Pulmonx Receives Japanese MHLW Approval of Zephyr Endobronchial Valve for the Treatment of Severe COPD/Emphysema
Pulmonx Corporation (Nasdaq: LUNG) (“Pulmonx”), a global leader in minimally invasive treatments for severe lung disease, announced today that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the Zephyr Endobronchial Valve for treating severe COPD/emphysema patients following a positive recommendation by Pharmaceuticals and Medical Devices Agency (PMDA). The Zephyr Valve is a minimally invasive treatment option that can deliver significant benefits to patients including improvements in lung function, exercise capacity, and quality of life.1 Placed by bronchoscopy, with no cutting or incision, the valves are for patients who remain symptomatic despite optimal management including medications, pulmonary rehabilitation, and supplemental oxygen. Pulmonx intends to collaborate with the Japanese MHLW to gain reimbursement prior to commercialization in Japan to ensure broader access to its innovative and clinically proven treatment.
“The Zephyr Valve is a breakthrough technology because it is the first bronchoscopic procedure option that can provide significant improvements to patients with no improvement in their symptoms despite optimal medical therapy,” stated Prof. Masamichi Mineshita, St. Marianna University School of Medicine, Department of Respiratory Medicine, Kawasaki, Japan. “Many patients with advanced disease continue to struggle to breathe, making even simple daily tasks difficult. Having a treatment that can help patients breathe easier and live a better quality of life, without surgical intervention, will be a major step forward in COPD care in Japan.”
Over 600,000 Japanese patients suffer from severe COPD, including approximately 100,000 patients with severe disease where hyperinflation causes them to remain symptomatic despite adhering to their medications, doing pulmonary rehabilitation, and using supplemental oxygen.2 Hyperinflation, in which air becomes trapped in the lungs and prevents new air from coming in, causes severe shortness of breath. The inability to get enough air and proper gas exchange in the lungs often prevents these patients from doing simple daily activities such as bathing, getting dressed, performing household chores and walking, without stopping to catch their breath. Until now, the only other options for these patients were invasive treatments such as lung volume reduction surgery or lung transplantation.