Pulmonx Receives Japanese MHLW Approval of Zephyr Endobronchial Valve for the Treatment of Severe COPD/Emphysema
Approval of First Minimally Invasive Treatment Option in
“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,
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.
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
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
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
National and global treatment guidelines for COPD include Endobronchial Valves like Zephyr Valves with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) giving valves an ‘Evidence A’ rating. More than 25,000 patients have been treated with the Zephyr Valve worldwide.
Forward Looking Statements
This release contains forward‐looking statements within the meaning of Sections 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. We may, in some cases, use terms such as “look forward,” “confident,” “promises,” “predicts,” “believe,” “potential,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward‐looking statements and include, without limitation, statements about Pulmonx’s ability to treat a greater number of patients and deliver significant benefits to patients. Forward‐looking statements should not be read as a guarantee of future performance or results and may not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. These forward‐looking statements are based on Pulmonx’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward‐looking statements as a result of these risks and uncertainties, which include, without limitation those related to the safety, efficacy and patient and physician adoption of the Company’s products, the designation of our products and therapies as a standard of care, the final results and outcomes of clinical trials and studies involving the Company’s products, the ability to obtain and maintain adequate reimbursement for its products, and the Company’s ability to procure and maintain required regulatory approvals for its products. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in Pulmonx’s filings with the
- Criner G et al. Am J Respir Crit Care Med. 2018; 198 (9): 1151–1164.
Tanabe N et. al. J. Thorac Dis. 2021 Jun; 13(6): 3878–3887; Soriano JB et al. Lancet Respir Med. 2015 Jun;3(6):443-50; Welling JBA et al. Int J Chron Obstruct Pulmon Dis. 2020; 15: 1179–1180. See also
Statistics Bureau of Japan(https://www.stat.go.jp/english/data/jinsui/tsuki/index.html) (accessed on 10-25-22)
- Valipour A. et al. Amer J Respir Crit Care Med. 2016; 194(9):1073–1082.
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