MENLO PARK, Calif.--(BUSINESS WIRE)--Intersect ENT, Inc. (Nasdaq:XENT), a company dedicated to improving the quality of life for patients with ear, nose and throat conditions, today announced preliminary results of PROGRESS, a prospective, randomized, blinded, multi-center trial to assess the safety and efficacy of the PROPEL® mini steroid releasing sinus implant 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.
“Frontal sinus disease contributes greatly to the debilitating symptoms of chronic sinusitis, including severe headaches, and is known to be the most difficult sinus to manage,” said Tim Smith, M.D., M.P.H., F.A.C.S, of Oregon Health and Science University, who serves as the principal investigator of the study. “These results offer an exciting prospect for this group of patients.”
As many as one in four patients undergoing surgery for chronic sinusitis suffers from frontal sinus disease. The trial is intended to support an expanded indication for 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.
“We are pleased with the positive outcomes from PROGRESS, which bring us another step closer to broadening access to sustained local steroid delivery to more patients suffering from chronic sinusitis,” said Lisa Earnhardt, president and CEO, Intersect ENT. “Our next step will be to compile and submit the results to the FDA this year.”
About PROPEL and PROPEL mini
Intersect ENT’s PROPEL and PROPEL mini are the first and only steroid releasing sinus implants approved by the FDA for use in patients following ethmoid sinus surgery. The products release mometasone furoate, an advanced steroid with anti-inflammatory properties, directly into the sinus lining, then dissolve. Use of PROPEL maintains the open passages created in surgery, reducing the need for oral steroids and additional surgical procedures. PROPEL’s effectiveness is supported by the highest level of clinical evidence, Level 1a, showing reduction of postoperative intervention, inflammation, scarring, and need for oral steroids in post-operative patients.
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 Intersect ENT's continued growth 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 potential surgical outcomes for patients with chronic sinusitis and the timing of any submission of data to the FDA. 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.