- Published: 29 September 2015
- Written by Editor
Intersect ENT Announces FDA Submission to Seek Expanded Indication of PROPEL Mini Steroid Releasing Implant to Treat Patients With Frontal Sinus Disease
MENLO PARK, Calif.-- Intersect ENT, Inc. (Nasdaq:XENT), a company dedicated to improving the quality of life for patients with ear, nose and throat conditions, today announced that the company has submitted a supplemental premarket approval (PMA-s) submission to the U.S. Food and Drug Administration (FDA) to seek approval to expand the indication of the PROPEL® mini steroid releasing sinus implant to the treatment of patients undergoing frontal sinus surgery.
An expanded indication would allow Intersect ENT to market placement of PROPEL mini in the frontal sinuses, which are located behind the eyebrows. PROPEL mini is currently indicated for placement in the ethmoid sinuses, located just behind the bridge of the nose.
At least one in four of the over 500,000 patients undergoing surgery for chronic sinusitis suffers from frontal sinus disease. The condition contributes greatly to the debilitating symptoms of chronic sinusitis, including severe headaches, and is known to be the most difficult sinus to manage.
“This is an exciting milestone for Intersect ENT,” said Lisa Earnhardt, president and CEO, Intersect ENT. “More than 75,000 patients have benefitted from PROPEL to date and we look forward to broadening access to sustained local steroid delivery to more patients suffering from chronic sinusitis.”
Last month, Intersect ENT announced preliminary results of PROGRESS, a prospective, randomized, blinded, multi-center trial to assess the safety and efficacy of PROPEL mini when used following frontal sinus surgery. The study met its primary efficacy endpoint, demonstrating a statistically significant 38% relative reduction in the need for post-operative interventions, such as the need for additional surgical procedures or need for oral steroid prescription, compared to surgery alone. The device placement success rate was 100% and there were no device-related adverse events.
About Intersect ENT
Intersect ENT, Inc. is dedicated to improving the quality of life for patients with ear, nose and throat conditions. The company markets two steroid releasing implants, PROPEL and PROPEL mini, clinically proven to improve surgical outcomes for patients with chronic sinusitis undergoing ethmoid sinus surgery. In addition, Intersect ENT is developing new steroid releasing implants designed to provide ENT physicians with even more customized options to treat patients with chronic sinusitis less invasively and more cost effectively. Chronic sinusitis is an inflammatory condition leading to debilitating symptoms and chronic infections, and is one of the most costly conditions to U.S. employers.
For additional information on the company or the products including risks and benefits please visit www.intersectENT.com.
The statements in this press release regarding the potential expanded indication for PROPEL® mini and the ability for Intersect ENT to broaden access to its products by patients with chronic sinusitis are "forward-looking" statements. These forward-looking statements are based on Intersect ENT's current expectations and inherently involve significant risks and uncertainties. These statements include those related to the review of data by and timing for approval by the FDA as well as the rate of patient adoption for Intersect ENT’s products, if approved. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, which include, without limitation, the performance of PROPEL and PROPEL mini, the development of competitive products, the uncertain timing of completion of and the success of clinical trials and market competition. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Intersect ENT’s filings on Form 10-K, Form 10-Q and the company's other filings with the Securities and Exchange Commission (SEC) 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.
Nicole Osmer, 650-454-0504
Jeri Hilleman, 650-641-2105