Intersect ENT®, Inc. announced positive results of an observational, cohort study using real-world evidence (RWE) data from adult patients with chronic rhinosinusitis (CRS) with or without nasal polyps who underwent endoscopic sinus surgery (ESS). Study results demonstrate that patients receiving PROPEL® sinus implants following sinus surgery had lower healthcare resource utilization (HCRU) over a postoperative period of 18 months compared with patients who did not receive an implant. These results from the first-of-its-kind study using RWE are published online in Current Medical Research and Opinion.

CRS causes severe symptoms, leading to patient discomfort, poor quality of life and added HCRU. While ESS can improve CRS symptoms, post-surgical scarring, adhesion formation and early polyp recurrence can compromise surgical outcomes. Intersect ENT's PROPEL sinus implants uniquely provide mechanical stenting of a patient's sinuses while providing localized delivery of the corticosteroid mometasone furoate directly to healing sinus tissue, features that have been shown previously to improve outcomes after sinus surgery.

The study examined claims, electronic medical records and other data from patients with CRS with or without nasal polyps who underwent ESS between 2014 and 2019 and had at least 18 months of data before and after surgery. Patients receiving PROPEL sinus implants (N = 1,983) were matched to patients who did not receive implants (N = 1,983). The matched cohorts were similar with respect to age, sex, race, year of surgery, and insurance type.

However, more patients in the implant cohort underwent surgery involving multiple sinuses than the non-implant cohort (94.8% vs. 85.1%), suggesting that patients in the implant cohort may have had greater disease severity than those in the non-implant cohort. Key study findings during the 18 months of post-surgical follow-up revealed that patients in the implant cohort compared to the non-implant cohort had a statistically significant reduction in: All-cause otolaryngologist visits (47.3% vs.

59.6%, p < 0.001); All-cause ER/urgent care visits (9.2% vs. 11.8%, p = 0.007); All-cause outpatient visits (94.3% vs. 96.6%, p < 0.001); Sinus-related endoscopies (39.1% vs.

43.8%, p = 0.003). Although not statistically significant, fewer patients in the implant cohort underwent repeat surgery compared to the non-PROPEL cohort (4.6% vs. 5.3%, p = 0.273).

It should be noted that RWE studies cannot definitively establish causality and are designed to evaluate associations. Study limitations included: no identification of the specific sinuses in which implants were placed, imaging studies were limited to sinus related procedures (it is possible that imaging was completed on non-CRS related sinus issues), a lack of medication data available to allow for a complete assessment of medications used to treat CRS patients, and incomplete data capture may have occurred during the study period.