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Intersect Ent Reports Third Quarter 2015 Results

The following excerpt is from the company's SEC filing.

Revenue Increased 56% Year over Year and Gross Margin at 80%

MENLO PARK, Calif. Intersect ENT, Inc. (NASDAQ:XENT), a company dedicated to improving the quality of life for patients with ear, nose and throat conditions, today reported financial results for the third quarter ended September 30, 2015.

Recent Highlights

Achieved third quarter revenue of $14.2 million, an increase of 56% over the third quarter 2014.

Realized third quarter gross margin of 80% compared to 72% in the third quarter 2014.

Submitted a premarket approval supplement to the U.S. Food and Drug Administra tion to seek approval to expand the indication of the PROPEL

mini steroid releasing implant to the treatment of patients following frontal sinus surgery. The company reported preliminary results for the 80 patients in the PROPEL mini cohort of the PROGRESS study showing that the study met its primary efficacy endpoint, demonstrating a statistically significant 38% relative reduction in the need for post-operative interventions such as 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.

Initiated enrollment of the second cohort of 80 patients in the PROGRESS study evaluating NOVA, an investigational bioabsorbable steroid releasing implant. This study is a prospective, randomized blinded multicenter trial to assess the safety and efficacy of NOVA when used following frontal sinus surgery.

Continued enrollment of patients in RESOLVE II, a 300-patient pivotal Phase III clinical study of the RESOLVE investigational steroid releasing implant designed to treat patients with recurrent sinus obstruction in the office setting.

Reported positive clinical results from three studies evaluating steroid releasing implants placed in the physicians office, including long-term results from a study evaluating office-based treatment with RESOLVE, a study assessing patient-reported and endoscopic outcomes after placement of the PROPEL steroid releasing implant following sinus surgery during a post-operative office visit, and three-month results from the EXCEED study evaluating NOVA.

Our progress this year demonstrates the value we are delivering to chronic sinusitis patients through PROPELs proven ability to improve surgical outcomes, stated Lisa Earnhardt, president and CEO of...