1. LIBERATE Clinical Study
Background, Study Overview,
Device Description, Patient Selection

2. Summary
Physicians’ efforts to help their severe emphysema patients are hampered by a lack of good therapeutic tools
Pulmonx produces minimally invasive medical devices to expand treatment options for emphysema patients
These have been available for many years in Europe
Multiple randomized trials have already been completed and have helped identify which patients are most likely to benefit
Based on this clinical experience, there is a US pivotal study of the Pulmonx Zephyr® EBV recruiting in your area

3. Emphysema
The core issue in advanced emphysema is reduced elasticity, leading to gas trapping and lung hyperinflation
Healthy Lung
Lung with Emphysema
Emphysema causes air sacs (called alveoli) to deteriorate and lose elasticity, making breathing difficult.
Oxygen exchange is reduced in the alveoli
Air gets trapped in the alveoli, causing the diseased lung region to expand
The diseased region compresses the healthier region, and breathing is even more difficult. 
Tissue is elastic with large surface area
Tissue destruction reduces elasticity and gas exchange
Breathing is easy; Lung expands and contracts normally
Diseased region compresses healthier region, making breathing difficult

4. The Burden of Emphysema
Creates a downward spiral of deconditioning and lung function decline that results in death
6 Million people in Europe and the US suffer from emphysema; 1.5M of these are severe or very severe
4th leading cause of death worldwide
Costs the US healthcare system >$30B in direct expense annually

5. Limited Treatment Options Today
Medical Management
Stop smoking
Medication/inhalers to help breathing
Supplemental oxygen
Pulmonary rehabilitation
Lung Volume Reduction Surgery
Remove diseased part of lung
Lung Transplant
Replace diseased lung

6. Summary of Treatment Options in Severe Emphysema
High
New Solutions Needed
Medical Management
%FEV1 improvement: 3.9% (vs. MCID of 15%)
Safety
Lung Volume Reduction Surgery
30 day mortality rate: 5%
Extended hospitalization: 59%
NETT: 30 days mortality rate: 16%
BeLieVeR-HIFi: FEV1 with MM 3.9% vs 24.8% with valves, 2 deaths but none related to valves
Low
Effectiveness
High

7. New Options
Pulmonx developed the Zephyr® Endobronchial Valve (EBV) System for bronchoscopic lung volume reduction
More than 60 clinical articles have been published to-date1
Approved in Europe in 2003 and over 9,000 patients treated outside of the USA
Supplements but does not replace ongoing medical management by their physician
The EBV system is available as an investigational device through the LIBERATE clinical study in the USA
1Data on file at Pulmonx

8. Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr® EBV
Minimally invasive, investigational implant reduces the volume of the diseased part of the lung
Allows the healthy part of the lung to expand and function efficiently

9. What is the LIBERATE study device?
The Zephyr® EBV System consists of:
Endobronchial Valve (EBV)
Valve Loading system
Delivery Catheter (EDC)

10. The Zephyr® EBV Flexible frame
Designed to seal against target lung airway and prevent tissue ingrowth
One-way valve
Designed to close when breathing in and open when breathing out

11. What is the study procedure?
A bronchoscope is inserted through the nose or mouth and into the lungs
The Zephyr® EBV is delivered through the bronchoscope
If needed, the EBV may also be removed through the bronchoscope

12. Lung Volume Reduction with EBVs
The Zephyr® EBV allows air and secretions to pass out through the valve but not back in, resulting in lung volume reduction
In turn, the healthy part of the lung expands again and takes part in the exchange of oxygen and carbon dioxide

13. Zephyr® EBV Implantation
A standard procedure will typically place 3-4 EBVs in the target lung area

14. What is collateral ventilation?
Collateral ventilation is like a backdoor for airflow between lobes in the lungs
If there is low collateral ventilation, the EBVs will keep air from entering the diseased area, reducing lung volume.
If there is collateral ventilation, air can enter the diseased area from behind the EBVs and lung volume will not reduce.
The Chartis® System can assess this prior to implanting the EBVs into the lung.

15. Chartis® System for Collateral Ventilation Assessment
The Chartis® System consists of:
Console for measuring flow and pressure
Balloon catheter
Similar to the EBV, the low pressure balloon catheter is delivered through a bronchoscope

16. Procedure Summary

17. Patient Selection Informed by Prior Clinical Experience
VENT RCT All Valve Patients
VENT RCT Patients with Low Collateral Ventilation (subgroup)
BeLieVeR-HIFi RCT Patients with Low Collateral Ventilation
Change in FEV1% vs Medical Control
Change in FEV1% vs Medical Control
Change in FEV1% vs Medical Control
MCID
MCID
MCID
Information from these studies is intended for scientific educational purposes only. References to published literature are available at request.
Caution: Safety and effectiveness of the EBV Zephyr® Valve have not been established.

18. Prior Clinical Experience: Safety (VENT study)
Major Complication Composite (MCC)
(Primary Safety Endpoint)
0 – 194 Days
Control % (n / N)
Zephyr® EBV % (n / N)
MCCs
1.2% (1 / 87)
6.1% (13 / 214)
Death
0.0% (0 / 87)
2.8% (6 / 214)
Empyema
0.0% (0 / 214)
Massive hemoptysis
0.5% (1 / 214)
Distal pneumonia --
1.4% (3 / 214)
Pneumothorax or prolonged air leak
Respiratory failure > 24 hours
1.9% (4 / 214)
Information from these studies is intended for scientific educational purposes only. References to published literature are available at request.
Caution: Safety and effectiveness of the EBV Zephyr® Valve have not been established.

19. The LIBERATE Study US FDA Investigational Device Exempt (IDE) Study
Purpose of Study
To determine the safety and effectiveness of bronchoscopic lung volume reduction using the Zephyr® EBV for treatment of emphysema
Key Endpoints
Primary: Proportion of treated patients achieving a clinically significant improvement in FEV1 % compared to control patients
Secondary: Improvements in lung function measures, shortness of breath, and quality of life
Safety: Frequency of adverse events or complications in study participants who receive the EBV

20. Who is eligible for study treatment?
Screening Eligibility for participation:
Age 40 to 75 years
BMI <35 kg/m2
Non-smoking for > 4 months
Spirometry (FEV1 >15% <45% pred)
Completed a pulmonary rehabilitation program in the last 6 months – Or willing to complete prior to study enrollment
CT scan (heterogeneous emphysema via thin slice HRCT)
Body plethysmography (RV >175% pred)
Assessment of collateral ventilation using the Pulmonx Chartis® System
Note: This list is not comprehensive; full set of requirements are in the Informed Consent Document
General test descriptions “lung function tests, blood test”

21. What happens on procedure day?
The procedure is performed in bronch suite/operating room
Final eligibility is determined by air flow evaluation
Chartis® assessment of collateral ventilation
The patient is randomly assigned to Treatment or Control
Zephyr® EBVs are placed if assigned to Treatment
The total procedure time is approximately 1 hour
Patients receiving the EBV treatment will stay overnight in the hospital for 5 nights

22. How long will my patient be in the study?
Study participants in the Treatment group
Post-procedure: 5-night hospital stay
Daily phone call for 10 days post-discharge
In-clinic visits scheduled –
7 days post-discharge
30 days and 45 days post-procedure
3, 6, 9, and 12 months post-procedure
2, 3, 4 and 5 years post-procedure
Total study participation will be approximately 5 ½ years

23. How long will my patient be in the study?
Study participants in the Control group
Post-procedure: Discharged on the day of procedure
In-clinic visits scheduled
45 days post-procedure
3, 6, 9, 12 months post-procedure
Total study participation will be approximately 1 ½ years
Patient can cross over to treatment group at 12 months

24. Post-Procedure Clinic Visits
Each visit involves medical tests which will vary by timepoint, including:
Physical exam, medical review, blood gases
Lung function testing
Imaging such as high resolution CT scan and x-rays
Quality of Life surveys and daily diary symptoms questionnaire

25. Please Consider Referring Qualifying Patients for This Study
Prior clinical experience informs study design
Zephyr® EBV technology used since 2003 in Europe to treat over 9,000 patients
Recent RCT shows the Chartis® system helps select patients most likely to benefit
Key parameters for referral for evaluation:
Age 40 to 75 years
BMI <35 kg/m2
Non-smoking for > 4 months
Spirometry (FEV1 >15% <45% pred)
Completed a pulmonary rehabilitation program in the last 6 months – Or willing to complete prior to study enrollment
Body plethysmography (RV >175% pred)
Additional criteria will be evaluated at treatment site

26. https://pulmonx.com/liberate-endobronchial-valve-study/
Questions/Comments
Who do I contact if I have eligible patients?
Pulmonx Call Center
LUNG ( ) Or
Find your nearest Study Site