Zephyr Endobronchial Valves From Pulmonx, Inc. Shown To Benefit Severe Emphysema Patients With Homogeneous Disease

Retrospective Analysis of VENT Trial Shows Positive Outcomes in New Patient Population

DENVER--(BUSINESS WIRE)--Pulmonx®, a leader in interventional pulmonology, today announced results from a retrospective analysis of the landmark VENT trial that demonstrated a statistically significant benefit in severe emphysema patients with homogeneous disease that received treatment with the Zephyr® Endobronchial Valve (EBV). The data was presented yesterday at the American Thoracic Society (ATS) Annual Meeting.

“We are actively researching ways to bring the benefits of our therapies to a broader range of patients”

The retrospective analysis of the VENT trial examined outcomes of Zephyr EBV treatment in 25 patients with homogeneous disease distribution, defined by heterogeneity scores of <15 percent between treated and adjacent lobes. At six months, FEV1 in the homogeneous cohort improved 16 percent, which was statistically significant compared to the baseline. The analysis showed that patients with homogeneous disease who have low collateral ventilation can benefit from endobronchial lung volume reduction. The findings were presented by Professor Felix Herth, MD, PhD, FCCP, Chairman and Head of Pneumology and Respiratory Care at Thoraxklinik, University of Heidelberg.

“While the VENT trial was not originally designed to evaluate patients with homogeneous disease, in our retrospective review we found that a number of them were included. Upon close examination of this group, we found that the Zephyr valves showed significant promise in improving their symptoms, which warranted further study,” said Professor Herth.

As a result of the promising results seen in the VENT analysis, the Company also announced active enrollment in the prospective, randomized, multi-center IMPACT study, the first study to examine the benefits of the Zephyr EBV exclusively in a homogeneous patient population. The study will enroll 56 patients to assess the clinical efficacy of the Zephyr EBV versus medical management. The IMPACT study leverages improved techniques not utilized in VENT for patient screening, selection and treatment, including using HRCT analysis and functional assessments of collateral ventilation using the Chartis system.

Co-principal investigators for the IMPACT study are Associate Professor Arschang Valipour, MD, FCCP, of The Ludwig-Boltzmann-Institute for COPD and Respiratory Epidemiology at Otto-Wagner-Spital in Vienna, Austria, and Professor Ralf Eberhardt, MD, of Thoraxklinik, University of Heidelberg. The IMPACT study is taking place at leading medical centers in Austria, Germany and the Netherlands.

Results from the STELVIO trial were also presented at ATS and provided further support that, independent of heterogeneity or homogeneity, severe emphysema patients with low collateral ventilation experience statistically and clinically significant improvements in pulmonary function, exercise capacity and quality of life after treatment with the Zephyr EBV.

“We are actively researching ways to bring the benefits of our therapies to a broader range of patients,” said Pulmonx Chief Executive Officer Glen French. “In addition to identifying homogeneous patients that may be treated with our Zephyr valve, and enrolling our U.S. LIBERATE study, we are enhancing our recently acquired AeriSeal therapy to allow patients with collateral ventilation to be eligible for treatment.”

The Zephyr EBV is a minimally invasive treatment for severe emphysema that has been proven in over a decade of clinical experience to significantly improve the lung function, exercise tolerance and quality of life for patients receiving treatment. A proprietary diagnostic – the Chartis system – is utilized prior to the procedure to identify likely responders. In the procedure, tiny, one-way valves are placed in the lungs to block airflow to diseased regions to achieve lung volume reduction. As a result, the remaining healthy regions may function more efficiently, enabling better breathing and an improved quality of life. Zephyr EBVs have been implanted globally in more than 10,000 patients.

About Pulmonx

Based in Redwood City, California, and Neuchâtel, Switzerland, Pulmonx is an interventional pulmonology company focused on developing life-changing, cost-effective technologies that improve the lives of patients suffering from lung disease worldwide. For more information, visit www.pulmonx.com.

The Zephyr^® EBV is an investigational device in the United States. Limited by U.S. law to investigational use.