Pulmonx Endobronchial Valves Used in Treatment of Emphysema (LIBERATE Study)

The Pulmonx Zephyr Endobronchial Valve (EBV) is an implantable bronchial valve intended to
decrease volume in targeted regions of the lung. It is indicated for the treatment of
patients with severe emphysema. The EBV are placed in the diseased region of the lung using
bronchoscopy. Bronchoscopy is a way to access the lungs using a small tube with a camera on
the end. As the diseased region of the lung shrinks in size, healthier regions may expand and
function more efficiently, resulting in improved breathing.

The LIBERATE Study is a clinical trial with two groups. Participants are assigned at random
to the 'Treatment' group or to the 'Control' group. The 'Treatment' group will receive the
Zephyr Endobronchial Valve (EBV) in combination with optimal medical therapy. The 'Control'
group will receive optimal medical therapy alone. For every three participants in the study,
two will go into the 'Treatment' group and one will go into the 'Control' group.

It is hypothesized that after placement of the EBV, lung function will be improved as
compared to standard medical therapy alone.

Based on the 12-month follow up data from the LIBERATE Study, the Zephyr Endobronchial Valve
System was approved by the FDA for the treatment of severe emphysema in June 2018. Following
this PMA approval, and in agreement with the FDA, the ongoing long term follow-up (out to 5
years) of patients in the LIBERATE Study will now be conducted as a Post-approval study under
the auspices of the "LIBERATE Extension Study". This is an administrative change with
absolutely no change to the design or conduct of the study and, therefore has no material
impact to the study participants or the study sites. All annual follow-up visits and
evaluations are per the original LIBERATE Study protocol. Reporting to the FDA will be as the
LIBERATE Extension Study.

Inclusion Criteria:

- Clinical and radiological evidence of emphysema

- Nonsmoking for 4 months prior to screening interview

- BMI less than 35 kg/m2

- Stable on current medication regimen

- Forced expiratory volume in one second (FEV1) between 15% and 45% of predicted value

- Residual Volume less than 175% predicted (determined by body plethysmography)

- Little or no collateral ventilation (CV-) as determined using the Chartis System

Exclusion Criteria:

- Had two or more hospitalizations over the last year for a COPD exacerbation

- Had two or more hospitalizations over the last year for pneumonia

- Had a prior lung transplant, lung volume reduction surgery, bullectomy or lobectomy

- Had a heart attack or congestive heart failure within the last 6 months

- Have heart arrhythmia

- Is alpha-1 antitrypsin deficient