Benzinga | Jul 27, 2021 11:13AM EDT

Pulmonx Announces Long-Term Follow-Up Data On Zephyr Valve

Newly Published Data Shows Positive, Durable Benefits of the Only Minimally Invasive Treatment Approved for Patients with Homogeneous Emphysema, a Form of Severe COPD with Widespread Destruction of Lung Tissue

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(r) 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."