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 publication of a position statement from the American Academy of Otolaryngology—Head and Neck Surgery regarding the use of biomaterials in sinonasal procedures such as endoscopic sinus surgery.
The position statement, which referenced multiple clinical studies of Intersect ENT’s PROPEL® steroid releasing implant, stated the Academy has determined the use of such FDA-approved products “can be utilized in sinonasal procedures to improve patient outcomes and reduce complications” and noted the products are “not investigational,” concluding that their use should be determined by the treating physician, factoring in scientific evidence, surgeon experience, the clinical situation, and individual patient preference.
“We are pleased the AAO-HNS has echoed a previous position statement released by the American Rhinologic Society recognizing the value of biomaterials in improving patient outcomes and reducing complications following endoscopic sinus surgery,” said Lisa Earnhardt, president and CEO, Intersect ENT. “PROPEL, which is the only biomaterial that has been approved by the FDA for this use, has been well received by the clinical community since its introduction following FDA approval in 2011 with more than 75,000 patients treated with this unique technology.”
In January 2014, the American Rhinologic Society published a similar position statement endorsing the utilization of FDA-approved biomaterials “to reduce complications and improve outcomes of sinonasal surgical procedures,” noting that these materials “should not be considered investigational.”
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.
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 use of Intersect ENT's products by physicians in patients suffering from chronic sinusitis and the value of biomaterials in improving patient outcomes and reducing complications following endoscopic sinus surgery 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.