Aerin Medical, Inc. (“Aerin”) announced that it has received regulatory clearance for its novel VIVAER® Non-Invasive Airway Remodeling System (“VIVAER”), a product developed to enable Ear, Nose & Throat (“ENT”) physicians to treat nasal airway obstruction within their physician office without the need for incisions or implants. The company has also completed a $25 million financing led by the KCK Group and Horizon Technology Finance Corporation and will be using the proceeds to embark on a nationwide launch of its novel technology.
Over 20 million people suffer from nasal airway obstruction in the United States alone. Given the very invasive surgical options currently available, only a small portion of these people obtain lasting relief. Aerin’s first of its kind, office-based, solution offers better nasal breathing to the millions of sufferers without having to undergo surgery.
Aerin has concluded clinical trials demonstrating the safety and efficacy of VIVAER with 94% of patients experiencing significant improvement of their persistent nasal obstruction. Additionally, European post-market data collected from patients who were treated with VIVAER upwards of two years ago continue to report sustained reduction of their nasal obstruction symptoms.
Scott Wolf, MD, Founder and Chief Medical Officer, stated “The principal complaint of patients visiting ENT physicians is typically a ‘stuffy’ or ‘blocked’ nose. Until now, many of these patients would have been offered invasive surgery or treated medically with nasal sprays or nasal breathing strips until their symptoms worsened sufficiently to warrant surgery. Now, with the availability of the VIVAER procedure, these patients can be treated in their ENT’s office with a 15-20-minute, non-invasive, office-based procedure and immediately return to work breathing better.”
Based on the strength of their clinical data, FDA clearance and successful financing, Aerin is now launching VIVAER into the market. They will also use the added funding to accelerate their product development pipeline. Fred Dinger, Aerin’s Chief Executive Officer and a successful serial entrepreneur, has built a commercialization team with an outstanding track record of bringing new technologies to the ENT and medical office areas. Mr. Dinger stated, “I have been fortunate enough to launch and exit several successful ENT companies, but have never seen one with a greater opportunity to improve the quality of life for millions of patients and fit seamlessly into what ENTs are doing in their offices today. This is a billion-dollar opportunity.”
Aerin Medical is an early commercialization stage medical device company with offices in Austin, TX, Sunnyvale, CA and Singapore. Aerin is a patient-centric company focused on the development and commercialization of products to improve the breathing and quality of life for millions of people. Aerin Medical and VIVAER are registered trademarks of Aerin Medical, Inc.