Gala Early Feasibility Study of RheOx

RheOx is a device-based, energy delivery system that delivers energy for the ablation of soft
tissue such as the airway epithelium and sub-mucosal tissue layers. The energy is delivered
via a proprietary catheter through the bronchoscope.

Two sessions of treatment will be delivered one month apart. The right lung is treated at the
first treatment session and the left lung is treated at the second treatment session
(approximately one month after the right side is treated). Treatment will be delivered by a
respiratory physician (interventional pulmonologist) in a tertiary teaching hospital during a
bronchoscopic procedure. The bronchoscopy will be delivered during general anesthesia. It is
anticipated that the bronchoscopic procedure will last less than 60 minutes in total.
Treatment will be deemed to have been delivered following the successful treatment during the
two bronchoscopies.

Subjects will be required to submit tests during the study including three CT scans (lung),
respiratory function tests, exercise testing.

Inclusion Criteria:

1. Subject is diagnosed with chronic bronchitis for a minimum of two years, where chronic
bronchitis is defined clinically as chronic productive cough for three months in each
of two successive years in a patient in whom other causes of productive cough have
been excluded.

2. Subject has preprocedure post-bronchodilator FEV1 of greater than or equal to 30% and
less than or equal to 80% of predicted within three months of enrollment.

3. Subject has had 1 or more COPD exacerbations, defined as an acute worsening in
respiratory symptoms that requires additional treatment, in the 12-months prior to
enrollment.

4. Subject has a cigarette smoking history of at least ten packs years.

5. Subject in the opinion of the site investigator can undertake the processes and
procedures of the clinical trial and has provided a signed informed consent.

Exclusion Criteria:

1. Subject has lower respiratory infection (e.g., common cold, pneumonia, MAI,
tuberculosis) within the six weeks prior to the initial treatment bronchoscopy or mild
or moderate COPD exacerbation (per GOLD guidelines) within 4 weeks of the procedure.

2. Subject is taking > 10 mg of prednisolone or prednisone per day.

3. Subject has an implantable cardioverter defibrillator or pacemaker.

4. Subject has a history of cardiac arrhythmia within past two years.

5. Subject has history of unresolved lung cancer in last 5 years.

6. Subject has bullous disease as defined by bullae exceeding 3 cm in diameter on HRCT.

7. Subject has pulmonary nodule or cavity rthat in the judgement of the investigator may
require intervention during the course of the study.

8. Subject has prior lung surgery, such as lung transplant, LVRS, lung
implant/prosthesis, metal stent, valves, coils, bullectomy, segmentectomy, or
lobectomy. Pneumothorax without lung resection is acceptable. Pleural procedures
without surgery are acceptable.

9. Subject has clinically significant cardiomyopathy.

10. Subject has severe bronchiectasis as outlined in the report of the CT scan of the
chest by the interpreting radiologist or in the view of the PI, those findings
bronchiectasis or any other significant second lung disease, are the main drivers of
the patient's clinical symptoms.

11. Subject actively smoked (including tobacco, marijuana, e-cigarettes, vaping, etc.)
within the last 6 months.

12. Subject has the inability to walk over 100 meters in 6 minutes.

13. Subject has clinically significant serious medical conditions, such as: congestive
heart failure, angina or myocardial infarction in the past year, renal failure, liver
disease cerebrovascular accident within the past 6 months, uncontrolled diabetes,
uncontrolled hypertension or autoimmune disease.

14. Subject has uncontrolled GERD.

15. Subject has sever pulmonary hypertension.

16. Subject has known sensitivity to medication required to perform bronchoscopy (such as
lidocaine, atropine, and benzodiazepines).

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

18. Subject has received chemotherapy within the past 6 months or is expected to receive
chemotherapy during participation in this study.

19. Subject is or has been in another clinical investigational study within 6 weeks of
baseline.

20. Subject on anticoagulation for cardiovascular indications and is unable to have
anticoagulants (i.e., Aspirin, Plavix, Coumadin) withheld for at least seven days
prior to bronchoscopy in the opinion of the Investigator.