Aerin Medical Archives - Medical Design Sourcing

Data supports Aerin Medical treatment for nasal airway obstruction

[Image from Aerin Medical]Aerin Medical today announced positive two-year data backing the use of its non-invasive nasal airway obstruction (NAO) treatment.

Mountain View, California-based Aerin Medical evaluated its VivAer system in the AERWAY clinical trial.

VivAer, which holds both CE mark and FDA 510(k) approval, uses patented, temperature-controlled radiofrequency energy through a thin, wand-like stylus attached to a console. The stylus is inserted via the nostril to gently remodel the nasal tissue and improve airflow. Aerin Medical featured on Medical Design & Outsourcing’s list of 20 medical device startups you need to know in 2020.

This trial looked at VivAer in the treatment of patients with severe or extreme NAO due to nasal valve collapse (NVC). Results published in Laryngoscope Investigative Otolaryngology demonstrated significant, long-term improvement in NAO symptom burden.

According to a news release, the outcomes showed the …

FDA clears next-generation RhinAer stylus from Aerin Medical

[Image from Aerin Medical]Aerin Medical announced today that it received FDA 510(k) clearance and launched its next-generation RhinAer stylus.

Sunnyvale, California-based Aerin designed the system as a non-invasive, temperature-controlled radiofrequency technology. It treats the causes of rhinorrhea (runny nose), post-nasal drip and congestion associated with chronic rhinitis in a single session.

The new RhinAer provides physicians with improved visualization, easier access and tissue apposition. Aerin said in a news release that this is especially helpful in patients with narrow nasal airways.

“The new RhinAer stylus gives me confidence that I can access and treat the posterior nasal nerve area more effectively,” said Dr. Randall Ow, otolaryngologist at Sutter Health in Sacramento and the first physician in the world to use the device on a patient. “This newer generation RhinAer allows me to confidently treat multiple target areas, in the office setting, e…

New data backs Aerin’s RhinAer for treating chronic rhinitis

[Image from Aerin Medical]Aerin Medical today announced the publication of positive results from a 12-month study of its RhinAer platform.

Results from Sunnyvale, California-based Aerin’s Rhintrac randomized, sham-controlled clinical trial, published in the International Forum of Allergy & Rhinology (IFAR), demonstrated that chronic rhinitis symptoms continued to improve through 12 months after treatment with RhinAer.

Findings build on previous data demonstrating superiority and safety with RhinAer compared to a sham procedure control, including last month’s two-year data that backed the temperature-controlled radiofrequency (RF) technology designed to disrupt nerve signals that cause chronic rhinitis symptoms, including constant runny nose and post-nasal drip.

Rhintrac enrolled 117 patients seeking treatment for chronic rhinitis symptoms of at least six months duration. Patients were randomly assigned to active treatment with RhinAer or to …

Aerin Medical reports positive 4-year results for VivAer treatment

[Image from Aerin Medical]Aerin Medical today announced published results from a four-year clinical trial of its VivAer treatment for nasal airway obstruction (NAO).

Sunnyvale, California-based Aerin designed VivAer, which holds both CE mark and FDA 510(k) approval, to use patented, temperature-controlled radiofrequency energy through a thin, wand-like stylus attached to a console. The stylus is inserted via the nostril to gently remodel the nasal tissue and improve airflow. Aerin Medical was included in MassDevice’s list of hottest startups in 2020.

Results from the trial, published in the International Forum of Allergy & Rhinology, showed the long-term durability of VivAer in those with NAO due to nasal valve collapse (NVC).

The follow-up study demonstrated that 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 evid…

Aerin Medical closes $60M equity financing

[Image from Aerin Medical]Ear nose and throat (ENT) treatment technology developer Aerin Medical announced today that it closed a $60 million equity financing.

Sunnyvale, California-based Aerin’s financing was led by new investor Ally Bridge Group with participation from all existing major investors, including KCK MedTech, Questa Capital and OrbiMed.

According to a news release, Aerin Medical intends to use the proceeds to scale commercialization and expand market access to meet demand from physicians and their patients.

The company develops the VivAer and RhinAer technologies, leveraging its proprietary temperature-controlled radiofrequency technology to address two nasal conditions with limited treatment options but a sizeable patient population that is affected.

VivAer treats nasal obstruction, while RhinAer treats chronic rhinitis. Both systems have launched in the U.S. (in 2018 and 2020, respectively) and more than 60,000 patients have bee…

Two-year data backs Aerin Medical’s chronic rhinitis treatment

[Image from Aerin Medical]Aerin Medical announced today that a study of its RhinAer technology demonstrated success in treating chronic rhinitis patients.

Sunnyvale, California-based Aerin Medical — one of MassDevice’s 20 medical device startups you need to know in 2020 — designed its RhinAer temperature-controlled radiofrequency (RF) technology to disrupt nerve signals that cause chronic rhinitis symptoms, including as constant runny nose and post-nasal drip.

According to a news release, data from the two-year safety and efficacy trial, published in Allergy and Rhinology, demonstrated that treatment with RhinAer to the posterior nasal nerve (PNN) is safe and provides significant, durable symptom improvement for both chronic non-allergic and allergic rhinitis patients.

“This long-term data confirms that RhinAer enables us to effectively provide lasting relief to our patients who suffer from chronic rhinitis,” Advanced ENT and Allergy (New Albony, Ind…

Aerin Medical touts study of chronic rhinitis treatment tech

[Image from Aerin Medical]Aerin Medical today touted one-year results from a trial evaluating the safety and efficacy of its RhinAer system in those with chronic rhinitis.

Sunnyvale, Calif.-based Aerin designed RhinAer as a temperature-controlled radiofrequency technology used to disrupt nerve signals that cause chronic rhinitis symptoms.

According to a news release, the study demonstrated that, following a single RhinAer treatment, symptom severity significantly decreased in the first two weeks and remained low through the one-year follow-up. Results were published in the American Journal of Rhinology & Allergy.

The prospective, single-arm, multi-center study enrolled 50 adult patients with moderate to severe rhinitis symptoms and monitored them at two, four, 12, 26 and 52 weeks following RhinAer treatment. It met its primary endpoint in demonstrating clinically significant symptom reduction three months after treatment, with lasting improvements obser…

Aerin Medical touts study of nasal airway obstruction treatment

[Image from Aerin Medical]Aerin Medical today touted results from a three-month study of its VivAer treatment for nasal airway obstruction (NAO).

Sunnyvale, Calif.-based Aerin’s VivAer was studied in the VATRAC trial, with results published by the International Forum of Allergy and Rhinology.

According to a news release, the study confirmed the safety and efficacy of VivAer in treating NAO caused by nasal valve collapse (NVC). Those treated with VivAer showed significant improvement in nasal obstruction symptoms compared to the control group.

The multi-center, prospective, single-blinded, randomized, sham-controlled trial enrolled 117 patients with extreme or severe NAO with NVC as a primary or significant contributor to their symptoms. Patients were randomized to undergo in-office treatment with VivAer or an in-office sham procedure that replicated the treatment experience without delivery therapeutic radiofrequency energy.

VATRAC met its prim…

DTW Podcast: KCK’s Long says deals getting done during COVID era

Karen Long, managing director at KCK Group

In this week’s DeviceTalks Weekly Podcast, Karen Long, managing director at KCK Group, says startups looking for funding have an opportunity to catch the eye and ear of investors.

KCK, an active medtech investor, has been involved in two sizable investments this summer including Aerin Medical and NeuroPace. Both were portfolio companies, but Long says KCK is in the market for new deals.

“We’re looking at companies and where we have the ability to take these ZOOM calls and take pitches that would have normally required a lot of travel and a lot of time to plan,” Long said in this week’s episode.” We can do it in a half hour, 45 minutes and at least we have the introduction and can see if it makes sense to continue.”

Medtech executives looking for more insight on the fundraising market can register for today’s DeviceTalks Tuesday discussion where …

DTW Podcast: KCK’s Long says deals getting done during COVID era

Karen Long, managing director at KCK Group

In this week’s DeviceTalks Weekly Podcast, Karen Long, managing director at KCK Group, says startups looking for funding have an opportunity to catch the eye and ear of investors.

KCK, an active medtech investor, has been involved in two sizable investments this summer including Aerin Medical and NeuroPace. Both were portfolio companies, but Long says KCK is in the market for new deals.

“We’re looking at companies and where we have the ability to take these ZOOM calls and take pitches that would have normally required a lot of travel and a lot of time to plan,” Long said in this week’s episode.” We can do it in a half hour, 45 minutes and at least we have the introduction and can see if it makes sense to continue.”

Medtech executives looking for more insight on the fundraising market can register for today’s DeviceTalks Tuesday discussion where …

Aerin Medical closes $48M financing, appoints new CEO

Aerin Medical announced today that it closed a $48 million equity financing and appointed Matt Brokaw as its new president & CEO.

Brokaw previously served in roles at Tusker Medical, Spirox, Entellus Medical, Stryker (NYSE:SYK), Acclarent, Johnson & Johnson (NYSE:JNJ) and Smith & Nephew (NYSE:SNN).

“Aerin is primed for its next phase of growth, propelled by non-invasive treatments embraced by patients, and in-office procedure options that are increasingly important to the ENT specialty,” Brokaw said in a news release. “I’m tremendously excited to join the team at this critical period, and I look forward to working in close partnership with the otolaryngology community and this experienced group of healthcare investors.”

New investor Questa Capital led the $48 million funding round, while OrbiMed and existing investor KCK Group also participated in the financing, according to the release.

Sunnvale, Calif.-based Aerin, a developer of tre…

20 medical device startups you need to know

The medtech industry isn’t immune from COVID-19 troubles, but exciting innovation continues. These 20 medical device startups have grabbed our attention.

Tom Salemi, DeviceTalks Editorial Director and Sean Whooley, Assistant Editor

A number of medical device startups continue to make waves across the space, with new technologies and eye-watering fundraising rounds highlighting some exciting prospects.

From treating children with congenital heart disease to therapy that alleviates the effects of traumatic nightmares — and with plenty more innovations between — there is no shortage of intriguing medical devices and therapies coming up through the ranks.

“Even in the face of the COVID-19 pandemic, we continue to see tremendous energy in the medtech innovation ecosystem,” said Paul Grand, CEO of MedTech Innovator. “We are noticing a strong trend of minimally invasive medical devices that improve patient outcomes and require less time spent in th…