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 obstruction eligible 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 priorsinus surgery), 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/or had 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 thickeningand obstruction 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 andinvasive fungal 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.Participants who had a sinonasal or sinus surgery changing the lateral wallstructure of the nose making 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 maybe rescreened 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 ofthe study, 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.Participation in studies for products approved in the US are not consideredinvestigational.

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