Intersect ENT, Inc. (Nasdaq: XENT), a global ear, nose and throat (“ENT”) medical technology leader dedicated to transforming patient care, today announced that it began the process of initiating the Company’s EXPAND Clinical Study by successfully registering on ClinicalTrials.gov (NCT04858802).
EXPAND is a prospective, randomized, single-blind, intra-patient controlled, post-market clinical trial enrolling approximately 80 patients in the United States.
The EXPAND study’s primary objective is to evaluate the efficacy of the Company’s PROPEL® Contour (mometasone furoate) sinus implant when placed in the frontal sinus ostium following in-office balloon dilation in patients with chronic rhinosinusitis (CRS) as compared to balloon sinus dilation alone. Patients will be assessed at various intervals throughout the study with a final follow-up at 6 months.
Consistent with the Company’s strategic initiative to drive more procedural growth into the office site of care, the EXPAND trial will focus on the clinical benefits of the PROPEL Contour implant in reducing inflammation and maintaining patency following sinus surgery when used in combination with balloon sinus dilation in patients suffering from CRS. There are approximately 150,000 balloon sinus dilation procedures performed annually in the United States with a substantial number of these procedures treating the frontal sinus ostia in ENT surgeons’ offices. In addition to near-term study claims, positive EXPAND results could also provide a pathway for the Company to consider additional clinical studies demonstrating the durability of outcomes to support label expansion and the collection of valuable health economic evidence for the use of PROPEL Contour in conjunction with balloon sinus dilation procedures.
“In our PROPEL Contour PROGRESS trial we observed a cohort of patients that received balloon dilation and PROPEL Contour resulting in a larger frontal sinus ostia opening versus the control group without PROPEL at day 30,” states Thomas A. West, President and CEO of Intersect ENT. “With the launch of our VenSure® sinus balloon following the acquisition of Fiagon AG, we would like to expand the number of patients examined and further solidify the benefit of PROPEL Contour post-sinus balloon dilation.” The Company anticipates enrollment to begin in the EXPAND trial in May 2021 and targets completion of enrollment by year-end with results in 2022.
The PROPEL Contour Steroid Releasing Sinus Implant
The PROPEL Contour sinus implant is intended to maintain patency of the frontal and maxillary sinus ostia and locally deliver steroid to the sinus mucosa in patients ≥18 years of age following sinus surgery. Contraindications include patients with confirmed hypersensitivity or intolerance to mometasone furoate (MF) or hypersensitivity to bioabsorbable polymers. Safety and effectiveness of the implant in pregnant or nursing females have not been studied. Risks may include, but are not limited to, pain/pressure, displacement of the implant, possible side effects of intranasal MF, sinusitis, epistaxis, and infection. For full prescribing information see IFU at www.IntersectENT.com/technologies/. Rx only.