FDA Grants Breakthrough Device Designation for Blackrock Neurotech’s MoveAgain BCI System

Blackrock Neurotech, the leader in brain-computer interface technology, has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for its groundbreaking MoveAgain Brain Computer Interface (BCI) System. The first-of-its-kind system is expected to provide immobile patients the ability to control a mouse cursor, keyboard, mobile device/tablet, wheelchair or prosthetic device simply by thinking.  
 
The FDA Breakthrough Device designation aims to expedite the review of innovative technologies that can improve the lives of people with irreversibly debilitating diseases or conditions. Approximately 5.35 million people in the United States live with some form of paralysis as a result of central nervous system disorders, autoimmune diseases and spinal cord injuries (SCIs). Many of these patients are completely dependent on permanent support from a caretaker, and their ability to communicate or control their external environment is severely limited. 
 
Blackrock’s portable MoveAgain BCI could offer these patients new possibilities for improved mobility and independence – such as returning to work, participating in leisure activities, and communicating more effectively and quickly. The goal of the device is to achieve long-term improvement in movement and independence, reduce patient reliance on caregivers and help them better engage with society and the world. 
 
“We look forward to working closely with the FDA to prioritize development of the MoveAgain Brain-Computer Interface System, which will bring us closer to our goal of commercialization in 2022.  Patients with tetraplegia are eager to get access, and we are committed to advancing their ability to increase their independence with our BCI technology,” said Marcus Gerhardt, co-founder and CEO of Blackrock Neurotech. 
 
The MoveAgain BCI system is built upon 25 years of groundbreaking clinical research in humans conducted by a number of leading institutions. The system consists of an array implanted in the brain, which decodes intended movement from neuronal activity. Those signals are then transmitted wirelessly to an external device, such as a cursor or wheelchair, providing people with control of their external environment.
 
“We are very grateful that commercialization of these life-changing products is now possible,” said Florian Solzbacher, chairman and president of Blackrock Neurotech. “We are confident we have sufficient safety and efficacy data to support the first applications, and very large-scale integration technologies have allowed further miniaturization, which will make a robust wireless version possible. We look forward to submitting plans to make these products widely available in 2022.
 
To qualify for the Breakthrough Device designation, a device must represent a novel application of an existing technology, and show that it has the potential to provide for more effective treatment of irreversibly debilitating diseases or conditions. The goal of the program is to provide patients and clinicians more timely access to these breakthrough devices by accelerating their development, assessment, and review, while preserving statutory standards for pre-market approval.
 
“We are seeing the beginning of a revolution in the diagnosis and treatment of neurological disorders and disabilities,” said Solzbacher. “Ten years from now, neural implants could be as common as cardiac pacemakers are today — offering patients a whole new world of options that restore their independence.”