Paclitaxel-Coated Nasal Balloon for the Treatment of Recurrent Chronic Rhinosinusitis With or Without Nasal Polyps (FIH)

Inclusion Criteria: Up to 45 CRS subjects with recurrent symptomatic nasal obstructioneligible for Airiver Nasal DCB treatment

1. Males or females, ≥18 years
2. Signed written informed consent
3. Recurrent, symptomatic CRS (with or without nasal polyps, with or without prior sinussurgery), have:

• Moderate or severe nasal congestion/blockage/obstruction
• AND decreased or loss of smell (hyposmia or anosmia),
• Or rhinorrhea (anterior/posterior)
• For recurrent CRSwNP:

1. candidates for RESS or other treatment due to recurrent symptom, andendoscopically confirmed present with unilateral or bilateral polyps,and/or unilateral or bilateral mucosal disease confirmed by nasalendoscopy and/or CT
2. bilateral sinonasal polyposis that despite prior treatment withsystemic corticosteroids (SCS) anytime within the past 2 years; and/orhad a medical contraindication / intolerance to SCS
3. with or without Aspirin-Exacerbated Respiratory Disease (AERD)

• For recurrent CRSsNP: refractory to optimal medical treatment and/orprevious surgery with positive CT scan of the sinuses mucosal thickening andobstruction or positive nasal endoscopic finding (purulence or edema)

4. Acute Exacerbation of CRS (AECRS)
5. Subjects with comorbid asthma or COPD must be stable with no exacerbations (e.g., noemergency room visits, hospitalizations) for 6 months before the screening visit

Exclusion Criteria: 1. Pediatric CRS (PCRS) 2. Acute bacterial sinusitis (ABRS), acute rhinosinusitis (ARS), or mycetoma and invasivefungal sinusitis 3. Malignancy 4. Experienced a cerebrospinal fluid (CSF) leak in prior skull-based dehiscence 5. Symptomatic without positive CT findings or an asymptomatic 6. Subjects whose symptoms are too severe (eg, temperature >102.58F or extrasinusmanifestations, such as orbital cellulitis; dental or facial or brain abscess;cavernous vein thrombosis; or altered mental status 7. Primary ciliary dyskinesia (PCD) 8. Unable to have nasal cavity examination due to septal deviation or spur. Participantswho had a sinonasal or sinus surgery changing the lateral wall structure of the nosemaking impossible the evaluation of NP 9. Have evidence of significant baseline mucosal injury, ulceration, or erosion (eg,exposed cartilage, perforation) on baseline nasal examination 10. Purulent nasal infection, or upper respiratory tract infection within 2 weeks beforethe screening visit. Potential subjects presenting with any of these infections may berescreened 4 weeks after symptom resolution 11. Allergy or hypersensitivity to any excipients and paclitaxel. 12. Patient has an inability to tolerate endoscopy 13. Suffering or recovering from COVID-19 (Fully recovered Covid-19 patients is notexcluded) 14. Study subject has any disease or condition that interferes with safe completion of thestudy, such as severe COPD or severe asthma 15. Subjects with abnormal screening laboratory/imaging test results that compromise theability to assess the benefits/risks (eg, abnormal ECG) 16. Pregnancy or planning on pregnant during the first 12 months of enrollment in thestudy 17. Life expectancy <1 year 18. Patient is currently enrolled in other current investigational studies. Participationin studies for products approved in the US are not considered investigational. 19. Lack of informed consent 20. Allergic granulomatous angiitis (Churg-Strauss syndrome), granulomatosis withpolyangiitis (Wegener's granulomatosis), Young's syndrome, Kartagener's syndrome orother dyskinetic ciliary syndromes