Clinical Study of the Pulsed Electric Field Ablation System in Chronic Obstructive Pulmonary Disease

Inclusion Criteria:

1. Subject's age is ≥35 years and ≤80 years.

2. Patient has chronic bronchitis, defined as productive cough for three months in eachof two successive years, whereas other causes of productive cough have been ruledout.

3. Patient has a CAT score ≥ 10.

4. Patient has an SGRQ score ≥ 25.

5. Patient's responses to the first two questions of the CAT instrument sum to ≥ 7points or the sum is 6 points and the patient's total CAT score is > 20 points.

6. Patient has FEV1/FVC < 0.70.

7. Patient has a pre-procedure post-bronchodilator FEV1 percent predicted of ≥ 30%.

8. Patient is receiving guideline directed pharmacotherapy which includes one or morelong acting bronchodilator (LAMA, LABA) with or without an inhaled corticosteroidfor at least 8 weeks prior to randomization, unless the patient has attempted suchtherapy within the past 1 year without significant clinical response or had anadverse reaction.

9. In the opinion of the Primary investigator, patient is able to undergo 2bronchoscopies under general anesthesia and is able to adhere to the study follow-upschedule.

10. Informed consent signed by the patient or legal representative.

Exclusion Criteria:

1. Patient has known unresolved lower respiratory tract infection (e.g., pneumonia,mycobacterium avium-intracellulare infection (MAI), fungus, tuberculosis).

2. Patient has a steroid-dependent condition requiring >10 mg of oral corticosteroidper day.

3. Patient has any implantable electronic device (e.g., pacemaker, cardioverterdefibrillator) that cannot be turned off during the procedure.

4. Patient has a history of ventricular tachy-arrhythmia or clinically significantatrial tachyarrhythmia within the past two years, or sinus bradycardia with a heartrate of under than 45 beats per minute, unless the arrhythmia has been treatedand/or patient is in regular rhythm during the screening phase.

5. Subject has lung cancer.

6. Patient has a pulmonary nodule or cavity that in the judgement of the Primaryinvestigator may require intervention during the course of the study.

7. Patient had prior lung surgery, such as lung transplant, LVRS, lobectomy, lungimplant/prosthesis, metal airway stent, valves, coils or bullectomy.

8. Patient has emphysema of greater than or equal to 50% as quantified on baseline HRCTscan as determined by the CT Core Lab.

9. Patient has asthma based on Global Initiative for Asthma (GINA) criteria.

10. Patient has clinically significant bronchiectasis influencing the patient's clinicalsymptoms of cough and phlegm.

11. Patient has actively smoked (including tobacco, marijuana, e-cigarettes, vaping,etc.) within the last 2 months.

12. Patient is unable to walk over 225 meters in 6 minutes.

13. Patient has a serious medical condition that, in the Primary investigator's opinion,could compromise patient safety or confound the interpretation of the patient'sresponse to therapy (e.g., congestive heart failure, cardiomyopathy, or myocardialinfarction in the past year, renal failure, liver disease, cerebrovascular accidentwithin the past 6 months, uncontrolled diabetes (HbA1c >8%), uncontrolledhypertension (diastolic BP >100mmHg) or autoimmune disease requiring treatment withimmunosuppressant medications or a disease requiring chemotherapy).

14. Patient has uncontrolled GERD.

15. Patient has known severe pulmonary hypertension (pulmonary artery SP ≥ 50 mmHg).

16. Patient has a known sensitivity to medication required to perform bronchoscopy (i.e., lidocaine, atropine, benzodiazepines).

17. Patient is pregnant, nursing, or planning to get pregnant during study duration.

18. Patient is currently participating in another clinical study involving aninvestigational product.

19. Patient is receiving anticoagulation for a cardiovascular indication and, in thePrimary investigator's opinion, unable to suspend anticoagulant medications (i.e.,aspirin, clopidogrel, warfarin) during bronchoscopy in accordance.

20. Patient has known airway colonization with drug-resistant bacteria such asPseudomonas aeruginosa, methicillin-resistant Staphylococcus aureus, Burkholderiacepacia complex, Mycobacterium tuberculosis, Mycobacterium abscessus, Trichoderma,or other significant fungi.