SUNNYVALE, Calif.--(BUSINESS WIRE)--Aerin Medical Inc., a company that provides Ear, Nose and Throat (ENT) physicians with non-invasive solutions to treat chronic nasal conditions, today announced that the International Forum of Allergy & Rhinology published positive four-year results from a VivAer® clinical trial. The results showed the long-term durability of VivAer® treatment for those with nasal airway obstruction (NAO) due to nasal valve collapse (NVC). In the follow-up study, patients experienced significant and sustained improvement in symptoms of NAO through four years following a single treatment of NVC with VivAer. The publication adds to a growing body of evidence supporting the safety and efficacy of VivAer.
“More than 20 million Americans suffer from chronic nasal obstruction,” said Ofer Jacobowitz, M.D, Ph.D., lead author of the study, ENT and Allergy Associates and department of otolaryngology, Zucker School of Medicine, Hofstra University, New York. “Nasal valve obstruction is a commonly overlooked and untreated cause due to the scarcity of non-invasive treatment options as alternatives to major surgical repair. I believe the outcomes of this study build upon previous evidence that VivAer offers patients a lasting, non-invasive option to effectively treat their condition without complex surgery and downtime.”
Twenty-nine patients with chronic severe or extreme NAO with NVC participated in the study. These patients had previously participated in a prospective multicenter study with follow-ups at 6, 12, 18, and 24 months. The study was extended to follow this cohort of patients out to 48 months. The average baseline (pre-procedure) Nasal Obstruction Symptom Evaluation (or “NOSE” score, a gold-standard measure of nasal obstruction), of participants was 81.0, which is considered in the “extreme” category (score of 80-100).
The study demonstrates that those treated with VivAer experienced significant improvements in mean total NOSE scores after treatment that were sustained throughout the 48-month study period. Among the study population:
- NOSE scores decreased from 81.0 (±9.9) at baseline to 25.7 (±19.1) after 48 months (68.3% change) (p<0.001).
- 96.4% of patients were treatment responders at the 48-month follow-up based on a ≥15-point improvement on the NOSE score scale. This responder rate was similar to observations at 12, 24 and 36 months.
“These study results represent the longest-term published outcomes for treatment with VivAer,” said Matt Brokaw, CEO of Aerin Medical. “We appreciate the efforts of the physician investigators and trial patients who have contributed over the past four years to demonstrate the significant, long-term benefits of temperature-controlled radiofrequency for chronic nasal obstruction caused by nasal valve collapse.”
NAO can take a heavy toll on daily life. The most common symptoms include nasal congestion or stuffiness, trouble breathing through the nose, trouble sleeping, and difficulty breathing well during exercise or exertion. NVC contributes to nasal obstruction for 73% of highly symptomatic individuals,1 but is often under-diagnosed and left untreated. This can have a significant impact on a person’s quality of life, as the nasal valve is the narrowest part of the nasal airway and even small obstructions can create an exponential reduction in airflow. VivAer offers ENT physicians a unique, non-invasive and office-friendly option that durably remodels tissue in the nasal valve to address nasal airway obstruction in appropriate patients.
VivAer is a non-invasive technology that uses patented, temperature-controlled radiofrequency energy and is clinically demonstrated to provide long-term relief from nasal obstruction. VivAer features a thin, wand-like stylus that attaches to a console. The stylus is inserted via the nostril to gently remodel the nasal tissue and improve airflow. VivAer does not involve any cutting, freezing, or removal of nasal tissue or bone. Treatment with VivAer may be performed during an office visit with local anesthesia. Patients typically experience little discomfort with minimal to no downtime and are often able to return to normal activities immediately following treatment.* The VivAer Stylus received CE Mark in 2016 and FDA 510(k) clearance in December 2017. For more information, visit www.VivAer.com.
About Aerin Medical
Aerin Medical is a privately held, venture-backed company, with U.S. offices in California and Texas. Aerin’s mission is to provide ENT physicians with non-invasive solutions for the treatment of chronic nasal conditions. The company’s products, VivAer® for nasal airway obstruction and RhinAer® for chronic rhinitis, leverage Aerin’s proprietary temperature-controlled technology, which allows ENT physicians to reliably improve patients’ symptoms with in-office procedures performed with local anesthetic. More than 50,000 patients have been treated with Aerin Medical products to date. For more information, please visit www.aerinmedical.com and follow Aerin Medical on Facebook, Twitter, Instagram, LinkedIn and YouTube.
*Individual results may vary.
1 Clark, David; Del Signore, Anthony; Raithatha, Roheen; Senior, Brent; 2018. Nasal airway obstruction: Prevalence and anatomic contributors; 2018 ENT Ear Nose & Throat Journal; 97(6).