Pulmonx Receives Japanese MHLW Approval of Zephyr Endobronchial Valve for the Treatment of Severe COPD/Emphysema - Seite 2

The one-way Zephyr Valves are placed in a selected lobe of the lung (generally the most diseased lobe and with little to no collateral ventilation) during a bronchoscopic procedure to occlude the target lobe and reduce hyperinflation. This relieves pressure off the diaphragm and allows the healthier parts of the lungs to expand and function more effectively, thereby decreasing shortness of breath and making breathing easier.¹

“We are excited about this approval and the opportunity to enable the Japanese medical community to bring a much-needed treatment option to patients with severe COPD/emphysema,” stated Glendon French, President and Chief Executive Officer of Pulmonx. “Japan is the second largest healthcare market in the world and represents a valuable opportunity to bring our innovative treatment to a large group of patients who have had few options once medical management alone fails to control their disease.”

The approval is based on a thorough review by the PMDA of the positive clinical data from the pivotal LIBERATE Study¹ that enrolled patients with heterogenous emphysema distribution and the IMPACT Study³ that included patients with homogeneous emphysema distribution. Both studies were published in the American Journal of Respiratory and Critical Care Medicine and showed that patients treated with Zephyr Valves had a statistically significant and clinically meaningful improvement in lung function, exercise capacity, and quality of life compared to patients who received medical management alone.

About Zephyr Valves

The Zephyr Valve is a minimally invasive treatment option for severe COPD/emphysema. Zephyr Valves are placed via bronchoscopy to block off a diseased portion of the lung to prevent air from getting trapped and reduce hyperinflation, which allows the healthier lung tissue to expand and take in more air. This results in patients being able to breathe easier, be less short of breath, and have an improvement in their quality of life.¹ Patients most likely to benefit from Zephyr Valve treatment can be identified with assessment tools also offered by Pulmonx. Physicians use the Pulmonx Chartis Pulmonary Assessment System to help identify potential responders to Zephyr Valve treatment.