Israeli stroke therapy granted FDA breakthrough device status
By JERUSALEM POST STAFF FEBRUARY 15 2022
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“Stroke is a debilitating condition with limited recovery options, creating a huge unmet need."
Israeli BrainQ's artificial intelligence stroke therapy, which reduces disability following strokes, was given Breakthrough Device designation by the US Food and Drug Administration (FDA), the start-up announced last week. The designation will allow BrainQ to work with the FDA to expedite the development and clearance process of BrainQ's device.
Some 50 to 70% of those who suffer a stroke experience chronic disability in the aftermath of these events, according to BrainQ. BrainQ's AI-powered, electromagnetic field therapy aims to reduce disability caused by stroke through a non-invasive therapy.
BrainQ's therapy is designed to treat patients in the weeks and months following a stroke. Currently approved interventions for reducing disability following a stroke are only relevant in the first few hours following the stroke and only 5% of stroke victims reach the hospital in time to benefit from these, according to BrainQ, whose therapy aims to fill this gap.
The FDA designation as a breakthrough device is given to treatments that can "provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions”.
BrainQ's therapy is based on biological insights from brainwaves and uses machine learning algorithms that translate into frequency-tuned, low intensity electromagnetic fields. The therapy is delivered through a wearable device that is connected to the cloud. It is designed so that it is a portable treatment that can be used in the patient's home.
“Stroke is a debilitating condition with limited recovery options, creating a huge unmet need," said BrainQ CEO and Co-founder Yotam Drechsler.
"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.”
