Intersect ENT Announces Results From the ASCEND Study of Company’s Investigational Drug-Coated Balloon for Sinus Dilation
Posted on October 07, 2019 by Medtech[y] Staff
The ASCEND study is the first prospective, randomized, double-blind, multi-center trial designed to assess the safety and efficacy of Intersect ENT’s drug-coated sinus balloon used to dilate the frontal sinus ostium. The investigational ASCEND product was randomized against an uncoated balloon control to evaluate whether it would reduce post-balloon dilation edema through localized steroid delivery directly to the dilated tissue. The primary endpoint was an intra-patient comparison of frontal sinus patency grade at day 30, as judged by an independent reviewer. Secondary endpoints were included to assess post-dilation inflammation, polypoid edema, scarring and the need for interventions such as oral steroids. As the first trial of its kind for this product platform, the company recognized that the outcomes of the ASCEND trial could require further clinical study to support PMA approval with the U.S. Food and Drug Administration.
The trial did not meet its primary endpoint of frontal sinus patency grade at day 30, as judged by an independent reviewer. However, the ASCEND drug-coated balloon showed statistically significant differences in several important secondary endpoints directly attributable to the drug, mometasone furoate. These endpoints included statistically significant reduction in inflammation and polypoid edema at all timepoints through day 30, as assessed by both the clinical investigators and the independent reviewer. There was also a statistically significant reduction in the need for oral steroid interventions at day 30, as determined by the independent reviewer. There were no adverse events related to the drug component of the ASCEND balloon, and no device-related serious adverse events observed in the study.
“An initial observation worth noting from the results of this study is the trend for the mometasone furoate to significantly minimize inflammation and edema at the site of dilation when delivered with the ASCEND drug-coated balloon as compared to the uncoated balloon,” said Boris Karanfilov, M.D., director of the Ohio Sinus Institute, who served as national principal investigator of the study. “We look forward to assessing the results of the study more extensively with our fellow clinical investigators and Intersect ENT.”
“The ASCEND trial gives us valuable insight into the performance of our novel drug-coated balloon, enabling us to refine our clinical and regulatory pathway. We are obviously disappointed that this initial trial did not demonstrate superiority in its primary endpoint. However, as in our prior clinical research with drug-eluting implants, we again observed benefits of providing localized drug delivery of mometasone furoate through combined drug-device offerings,” said Tom West, President and CEO of Intersect ENT. “We will continue to analyze the ASCEND study findings to inform our clinical and regulatory strategy. We remain committed to leading innovation with clinical evidence for the benefit of clinicians and patients with chronic sinusitis.”
About Intersect ENT
Intersect ENT® is dedicated to transforming ear, nose and throat care by providing innovative, clinically meaningful therapies to physicians and patients. 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.
The ASCEND drug-coated sinus balloon is an investigational product and is limited by federal law to investigational use only.
For additional information on the company or the products including risks and benefits please visit www.IntersectENT.com.
Intersect ENT is a registered trademark 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. 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 the company’s ability to procure and maintain required regulatory approvals for our products, and the adoption of the company’s therapies and products by physicians and patients, 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.