|Propel's springlike design conforms to patient's unique anatomy and props open the sinus.--Courtesy of Intersect ENT|
Recent med tech IPO candidate Intersect ENT ($XENT) has reported the results of three studies for its chronic sinusitis implants at the American Rhinologic Society meeting in Dallas, TX. The company designed all three studies for physician office use--which is expected to broaden the potential market for these kinds of procedures.
The studies were for the already-approved Propel steroid-releasing implant for after sinus surgery; the investigational Resolve implant for sinus obstruction and the investigational bioabsorbable steroid eluting implant Nova.
Despite the positive data, Intersect ENT fell 7% in early trading on the news. It's been heavily punished with recent market volatility trimming its gains for the year to date from as much as about 75% in July down to only around 5%. At about $20, its share price remains well above its $11 debut price from a July 2014 IPO.
In the Resolve data, researchers compared treated patients with those that had revision surgery instead. The Resolve implant is expected to be a less invasive alternative for patients with recurrent sinus obstruction who might otherwise need revision surgery. The data showed control patients were at a 3.6x higher risk of revision sinus surgery than the Resolve treated patients.
As for the Propel results, they showed a statistically significant improvement in symptoms at four weeks that was sustained to 12 weeks in patients who has the Propel steroid-releasing implant placed after sinus surgery during a post-op office visit.
In the study for the Nova bioabsorbable, steroid-eluting implant, implants were placed successfully in the sinuses 96% of the time--with a reduction in patient symptoms, inflammation and scarring at three months after use.
"More than 500,000 patients undergo sinus surgery in the operating room every year, but there are many more suffering from chronic sinusitis who either don't want to undergo a procedure under general anesthesia, or have symptoms that are not severe enough to warrant surgery," said Intersect ENT President and CEO Lisa Earnhardt in a statement. "We are excited that our minimally invasive steroid releasing implants hold promise for sustainable relief across the continuum of care for chronic sinusitis patients."
- here is the announcement
Special Report: Intersect ENT – 2013 Fierce 15