The implant is designed to prop open the sinuses and deliver anti-inflammatory medication after surgical interventions, the Menlo Park, Calif.-based company said.
“Clinical evidence to date has shown that Propel and Propel mini meaningfully improve the outcomes of patients undergoing ethmoid sinus surgery. Patients with chronic sinusitis may benefit similarly from a steroid-releasing implant as part of treatment of the frontal sinus. I am pleased to be involved with the clinical assessment of both Propel mini and Nova and believe that each of these products has the potential to offer a differentiated solution in the continuum of care for patients with chronic sinusitis,” principal investigator Dr. Tim Smith of Oregon Health and Science University said in prepared remarks.
The 80-patient randomized, prospective trial is the 2nd of a cohort of the company’s Progress study, Intersect Ent said. The 1st 80-patient trial examined the company’s Propel mini drug eluting implant in hopes of receiving expanded indication for the drug-device combo.
“We are excited to commence enrollment in our pivotal study of Nova and to have completed enrollment in the Propel mini cohort of the Progress trial. Intersect ENT is committed to furthering clinical evidence that expands options for people suffering from sinusitis, a chronic condition that severely impacts quality of life,” CEO Lisa Earnhardt said in a press release.
Last month, Intersect Ent closed a public offering of 4.1 million shares of common stock at $25 per share, bringing in an approximate $103 million for the ear, nose and throat-focused device company.