The breakthrough designation gives BrainQ access to the new Medicare Coverage of Innovative Technology pathway.
BrainQ, an Israeli start-up medtech company, announced that the FDA has designated its AI-powered technology with breakthrough device designation, which aims to enhance recovery and reduce disability after neurological damage caused by stroke.1
The FDA’s decision was based on results from the company’s latest randomized controlled clinical trial, which have yet to be released, but will be presented publicly at the upcoming American Heart Association’s 2021 International Stroke Conference, March 17 to 19, 2021.
The AI-powered therapy is based on biological insights retrieved from brainwaves, using proprietary machine learning algorithms that translate into a frequency-tuned low intensity electromagnetic field (ELF-EMF). It is delivered through a cloud-connected wearable device, the non-invasive BQ System, and is designed for scalable and portable treatment with the flexibility to be accessed at home.
Excited with the FDA’s decision, Yotam Drechsler, chief executive officer and co-founder, BrainQ, wrote in a statement, “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.”
Not only does the designation allow for an expedited process for developmental plans and premarket clearance, but it gives BrainQ access to the new Medicare Coverage of Innovative Technology (MCIT) pathway. The MCIT role will provide national Medicare coverage as early as the same day as the FDA market authorization for breakthrough device, with coverage lasting for 4 years. This coverage pathway offers beneficiaries nation-wide predictable access to new, breakthrough devices to help improve their health outcomes.2
Recently added to the company’s Board of Directors, Eilon D. Kirson, MD, PhD, said in a statement, “FDA breakthrough device designation provides hope for the millions of stroke survivors who will be eligible for BrainQ’s therapy.”
"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,” she added.1
The novelty of BrainQ’s investigational treatment lies in the data-driven method deployed in order to inform the ELF-EMF frequency parameters. In choosing these parameters, the company’s aim is to select frequencies that characterize motor related neural networks in the central nervous system (CNS), and are related to the disability a patient experiences following stroke or neurological trauma.3