MENLO PARK, Calif.--(BUSINESS WIRE)--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.
About Intersect ENT®
Intersect ENT is a global ear, nose and throat medical technology leader dedicated to transforming patient care. The Company’s steroid releasing implants are designed to provide mechanical spacing and deliver targeted therapy to the site of disease. In addition, Intersect ENT is continuing to expand its portfolio of products based on the Company’s unique localized steroid releasing technology and is committed to broadening patient access to less invasive and more cost-effective care. In October 2020, Intersect ENT acquired Fiagon AG Medical Technologies, a global leader in electromagnetic surgical navigation solutions with an expansive portfolio of ENT product offerings, including the VENSURE sinus dilation balloon, that complement the Company’s PROPEL® and SINUVA® sinus implants and extend its geographic reach.
For additional information on the Company or the products including risks and benefits please visit www.IntersectENT.com. For more information about PROPEL® (mometasone furoate) sinus implants, please visit www.PROPELOPENS.com.
Intersect ENT®, PROPEL® and are registered trademarks of Intersect ENT, Inc.
This release contains forward-looking statements within the meaning of Sections 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. We may, in some cases, use terms such as “look forward,” confident,” “promises,” “predicts,” “believe,” “potential,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements should not be read as a guarantee of future performance or results and may not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. These forward-looking statements are based on Intersect ENT’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation those related to the safety, efficacy and patient and physician adoption of the Company’s products and therapies, the ability to obtain and maintain reimbursement codes for its products, the Company’s ability to procure and maintain required regulatory approvals for our products, the Company’s ability to grow and expand its business, as well as other risks detailed from time to time in Intersect ENT’s filings with the Securities and Exchange Commission (SEC), including Intersect ENT’s filings on Form 10-K and Form 10-Q available at the SEC's Internet site (www.sec.gov). Intersect ENT does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.
Source: Intersect ENT, Inc.