Intersect ENT is launching its Sinuva Sinus Implant, a new approach to treating nasal polyp disease in adult patients who have had previous sinus surgery. The Menlo Park, CA-based company said nearly 635,000 Americans have gone through these surgeries and are looking for treatments to cure side effects.
Sinuva’s targeted launch comes at an opportune time – right in the middle of allergy season.
“We were really looking at the launch regardless of the time of year,” Susan Stimson, general manager for Sinuva, told MD+DI. “The timing however, we believe works out very much in our favor in that in the first quarter we had the opportunity to train our salesforce at our national sales meeting. It just so happens that the timing of the launch coincides with allergy season and tends to drive many patients who have an exacerbation of their symptoms into their ENT physician’s office.”
Sinuva is placed during a routine office visit and it is designed to provide a less invasive treatment option for patients who have previously undergone sinus surgery, yet suffer from recurrent sinus obstruction. The company said the device delivers anti-inflammatory medication directly to the site of the disease.
The technology differs from Intersect ENT’s Propel Implant. The Propel Contour features a low-profile flexible delivery system to make it easier to access tight areas of the sinus anatomy.
“When in the operating room we believe that surgeons will still want to surgically remove the sinus obstruction and use Propel,” Stimson said.
FDA gave approval to Sinuva in December of 2017.
Sinuva was approved based off the results from the RESOLVE II pivotal study of 300 patients, who were indicated for repeat sinus surgery. The study met both co-primary efficacy endpoints as patients receiving Sinuva experienced a statistically significant reduction from baseline to 90 days in bilateral polyp grade (p=0.007), which corresponded to 74% relative reduction in the extent of ethmoid polyp disease; and a significant reduction from baseline to 30 days in nasal obstruction/congestion score (p=0.007), which corresponded to 30% relative improvement, compared to controls.
"The approval and launch of Sinuva is a significant accomplishment and represent the start as an exciting new chapter for us," Lisa Earnhardt, president and CEO of Intersect ENT said, according to a transcript from Seeking Alpha. "Our overarching goal with Sinuva is not only to assure the best clinical outcomes but also to optimize the patient and provider experience throughout the entire process. "