FDA designates solutions to reduce disability from stroke a Breakthrough Device

BrainQ, the Israeli start-up with a therapeutic solution to reduce disability following stroke, has received Food and Drug Administration (FDA) designation for its AI-powered technology as a Breakthrough Device. 

The designation, which was based on BrainQ’s latest randomised controlled clinical trial results for ischemic stroke patients, provides the start-up with the opportunity to work closely with the FDA to expedite development plans and premarket clearance. Breakthrough status also gives BrainQ access to the new Medicare Coverage of Innovative Technology (MCIT) pathway, allowing for Medicare coverage to be provided concurrently with FDA market authorisation.

BrainQ is developing an AI-powered electromagnetic field therapy that aims to enhance recovery and reduce disability after neurological damage caused by stroke. The therapy is based on biological insights retrieved from brainwaves, using proprietary machine learning algorithms that translate into a frequency-tuned low intensity electromagnetic field. BrainQ’s therapy is delivered via a cloud-connected wearable device, the non-invasive BQ System, and is designed for scalable and portable treatment, with the flexibility to be accessed from home. 

Yotam Drechsler, BrainQ CEO and co-founder, said: “We’re excited that the FDA has granted BrainQ a Breakthrough Device Designation. Stroke is a debilitating condition with limited recovery options, creating a huge unmet need in the US. COVID-19 has only made things worse by limiting patients’ access to treatment facilities. FDA Breakthrough Designation is an important milestone in our mission to reduce disability for these patients and treat them in the comfort of their homes.”

The currently-approved interventions for reducing global disability after a stroke, including medical and surgical options, are relevant only in the first few hours following stroke. Approximately 5% of victims in the US currently arrive at the hospital in time to benefit from these treatments. BrainQ aims to extend this window of opportunity from the acute phase to the sub-acute phase, offering a treatment that can be used in the days and weeks following stroke, helping the wider stroke population who have residual disability.

The FDA awards Breakthrough Device Designation to new types of therapeutic devices that present a reasonable expectation to “provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions”. The designation included the evaluation of evidence from a recently-completed clinical trial of BrainQ. The results of this trial will be presented publicly at the American Heart Association’s 2021 International Stroke Conference from March 17–19.