MENLO PARK, Calif., Sept. 17, 2014 (GLOBE NEWSWIRE) -- Intersect ENT, Inc. (Nasdaq:XENT), a company dedicated to improving the quality of life for patients with ear, nose and throat conditions, today announced the enrollment of the first patient in PROGRESS, a prospective, randomized, blinded, multi-center trial to assess the safety and efficacy of the PROPEL® mini steroid eluting sinus implant to treat patients with frontal sinusitis.
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. As many as one in four patients undergoing surgery for chronic sinusitis suffers from frontal sinus disease.
"Better treatments are needed for patients with frontal sinus disease, which contributes greatly to the debilitating symptoms of chronic sinusitis, including severe headaches," 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. "The PROGRESS study is an important step in evaluating the benefit that PROPEL mini's spacing and local drug delivery can provide in improving outcomes for patients undergoing surgery of the frontal sinus, which is one of the more difficult sinuses to treat."
The bioabsorbable PROPEL mini implant is used in conjunction with sinus surgery to maintain the surgically opened sinus and deliver mometasone furoate, an advanced steroid with anti-inflammatory properties, directly into the sinus lining over 30 days. Use of PROPEL maintains the open passages created during ethmoid surgery, reducing the need for oral steroids and additional surgical procedures.
"Enrollment of the first patient in the PROGRESS study is an exciting milestone, and the first step toward broadening access to sustained local steroid delivery to even more patients suffering from chronic sinusitis," said Lisa Earnhardt, president and CEO, Intersect ENT.
The Company plans to enroll approximately 80 patients in the study using an intra-patient control design to assess both safety and efficacy of PROPEL mini when placed following surgery of the frontal sinus, versus surgery alone. The primary efficacy endpoint is the reduction in need for post-operative interventions such as the need for additional surgery and oral steroids.
About PROPEL and PROPEL mini
Intersect ENT's PROPEL and PROPEL mini are the first and only drug-eluting 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 drug-eluting implants, PROPEL and PROPEL mini, clinically proven to improve surgical outcomes for patients with chronic sinusitis. In addition, Intersect ENT is developing new drug-eluting 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.
Forward-Looking Statements
The statements in this press release regarding the Company's plans to enroll approximately 80 patients and that PROPEL mini may be used to treat patients suffering from chronic sinusitis in the frontal sinus are forward-looking statements. 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 effects of PROPEL and PROPEL mini relative to alternative treatments may not be as Intersect ENT expects, the development of competitive products, the uncertain timing of completion of and the success of clinical trials, market competition, as well as other risks detailed from time to time in Intersect ENT's filings with the Securities and Exchange Commission, including its prospectus filed with the SEC on July 24, 2014 and 10-Q filed September 4, 2014. 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.