Intersect ENT Announces Publication of Pooled Analysis of Steroid Releasing Implants in Patients Following Frontal Sinus Surgery
MENLO PARK, Calif.--(BUSINESS WIRE)--Nov 15, 2018--Intersect ENT, Inc. (NASDAQ: XENT), a company dedicated to transforming care for patients with ear, nose and throat conditions, today announced publication of a pooled analysis in the , the official journal of the American Rhinologic Society, of the company’s PROPEL ® Contour and PROPEL ® Mini steroid releasing sinus implants showing improved outcomes of frontal sinus surgery.
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The analysis included a total of 160 patients enrolled in two clinical trial cohorts. Patients were randomized following sinus surgery to receive an implant in one frontal sinus ostium with the contralateral ostium as control.
The pooled analysis showed that the PROPEL frontal steroid releasing implants significantly improve endoscopic outcomes of frontal sinus surgery compared to surgery alone. The use of implants resulted in a relative reduction in the need for postoperative interventions of 46.8% at Day 30. A significant reduction in postoperative interventions was also observed at Day 90. There were no implant-related adverse events.
“Frontal sinus surgery in patients with chronic rhinosinusitis has historically been associated with poorer outcomes than that of the other paranasal sinuses” said Ameet Singh, M.D., Division of Otolaryngology at George Washington University Medical Center and lead author of the study. “This analysis provides important insights into outcomes in various patient subgroups and also demonstrates that PROPEL implants improve the outcomes of frontal sinus surgery by reducing the need for post-operative interventions through 90 days.”
Placed following endoscopic sinus surgery, the PROPEL family of implants is designed to maintain the surgical opening and prop open the sinus ostia while delivering drug directly to the sinus lining as the implant dissolves.
“We are very pleased to see the positive findings of this study added to the robust pool of clinical evidence supporting our steroid releasing implants,” said Lisa Earnhardt, president and CEO, Intersect ENT. “We’re delighted that the PROPEL family of implants continues to be a strong, evidence-based option for ENTs seeking improved outcomes for patients following 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 ethmoid sinus surgery, thereby lessening the need for post-operative oral steroids and repeat surgical interventions. PROPEL is indicated for the ethmoid sinus; PROPEL Mini is indicated for the ethmoid and frontal sinuses; and PROPEL Contour is indicated for the frontal and maxillary sinuses.
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.
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.
IMPORTANT SAFETY INFORMATION FOR THE PROPEL ® FAMILY OF SINUS IMPLANTS
The PROPEL sinus implants are intended for use following sinus surgery to maintain the sinus openings and to locally deliver a drug to the sinuses: PROPEL for use in the ethmoid sinus, PROPEL Mini for use in the ethmoid sinus and frontal sinus opening and PROPEL Contour for use in the frontal and maxillary sinus openings. The products are intended for use in patients ≥18 years of age.
IMPORTANT SAFETY INFORMATION
These products are not intended for people who are allergic to the drug (mometasone furoate) or to certain 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, movement of the implant (within or out of the sinus), possible side effects of the drug, infection, and nose bleed. For more information on the risks and benefits of PROPEL sinus implants, please talk to your doctor. The FDA approved labeling can be found at www.IntersectENT.com. Rx only.
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 statements include those related to the safety, efficacy and patient and physician adoption of the PROPEL family of steroid releasing sinus implants. These forward-looking statements are based on the pooled analysis discussed above and 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 replicate the studied results, the company’s ability to procure and maintain required regulatory approvals for our products and the adoption of the company’s therapies 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.
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KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA
INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY CLINICAL TRIALS MEDICAL DEVICES PHARMACEUTICAL RESEARCH SCIENCE
SOURCE: Intersect ENT, Inc.
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PUB: 11/15/2018 04:06 PM/DISC: 11/15/2018 04:06 PM