT II Pivotal Trial

Pulmonx Corporation (Nasdaq: LUNG) (“Pulmonx” or the “Company”), a global leader in minimally invasive treatments for chronic obstructive pulmonary disease (COPD), today announced the treatment of the first patient in the CONVERT II Pivotal Trial, a multicenter, international study evaluating the safety and effectiveness of the AeriSeal System in limiting collateral ventilation in severe COPD/emphysema patients. Collateral ventilation is caused by openings in the lung fissures, or walls between the lung lobes. The AeriSeal System is designed to occlude these naturally occurring openings in a lobe targeted for bronchoscopic lung volume reduction (BLVR) and block collateral ventilation. Successful treatment with the AeriSeal System is followed by treatment with commercially available Zephyr Valves. Pulmonx received a staged IDE approval by the Food and Drug Administration (FDA) to commence the CONVERT II Pivotal Trial for the AeriSeal System in late 2023.

The goal of the CONVERT II Pivotal Trial is to establish the safety and effectiveness of using the AeriSeal System to target and treat the fissural defects that allow collateral ventilation between lung lobes which preclude some severe COPD/emphysema patients from benefiting from BLVR with Zephyr Valves. Severe COPD/emphysema patients with collateral ventilation confirmed with Pulmonx’s proprietary Chartis Pulmonary Assessment System (Chartis) undergo the AeriSeal System treatment. For those patients who experience conversion (as assessed with the Chartis System 45 days later), Zephyr Valves are implanted per current standard of care for lung volume reduction. Procedural success (lung volume reduction) and other clinical parameters including lung function, quality of life and exercise capacity, will be evaluated at 6 months post-valve treatment. The 6-month results will be used to support a Pre-Market Approval (PMA) application. Up to 200 patients will be enrolled at up to 30 sites in the US, Australia, and Europe (ClinicalTrials.gov Identifier: NCT06035120). The study will complement the positive experience that the Company has already gained with the CONVERT Trial (ClinicalTrials.gov Identifier: NCT04559464)¹.