HomeIH InterestsOptinose Receives FDA Approval & Plans IPO

Optinose Receives FDA Approval & Plans IPO

Optinose received FDA approval for their EXHANCE device for the treatment of nasal polyps and their symptoms, a condition that may affect up to 10 million adults. The product utilizes the company’s novel Exhalation Delivery System (EDS) to deliver a steroid (fluticasone propionate) deep into the nose. The unique design requires the patient to actuate the pump spray into one nostril while simultaneously blowing into the mouthpiece of the device.

The development program for XHANCE included five clinical trials evaluating over 1,500 adult patients, including two randomized, double-blinded, placebo-controlled Phase 3 pivotal trials in adults with nasal polyps (NAVIGATE 1 and NAVIGATE 2) and two open-label Phase 3 clinical trials in adults with chronic sinusitis with and without nasal polyps (XHANCE-12 and XHANCE-3). In their last release of data from NAVIGATE II, the company delivered positive results including reduction in the co-primary endpoints of nasal congestion/obstruction and endoscopically measured total polyp grade. Further, XHANCE-12 showed improvement in patient-reported symptoms.

On the heels of FDA approval comes the announcement that Optinose plans to join fellow ENT and sinusitis companies Intersect ENT and Entellus on the public markets. Optinose seeks to raise $100 million in an IPO, which the company will use to fund the launch of XHANCE in 2Q:2018, to run a pediatric study on the use of the device and for general working purposes.