A small company developing an implantable brain computer interface to help treat conditions like paralysis has received the go-ahead from the Food and Drug Administration (FDA) to kick off clinical trials of its flagship device later this year.
New York-based Synchron announced Wednesday it has received FDA approval to begin an early feasibility study of its Stentrode implant later this year at Mount Sinai Hospital with six human subjects.
The study will examine the safety and efficacy of its motor neuroprosthesis in patients with severe paralysis, with the hopes the device will allow them to use brain data to “control digital devices and achieve improvements in functional independence.”
“Patients 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 and accessing telemedicine,” the company said in a release.
Synchron got the nod from the FDA ahead of Elon Musk’s Neuralink, which is developing similar technology. Neuralink most recently demonstrated how a monkey with the company’s implant could play a video game using only signals from its brain.
Unlike Neuralink’s device, Synchron’s implantation procedure is much less invasive. It is delivered to the brain through blood vessels in a two-hour procedure similar to how stents are inserted into the heart.
Other brain computer interfaces under development currently involve drilling into the skull and placing needle electrodes directly into brain tissue. Synchron said such an invasive procedure can result in long-term brain inflammation, an issue that has posed a challenge for moving into human trials.
Four human patients in Australia have already received Synchron’s implant as part of a separate clinical trial. The company published a study detailing how two patients were able to control devices to text and type. They eventually used the technology at home to send text messages, shop online and manage finances, according to the study.
“Synchron’s north star is to achieve whole-brain data transfer,” Synchron CEO Thomas Oxley said in a statement.
“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,” he said.
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