Intersect ENT has enrolled first patient in its pivotal study of the bioabsorbable steroid releasing sinus implant, NOVA.
NOVA is being developed to mechanically prop sinuses open while delivering anti-inflammatory medication following surgical interventions such as sinus surgery in the operating room or in-office sinus dilation.
The trial is a prospective, randomized, blinded and multi-center study, including around 80 patients, to evaluate implant safety and efficacy.
According to the firm, the trial is being conducted as a second cohort of patients of the Progress study.
The first cohort of the Progress study includes 80 patients and is also a prospective, randomized blinded, multi-center trial to evaluate the safety and efficacy of the PROPEL mini drug eluting implant to improve outcomes following frontal sinus surgery.
It has been designed to support an expanded indication for PROPEL mini and currently approved for use in the ethmoid sinus. The company recently completed enrollment in the PROPEL mini cohort of the study.
Intersect ENT president and CEO Lisa Earnhardt said: "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."
Currently, the NOVA implant is an investigational device and will not be sold commercially in the US.