Open-Label Study to Evaluate the Safety and Effectiveness of the Spirair Implant

Inclusion Criteria:

• ≥21 to ≤ 70 years of age at time of consent

• Seeking treatment for nasal airway obstruction (NAO) symptoms due primarily tocartilaginous nasal septal deviation

• Willing to undergo a nasal implant procedure

• NOSE score ≥30 at Baseline Visit

• Non-calcified, mobile cartilaginous nasal septal deviation

Exclusion Criteria:

• Target nasal septal deviation that is calcified or non-mobile

• Previous septoplasty or rhinoplasty

• Having a concurrent ENT procedure, other than turbinate reduction

• Saddle nose deformity

• Congenital nasal defect

• Documented evidence that middle meatus is not visualized on endoscopic exam due tosevere septal deviation

• Turbinate reduction within the past six (6) months

• Permanent implant or dilator in the nose

• History of nasal vasculitis, unhealed wounds, cartilaginous nasal septal perforationor mucosal irregularities

• Active infection at the impllantation site e.g., folliculitis

• Current or chronic systemic steroid and/or has had radiation exposure or activechemotherapy in the treatment area

• Polyps or pathology, other than turbinate hypertrophy, that may be primarycontributor to airway obstruction, in the opinion of the Investigator

• History of a significant bleeding disorder(s) and or taking current prescriptionblood thinner medication

• Hypersensitivity to any investigational device materials inclusing known orsuspected allergy to poly(dioxanone) (PDO) or other bioabsorbable materials

• Major medical condition that could affect quality of life or wound healing andinfluence the results of the study (e.g., poorly controlled diabetes, HIV or otherimmunosuppressive conditions, active malignancy in the past 5 years, acute MI, CVA,etc.)

• Active smoker or history of tobacco or tobacco-related product use within the past 1year

• Documented evidence of a history (e.g., liver testing) of drug/alcohol abuse within 12 months of enrollment

• Females of child-bearing potential who are either pregnant or breastfeeding or planto become pregnant during the course of the study

• Currently participating, or plans to enroll in another clinical trial during thisstudy or undergo another nasal septal treatment during study participation

• History of non-compliance with medical treatment or clinical trial participation

• Subject is physically or mentally compromised (e.g., currently being treated for apsychiatric disorder, senile dementia, Alzheimer's disease, etc.), to the extentthat the Investigator determines the subject to be unable or unlikely to comply withprotocol required follow-up

• Any comorbidity or condition that renders the patient a poor surgical candidate asdetermined by the Investigator

• The subject is receiving prescription narcotic pain medication

• The subject's condition represents a worker's compensation case

• Symptoms of an upper respiratory infection e.g., runny nose, sneezing

• History of untreated or inadequately controlled rhinitis (allergic and/ornonallergic)