Intersect ENT Announces Positive Clinical Results From Study of Sinus Implant

Intersect ENT Inc.’s NOVA bioabsorbable steroid releasing sinus implant helped significantly reduce the need for post-operative interventions, according to clinical trial results.
 
The conclusion was reached during the second cohort of Intersect ENT’s PROGRESS study, a prospective, randomized, blinded, multi-center trial to assess the safety and efficacy of the company’s investigational NOVA bioabsorbable steroid releasing sinus implant.
 
The NOVA implant is designed to support the sinus opening mechanically while delivering anti-inflammatory medication following surgical interventions such as sinus surgery in the operating room or in-office sinus dilation. NOVA’s unique hourglass shape and lower profile is designed to allow for placement in smaller sinus openings, and may expand the applicable patient population for steroid releasing implants.
 
The NOVA cohort of the PROGRESS study is a prospective, randomized, blinded, multi-center trial of 80 patients designed to assess implant safety and efficacy when placed in the frontal sinuses, which are located behind the forehead. The study met its primary efficacy endpoint, demonstrating a statistically significant 65 percent relative reduction in the need for post-operative interventions, such as the need for additional surgical procedures or need for oral steroid prescription, compared to surgery alone. The device placement success rate was 100 percent and there were no device-related adverse events.
 
“The positive results of the PROGRESS NOVA study are exciting for patients with frontal sinus disease as the condition can be challenging to manage due to the potential for restenosis,” said Amber U. Luong, M.D., Ph.D., associate professor in the department of Otorhinolaryngology at the University of Texas at Austin, who serves as the principal investigator of the study. “This is the second randomized controlled study to demonstrate the benefit of steroid releasing implants in the treatment of frontal sinus disease.”
 
“Intersect ENT’s mission is to address unmet needs for chronic sinusitis patients across the continuum of care. The positive outcomes from PROGRESS NOVA bring us another step closer to providing access to steroid releasing sinus implants to more patients on this continuum,” said Lisa Earnhardt, president and CEO, Intersect ENT. “Our next step will be to compile and submit the results in a premarket approval supplement (PMA-s) filing to the FDA in the fall.”
 
NOVA is an investigational device and is not available for sale in the United States.
 
Intersect ENT Inc. is dedicated to improving the quality of life for patients with ear, nose and throat conditions. The Menlo Park, Calif.-based company markets two steroid releasing implants, PROPEL and PROPEL mini, which have been clinically proven to improve surgical outcomes for chronic sinusitis patients undergoing sinus surgery. In addition, Intersect ENT is developing a pipeline of steroid releasing implants designed to provide ENT physicians with options to treat patients across the continuum of care for chronic sinusitis less invasively and more cost effectively. Chronic sinusitis is an inflammatory condition that can lead to debilitating symptoms and chronic infections, and is one of the most costly conditions to U.S. employers.