Neuralink Secures Canadian Approval for Groundbreaking Brain-Computer Interface Trial

Published: 27 Nov 2024

Author: Precedence Research

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Neuralink, a brain-computer interface (BCI) startup of Elon Musk, has been sanctioned by Health Canada to perform a clinical trial regarding its N1 brain implant as well as R1 surgical robot. The Canadian Precise Robotically Implanted Brain Computer Interface (CAN-PRIME) study is going to take place at the Toronto Western Hospital under health research from the University Health Network (UHN). It aims to study safety and performance of the N1 implant and the R1 robot concerning patients suffering from severe motor disabilities. Such disabilities may include conditions like tetraparesis or tetraplegia, causing impairment because of cervical spinal cord injury or the neurological disease, ALS.

The N1 implant lets users operate devices using their thoughts, while the R1 robot is responsible for implanting the device using its 64 ultra-thin threads into the brain areas defined specifically. This trial would include only Canadian citizens, whose life expectancy is 12 months or more, which, according to the research, would be useful in deciding effectiveness.

The entire program would conduct all the operations for UHN under a highly specialized team that would conduct the procedures. Neuralink's trial in Canada is in concert with its PREME study being conducted in the United States. The latter is geared towards helping people with quadriplegia control digital devices.

The BCI landscape is getting more crowded with innovators. Boston-based Neurable partnered with Healthspan Digital early this March to take BCI processes beyond the precision health applications, while Precision Neuroscience recently inked $93 million in funding, which takes its valuation to $500 million. Precision neuroscience combines AI with human intelligence, thus expanding the existing boundaries of BCIs, evermore pushing the limits of what they can do.

Brain Computer Interface Market Size and Growth 2024 to 2033

The global brain computer interface market size accounted for USD 2.61 billion in 2024 and is anticipated to reach around USD 10.89 billion by 2033 with a registered CAGR of 16.55% from 2024 to 2033.

Brain Computer Interface Market Companies

• Openbci
• Nihon Kohden Corporation
• Neuroky
• Natus Medical Incorporated
• Integra Lifesciences
• G.Tec Medical Enginneering Gmbh
• Emotiv
• Cortech Solutions
• Cadwell Industries
• Advanced Brain Monitoring, Inc
• Mind Technologies, Inc
• Covidien, Plc
• Compumedics, Ltd
• Cas Medical Systems
• Others

Government Initiatives

• The FDA and NIH co-hosted a workshop in September 2024 on bringing together standardized Clinical Outcome Assessments (COAs) for Brain-Computer Interactions (BCIs), with the exact purpose of assessing effectiveness in real-world environments and improving reliability for uses in medicine.
• Massachusetts General Brigham has set up the iBCI-CC, a clinical neurosciences initiative aimed at developing implantable brain-computer interfaces for movement and neurological disorders, all initiated by the FDA; it should be considered in the context of improving neurorehabilitation technologies and access.
• The BRAIN Initiative has released its funding opportunity announcement for 2024, for transformative projects and tools for measuring specific cell types and circuits. This includes projects such as BRAIN CONNECTS, BICAN, and Armamentarium for Precision Brain Cell Access, which will advance neuroscience, shine a light on circuit basis of behavior, and inform new treatments for disorders of the human brain.

Brain-Computer Interface Market Recent Developments

• In November 2024, Neuralink, led by Elon Musk, is set to launch a feasibility trial involving the N1 Implant, a brain-computer interface technology, to enable paralysis patients to control a robotic arm.
• In November 2024, Researchers at Johns Hopkins APL developed a digital holographic imaging system that permits non-invasive brain-computer interfaces, providing the ability to detect high-resolution neural signals without the use of surgical implants. 
• In March 2024, Mount Sinai is testing Precision Neuroscience's Layer 7 Cortical Interface, an ultra-thin, flexible electrode array for mapping brain activity, aiming to improve speech, motor control, and cognitive functions without harming brain tissue.

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