Aurenar Receives FDA Breakthrough Device Designation for Non-Invasive Neuromodulation Therapy Designed for the Reduction of Cerebral Vasospasm Following Brain Hemorrhage

Designation for Aurenar's V-Link System recognizes the potential of non-invasive transauricular vagus nerve stimulation to address a life-threatening ICU complication

ST. LOUIS, June 30, 2026 /PRNewswire/ -- Aurenar, developer of a non-invasive neuromodulation platform for patients in intensive care, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its V-Link™ System for the reduction of cerebral vasospasm in adults with aneurysmal subarachnoid hemorrhage (aSAH). The designation applies to the use of V-Link in adult patients (22 years of age and older) with aSAH as an adjunct to clinical management to reduce the incidence of cerebral vasospasm while in the ICU.

The FDA's Breakthrough Devices Program is designed to accelerate the development, assessment, and review of technologies that have the potential to provide for more effective treatment of life-threatening or irreversibly debilitating conditions. The designation gives Aurenar priority, interactive engagement with FDA reviewers and a more efficient path through the agency's premarket process as the company advances V-Link toward pivotal trials and regulatory submission.

Aurenar's V-Link delivers low-energy electrical stimulation to a branch of the vagus nerve through the outer ear. This is designed to help regulate the body's inflammatory response, which plays a significant role in the secondary brain injury that can occur after a hemorrhagic stroke and other critical illnesses. Its simple, wireless design is intended to allow neuro-intensive care physicians and ICU nursing staff to use the device efficiently.

"Breakthrough Device Designation is an important validation of both the science behind V-Link and the urgency of the problem it addresses," said Dr. Eric Leuthardt, founder and CEO of Aurenar and a professor of neurosurgery at Washington University School of Medicine in St. Louis. "Families watch helplessly as vasospasm threatens patients who have already survived a devastating hemorrhage. This designation lets us work together with the FDA to bring a non-invasive therapy to these patients as efficiently and responsibly as possible."

Aneurysmal subarachnoid hemorrhage occurs when a ruptured brain aneurysm causes bleeding around the brain. For patients who survive the ruptured brain aneurysm, danger often does not end when the bleeding stops. In the following days, blood vessels in the brain can suddenly constrict, reducing blood flow and causing additional injury. Known as cerebral vasospasm, this complication remains a leading cause of disability and death after subarachnoid hemorrhage, yet there are currently no FDA-approved device therapies designed to prevent it.

The core method underlying V-Link, known as transauricular vagus nerve stimulation, originated from research led by Dr. Anna Huguenard and Dr. Leuthardt at WashU Medicine. In a randomized clinical trial involving 27 patients with subarachnoid hemorrhage, the therapy reduced moderate-to-severe vasospasm by more than 40% and was associated with improved patient outcomes. There were no associated adverse events. A companion analysis showed a 20% drop in 30-day hospitalization costs directly linked to the method.

"Vasospasm has frustrated the neurocritical care community for generations, and our trial data suggest that modulating inflammation through the vagus nerve has the potential to meaningfully change that trajectory," said Dr. Huguenard, Co-founder of Aurenar and an assistant professor of neurosurgery at WashU Medicine. "Earning this designation reflects the positive clinical signal we've seen and moves us closer to a tool clinicians can use at the bedside."

Moving forward, Aurenar plans to advance the development and commercialization of V-Link while evaluating additional applications for its neuromodulation platform.

About Aurenar
Aurenar is a company developing a non-invasive, single-use neuromodulation platform to reduce life-threatening complications in ICU patients. The company's transauricular vagus nerve stimulation (taVNS) device targets the body's inflammatory response to improve outcomes, lower total cost of care, and transform critical care management. Beginning with the impacts of stroke, Aurenar's platform is positioned to expand to address multiple high-acuity indications. Aurenar is headquartered in St. Louis, Missouri. Learn more at www.aurenar.com.

V-Link is an investigational device and is not currently approved or cleared by the FDA for commercial distribution.

Media Contact
Deborah Barta, Chief Strategy Officer, Aurenar,
[email protected]

SOURCE Aurenar