Intersect ENT Announces Completion Of Enrollment In RESOLVE II Clinical Trial Of New In-Office Implant For Recurrent Chronic Sinusitis

Company Also Announces Publication of Positive Six-Month Results from RESOLVE Clinical Trial

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:

“We are pleased with the positive results from the RESOLVE study, and that we’ve completed enrollment of the RESOLVE II pivotal study ahead of schedule”

• Completion of enrollment in RESOLVE II, the second of two Phase III clinical studies to support U.S. Food and Drug Administration (FDA) approval of the company’s investigational RESOLVE steroid-releasing implant; and
• Publication of long-term clinical data from RESOLVE, the initial Phase III study of the product, in the International Forum of Allergy and Rhinology.

RESOLVE and RESOLVE II are both prospective, randomized, blinded, multi-center clinical trials conducted to study the use of the company’s investigational RESOLVE steroid-releasing implant, placed during a routine physician office visit. The RESOLVE implant is designed to be a less-invasive alternative to treat patients with recurrent sinus obstruction, typically due to polyps, that would otherwise warrant revision surgery. The RESOLVE implant is designed to reduce inflammation by releasing mometasone furoate, an advanced steroid with anti-inflammatory properties, directly into the sinus lining.

RESOLVE II is the final planned clinical trial to support the FDA approval of the RESOLVE steroid-releasing implant. The study enrolled 300 patients at 34 U.S. centers. Robert Kern, M.D., of Northwestern University and Pablo Stolovitzky, M.D., of ENT of Georgia serve as co-principal investigators of the study. Study endpoints include assessment of both patient-reported symptoms and objective endoscopic outcomes. Intersect ENT expects to announce preliminary topline data from RESOLVE II in the fourth quarter of 2016, following completion of the blinded treatment period.

Long-term data from RESOLVE, the initial Phase III clinical study of the product, was published in the International Forum of Allergy and Rhinology journal. The RESOLVE study demonstrated 100% implant placement success and no implant related serious adverse events. Through six-month follow-up, treated patients experienced statistically significant improvement in symptom scores, ethmoid sinus obstruction and polyp grade, compared to control patients. In addition, control patients were at 3.6 times higher risk of remaining indicated for revision sinus surgery than treated patients.

“We are pleased with the positive results from the RESOLVE study, and that we’ve completed enrollment of the RESOLVE II pivotal study ahead of schedule,” said Lisa Earnhardt, president and CEO of Intersect ENT. “We look forward to completing patient follow-up for RESOLVE II and seeking FDA approval of the product.”

ABOUT RESOLVE

The investigational RESOLVE steroid-releasing implant is designed to be placed during a routine physician office visit to provide a less invasive treatment option for patients with recurrent ethmoid sinus obstruction, typically due to polyps, that would otherwise warrant revision surgery. RESOLVE implant releases mometasone furoate directly into the sinus lining to target inflammation directly. It was designed with greater radial strength than the PROPEL products in order to dilate an obstructed sinus and releases steroid over a longer period of time to reduce inflammation. The RESOLVE implant is investigational and is not available for commercial use.

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, which have been clinically proven to improve surgical outcomes for chronic sinusitis patients undergoing sinus surgery. In addition, Intersect ENT is developing a pipeline of steroid-releasing implants designed to provide ENT physicians with options to treat patients across the continuum of care for chronic sinusitis less invasively and more cost effectively. Chronic sinusitis is an inflammatory condition that can lead 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.

INTERSECT ENT^® and PROPEL^® are registered trademarks of Intersect ENT, Inc.

Forward-Looking Statements

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 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, that the short-term and long-term effects of the investigational product relative to alternative treatments may not be as Intersect ENT expects, the development of competitive products, the uncertain timing of the completion and success of clinical trials, physician acceptance of our products and therapies, reimbursement coverage of our products, 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 most recent filings on Form 10-K, Form 10-Q and other SEC filings 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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