Intersect ENT (NSDQ:XENT) launched its steroid-releasing sinus implant, Sinuva, in the U.S. today. The company’s drug-eluting device is designed to treat nasal polyp disease in patients who have undergone previous sinus surgery.
Sinuva is placed during a routine doctor’s office visit and releases an anti-inflammatory steroid, mometasone furoate, directly to the patient’s nasal polyps for up to 90 days.
Intersect ENT estimates that nearly 635,000 Americans have undergone surgery to remove nasal polyps and ultimately have to return to their ENT physicians due to recurring symptoms.
“After years of development and multiple clinical studies, we are thrilled to provide physicians with Sinuva to treat patients with nasal polyps. Sinuva offers an alternative to patients who have exhausted routine medical management who don’t want to return to the operating room for a repeat surgery,” president & CEO Lisa Earnhardt said in prepared remarks. “We are introducing Sinuva through a targeted launch, working to build success through positive initial adoption and positioning Sinuva for the long-term growth we believe is achievable.”
In a 300-patient pivotal trial, participants treated with Sinuva had a statistically significant reduction in bilateral polyp grade from baseline to 90 days and a signification reduce in nasal obstruction score after 30 days. The drug-device combo won FDA approval in December last year.