The Propel device is already approved for use in the ethmoid sinuses, behind the bridge of the nose, in conjunction with sinus surgery to treat symptoms of chronic sinusitis, the company said.
The device met its primary efficacy endpoint with a 38% relative reduction in the need for post-operative interventions; device placement was successful in 100% of patients with no device-related adverse events, Intersect ENT said.
“Frontal sinus disease contributes greatly to the debilitating symptoms of chronic sinusitis, including severe headaches, and is known to be the most difficult sinus to manage. These results offer an exciting prospect for this group of patients,” principal investigator Dr. Tim Smith of Oregon Health & Science University said in a press release.
The trial is intended to support an expanded indication for Propel for use in the frontal sinuses located behind the eyebrows, the company said. Intersect ENT said it plans to submit an application for the expanded indication this year.
“We are pleased with the positive outcomes from Progress, which bring us another step closer to broadening access to sustained local steroid delivery to more patients suffering from chronic sinusitis. Our next step will be to compile and submit the results to the FDA this year,” CEO Lisa Earnhardt said in prepared remarks.
According to a letter from Leerink Partner investor Richard Newitter, the Propel mini is already being used off-label for frontal sinus surgeries, and an official indication for the procedure could boost adoption of the device.
Newitter said he estimated a 4-5% penetration of the frontal functional endoscopic sinus surgery market in the 1st year post-approval, or around $1-1.5 million in revenue per quarter with the new indication. Newitter added that the firm believes reimbursement through Medicare will be crucial to in-office adoption.
Shares haven’t budged on the news, however, moving less than 1¢ as of mid-day trading today.