ENTL Entellus Medical, Inc. (delisted)

Entellus Medical Inc., now part of Stryker, today announced the publication of a multi-site market research study evaluating symptom severity for nasal airway obstruction (NAO) patients seen in otolaryngology (ENT) practices, and the prevalence of anatomical causes. Results show that the prevalence of nasal valve collapse (NVC) is comparable to septal deviation and turbinate hypertrophy across all patients evaluated and in the subset of patients with severe/extreme Nasal Obstruction Symptom Evaluation (NOSE) scores. The market research study was conducted in 1,906 patients complaining of NAO who were surveyed by 50 physicians in nine U.S. states. It is the largest known prevalence assessment for anatomic contributors of NAO. The data appear in the latest issue of ENT Journal.

“This landmark study is unique with respect to its comprehensive review of data across a broad range of ENT, rhinology and facial plastic surgery practices,” said Brent Senior, MD, FACS, FARS of University of North Carolina, and lead author of the paper. “These data demonstrate that nasal valve collapse, septal deviation and turbinate hypertrophy occur at similar prevalence rates. This suggests that missed or untreated NVC may be associated with the persistence of NAO symptoms, indicating that as physicians we should be looking for all three contributors routinely when we examine our patients.”

NAO is the most common complaint ENTs hear from patients, affecting more than 20 million Americans.i NAO has three anatomic contributors: septal deviation, turbinate hypertrophy and NVC. While septal deviation and turbinate hypertrophy can be addressed with surgical procedures, NVC is significantly undertreated due to limitations in current tools and techniques. NVC independently affects the quality of life for NAO patients, who fare significantly worse when NVC is left untreated. [ii],[iii]

Key findings from the study include:

• A majority of patients had severe or extreme NAO based on NOSE scores (63%).
• The prevalence of NVC, septal deviation and inferior turbinate hypertrophy was 73%, 80% and 77%, respectively, in patients with severe or extreme NOSE scores. The majority of patients suffered with multiple anatomic contributors.
• NVC was present in 82% of patients with severe or extreme NAO who had previously undergone septoplasty and/or inferior turbinate reduction.

“Surgical correction of NVC is less common than procedures for other anatomic defects despite comparable prevalence,” said Don Gonzales, MD, Entellus Chief Medical Officer. “This likely results from the fact that traditional techniques and procedures to address NVC to completely treat NAO risks cosmetic changes with unpredictable outcomes. The LATERA bio-absorbable implant has the potential to provide more physicians with a minimally invasive, safe and predictable procedure that can address symptoms of NVC.”

About LATERALATERA® is an absorbable nasal implant that supports the lateral nasal cartilage (side wall of the nose). LATERA addresses the symptoms of nasal valve collapse (NVC) and may reduce nasal airway obstruction (NAO) symptoms, helping patients breathe better. Through a minimally invasive procedure, the nasal implant is inserted through a small incision made inside a patient’s nose. Patients who received the implant reported satisfaction with their breathing (86%) and appearance (93%) results.iv Recent 18 and 24-month data has demonstrated durable relief of NAO symptoms with LATERA with no negative cosmetic changes.v

For more information about the LATERA device including the indications for use, contraindications and warnings, please see the LATERA IFU [http://www.spiroxmed.com/wp-content/uploads/2016/10/LATERA_IFU.pdf].

About Entellus Medical, Now a Part of StrykerEntellus is a medical technology company focused on delivering superior patient and physician experiences through products designed for less invasive treatment.  Entellus products are used for the treatment of adult and pediatric patients with chronic and recurrent sinusitis, patients with nasal airway obstruction, as well as adult patients with persistent Eustachian tube dysfunction, and combine to enable ENT physicians to conveniently and comfortably perform a broad range of procedures in the most cost effective and efficient site of care. Entellus was acquired by Stryker in February of 2018.

About StrykerStryker is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com.

Media Contact:Erich SandovalLazar Partners Ltd.917-497-2867 esandoval@lazarpartners.com

i Value calculated based on 2014 US population estimate from US Census and World Bank data in conjunction with incidence numbers cited in: Stewart M, Ferguson BJ, Fromer L. Epidemiology and burden of nasal congestion. Intl J Gen Med. 2010;3:37-45.

ii Rhee et al.  Nasal Valve Surgery Improves Disease-Spec ific Quality of Life. Laryngoscope  115:  March  2005.

iii Rhee et al. Quality of Life Assessment in Nasal Airway Obstruction. Laryngoscope, 113: 1118–1122. July 2003.

iv Data on file (TR-21076 Spirox NVC Experience). Individual patient results may vary and may include other procedures. Use of the LATERA device in conjunction with other procedures (such as septoplasty and/or turbinate reduction) has not been clinically evaluated. Patient satisfaction results may be attributed to LATERA with other procedures.

v San Nicolo M, Stelter K, Sadick H, Bas M, Berghaus A. Long term safety and effectiveness of a novel absorbable implant in patients with nasal valve collapse. In: Annual Meeting of the American Academy of Facial Plastic and Reconstructive Surgery. Phoenix, AZ; 2017.