BRAIN.Q's Revolutionary Stroke Therapy Earns CE Mark Approval: A New Era in Brain Recovery

BRAIN.Q Achieves CE Mark for Its Innovative Therapy to Aid Stroke Recovery

BRAIN.Q, a pioneering biotechnology company focused on neurological disorders, has achieved a significant milestone by receiving the CE Mark for its BQ 2.0 system. This groundbreaking therapy targets the reduction of disabilities that often follow ischemic stroke, which is recognized as the leading cause of disability worldwide.

The challenge of reducing stroke-related disabilities has traditionally been managed through endovascular clot removal during the acute phase, typically within the first 12 hours post-stroke. The introduction of BRAIN.Q's BQ 2.0 therapy marks a shift in this paradigm, as it stands as the first treatment option to demonstrate a reduction in global disability beyond this critical timeframe. Currently, BRAIN.Q is enrolling participants in the EMAGINE II pivotal study across the United States, aiming for FDA approval.

The BQ 2.0 system employs artificial intelligence-powered, non-invasive electromagnetic precision therapy, which is designed to enhance the brain's recovery process after a stroke. Utilizing a cloud-based platform, this innovative therapy ensures ease of use for patients in both clinical and home environments. According to Yotam Drechsler, CEO and Co-founder of BRAIN.Q, the advancements in artificial intelligence over the past two decades have played a pivotal role in developing a therapy that effectively aids the brain in relearning and recovering. Drechsler expressed his vision to restore brain health and improve the quality of life for stroke survivors, highlighting the enormous potential of their technology.

In addition to this significant achievement, BRAIN.Q has named Stacey Pugh as the new Chair of its Board. Pugh, a recognized leader in the stroke domain who previously led Medtronic's Neurovascular business, has been an integral part of BRAIN.Q's Board for three years. Her appointment reflects the confidence in her ability to steer the company towards further advancements in stroke care.

"Stacey's leadership has been crucial to our progress," Drechsler stated. "We believe that under her guidance, BRAIN.Q will continue to innovate and provide meaningful solutions that can vastly improve patient outcomes worldwide."

Pugh expressed her enthusiasm for taking on this leadership role during such a pivotal time. Despite advancements in interventional stroke care, she noted that over 60% of stroke patients still experience significant disabilities. She stated, "BRAIN.Q’s unique therapeutic approach not only offers hope for brain recovery but also aims to enhance long-term outcomes. The prospect of returning independence to survivors is becoming more attainable, and I am eager to collaborate closely with the team to realize this goal."

BRAIN.Q, a privately held startup based in the U.S. and Israel, is committed to developing innovative therapies that can transform the lives of individuals suffering from neurological conditions. The company has been recognized with Breakthrough Device Designation from the FDA for its Q Therapeutic System (formerly known as BQ) and has garnered acclaim as a groundbreaking innovation by the European Innovation Council.

For ongoing updates on their innovations and scientific endeavors, interested parties can explore brainqtech.com and follow them on LinkedIn. It's important to note that while BRAIN.Q's therapies have received approval within the European Economic Area (EEA), they remain investigational and not yet approved outside of this jurisdiction. The company underscores that they cannot guarantee the outcomes of clinical trials or ensure regulatory approval for its products.

With milestones such as the CE Mark approval and the appointment of Stacey Pugh, BRAIN.Q is poised to revolutionize the landscape of stroke recovery, continuing to prioritize the well-being of stroke survivors and the advancement of essential therapies in this critical field.