Aurenar announced today that it received FDA breakthrough device designation for its V-Link noninvasive neuromodulation system.
The breakthrough nod enables the acceleration of the development, assessment and review of the technology for the reduction of cerebral vasospasm in 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.
St. Louis-based Aurenar said the breakthrough nod gives it priority, interactive engagement with FDA reviewers. It also offers a more efficient pathway through the approval process as it works toward pivotal trials and regulatory submissions.
The company designed V-Link to deliver low-energy electrical stimulation to a branch of the vagus nerve through the outer ear. It helps to regulate the body’s inflammatory response. This plays a key role in the secondary brain injury that can occur after a hemorrhagic stroke and other illnesses.
With a simple, wireless design, V-Link enables neuro-intensive care physicians and ICU nursing staff to use the device efficiently.
The method driving V-Link is called transauricular vagus nerve stimulation. It came from research led by Dr. Anna Huguenard and Dr. Eric Leuthardt, two of Aurenar’s co-founders, at Washington University School of Medicine in St. Louis.
A randomized clinical trial of 27 patients saw moderate-to-severe vasospasm reduced by more than 40%. Investigators also saw improved patient outcomes and no associated adverse events. A companion analysis showed a 20% drop in 30-day hospitalization costs directly linked to the method.
With the breakthrough nod in hand, Aurenar plans to continue advancing the development and commercialization of V-Link. It also intends to add further applications for the neuromodulation platform.
Commentary from Aurenar leadership
Leuthardt, Aurenar founder and CEO and a professor of neurosurgery at WashU Medicine, said:
“Breakthrough device designation is an important validation of both the science behind V-Link and the urgency of the problem it addresses. 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.”
Huguenard, a co-founder and assistant professor of neurosurgery at WashU Medicine, said:
“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. Earning this designation reflects the positive clinical signal we’ve seen and moves us closer to a tool clinicians can use at the bedside.”
