Intersect ENT (NSDQ:XENT) said Tuesday it submitted a supplemental premarket approval application to the FDA to expand the indication on its Propel mini steroid releasing implant to cover frontal sinus surgeries.
The new indication would allow the drug-device combo to be used in the frontal sinuses, located behind the eyebrows, the Menlo Park, Calif.-based company said.
“This is an exciting milestone for Intersect ENT. More than 75,000 patients have benefitted from Propel to date and we look forward to broadening access to sustained local steroid delivery to more patients suffering from chronic sinusitis,” CEO Lisa Earnhardt said in prepared remarks.
Currently, the Propel is only indicated for placement in the ethmoid sinuses located just behind the bridge of the nose.
Earlier this week, Intersect ENT said results from 3 clinical studies of its Propel, Resolve and Nova products showed positive results. Data from the studies was presented at the American Rhinologic Society’s annual meeting in Dallas.
Each of the studies evaluated steroid releasing sinus implants placed in minimally invasive in-office procedures to reduce inflammation for patients with chronic sinusitis, the Menlo Park, Calif.-based company said.
A 20-patient study of patient-reported and endoscopic outcomes for patients treated with the company’s Propel drug-releasing implant showed a significant improvement in patient systems over 4 weeks, sustained through 12 weeks, the company said. Significant reductions in ethmoid sinus inflammation were also reported.