Intersect ENT Reports Third Quarter 2016 Results

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, 2016.
  • Third quarter 2016 revenue was $18.5 million, representing a 30% increase over the third quarter 2015.
  • Third quarter 2016 gross margin was 85% compared to 80% in the third quarter 2015.

Key recent highlights include:
  • Reporting of positive topline results of the RESOLVE II clinical study. The study met both primary efficacy endpoints: reduction in nasal congestion and polyp burden. RESOLVE II, a 300-patient randomized, blinded, multi-center clinical trial, evaluated the placement of the investigational RESOLVE steroid releasing implant in the physician's office.
  • Submission of a supplemental premarket approval (PMA-s) application to the U.S. Food and Drug Administration (FDA) to seek approval for PROPEL ® Contour TM (formerly referred to as NOVA) steroid releasing implant for patients with chronic sinusitis.
  • Endorsement by the American Rhinologic Society (ARS) for the use of drug releasing implants, citing the volume of well-controlled studies supporting the use of implants that release steroids to the local tissues and highlighting the importance of reducing polyp burden and inflammation, which can result in delaying the time to revision surgery. The ARS also strongly stated its position that drug releasing implants are not investigational and should be made available to patients, when selected by the physician, in order to maximize outcomes.

"We are pleased to see the PROPEL ® products continuing to gain adoption, including expanded usage of PROPEL ® Mini following the recently approved frontal indication," stated Lisa Earnhardt, president and CEO of Intersect ENT. "In addition to our commercial products, we advanced our pipeline considerably this quarter with the submission of the PMA-s for PROPEL Contour and the successful conclusion of the RESOLVE II trial."

The company also noted that on November 1, 2016, the Centers for Medicare & Medicaid Services (CMS) released the 2017 Medicare Hospital Outpatient Final Rule, effective January 1, 2017, which implements a comprehensive ambulatory payment classification (APC) for upper airway procedures, including sinus surgery.

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