You know how texting might be meddling with the evolution of the human thumb? Well, we have good news.
Synchron, a brain data transfer company responsible for the device that successfully allowed two paralyzed people to control computers with just their thoughts last year, announced this week that the US Food and Drug Aministration (FDA) has approved their request to start clinical trials.
“The approval … reflects years of safety testing performed in conjunction with [the] FDA,” Synchron CEO Thomas Oxley said in a press release. “We are thrilled to finally be launching a U.S. clinical trial this year.”
While brain-computer interfaces, or BCIs, have been around for a while – even meme magnate Elon Musk has his own BCI company, Neuralink – they are notoriously difficult to implement outside of a clinical setting. That’s largely because most brain implants require, well, brain surgery, which is difficult, expensive, and dangerous. Even a successful surgery can face problems later on, as the presence of a foreign object can cause the brain to form scar tissue around the implant, which reduces its effectiveness.
But Stentrode, the flagship device which will be trialed later this year by Synchron, avoids these problems – and it can be implanted in a minimally invasive 2-hour procedure, the company says. The key to this convenience is that Stentrode is not implanted directly into the brain. Instead, it is fed in via the blood vessels, in a procedure similar to stent insertion.
“Synchron’s north star is to achieve whole-brain data transfer,” Oxley explained. “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 aims to enroll six patients with severe paralysis for the upcoming trial, which will be running at Mount Sinai Hospital, New York. A similar trial is currently ongoing in Australia, where four patients have already received the Strentrode implant. Two of those patients were able, after implantation and a short training period, to use the BCI at home without supervision, according to an analysis of the procedure published in the Journal of Interventional Neurosurgery in October 2020.
But the Stentrode has wider applications than just helping people with paralysis live independently, the company says. At the moment, the technology works by using brain activity to control external devices, but it could potentially work in the opposite direction – sending signals from external devices into the brain to treat neurological conditions like Parkinson’s disease, epilepsy, depression, and so on.
Should the upcoming trial be a success, we might see the implant available commercially in as little as three to five years, Synchron’s chief medical officer Dr J. Mocco told Bloomberg. If so, this venture-backed outfit from Australia might beat Elon Musk to become the first brain implant on the open market.