VivAer® Continues to Demonstrate Long-Term Effectiveness and Safety for Nasal Airway Obstruction Treatment in Third Study Published with Three-Year Follow-Up Results

Following Recently Published VATRAC 3-Year RCT, New Findings Reinforce Consistent, Durable Benefits of Temperature-Controlled Radiofrequency (TCRF) Ablation for Nasal Airway Obstruction (NAO)

MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Aerin Medical Inc., a leader in minimally invasive solutions for chronic nasal conditions, today announced the publication of positive three-year outcomes from the AERWAY clinical study that underscore the durability of the VivAer procedure. The prospective, single-arm, multicenter clinical study, published in OTO Open, confirms that VivAer provides consistent and long-lasting symptom relief for patients suffering from nasal airway obstruction (NAO) due to nasal valve collapse (NVC).

AERWAY was conducted at 12 sites across the U.S. to evaluate the long-term efficacy and safety of temperature-controlled radiofrequency (TCRF) treatment with VivAer. At three years post-procedure, patients demonstrated sustained symptom relief, meaningful reductions in medication use, and no serious device- or procedure-related side effects. These improvements in symptom burden at three years are consistent with outcomes reported at previously assessed intervals of 3, 6, 12, and 24 months.

Key Study Findings:

• Sustained Symptom Relief
  • 83.3% of patients were responders, with mean NOSE scores improving by 52.6%
• Low Nasal Valve Reintervention Rate
  • 3.2% of patients required additional procedures targeting the nasal valve at 3 years
• Excellent Safety Profile
  • No device- or procedure-related serious side effects reported over the 3-year follow-up

“These long-term results reinforce VivAer’s potential as a safe and effective long-term solution for patients experiencing nasal airway obstruction,” said William C. Yao, MD, Associate Professor at McGovern Medical School at UTHealth Houston and principal investigator of the AERWAY study. “Providing sustained symptom relief through a durable, minimally invasive alternative to traditional surgery may elevate the standard of care available to our patients.”

“Combined with the recently published VATRAC study, these findings further validate VivAer as a consistently effective solution supported by high quality evidence,” said Scott Wolf, Founder and Chief Medical Officer of Aerin Medical. “With 20 peer-reviewed publications to date, the growing body of evidence continues to build confidence among physicians treating nasal valve dysfunction.”

About VivAer

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, removal of nasal tissue or bone, or the use of an implant. Treatment with VivAer may be performed during an office visit with local anesthesia. Patients typically experience little discomfort and are often able to return to normal activities with minimal to no downtime. 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, headquartered in Mountain View, California. Aerin’s mission is to expand access to meaningful relief for millions of patients suffering from chronic ENT 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 unique technologies that are appealing alternatives to invasive surgery. More than 150,000 patients have been treated with Aerin Medical products to date. For more information, please visit www.aerinmedical.com and follow Aerin Medical on Facebook, X, Instagram, LinkedIn and YouTube.