Pulmonx Corporation (Nasdaq: LUNG) (“Pulmonx”), a global leader in minimally invasive treatments for severe lung disease, today announced the publication of long-term follow-up data of the IMPACT Study, a multi-center randomized clinical trial of the Zephyr® Valves. The IMPACT data show that Zephyr Valves deliver significant benefits to a group of severe COPD/emphysema patients that have very few treatment options because of widespread destruction of lung tissue across their lungs (also known as homogenous distribution of emphysema). The Zephyr Valve is the only endobronchial valve to receive approval from the FDA for treatment of patients with homogenous distribution of the disease, making it the only minimally invasive option to help these patients breathe easier once medications no longer control disease symptoms.
The findings reported in the July edition of RESPIRATION - International Journal of Thoracic Medicine1 show the durability of the benefits of Zephyr Valve treatment in patients with homogeneous emphysema out to at least 12-months with clinically and statistically significant improvements including:
- Improved Lung Function (FEV1)
- Sustained Increase in Quality of Life (SGRQ)
- Increased Exercise Capacity (6MWD)
- Long-term Reduction in Hyperinflation (RV) resulting in better breathing.
This is the first report of a multicenter study showing benefits out to at least one year for this patient population. The improvements from Baseline to 6-months seen in the Zephyr Valve group were maintained out to 12-months. Data for the medically managed control group was only available out to 6-months as these patients opted to have the Zephyr Valve procedure after completing the 6-month evaluation.
“This is very important data because patients with severe COPD/emphysema have few treatment options once medications no longer alleviate symptoms. Those with homogenous emphysema, where the disease is equally spread throughout the lungs, have had even fewer options,” states Ralf Eberhardt, MD, Professor of Medicine of the Thoraxklinik at the University of Heidelberg, co-principal investigator of the IMPACT Study and the lead author of the current publication. “Having a minimally invasive bronchoscopic treatment that can improve breathing and quality of life for these patients is a big advancement in the pulmonary field.”
Associate Professor Arschang Valipour, MD, FCCP, of the Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology in Vienna, Austria and co-principal investigator of the IMPACT study explains, “The IMPACT study results reinforce our previous assertion that careful selection of patients for Zephyr Valve treatment, with focus on hyperinflation and the absence of collateral ventilation, rather than on the homogeneity or heterogeneity of the disease, is key to clinical success of the procedure. To date, other than lung volume reduction surgery or lung transplantation, there have been no treatment options for COPD/emphysema patients with homogeneous disease distribution. This is the first study of Zephyr Valves in such patients with assessments out to 12-months. We are excited about these results and can now confidently offer this as a treatment option to patients with the homogeneous emphysema phenotype.”
“In close collaboration with global clinical experts, Pulmonx continues to generate important scientific evidence related to our Zephyr Valve,” said Glen French, President and Chief Executive Officer of Pulmonx. “The significance of the IMPACT study is that the Zephyr Valve has been shown in a randomized, controlled clinical trial to be effective in treating patients with homogeneous emphysema. The Zephyr Valve is the only endobronchial valve approved for the treatment of this large subset of emphysema patients.”
About the Study
The IMPACT study is the first prospective, randomized, multi-center study examining the effectiveness of the Zephyr Valve specifically in patients with homogeneous emphysema. The study enrolled and randomized 93 patients with severe homogeneous emphysema to compare the safety and effectiveness of Zephyr Valve treatment against medical management. The company’s proprietary Chartis® Pulmonary Assessment System was used to select patients with little or no collateral ventilation who are most likely to benefit from treatment, and advanced imaging technology (HRCT and perfusion) was used to select a target lobe for treatment.
About the Zephyr Valve Treatment
The Zephyr Valve is a minimally invasive treatment for severe COPD/emphysema, a chronic, progressive, and irreversible lung disease characterized by destruction of lung tissue. The loss of the lungs' natural elasticity and collapse of airways cause air to become trapped in the lung. This makes breathing inefficient and patients feel short of breath, making the most nominal physical activities difficult. Placed via bronchoscopy, the valves block off a diseased portion of the lung to prevent air from getting trapped and reduce hyperinflation, allowing 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 quality of life2. More than 20,000 patients have been treated with the Zephyr Valve worldwide and the 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).
About Pulmonx Corporation
Pulmonx Corporation (NASDAQ: LUNG) is a global leader in minimally invasive treatments for severe lung disease. Pulmonx’s Zephyr® Endobronchial Valve, Chartis® Pulmonary Assessment System and StratX® Lung Analysis Platform are designed to assess and treat patients with severe emphysema/COPD 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.
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 filed with the SEC on May 12, 2021, 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.
1 Eberhardt R. et al. Respiration 2021. doi: 10.1159/000517034
2 Criner G et al. Am J Respir Crit Care Med. 2018; 198 (9): 1151–1164.