The Breakthrough Device designation, which comes after new trial data, is expected to expedite the device's path to market.
Jerusalem /PRNewswire/ - BrainQ, the Israeli start-up with a therapeutic solution to reduce disability following stroke, announced today that the United States Food and Drug Administration (FDA) has designated its AI-powered technology as a Breakthrough Device. The designation, which was based on BrainQ's latest randomized controlled clinical trial results for ischemic stroke patients, provides BrainQ 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 authorization.
Stroke is one of the leading causes of disability, affecting 800,000 people every year in the United States alone. In the days and weeks following stroke, the brain attempts to repair damaged neural pathways and develop new ones to restore function, but often with limited success. This results in chronic disability for about 50-70% of survivors.
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.
"We're excited that the FDA has granted BrainQ a Breakthrough Device Designation," said BrainQ CEO and Co-founder Yotam Drechsler. "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. Only about 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.
BrainQ also announced the addition of Eilon D. Kirson, MD, PhD, previously Chief Scientific Officer of Novocure, to the company's Board of Directors. "FDA Breakthrough Device Designation provides hope for the millions of stroke survivors who will be eligible for BrainQ's therapy," said Dr Kirson. "More than half of stroke patients in the United States are covered by Medicare. Breakthrough Designation holds the potential to provide immediate access to BrainQ's therapy for the majority of stroke patients in desperate need of improvement in function and mobility in the coming future."
Israel-based start-up BrainQ is conducting clinical trials in top medical centers worldwide and has secured patents in all major global markets. BrainQ's team and advisory board include a unique, multidisciplinary group with a vast background in neurology, neuroscience, data science and machine learning.
The BrainQ device is limited to investigational use and is not available for sale in the United States.