Research & Development
Pulmonx Receives Japanese MHLW Approval of Zephyr Endobronchial Valve for the Treatment of Severe COPD/Emphysema
1 December 2022 - - The Japanese Ministry of Health, Labour and Welfare has approved the Zephyr Endobronchial Valve for treating severe COPD/emphysema patients following a positive recommendation by Pharmaceuticals and Medical Devices Agency, US-based Pulmonx Corp. (NASDAQ: LUNG) said.

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.

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 said it plans 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.

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.

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.

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.

The approval is based on a thorough review by the PMDA of the positive clinical data from the pivotal LIBERATE Study that enrolled patients with heterogenous emphysema distribution and the IMPACT Study 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.

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.

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.

National and global treatment guidelines for COPD include Endobronchial Valves like Zephyr Valves with the Global Initiative for Chronic Obstructive Lung Disease giving valves an 'Evidence A' rating.

More than 25,000 patients have been treated with the Zephyr Valve worldwide.

Pulmonx Corp. (NASDAQ: LUNG) is in minimally invasive treatments for severe lung disease.

Pulmonx's Zephyr Endobronchial Valve and Chartis Pulmonary Assessment System are designed to assess and treat patients with severe emphysema/COPD who, despite medical management, are still profoundly symptomatic.

Pulmonx received FDA premarket approval to commercialize the Zephyr Valve following its designation as a "breakthrough device."

The Zephyr Valve is commercially available in more than 25 countries, with over 100,000 valves used to treat more than 25,000 patients.