Elon Musk may be well positioned in aerospace and electric vehicles, but the world’s second richest person takes a back seat when it comes to a brain-computer interface (BCI).
New York-based Synchron announced Wednesday that it has received Food and Drug Administration approval to begin clinical trials on its Stentrode motor neuroprosthesis — a brain implant it hopes could eventually be used to cure paralysis.
The FDA approved Synchron’s Investigational Device Exemption (IDE) application, according to a release, paving the way for an early feasibility study of Stentrode to start later this year at New York’s Mount Sinai Hospital.
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New York-based Synchron announced Wednesday that it has received FDA approval to begin clinical trials on Stentrode, the brain computer interface, making Elon Musk’s Neuralink a critical benchmark.
The study will analyze the safety and efficacy of the device, smaller than a match, in six patients with severe paralysis.
Meanwhile, Musk has been promoting Neuralink, his brain implant startup, for several years — most recently showing a video of a monkey with the chip playing Pong using only signals from his brain.
However, the company is reportedly plagued with setbacks and unrealistic timelines.
“The approval of this IDE reflects years of safety testing conducted in conjunction with the FDA,” Synchron CEO Thomas Oxley said in the release.
The stentrode is introduced through blood vessels through a “minimally invasive” procedure that takes just two hours, “similar to inserting stents into the heart,” the company said.
The implant is completely internal, Synchron said, “with no wires coming out of the head or body”
“We have worked together to pave a path toward the first commercial approval for a permanently implanted BCI for the treatment of paralysis. We are excited to finally launch a clinical trial in the US this year.”
Like other BCIs, the stentrode is intended to provide greater independence for people with brain injury, trauma, ALS or other conditions that sever connections between the brain and the body’s motor control system.
A Stentrode user can text, email, shop online or even communicate with a smart home.
Ultimately, the technology could potentially treat the paralysis directly and restore mobility.
The implantation procedure is much less invasive than other BCIs, which involve drilling into the skull and placing needle electrodes directly into brain tissue.
Signals from the stentrode are sent to a wireless unit implanted in the chest and sent to a computer near the subject. A user can text, email, shop online or even interact with a smart home
However, the stentrode is introduced through blood vessels through a “minimally invasive” procedure that takes just two hours, “similar to inserting stents into the heart,” the company said.
The implant is completely internal, Synchron said, “with no wires coming out of the head or body.”
Signals from the stentrode are then sent to a wireless unit implanted in the chest and sent to a computer near the subject.
The procedure can be performed in a typical angiography suite without the need for robotic technology.
“Synchron’s north star is achieving whole-brain data transfer,” Oxley said. ‘The blood vessels provide surgery-free access to all areas of the brain, and at scale. Our first target is the motor cortex for the treatment of paralysis, which represents a major unmet need for millions of people around the world.”
If the clinical trial process proves successful, a Synchron device could be on the market within five years, Synchron medical director J. Mocco told Bloomberg.
Despite Elon Musk’s hype, Neuralink has not yet received permission to try its brain-computer interface on human subjects, or even indicated that it is close to this crucial step. Pictured: Musk stands next to a surgical robot during a Neuralink presentation in August 2020
In August 2020, ex-Neuralink employees told STAT that Musk’s brain-computer interface company is rife with internal conflict because the slow pace of science and government approvals failed to keep up with its demanding timelines.
They claimed scientists were given weeks to complete certain projects, knowing the research took longer to perfect, creating a “pressure cooker” within the company.
Neuralink also appeared to be testing its surgical procedure on monkeys, even though the system posed a risk to the animals, a former employee reported.
Neuralink, founded in 2016, designs small flexible ‘wires’ that are ten times thinner than a human hair for the purpose of treating brain injuries and trauma.
Musk has claimed that the technology could even enable a symbiosis between humans and artificial intelligence within 25 years.
Former Neuralink employees have claimed the company is plagued by unrealistic timelines and may be looking to China or Russia to carry out human tracks as the US regulatory process is too strict to continue
However, according to STAT, behind-the-scenes turmoil has left only two of the company’s eight founding scientists left.
In May 2020, Musk told podcaster Joe Rogan in May that Neuralink would have a version ready for human trials within a year, but it hasn’t met that benchmark.
Scientific papers show that the company has tested its technology on rats and monkeys, but has not yet done so with humans, or even indicated that it is close to this critical step.
Former employees said Neuralink was looking to China or Russia to conduct human tracks because the US regulatory process is too strict to continue.
Commercial brain-computer interfaces are a new arena for the FDA, Bloomberg reports — the agency plans to hold a webinar Thursday to provide more advice on topics such as designing appropriate clinical trials.