S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Nasal Polyps

The RESOLVE II Study is a randomized, sham-controlled, double-blind, parallel arm multicenter
trial conducted in up to 45 clinical centers (academic and private) across the United States
in 300 adults with chronic sinusitis, who are indicated for revision surgery because of
recurring nasal obstruction/congestion symptoms and bilateral ethmoid polyposis.

Key inclusion criteria:

- Confirmed diagnosis of chronic sinusitis

- Patient has undergone bilateral total ethmoidectomy at least 90 days prior to
screening

- Patient has Nasal Obstruction/Congestion score of at least 2 (scale from 0 to 3) on at
least 5 days during the 7 days following informed consent, despite use of topical
intranasal steroid irrigations or sprays for at least 14 days preceding scoring, as
documented in medication records

- Indication for repeat ESS:

- Complaints of at least 2 symptoms of chronic sinusitis: nasal
obstruction/congestion, post-nasal discharge, thick nasal discharge, facial
pain/pressure, or decreased sense of smell

- Endoscopic evidence of bilateral sinus obstruction due to polyposis (minimum
grade 2 on each side)

- History of high-dose steroid use and/or sinus steroid irrigations within the
preceding 1 year

Exclusion criteria:

- Patient has presence of polyposis grade 1, 1.5 or 4 on either side

- Patient has presence of adhesions/synechiae grades 3 or 4

- Patient has known history of immune deficiency

- Patient has concurrent condition such as cancer or HIV requiring active chemotherapy
and/or immunotherapy management for the disease

- Patient has oral-steroid dependent condition such as COPD, asthma or other condition

- Patient has known history of allergy or intolerance to corticosteroids or mometasone
furoate

- Patient has presence of physical obstruction that would preclude access to either
ethmoid sinus for implant delivery (e.g., severe septal deviation, septal spur, very
small middle meatus, total obstruction of the nasal passage with severe scarring,
polyposis)

- Patient has clinical evidence of acute bacterial sinusitis

- Patient has clinical evidence or suspicion of invasive fungal sinusitis

- Patient has evidence of disease or condition expected to compromise survival or
ability to complete follow-up assessments during the 90-day follow-up period

- Patient is currently participating in another clinical trial or has already
participated in this clinical trial

- Patient has history of insulin dependent diabetes mellitus

- Patient has previously undergone ESS and experienced a cerebrospinal fluid (CSF) leak
or has residual compromised vision as a result of a complication in a prior ESS
procedure

- Patient has known dehiscence of the lamina papyracea

- Patient has evidence of active viral illness

- Patient has known history or diagnosis of glaucoma or ocular hypertension (prior
ocular exam with IOP>21 mm Hg and pressure lowering medication given) or posterior
subcapsular cataract