MENLO PARK, Calif.--(BUSINESS WIRE)--Intersect ENT, Inc. (Nasdaq:XENT), a company dedicated to improving the quality of life for patients with ear, nose and throat conditions, today announced the enrollment of the first patient in the company’s pivotal study of its latest bioabsorbable steroid releasing sinus implant, currently called NOVA. NOVA is designed 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. NOVA’s unique hourglass shape and lower profile is designed to allow for placement in the smaller frontal and maxillary sinus openings, and may expand the applicable patient population for steroid releasing implants.
The NOVA study is a prospective, randomized, blinded, multi-center trial of 80 patients designed to assess implant safety and efficacy. The company is conducting the NOVA trial as a second cohort of patients of the PROGRESS study.
The first cohort of the PROGRESS study was an 80-patient prospective, randomized blinded multi-center trial to assess the safety and efficacy of the PROPEL® mini drug eluting implant to improve outcomes following frontal sinus surgery and was designed to support an expanded indication for PROPEL mini, currently approved for use in the ethmoid sinus.
In addition to announcing the initiation of patient enrollment in the NOVA study, the company also announced that enrollment in the PROPEL mini cohort of the study has recently been completed.
“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,” said Tim Smith, M.D., M.P.H., F.A.C.S, of Oregon Health and Science University, who serves as the principal investigator of the study. “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.”
“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,” said Lisa Earnhardt, president and CEO of Intersect ENT. “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.”
About Intersect ENT
Intersect ENT, Inc. is dedicated to improving the quality of life for patients with ear, nose and throat conditions. The company markets two steroid releasing implants, PROPEL and PROPEL mini, clinically proven to improve surgical outcomes for patients with chronic sinusitis undergoing ethmoid sinus surgery. In addition, Intersect ENT is developing new steroid releasing implants designed to provide ENT physicians with customized options to treat patients with chronic sinusitis less invasively and more cost effectively. Chronic sinusitis is an inflammatory condition leading to debilitating symptoms and chronic infections and is one of the most costly conditions to U.S. employers.
The NOVA implant is an investigational device and is not available for sale in the U.S.
The statements in this press release regarding Intersect ENT's continued growth are "forward-looking" statements. These forward-looking statements are based on Intersect ENT's current expectations and inherently involve significant risks and uncertainties. These statements include those related to the expansion of the patient population for drug eluting implants, the ability of PROPEL and PROPEL mini to improve the outcomes of patients undergoing ethmoid sinus surgery and the attractiveness of Intersect ENTs products to ear, nose and throat physicians. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the performance of PROPEL and PROPEL mini, the investigational use of PROPEL mini to treat frontal sinusitis and the investigational NOVA drug eluting sinus implant relative to alternative treatments may not be as Intersect ENT expects, the development of competitive products, the uncertain timing of completion of and the success of clinical trials, market competition. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s filings on Form 10-K, Form 10-Q and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov). Intersect ENT does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.