Intersect ENT touts sinus-implant study results

Intersect ENT (NSDQ:XENT) said today results from 3 clinical studies of its Propel, Resolve and Nova products showed positive results. The data 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.

“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. We are excited that our minimally invasive steroid releasing implants hold promise for sustainable relief across the continuum of care for chronic sinusitis patients,” CEO Lisa Earnhardt said in prepared remarks.

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.

Long term results of the company’s investigative Resolve implant, designed as a less invasive alternative treatment for recurrent sinus obstruction, showed durability at 6 months with significant improvements in patient symptom scores, Intersect ENT said. The study also reported improvement in ethmoid sinus obstruction and polyp grade, and a significant reduction in risk for remaining indicated for revision sinus history.

The company’s 3-month Exceed study of its investigational Nova bioabsorbable steroid-eluting implant reported a 96% rate of successful implantation and a reduction in patient symptoms, inflation and scarring, with no required oral steroids or intrventions at follow-up.

“These studies illustrate the wide variety of potential clinical applications for steroid releasing implants in the management of patients with chronic sinusitis. The study findings show not only the technical feasibility and tolerability of placement in the office, but also the very significant improvements in endoscopic and patient-reported outcomes, which our specialty relies upon to make evidence-based decisions,” Dr. David W. Kennedy of Philadelphia’s University of Pennsylvania Health System said in a press release.

In August, the company said a new study of its Propel mini steroid-releasing sinus implant used after frontal sinus surgery met the primary endpoint in a clinical trial.

The Propel device is already approved for use in the ethmoid sinuses, behind the bridge of the nose, in conjunction with sinus surgery to treat symptoms of chronic sinusitis, the company said.

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