Aerin Medical Inc., an Austin, Texas-based company focused on minimally invasive solutions for chronic nasal conditions, has won U.S. FDA clearance for the Rhinaer Stylus to treat chronic rhinitis.

The Rhinaer procedure aims to help nonallergic rhinitis patients by disrupting the signals that cause symptoms. The procedure can be performed under a local anesthetic in an ear, nose and throat (ENT) physician’s office, with no incisions and minimal discomfort.

Citing a journal article, the company placed the number of people in the U.S. suffering from nonallergic rhinitis at in excess of 30 million. Sufferers experience runny nose, postnasal drip, congestion, chronic cough and other symptoms.

Adil Fatakia, a rhinologist at West Jefferson Medical Center in Marrerro, La., explained that chronic rhinitis can have a huge impact on quality of life. “The Rhinaer procedure’s compelling clinical results, including its high responder rate, clean side effect profile and tolerability, make it a highly attractive option for my patients.”

Results from the prospective, multicenter pivotal clinical trial of the Rhinaer Stylus demonstrated meaningful benefits to patients. In the study, 96% of those treated with the procedure reported an improvement in their rhinitis symptoms at six months. In addition, symptoms improved on average by 61%. The procedure was safe and generally well-tolerated, with significant improvements seen in runny nose and postnasal drip.

Radiofrequency

“We use radiofrequency, which is a widely used technology in medical devices today … to disrupt the overproduction of mucus,” Fred Dinger, Aerin Medical’s president and CEO, told BioWorld. “We use our energy to go in and treat below the surface. We put our device on the surface of the nose … on what’s called the mucosal surface. And we treat below the mucosal surface.”

As a result, the signals of mucus overproduction are disrupted, allowing the body to bring the production levels down to within normal amounts.

The product has been rolled out nationally to the company’s sales force as of February, Dinger added, noting that there are physicians purchasing and using the solution today.

“Right now, we’re 100% focused on the U.S.,” Dinger replied when asked about the potential for going to other geographies. However, the company has an interest in one day expanding its reach.

Vivaer offering

“More than 13,000 patients with nasal airway obstruction have now been treated with our first product, the Vivaer Stylus with the Aerin Console,” Dinger explained. “With the addition of the Rhinaer Stylus, we now offer ENT physicians a platform solution that can be used to improve the lives of the millions of patients suffering from chronic rhinitis.”

Dinger told BioWorld that patients have been extremely satisfied with Vivaer. “We’ve established hundreds of accounts across the U.S.,” he added. Early on, Rhinaer patients also have seen good results, comparable to what was seen in the clinical study.

Both procedures rely on the company’s proprietary temperature-controlled technology, which aims to provide a precise therapeutic effect while minimizing risk to surrounding tissue.

Over the next 12 to 18 months, the company will take its platform and develop solutions to bring procedures from the operating room to the physician’s office. Doing so can not only help in terms of saving health care costs, but also enhance the patient experience. “For the patient, it’s under an hour of time, where they drive themselves to and from the appointment [with] no downtime.”

In May 2019, the company said it had closed on a $50 million non-dilutive term loan agreement with Crg LP. Aerin received $35 million at closing and said it would gain an additional $15 million in two tranches upon achieving certain milestones. The company used roughly $16.5 million of these proceeds to retire its existing debt, with the remaining proceeds earmarked to accelerate Aerin's sales and marketing reach and product launch.

Another player

For its part, Neurent Medical Ltd., of Galway, Ireland, also is looking at rhinitis. It has developed a minimally invasive, hand-held radio-frequency device that aims to help surgeons treat patients in an office setting. In 2018, the company raised €9.3 million (US$10.4 million) in a series A funding round.

At the time, the company said the funding would go toward clinical trials and preparing for U.S. commercialization of the device. It also planned to create new positions within the company.

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