An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients with Severe Emphysema: The CONVERT II Trial

1. Subject is willing and able to provide informed consent and to participate
in the study.
2. Subject is aged >= 22 and <= 80 years at the time of the ICF signature date.
3. Subject has completed a documented pulmonary rehabilitation (in clinic or
home-based) program within 6 months prior to Baseline.
4. Subject has stopped smoking for at least 8 weeks prior to the ICF signature
date as confirmed by carboxyhemoglobin or cotinine levels.
5. Subject has an HRCT from the screening institution within 3 months of the
ICF signature date with the following findings at -910 Hounsfield Units:
a. At least one (1) lobe with segmental emphysema destruction score >= 50%.
b. Subject has heterogenous emphysema, defined as difference in emphysema
destruction score of >= 15 between the density scores of the target lobe and the
ipsilateral non-target
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lobe(s) per QCT report with % voxel density of < -910 HU. For non-target lobes
that include the RML, calculate the combination of non-target lobes as a single
density score using volume-weighted percent.
c. LUL, LLL, RUL, RLL, or RUL+RML are targets for valve intervention.
d. Subject has a gap in the interlobar fissure that corresponds to one or more
segments and the fissure(s) contacting the target lobe is >= 80% complete per
QCT report.
e. Subject has 98% of the fissure gap confined to a maximum of 3 segments
within the target lobe per Fissure Targeting Report (FTR).
6. Subject has 6MWD >= 250 m and <= 450 m.
7. Subject has clinically significant dyspnea with an mMRC score of >= 2.
8. Subject has post-bronchodilation FEV1 >= 15% predicted and <= 45% predicted.
9. Subject has an FEV1/FVC ratio of < 0.7.
10. Subject has post-bronchodilation TLC, measured by body plethysmography, >=
100% predicted.
11. Subject has post-bronchodilation RV >= 175% predicted, measured by body
plethysmography.
12. Subject has post-bronchodilation DLCO >= 20% predicted.
13. Subject has received preventative vaccinations against potential
respiratory infections, including COVID-19, consistent with local
recommendation or policy.
14. Subject is on optimal medical management for more than one month prior to
the ICF signature date.
15. Subject has collateral ventilation (CV+) as confirmed per the Chartis
assessment prior to the AeriSeal Index Procedure.

1. Subject has prior lung volume reduction surgery, lobectomy or pneumonectomy,
lung transplantation, airway stent placement, pleurodesis, or BLVR of any type,
except BLVR using Zephyr Valve with < 50% TLVR at 6 months, followed by valve
removal > 6 months prior to ICF signature date.
2. Subject has visible radiological abnormality on HRCT scan such as pulmonary
nodule greater than 0.8 cm in diameter (does not apply, if present for 2 years
or more without increase in size or if deemed benign by biopsy) or active
pulmonary infection (e.g., unexplained parenchymal infiltrate, significant
interstitial lung disease or significant pleural disease).
3. Post-COVID-19 pathology on CT, including ground glass opacities with or
without consolidation, adjacent pleura thickening, interlobular septal
thickening, or air bronchograms.
4. Large bullae encompassing greater than 1/3 of the total lung.
5.Subject had 3 or more COPD exacerbations requiring hospitalization within 12
monthspreceding theICFsignature date or a COPD exacerbation requiring
hospitalization within t 8 weeks of the ICF signature date. Subjects may be
re-considered for future enrollment.
6.Subject has asthma as their primary diagnosis.
7.Subject has chronic bronchitis(defined as greaterthan 4 tablespoons of sputum
production perday) as their primary diagnosis.
8.Subject has clinically significant bronchiectasis.
9.Subjectswithevidence of active respiratory infectionshould be considered
forenrollmentonlyafter satisfactory resolution.
10.Subject requires invasive ventilatory support. Note: The use of Continuous
Positive Airway Pressure (CPAP) or BiPAP devices for sleepapnea is permitted.
11.Subject has severe gas exchangeabnormalities as defined by any one of the
following tests,conducted at rest, on room air, as tolerated.
•PaCO2>= 50 mm Hg (7.3 kPa)
•PaO2 < 45 mm Hg (6.0 kPa)
12.Subject has pulmonary hypertension, defined as mean pulmonary systolic
pressure > 45 mmHg.
13.Subject has known documented alpha-1 antitrypsin deficiency.
14.Subject has clinically significant hematological disorder.
15.Subject has recent significant unplanned or unexplained weight loss or other
relevantcomorbidities considered by the investigator to be potentially
confounding or limiting to thesubject*s participation in the study.
16.Subject has non-atrial arrhythmias or conduction abnormalities on EKG.
17.Subjecthashigh cardiac risk after undergoing cardiac risk assessmentin
accordance withpublished guidelines (Fleisher 2007)or hasischemic heart
disease, congestive heart failure,cerebrovascular disease (stroke or TIAwithin
6 months of the ICF signature date),or serumcreatinine > 2.0 mg/dL (177 µmol/L).
18.Subject has uncontrolled exercise induced syncope.
19.Subject has evidence of severe diseasewhich in the judgment of
theinvestigator may compromise the anticipated treatmenteffect or the subject*s
survivalfortheduration ofatleast 12 months.
20.Subject has any other condition that theinvestigator believes would
interfere with the intent ofthe study or would make participation not in
thebest interest of the subject including but notlimited to alcoholism, high
risk for drug abuse, or noncompliance in returning forfollow-up visits.
21.Subject cannot toleratecorticosteroids or relevant antibiotics.
22.Subject use of systemic corticosteroids > 20 mg/day prednisolone or
equivalent within four (4)weeks of the ICF signature date. Subjects may be
re-considered for future enrollment.
23. Subject use of immunosuppressive agents within four (4) weeks of the ICF
signature date. Subjects may be re-considered for future enrollment.
24. Subject is unable to temporarily discontinue heparins and oral
anticoagulants (e.g., warfarin, dicumarol) according to local pre-procedural
protocols. Note: Antiplatelet drugs including aspirin, thienopyridines and
ticagrelor are permitted.
25. Subject has allergy or sensitivity to medications required to safely
perform bronchoscopy under conscious sedation or general anesthesia.
26. Subject has known allergy to the following device components: Polyether
block amide (PEBAX), Polyvinyl Alcohol or Glutaraldehyde, Nitinol
(nickel-titanium) or its constituent metals (nickel or titanium) or Silicone.
27. Subject is a female who is pregnant (positive βHCG Pregnancy test),
breast-feeding, or planning to be pregnant in the next 12 months.
28. Subject has Body Mass Index < 18 kg/m2 or > 35 kg/m2.
29. Subject participated in an investigational study of a drug, biologic, or
device not currently approved for marketing within 30 days prior to the ICF
signature date. Note: Subjects being followed as part of a long-term
surveillance of a non-pulmonary study that has reached its primary endpoint are
eligible for participation in this study.