The propel device is a small steroid releasing implant designed to improve surgical outcomes for patients with chronic sinusitis undergoing ethmoid sinus surgery.
“We believe that the robust clinical evidence supporting Propel was key to this favorable decision, which we received on the 1st application round. While our focus as a company is very much on U.S. commercialization as well as development of our pipeline products, this represents an important step in our efforts to build a foundation for international expansion over the coming years,” CEO Lisa Earnhardt said in a press release.
The company said the German Institute assigned Neue Untersuchungs und Behandlungsmethoden status 1 for its Propel mometasone furoate implants. The NUB Status 1allows for the introduction of new medical products by allowing a limited number of hospitals to receive reimbursement for them.
In October, Intersect ENT said 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.
Currently, the Propel is only indicated for placement in the ethmoid sinuses located just behind the bridge of the nose.