Intersect ENT Announces Positive Clinical Results From Pivotal Study Of Newest Steroid Releasing Sinus Implant

New Device May Broaden Patient Population for Steroid Releasing Implants

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 results of the second cohort of the PROGRESS study. The second cohort of PROGRESS is a prospective, randomized, blinded, multi-center trial to assess the safety and efficacy of the company’s investigational NOVA bioabsorbable steroid releasing sinus implant.

“This is the second randomized controlled study to demonstrate the benefit of steroid releasing implants in the treatment of frontal sinus disease.”

The NOVA implant is designed to support the sinus opening mechanically while delivering anti-inflammatory medication following surgical interventions such as sinus surgery in the operating room or in-office sinus dilation. NOVA’s unique hourglass shape and lower profile is designed to allow for placement in smaller sinus openings, and may expand the applicable patient population for steroid releasing implants.

The NOVA cohort of the PROGRESS study is a prospective, randomized, blinded, multi-center trial of 80 patients designed to assess implant safety and efficacy when placed in the frontal sinuses, which are located behind the forehead. The study met its primary efficacy endpoint, demonstrating a statistically significant 65% 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.

“The positive results of the PROGRESS NOVA study are exciting for patients with frontal sinus disease as the condition can be challenging to manage due to the potential for restenosis,” said Amber U. Luong, M.D., Ph.D., associate professor in the department of Otorhinolaryngology at the University of Texas at Austin, who serves as the principal investigator of the study. “This is the second randomized controlled study to demonstrate the benefit of steroid releasing implants in the treatment of frontal sinus disease.”

“Intersect ENT’s mission is to address unmet needs for chronic sinusitis patients across the continuum of care. The positive outcomes from PROGRESS NOVA bring us another step closer to providing access to steroid releasing sinus implants to more patients on this continuum,” said Lisa Earnhardt, president and CEO, Intersect ENT. “Our next step will be to compile and submit the results in a premarket approval supplement (PMA-s) filing to the FDA in the fall.”

ABOUT NOVA

The investigational NOVA steroid releasing implant is designed to prop sinuses open mechanically while delivering anti-inflammatory medication following surgical interventions, such as sinus surgery in the operating room or sinus dilation in the physician’s office. NOVA’s unique hourglass shape and lower profile is designed for placement in the smaller sinus openings, which may expand the applicable patient population for steroid releasing implants. NOVA is an investigational device and is not available for sale in the United States.

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

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 NOVA, PROPEL and PROPEL mini, our ability to receive and maintain FDA approval of our devices, the development of competitive products, the uncertain timing of completion of and the success of clinical trials, and physician adoption of our products. 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.

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