Treatment of Nasal Airway Obstruction Using the Aerin Medical Device

This is a non-significant risk, prospective, multi-center, non-randomized study to evaluate
the safety and efficacy of the Aerin Medical device (Vivaer Stylus) when used to deliver
radiofrequency (RF) energy to the nasal valve area to improve symptoms in those diagnosed
with nasal airway obstruction.

Inclusion Criteria:

- Seeking treatment for nasal obstruction and willing to undergo an office-based
procedure

- Nasal Obstruction Symptom Evaluation (NOSE) score of ≥ 60 at Baseline

- Nasal valve is a primary or significant contributor to the subject's nasal obstruction
as determined by the study investigator (based on clinical presentation, physical
examination, nasal endoscopy, etc.) and the subject has a positive response to any of
the following temporary measures (based on patient history or office exam):

- Use of external nasal dilator strips (e.g., Breathe Right Strips)

- Q-Tip test (manual intranasal lateralization)

- Use of nasal stents

- Cottle Maneuver (manual lateral retraction of the cheek)

Exclusion Criteria:

- Prior surgical treatment of the nasal valve

- Rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal
procedures within the past twelve (12) months

- Chronic sinusitis, recurrent sinusitis, or allergies leading to nasal obstruction

- Septal deviation, turbinate hypertrophy, polyps, or ptotic nose tip believed to be a
significant contributor to the subject's nasal obstruction symptoms

- Known or suspected allergies or contraindications for any general or local anesthetic
agents and / or any antibiotic medications

- Known or suspected to be pregnant, or is lactating

- Other medical conditions which in the opinion of the investigator could predispose the
subject to poor wound healing or increased surgical risk