Studies show treatment with XprESS Multi-Sinus Dilation System leads to a rapid and sustained improvement in chronic symptoms, fewer acute episodes, and improved quality of life
PLYMOUTH, Minn., Dec. 13, 2016 (GLOBE NEWSWIRE) -- Entellus Medical, Inc. (NASDAQ:ENTL), a medical technology company focused on delivering superior patient and physician experiences through products designed for the minimally invasive treatment of chronic and recurrent sinusitis patients, today announced that the National Institute for Health and Care Excellence (NICE) Medical Technologies Advisory Committee provided positive guidance for use of the XprESS Multi-Sinus Dilation System (XprESS) for the treatment of chronic sinusitis after medical treatment has failed.
NICE provides evidenced-based guidance and advice for the National Health Service (NHS) in England and other public health and social care services to improve health and social care. The guidance helps people in the NHS make efficient, cost-effective and consistent decisions about adopting new products.
Following the examination of information submitted by Entellus Medical along with independently sourced clinical studies and expert advice, NICE’s Medical technologies guidance determined that treatment with XprESS leads to rapid and sustained improvement in chronic symptoms associated with sinusitis, fewer acute episodes and improved quality of life which is comparable to functional endoscopic sinus surgery (FESS). NICE recommends XprESS for use in patients with uncomplicated chronic sinusitis who do not have severe nasal polyposis. In these patients, NICE has asserted XprESS works as well as FESS, is associated with faster recovery times, and can more often be done under local anesthesia.
“This guidance further confirms that use of the XprESS Multi-Sinus Dilation System in an out-patient setting under local anesthetic offers an effective and cost saving alternative to the current standard of care,” said Robert White, President and Chief Executive Officer of Entellus Medical. "NICE is internationally recognized for its evidence-based review process. This guidance builds on their commitment to ensure that the NHS is able to adopt clinically and cost effective technologies to improve patient outcomes.”
The NICE guidance indicated that the XprESS Multi-Sinus Dilation System is cost saving compared to FESS based on device cost, length of FESS procedure and assuming the treatments are performed under local anesthetic in an outpatient setting. By adopting this technology, NICE estimates that NHS in England may save around £7.4 million a year by 2020. The estimated savings are largely achieved through the shift of treatment from the operating theatre to the outpatient setting. Additionally, the Medical Technologies Advisory Committee considered that XprESS has the potential to treat uncomplicated chronic sinusitis earlier in disease progression than is currently available in the NHS. As such, it may improve quality of life and clinical outcomes, as well as reduce surgical waiting lists. The NICE guidance is specific to the XprESS Multi-Sinus Dilation System and does not cover any other balloon sinus dilation technology.
Chronic rhinosinusitis (CRS) is a common disease worldwide, some estimates indicating that up to 16% of the population suffer from CRS, making it more prevalent than asthma or diabetes. CRS has a negative impact on the quality of life with chronic symptoms and effects including facial pain and pressure, headaches, fatigue, loss of smell, and sinus infections.
Prior to the development of sinus balloon dilation technology, CRS treatment options included nasal saline irrigation, intranasal corticosteroids, systemic antibiotics or topical drops, and FESS. With the development of standalone sinus balloon technology, CRS can now be treated in the comfort and convenience of a physician’s office and in a manner that preserves the natural sinus anatomy. In-office balloon sinus dilation is a proven, effective alternative treatment to endoscopic sinus surgery and provides patients lasting relief at a lower cost than traditional sinus surgery.
About Entellus Medical, Inc.
Entellus Medical is a medical technology company focused on delivering superior patient and physician experiences through products designed for the minimally invasive treatment of chronic and recurrent sinusitis in both adult and pediatric patients. The Entellus Medical platform of products provides effective and easy-to-use solutions to simplify everything from diagnosis and patient selection, to complex case revisions and post-operative care. Entellus Medical’s three core product lines, XprESS Multi-Sinus Dilation Systems, MiniFESS Surgical Instruments, and FocESS Imaging & Navigation, combine to enable ENT physicians to conveniently and comfortably perform a broad range of procedures in the office and simplify OR based treatment. Entellus Medical is committed to broadening its product portfolios with high-quality and purposeful innovations for the global ENT market. For more information, please visit the Company's website at www.entellusmedical.com.
All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally can be identified by the use of words such as “expect,” “anticipate,” “could,” “may,” “intend,” “will,” “estimate,” “continue,” “future,” other words of similar meaning and the use of future dates. These forward-looking statements are based on the current expectations of Entellus Medical's management and involve known and unknown risks and uncertainties that may cause Entellus Medical's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the dependence of the Company’s net sales on its XprESS family of products, future market acceptance and adoption of such products and adequate levels of coverage or reimbursement for procedures using such products; the Company’s ability to successfully develop and commercialize new ENT products; competition; ability to expand, manage and maintain its direct sales organization and market and sell its products in the United States and internationally; risks and uncertainties involved in its international operations, especially in light of the recent referendum vote of the United Kingdom to exit the European Union; the compliance of its products and activities with the laws and regulations of the countries in which they are marketed; failure or delay in obtaining FDA or other regulatory approvals or the effect of FDA or other regulatory actions; risks and uncertainties involved in the XeroGel acquisition, including the failure to realize intended benefits from the transaction or delay in realization thereof, the integration taking longer or being more difficult, time-consuming or costly to accomplish than expected and business disruption after the transaction; the Company’s ability to manage its anticipated growth; risk of product recalls, product liability claims and litigation and inadequate insurance coverage relating thereto; intellectual property disputes; loss of key suppliers; inadequacy of capital resources and inability to raise additional financing when needed and on favorable terms. Other factors that could cause actual results to differ materially from those contemplated in this press release can be found under the caption “Risk Factors” in the Company's Securities and Exchange Commission (“SEC”) reports, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2015 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2016 to be filed with the SEC. Entellus Medical undertakes no obligation to update or revise any forward-looking statements, even if subsequent events cause its views to change.
Contact: Lynn Pieper Lewis
Entellus Medical, Inc.