New York-based Synchron has taken an important step for its Stentrode to become first commercially available implantable brain computer interface.
The firm announced that it has gained offical approval from the the US Food and Drug Administration (FDA) to begin a breakthrough clinical trial of its “Investigational Device Exemption (IDE) application for its flagship product, the Stentrode motor neuroprosthesis.”
This approval will allow Synchron to begin a early feasibility study of the device at Mount Sinai Hospital, New York, later this year.
The clinical trial will assess the safety and efficacy in patients with severe paralysis.
Essentially, Synchron’s Stentrode motor neuroprosthesis (MNP) will be implanted in a person’s brain, via the jugular vein using neurointerventional techniques.
The system is designed for patients suffering from paralysis, and aims to be user friendly and dependable for patients to use autonomously. For example allowing paralysed people to send emails, simply by the power of their brain.
Synchron is hoping the trial will also allow patients to use of brain data to control digital devices and achieve improvements in functional independence.
“The approval of this IDE reflects years of safety testing performed in conjunction with FDA,” said Synchron CEO Thomas Oxley, MD, PhD.
“We have worked together to pave a pathway forward, towards the first commercial approval for a permanently implanted BCI for the treatment of paralysis,” he added. “We are thrilled to finally be launching a US clinical trial this year.”
The company explained that its technology solves challenges that have previously restricted the commercial translation of BCIs out of the experimental laboratory.
It said other implantable BCI approaches involve drilling into the skull and placing needle electrodes directly into the brain tissue, which can result in long term brain inflammation.
The Stentrode device on the other hand is delivered into the brain via the blood vessels in a minimally invasive 2-hour procedure, similar to the insertion of stents in the heart.
Stentrode said that no robotic assistance is required for the procedure, which can be performed in widely available angiography suites. The implant is fully internalized with no wires coming out of the head or body.
Patients can apparently begin using the device at home soon after implantation, and may wirelessly control external devices by thinking about moving their limbs.
The system is designed to facilitate better communication and functional independence for patients by enabling daily tasks like texting, emailing, online commerce etc.
“Synchron’s north star is to achieve whole-brain data transfer,” Dr Oxley added. “The blood vessels provide surgery-free access to all regions of the brain, and at scale. Our first target is the motor cortex for treatment of paralysis, which represents a large unmet need for millions of people across the world, and market opportunity of $20B.”
Synchron is collaborating with Carnegie Mellon University, the University of Pittsburgh Medical Center and Mount Sinai Health System, New York City, on the new study.
A total of six patients are planned for the trial, with enrollment beginning later this year.
The firm is already conducting a clinical trial in Australia, where four patients have received the Stentrode implant and are utilising this neuroprosthesis for data transfer from motor cortex to control digital devices.
Data from the first two Australian patients reportedly show that each patient was able to control their devices to text and type through direct thought – after a short period of machine learning-assisted training, they were able to use the system unsupervised in their homes to send text messages, do online shopping and manage their finances.
The arrival of Stentrode and its clinical trials poses a challenge to Elon Musk and the Neuralink human brain to machine interface.
In September last year during a webcast, Elon Musk unveiled a pig called Gertrude who had a computer chip in her brain.
During the webcast, Musk made clear his demonstration was an effort for Neuralink to hire new scientists to help develop the technology.
Musk said the goal of the project was to “solve important brain and spine problems with a seamlessly implanted device.”
Musk had first revealed his plans to develop a human brain to computer interface back in 2017.
Neuralink is focusing on creating chips that can be implanted in the human brain, with the end goal of enabling people to effectively merge with software and adapt to the advancements in artificial intelligence (AI).
In July 2020 Musk touted the Neuralink implant would eventually be able to stream music directly into a person’s brain, bypassing the need for earphones (and even ears) altogether.
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