Over 20,000 Patients Treated with the Non-Surgical Zephyr Valve for Severe Emphysema, a Form of COPD
he Zephyr Valve Helps COPD/Emphysema Patients Breathe Easier Without the Risk of Major Surgery1
REDWOOD CITY, Calif., Nov. 30, 2020 (GLOBE NEWSWIRE) — As part of COPD Awareness Month, Pulmonx Corporation is announcing that over 20,000 patients have been treated worldwide with their Zephyr® Endobronchial Valves (Zephyr Valve), the first FDA-approved minimally-invasive treatment for severe emphysema, a form of COPD. The Zephyr Valve has been shown to deliver significant benefits to patients with emphysema, including improvements in lung function, exercise capacity and quality of life.1 The valves are placed via bronchoscopy, with no incision or cutting, so these benefits are achieved without the risks of traditional surgical options.
“The Zephyr Valve treatment represents a major advancement in the field of bronchoscopy and can be truly life changing for patients with advanced disease,” states Dr. D. Kyle Hogarth, MD, Professor of Medicine and Director of Bronchoscopy at the University of Chicago Medical Center. “Before this option, many COPD/emphysema patients struggled to breathe despite maximum medical therapy. Endobronchial valves are the first option we have had to help patients breathe easier and re-engage with life without the risks of major surgery. The Zephyr Valve is quickly becoming a standard of care for patients with advanced COPD/emphysema.”
Despite taking the best available medications, many patients with emphysema, a common form of COPD, suffer from hyperinflation of their lungs where air becomes trapped in the lungs, preventing fresh air from entering and thereby causing severe shortness of breath. Patients with hyperinflation have difficulty doing even the simplest tasks like showering or walking up a flight of stairs. The Zephyr Valves reduce lung hyperinflation by allowing trapped air to escape and preventing new air from entering that diseased lobe. This allows the healthier parts of the lung to function better and results in patients being able to breathe more easily and experience less shortness of breath.1
“Our corporate mission is to improve the lives of patients with severe COPD/emphysema, so we are very excited about achieving this significant milestone of treating more than 20,000 patients,” said Glen French, President and Chief Executive Officer. “Hundreds of hospitals in the US and abroad now offer our Zephyr Valves, so we are on our way to enabling many patients to breathe easier in the years to come.”
“Helping patients breathe easier changes not only their immediate quality of life, but also breaks the cycle of deterioration that comes from inactivity and can contribute to a higher-quality of life long-term,” states D.J. (Dirk-Jan) Slebos, MD, Professor of Interventional Pulmonology, University of Groningen, The Netherlands. “My patients report that they are back to being more active and participating in hobbies like gardening and biking that, before the valves, had become too difficult because of the disease.”
Patients treated with the Zephyr Valves report experiencing significantly more days when their symptoms were “better” and fewer days that were “worse” over 12 months compared to the control group.2 Cumulative clinical data suggests that patients treated successfully with endobronchial valves, like the Zephyr Valve, have increases in the BODE Index (a multi-dimensional health status scoring system for patients with COPD) that have been associated with survival benefits.3–10 The Zephyr Valve treatment is included in national and global treatment guidelines for COPD including an ‘Evidence A’ rating from The Global Initiative for Chronic Obstructive Lung Disease (GOLD).
Pulmonx Corporation (NASDAQ: LUNG) is a commercial-stage medical technology company that provides minimally invasive treatment for patients with severe emphysema, a form of COPD. The Pulmonx solution, which is comprised of the Zephyr Endobronchial Valve, the Chartis® Pulmonary Assessment System and the StratX® Lung Analysis Platform, is designed to treat severe emphysema/COPD patients who, despite medical management, are still profoundly symptomatic. Pulmonx received FDA pre-market 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 80,000 valves used to treat more than 20,000 patients. For more information on the Zephyr Valves, please visit www.MyLungsMyLife.com. For more information on the company, please visit www.Pulmonx.com.
Pulmonx, Chartis®, StratX®, and Zephyr® are registered trademarks of Pulmonx Corporation.
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 ability to obtain and maintain reimbursement codes 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 Securities and Exchange Commission (SEC), including the Company’s quarterly report on Form 10-Q for the fiscal quarter ended September 30, 2020 filed with the SEC and available at www.sec.gov. Pulmonx does not undertake any obligation to update forward‐looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward‐looking statements contained herein.
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|2.||Dransfield M. et al. Ann Am Thorac Soc. 2020 Jul; 17 (7):829-838.|
|3.||Criner, GJ, Delage, A, Voelker, K, Hogarth, DK, et al. Improving Lung Function in Severe Heterogenous Emphysema with the Spiration Valve System (EMPROVE). A Multicenter, Open-Label Randomized Controlled Clinical Trial. Am J Respir Crit Care Med, 2019; 200(11), 1354–1362.|
|4.||Kemp, SV, Slebos, DJ, Kirk, A, Kornaszewska, M, Carron, K, Ek, L, & Briault, A. A multicenter randomized controlled trial of Zephyr endobronchial valve treatment in heterogeneous emphysema (TRANSFORM). Am J Respir Crit Care Med, 2017; 196(12), 1535–1543.|
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|6.||Klooster, K, ten Hacken, NH, Hartman, JE, Kerstjens, HA, van Rikxoort, EM, & Slebos, DJ. Endobronchial valves for emphysema without interlobar collateral ventilation. N Engl J Med, 2015; 373(24), 2325–2335.|
|7.||Welling J et al. Patient Selection for Bronchoscopic Lung Volume Reduction. International Journal of Chronic Obstructive Pulmonary Disease 2020; 15, 871–881.|
|8.||Gompelmann et al. Survival after endoscopic valve therapy in patients with severe emphysema. Respiration 2019; 97(2), 145-152.|
|9.||Garner et al. Survival after endobronchial valve placement for emphysema: A 10-year follow-up study. Am J Respir Crit Care Med. 2016; 194(4), 519-521.|
|10.||Klooster et al, Improved Predictors of Survival after Endobronchial Valve Treatment in Patients with Severe Emphysema Letter to the editor, American Journal of Respiratory and Critical Care Medicine Volume 195 Number 9 | May 1, 2017.|