MENLO PARK, Calif., Oct. 8, 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 publication of positive data from three studies evaluating the company's drug eluting sinus implants. All were published in the International Forum of Allergy & Rhinology, the official journal of the American Rhinologic Society.
The first paper describes a 20-patient prospective clinical case series evaluating the use of the PROPEL® steroid eluting sinus implant when placed in the ethmoid sinus within seven days following sinus surgery. The study demonstrated that placement of the device in the physician's office during a routine post-operative visit was feasible and resulted in patient benefit. As with previous studies in which the implants were placed in the operating room immediately following sinus surgery, use of PROPEL demonstrated significant reductions from baseline in sinus inflammation and symptom scores. In addition, PROPEL was well tolerated, with 90% of patients very satisfied with the overall experience.
"Steroid-eluting sinus implants represent a new frontier in the treatment of patients suffering from chronic sinusitis, who need new options to ensure long-term success following sinus surgery," said Keith Matheny, M.D., Collin County Ear, Nose, and Throat in Frisco, Texas. "In previous studies, placement of PROPEL immediately following sinus surgery resulted in reduction of post-operative interventions, inflammation, scarring, and reduced need for oral steroids during the recovery period. This case series shows that use of PROPEL in the days following sinus surgery leads to similar improvements in surgical outcomes in patients who, for whatever reason, are not treated with PROPEL during the initial surgery."
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 sinus surgery. The products release mometasone furoate, an advanced steroid with anti-inflammatory properties, directly into the sinus lining, then dissolve, to maintain the open passages created in surgery.
The second paper describes results from the prospective, randomized, blinded, multi-center RESOLVE clinical trial. These results were announced and presented last month at the annual American Rhinologic Society meeting in Orlando, Fla., where they were recognized with the society's Cottle Award for Best Clinical Science Research.
Intersect ENT's investigational RESOLVE steroid eluting implant was designed to be placed during a routine physician office visit as an alternative to current treatment options for patients who have previously had sinus surgery yet return to the ENT physician with symptoms of recurrent sinus obstruction. Like the company's commercially available PROPEL and PROPEL mini implants used to improve surgical outcomes following sinus surgery, the RESOLVE product releases mometasone furoate directly into the sinus lining to reduce inflammation. The RESOLVE product has more radial strength than the PROPEL products in order to dilate the obstructed sinus, and releases the steroid over a longer period of time.
Finally, results were published from a prospective single-center pharmacokinetic study designed to assess systemic safety of the company's investigational RESOLVE steroid eluting implant. The implant placement success rate was 100%. There was negligible systemic exposure to mometasone furoate delivered by the implant, and no adrenal suppression nor serious adverse events.
"We are pleased with the positive results from these studies, which continue to build upon the solid foundation of clinical evidence supporting the benefits of our technology for patients with chronic sinusitis," said Lisa Earnhardt, president and CEO, Intersect ENT.
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 undergoing ethmoid sinus surgery. 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.
The statements in this press release that the in-office steroid delivery implant may be used to treat recurrent sinusitis and that the implant may be further developed and approved by the FDA 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 short-term and long-term effects of PROPEL and PROPEL mini and the investigational RESOLVE drug eluting sinus implant 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.
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