Study Initiates with Registration on ClinicalTrials.gov
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
“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
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®
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
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
Executive Vice-President & CFO