BRAIN.Q has announced that the CE mark has been granted for its BQ 2.0 system, which is designed to reduce disability following ischaemic stroke.
A company press release details that this regulatory approval marks the first therapy to show a reduction in global disability outside of the acute time window (during the first 12 hours after a stroke).
BRAIN.Q is also currently enrolling patients in the EMAGINE II pivotal study in the USA with the aim of achieving US Food and Drug Administration (FDA) clearance.
The BQ 2.0 system provides artificial intelligence (AI)-powered, non-invasive, network-targeting electromagnetic precision therapy aimed at accelerating and enhancing the brain’s recovery from stroke. Delivered via a cloud-based platform, it is designed for seamless use by patients in both hospital and home settings, BRAIN.Q states.
“The past two decades have witnessed unprecedented advancements in our ability to efficiently train artificial intelligence learning systems,” said Yotam Drechsler, chief executive officer (CEO) and co-founder of BRAIN.Q. “BRAIN.Q has harnessed these insights to design a precision therapy that helps the brain efficiently relearn and recover following a stroke. It’s a big step toward our vision of restoring brain health and dignity of life for stroke survivors.”
In addition, the company has announced the appointment of Stacey Pugh as chair of its board. Pugh is described in the recent release as a “seasoned leader” in the stroke space who previously led Medtronic’s neurovascular business and has been a dedicated member of BRAIN.Q’s board for the past three years.
“I am so pleased to be stepping into this role at this time,” she commented. “Interventional stroke care has seen so many advances in the past decade but, still, over 60% of patients survive to live with a meaningful disability. BRAIN.Q’s therapeutic approach allows us to further advance brain recovery and impact long-term outcomes for this group of people. Returning survivors to independence looks more and more possible, and I look forward to working with the company closely towards achieving this goal.”