Clinical Utility for Ion Endoluminal System

Inclusion Criteria:

- Patients aged 18 years and older

- Patient is suitable for elective bronchoscopy

- Patients with a moderate to high risk of lung cancer based on clinical, demographic
and radiologic information or with suspected metastatic disease

- Solid or semi-solid pulmonary nodules of ≥ 1cm and ≤ 3cm in largest dimension

- Nodule is located in bronchial generation 4+ (i.e. beyond segmental bronchus*

- Patients are candidates for CT-guided needle biopsy and/or surgical resection

- Patient able to understand and adhere to study requirements

- Patient able to understand and adhere to study requirements and able to provide
informed consent

- Patient not legally incapacitated or in legal/court ordered institution

- Patients with no dependency on the investigator or sponsor

Exclusion Criteria:

- Lack of fitness or exercise capacity to undergo bronchoscopy under general anesthesia
as determined by physician investigator prior to procedure

- Acute myocardial infarction or unstable angina ≤ 6 weeks prior to study procedure

- Partial trachea obstruction or obstruction of vena cava

- Moderate to severe hypoxemia, acute respiratory failure or respiratory rate per
physician assessment (i.e. > 30 breaths per minute)

- Subjects with renal insufficiency that presents risk per physician's discretion or
liver failure (i.e. CHILD-PUGH Class C)

- Established history or clinical indication of pulmonary hypertension (i.e. history of
mPAP > 35 mmHg)

- Lung abscess

- Debility and malnutrition

- Known or suspected pregnancy

- Recent head injury (<12 weeks pre-procedure) or subjects presenting with neurologic
deficits or decreased cranial compliance

- Unstable hemodynamic status (i.e. uncontrolled blood pressure or hypotension,
dysrhythmia requiring intervention, altered mental status/consciousness)

- Subjects with pure ground glass opacity target nodule

- Inability to adequately oxygenate subject during procedure per physicians discretion
(i.e. unable to achieve S02 > 92% or requiring >4L of oxygen via nasal cannula)

- Subject with uncorrectable coagulopathy, bleeding or platelet disorders, history of
major bleeding with bronchoscopy

- Subjects contraindicated for intubation or general anesthesia, or subjects with ASA≥ 4

- Subjects taking antiplatelet (i.e. clopidogrel), anti-coagulant (i.e heparin or
warfarin) or /platelet aggression inhibitors (i.e. Abciximab or Eptifibatide)
medications that cannot be stopped at least 7 days prior to procedure (aspirin not
included)

- Any severe or life-threatening comorbidity that could increase the risk of
bronchoscopic biopsy (i.e. >Stage 3 heart failure)

- Moderate-to-severe pulmonary fibrosis

- Mediastinal lymphadenopathy on chest CT scan and/or PET CT

- Endobronchial lesion associated with lobar atelectasis

- Large or Giant bullae within the same lobe of the target pulmonary nodule

- Known allergy, sensitivity or previous allergic reaction to ortho-phthalaldehyde (OPA)

- Subjects taking the following medications: Immunosuppressive treatment with systemic
azathioprine, Cyclosporine, antibodies or cytostatics, or medications acting on
immunophilins

- Participation in any other clinical study in last 30 days prior to screening