MENLO PARK, Calif. & DALLAS--(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 positive results from three clinical studies evaluating treatment of patients with sinus disease in the physician’s office.
Findings from the studies, which assessed the company’s flagship PROPEL® sinus implant and two investigational products, were presented during the annual meeting of the American Rhinologic Society, held in conjunction with the AAO-HNSF meeting in Dallas.
“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,” said Lisa Earnhardt, president and CEO, Intersect ENT. “We are excited that our minimally invasive steroid releasing implants hold promise for sustainable relief across the continuum of care for chronic sinusitis patients.”
The studies evaluated steroid releasing sinus implants placed in the office to maintain patency and reduce inflammation for patients suffering from chronic sinusitis.
- Joseph Han, M.D. (Norfolk, Va.) presented long-term results from a study evaluating office-based treatment with an investigational steroid releasing implant currently called RESOLVE. The RESOLVE implant is designed as a less invasive alternative to treat patients with recurrent sinus obstruction that would otherwise warrant revision surgery. Data demonstrated durability at six months, with treated patients experiencing statistically significant improvement in symptom scores, ethmoid sinus obstruction and polyp grade, compared to controls. In addition, control patients were at 3.6 times higher risk of remaining indicated for revision sinus surgery than treated patients.
- Keith Matheny, M.D. (Frisco, Texas) presented results of a 20-patient study assessing patient-reported and endoscopic outcomes after placement of the PROPEL steroid releasing implant following sinus surgery during a post-operative office visit. Findings included a statistically significant improvement in patient symptoms observed at four weeks, which were sustained to 12 weeks. Statistically significant reductions were also observed in ethmoid sinus inflammation. The results suggest a therapeutic effect sustained beyond the implant’s biodegradation.
- William Brown, M.D. (Miami, Fla.) presented three-month results from the EXCEED study evaluating the company’s newest investigational bioabsorbable steroid eluting implant, currently called NOVA. EXCEED evaluated the feasibility, safety and efficacy of NOVA when placed in frontal and maxillary sinus ostia following dilation in the physician’s office. Implants were successfully placed in 96% of sinuses. At three months, the study showed reduction in patient symptoms, inflammation and scarring. No patients required oral steroids or surgical intervention during follow-up.
“These studies illustrate the wide variety of potential clinical applications for steroid releasing implants in the management of patients with chronic sinusitis,” said David W. Kennedy, M.D., F.A.C.S., professor of Otorhinolaryngology at the University of Pennsylvania Health System in Philadelphia, a widely recognized pioneer in otolaryngology. “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.”
About PROPEL and PROPEL mini
Intersect ENT’s PROPEL and PROPEL mini are the first and only steroid releasing sinus implants approved by the FDA for use in patients following ethmoid sinus surgery. The products release mometasone furoate, an advanced steroid with anti-inflammatory properties, directly into the sinus lining, then dissolve. Use of PROPEL maintains the open passages created in surgery, reducing the need for oral steroids and additional surgical procedures. PROPEL’s effectiveness is supported by the highest level of clinical evidence, Level 1a, showing reduction of postoperative intervention, inflammation, scarring, and need for oral steroids in post-operative patients.
RESOLVE, Intersect ENT’s investigational product placed during a routine physician office visit, is designed as a less invasive treatment alternative for patients with recurrent sinus obstruction that would otherwise warrant revision surgery. RESOLVE releases mometasone furoate directly into the sinus lining to resolve inflammation. The product is designed to have more radial strength than the PROPEL products in order to dilate the re-obstructed sinus, and to release the steroid over a longer period of time to keep inflammation at bay.
The investigational NOVA implant is designed to mechanically prop sinuses open while delivering anti-inflammatory medication following surgical interventions such as sinus surgery in the operating room or sinus dilation in the physician’s office. 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.
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 even more 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.
For additional information on the company or the products including risks and benefits please visit www.intersectENT.com.
The statements in this press release regarding the potential adoption of Intersect ENT's products by patients suffering from chronic sinusitis and the wide variety of clinical applications for steroid releasing implants in the management of patients with chronic sinusitis 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 potential surgical outcomes for patients with chronic sinusitis and the results of Intersect ENT’s clinical trials. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, which include, without limitation, the performance of PROPEL and PROPEL mini, the development of competitive products, the uncertain timing of completion of and the success of clinical trials and market competition. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Intersect ENT’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.