Study Builds on the Extensive Clinical Evidence for Steroid Releasing Sinus Implants
MENLO PARK, Calif.--(BUSINESS WIRE)--Nov. 2, 2017-- Intersect ENT, Inc. (NASDAQ: XENT) today announced a pivotal study publication of the second cohort of the prospective, randomized, blinded, multi-center PROGRESS study – a trial to assess the safety and efficacy of the company’s PROPEL® Contour steroid releasing sinus implant when placed in the frontal sinuses, which are located behind the forehead.
The study was published in the Journal of the American Medical Association – Otolaryngology-Head & Neck Surgery. The authors concluded that frontal sinus surgery followed by placement of PROPEL Contour significantly minimizes scarring and inflammation, reducing the need for post-operative surgical and medical interventions compared to standard frontal sinus surgery.
The study met its primary efficacy endpoint, demonstrating a previously reported statistically significant 65% relative reduction in the need for post-operative interventions, such as the need for additional surgical interventions or need for oral steroid prescription, compared to surgery alone. The implant’s placement success rate was 100% and there were no implant-related adverse events. There were three adverse events, which were judged by clinical investigators to have an ‘indeterminate’ relationship to the implant (headache, epistaxis and acute sinusitis).
“This study is the second randomized controlled trial to demonstrate the important benefits of steroid releasing implants in the treatment of frontal sinus disease,” said Amber Luong, M.D., Ph.D., Department of Otolaryngology – Head and Neck Surgery, at the McGovern Medical School at the University of Texas Health Science Center, in Houston, Texas, and lead author of the study. “This data provides clear evidence that the use of PROPEL Contour offers improved clinical outcomes for patients, reducing the need for post-operative intervention including oral steroids, which can have significant side effects.”
Approved by the U.S. Food and Drug Administration (FDA) in February 2017, PROPEL Contour features an innovative hourglass design that facilitates treatment of patients with chronic sinusitis in the frontal (behind the forehead) and maxillary (behind the cheeks) sinuses. The latest in the PROPEL family of steroid releasing sinus implants, PROPEL Contour is specifically designed to conform to the sinus ostia (openings), focusing drug delivery and mechanical support where it is needed in order to maximize sinus surgery outcomes. The implant features a low-profile flexible delivery system to access tight areas of the sinus anatomy.
“PROPEL Contour, our third product in the PROPEL family, has been an important new addition for ENTs managing chronic sinusitis patients following frontal or maxillary sinus surgery,” said Lisa Earnhardt, president and CEO, Intersect ENT. “The PROPEL line has been studied extensively, with data from more than 350 patients enrolled in prospective studies contributing to a strong foundation of clinical evidence supporting its use. We are pleased with the positive reception of the PROPEL Contour device to date, and we look forward to expanding its use among ENTs as additional physicians experience firsthand improved outcomes for patients undergoing frontal sinus surgery.”
About PROPEL® Steroid Releasing Sinus Implants
Intersect ENT’s PROPEL products are the first and only dissolvable steroid releasing sinus implants approved by the FDA. Clinically proven to improve outcomes for chronic sinusitis patients following sinus surgery, PROPEL sinus implants mechanically prop open the sinuses and release mometasone furoate, an advanced corticosteroid with anti-inflammatory properties, directly into the sinus lining then dissolve. PROPEL’s safety and effectiveness for use in ethmoid sinuses is supported by Level 1-A clinical evidence from multiple clinical trials, which demonstrates that PROPEL implants reduce inflammation and scarring after surgery, thereby lessening the need for post-operative oral steroids and repeat surgical interventions. PROPEL is indicated for the ethmoid sinus; PROPEL Mini is indicted for the ethmoid and frontal sinuses; and PROPEL Contour is indicated for the frontal and maxillary sinuses.
About PROPEL® Contour Steroid Releasing Sinus Implant
PROPEL Contour represents the newest addition to the PROPEL family of dissolvable steroid releasing implants, clinically proven to improve results of frontal sinus surgery. With its unique hourglass shape, PROPEL Contour conforms to sinus ostia, propping sinuses open while delivering anti-inflammatory medication when placed in the operating room or sinus dilation in the physician’s office. PROPEL Contour’s low-profile design allows for placement in smaller sinus openings, like those of the frontal and maxillary sinuses, expanding the applicable patient population for steroid releasing implants.
About Intersect ENT®
Intersect ENT is dedicated to transforming the landscape of care for patients with ear, nose and throat conditions. The company’s PROPEL family of dissolvable steroid releasing implants are clinically proven to improve outcomes for chronic sinusitis patients following sinus surgery. 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.
For additional information on the company or the products including risks and benefits please visit www.IntersectENT.com.
Intersect ENT® and PROPEL® 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. These forward-looking statements include, but are not limited to, the expansion of adoption of our sinus implants by clinical practitioners, and improved outcomes for patients undergoing frontal sinus surgery. 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 development of competitive products, completion and success of FDA submissions, physician acceptance of our products and therapies, reimbursement coverage and cost effectiveness of our products, 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, 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.
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Source: Intersect ENT, Inc.
Intersect ENT, Inc.
Nicole Osmer, 650-454-0504
Jeri Hilleman, 650-641-2105