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Intersect, ENT

Intersect ENT, Inc.

23.06.2020 - 09:02:23

Intersect ENT Announces Independent Analysis in UK Confirming Cost Effectiveness of PROPEL® Steroid Releasing Sinus Implant Following Sinus Surgery for Chronic Sinusitis. (NASDAQ: XENT), a company dedicated to transforming care for patients with ear, nose and throat conditions, today announced the results of a United Kingdom-based independent analysis measuring costs and patient outcomes of the PROPEL steroid releasing sinus implant compared to a non-drug-eluting spacer following endoscopic sinus surgery for patients with chronic sinusitis. The study demonstrated that the use of PROPEL following surgery resulted in fewer post-operative complications and could save the National Health System (NHS) approximately £160,692 over a six-month time horizon.

The study, conducted by Device Access UK, showed that use of PROPEL following sinus surgery is a more effective intervention (than non-drug-eluting spacers) causing fewer occurrences of symptom recurrence or surgical failure when compared to spacers alone. Through localized, gradual delivery of mometasone furoate over 30 days, PROPEL maintained patency and provided drug delivery without the need for patient interaction, minimizing reliance on patient compliance. While the cost of initial treatment with PROPEL was greater, a reduction in the number of post-operative complications resulted in an overall cost savings.

Chronic rhinosinusitis is one of the most common chronic health problems among adults in the United Kingdom resulting in approximately 75,000 annual physician visits.1 Of those with chronic rhinosinusitis, approximately 15% undergo sinus surgery yearly after failing medical treatment.2 Quality of life scores of patients with chronic rhinosinusitis are significantly lower than in other common chronic diseases, such as congestive heart failure, angina, chronic obstructive pulmonary disease, and back pain.3 Chronic rhinosinusitis symptoms may include drainage of excess mucus, nasal blockage or congestion, difficulty breathing, pain and tenderness around the eyes, cheeks, nose and forehead, a reduced sense of smell and taste, and fatigue and irritability.4

“The data analysis provides promising insight into the potential cost savings and improved patient outcomes associated with the use of the PROPEL drug eluting sinus implant following endoscopic sinus surgery,” said study author Dr. Mehdi Javanbakht, Head of Health Economics Unit at Device Access UK Ltd, University of Southampton Science Park. “Post-operative treatment regimens are critical to surgery success, but current options fall short in minimizing post-operative complications. PROPEL offers patients with chronic rhinosinusitis a safe and effective option that reduces the likelihood of unpleasant complications, thereby decreasing the need for post-operative interventions.”

The PROPEL family of drug-eluting stents expand to prop open the sinuses after sinus surgery and gradually deliver mometasone furoate, an anti-inflammatory medicine, directly to the sinus lining before dissolving. PROPEL and PROPEL Mini received CE Mark in July 2014.

“More than 350,000 patients have been treated with PROPEL products globally, demonstrating acceptance among patients, their physicians and payors in the United States,” said Thomas A. West, President and Chief Executive Officer at Intersect ENT. “We are pleased that this independent analysis adds to the robust clinical data supporting the effectiveness of the PROPEL family of sinus implants as well as highlighting the potential economic and quality of life benefits associated with PROPEL products.”

About Intersect ENT

Intersect ENT is dedicated to transforming ear, nose and throat care by providing innovative, clinically meaningful therapies to physicians and patients. The company’s steroid releasing implants are designed to provide mechanical spacing and deliver targeted therapy to the site of disease. In addition, Intersect ENT is continuing to expand its portfolio of products based on the company’s unique localized steroid releasing technology and is committed to broadening patient access to less invasive and more cost-effective care.

For additional information on the company or the products including risks and benefits, please visit www.IntersectENT.com. For more information about PROPEL, please visit https://propelopens.com/.

Intersect ENT and PROPEL are registered trademarks of Intersect ENT, Inc. in the US and other countries.

IMPORTANT SAFETY INFORMATION FOR PROPEL® SINUS IMPLANTS (UK Audience)

The PROPEL sinus implants are indicated to maintain patency and locally deliver steroid to the sinus mucosa in patients ?18 years of age after sinus surgery: PROPEL for the ethmoid sinus and PROPEL Mini for the ethmoid sinus/frontal sinus opening. Contraindications include patients with intolerance to mometasone furoate (MF) or hypersensitivity to bioabsorbable polymers. Safety and effectiveness of the implant in pregnant or nursing females have not been studied. Risks may include, but are not limited to, pain/pressure, displacement of the implant, possible side effects of intranasal MF, sinusitis, epistaxis, and infection. For full prescribing information see IFU at www.IntersectENT.com/technologies/.

Forward-Looking Statements

Statements in this press release regarding the potential cost savings and other benefits associated with Intersect ENT's PROPEL products are "forward-looking" statements. These forward-looking statements are based on Intersect ENT's current expectations and inherently involve significant risks and uncertainties. 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 are described in the company's latest filings on Form 10-K, Form 10-Q, especially under the caption “Risk Factors”, 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.

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1 Philpott C, Hopkins C, Erskine S, Kumar N, Robertson A, Far- boud A, et al. The burden of revision sinonasal surgery in the UK—data from the chronic rhinosinusitis epidemiology Study (CRES): a cross-sectional study. BMJ Open. 2015;5(4):e006680.
2 https://link.springer.com/article/10.1007/s41669-020-00198-8
3 Metson RB, Gliklich RE. Clinical outcomes in patients with chronic sinusitis. Laryngoscope. 2000;110(3 Pt 3):24–8.
4 Mayo Clinic. Chronic Sinusitis Symptoms and Causes

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