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These early results reinforce our expectation that the frontal indication will drive incremental business, both among our current PROPEL users, as well as among those who had not yet found a well for PROPEL in their practice. We estimate that approximately 25% to 30% of all FESS procedures in the US involve the frontal sinus, or about 150,000 cases a year. Shifting to our pipeline, our products provide a less invasive, potentially more cost effective solutions for chronic sinusitis sufferers, with our two pipeline products enabling treatment to the physician’s office. We submitted the nova PMA supplement to the FDA late July, a bit ahead of schedule, and continue to expect FDA approval by mid-2017. In anticipation of that approval and launch, we have branded the NOVA product PROPEL Contour. This product, which delivers the same amount of drug as PROPEL and PROPEL Mini, rounds out the PROPEL family of products. Contour is similarly backed by a high level of clinical evidence, included an 80-patient randomized blinded trial that met its primary efficacy endpoint, demonstrating a statistically significant, 65% relative reduction in the need for postoperative intervention. PROPEL Contour has a unique hourglass shape and lower profile, designed specifically to allow for placement in smaller or more difficult to access sinus openings. We expect that Contour will facilitate use by ENT physicians, both in the OR, as well as in the office, especially following balloon dilation. While physicians may choose between Mini or Contour in some procedures, we believe that offering physicians a choice of size and shape to accommodate the wide variety of patient anatomy, will ultimately lead to broader overall usage.
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