A Clinical Evaluation of the RheOx Bronchial Rheoplasty System

Inclusion Criteria:

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

2. Subject 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. Subject has a CAT score ≥ 10.

4. Subject's responses to the first two questions of the CAT questionnaire sum to ≥ 7points or the sum is 6 points and the subject's total CAT score is > 20 points.

5. Subject has a SGRQ score ≥ 25.

6. Subject has post -bronchodilator FEV1/FVC < 0.7.

7. Subject has post-bronchodilator FEV1 percent predicted of ≥ 30%.

8. Subject 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 enrollment.

9. Subject has a cigarette smoking history of at least ten pack years (packs per day xyears of smoking), and has had quit smoking for at least 6 months before enrollment;

10. In the opinion of the investigator, subject is able to undergo 2 bronchoscopiesunder general anesthesia and is able to adhere to the study follow-up schedule.

Subject has provided informed consent.

Exclusion Criteria:

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

2. Subject has a pulmonary nodule or cavity . In the judgement of the investigator, thesubject may require intervention during the course of the study.

3. Subject has clinically significant bronchiectasis influencing the subject's clinicalsymptoms of cough and phlegm.

4. Subject has severe other lung diseases (including interstitial pneumonia, lungfibrosis, pulmonary fibrosis with emphysema, atelectasis, unresolved lung Cancer,giant pulmonary bullae);

5. Subject has asthma based on Global Initiative for Asthma (GINA) criteria.

6. Subject has had prior severe respiratory infection with SARS-CoV-2 (COVID-19) thatrequired ICU support with non-invasive and/or invasive mechanical ventilation.

7. Subject had prior lung surgery, such as lung transplant, LVRS, lobectomy, lungimplant/prosthesis, metal airway stent, valves, coils or bullectomy. Priorpneumothorax without lung resection, pleural procedures without surgery, orsegmentectomy are acceptable

8. Subject has a history of arrhythmia within past two years which includestachy-atrial arrhythmias, any ventricular tachy-arrhythmias, grade II, II or III AVtransmission history of conduction blockor, sinus bradycardia with heart rate lessthan 45 beats per minute.

9. Subject is on anticoagulation for cardiovascular indications and, at the discretionof the investigator, is unable to have anticoagulants (i.e., Aspirin, Plavix,Coumadin) withheld for the bronchoscopy procedure per institution's standard ofcare.

• If the anticoagulants withheld is clinically acceptable, five to seven dayswithheld before enrollment is advised.

10. Subject has other serious diseases (e.g. congestive heart failure, cardiomyopathy,or myocardial infarction in the past year, renal failure, liver failure,cerebrovascular accident within the past 6 months, uncontrolled diabetes (HbA1c >8%), uncontrolled hypertension (diastolic BP >100mmHg) or autoimmune diseaserequiring treatment with immunosuppressant medications or a disease requiringchemotherapy).

11. Subject has uncontrolled gastroesophageal reflux disease（GERD）that indicated by thecommon symptoms and signs like stomach burning, acid reflux, regurgitation ofpartial digested food or acid into throat.

12. Subject has any implantable electronic device (e.g., pacemaker, cardioverterdefibrillator, neuro-stimulation devices).

13. Subject has known airway colonization with resistant organisms, such as pseudomonas,methicillin-resistant Staphylococcus aureus (MRSA), Burkholderia cepacia complex,Mycobacterium Tuberculosis (MTB), Mycobacterium abscessus mucor or significantfungus.

14. Subject has known severe pulmonary hypertension.

15. Subject has a known sensitivity to medication required to perform bronchoscopy (i.e., lidocaine, atropine, benzodiazepines, Propofol).

16. Subject has known allergy to nickel.

17. Subject is receiving any traditional Chines herbs for cough or phlegm. * mucolyticsmay be recommended by institute clinical practice, carbocysteine, oral or inhaledN-acetylcysteine, Eucalyptol and ambroxol hydrochloride are suggested.

• The treatrment of this study is to ablate bronchial mucosa by airway intervention,then mucosa epithelium is repaired. The effect of inhalation on the repair of airwaymucosal epithelium is unknown. Therefore, it is not recommended to oral or inhaledN-acetylcysteine during treatment and follow-up.

18. Subject has a steroid-dependent condition requiring >10 mg of oral corticosteroid (e.g. prednisone or equivalence.) per day.

19. Subject is unable to walk over 225 meters in 6 minutes.

20. Subject has emphysema of greater than or equal to 35% (low attenuation area≤ -950HU)as determined by HRCT quantitative analysis.

21. Subject is pregnant, nursing, or planning to get pregnant during study duration.

22. Subject has HIV infection or active syphilis infection;

23. Subject is currently participating in another clinical study involving aninvestigational product.

24. Subject is not suitable for bronchoscopy by the judgement of investigator.