Factbox: Neuralink, other brain-chip makers face long road to FDA approval

NeuroPace

02/03/2023 11:00

(This is a sidebar to the Special Report NEURALINK/MUSK-FDA,
headlined, 'U.S. regulators rejected Neuralink’s bid to test
brain chips in humans, citing safety risks')
    By Marisa Taylor
       March 2 (Reuters) - Neuralink, founded in 2016, has yet
to receive FDA approval to test its brain chip in humans. Other
implant makers have spent years or decades on research to secure
U.S. regulatory approvals.

SYNCHRON
Synchron, like Neuralink, aims to help patients with severe
paralysis control digital devices. It received U.S. approval for
human testing in July 2021, five years after applying to the
U.S. Food and Drug Administration (FDA). The company first
tested its device on four patients in Australia who successfully
sent text messages with their minds – no typing required.
Synchron recently raised $75 million, including from funds
backed by tech billionaires Bill Gates and Jeff Bezos. As of
late February, Synchron had implanted two patients with the
device out of a total of six planned for its first U.S. trial.

MEDTRONIC
Medtronic  MDT.N  is a leader among several companies producing
deep-brain stimulation (DBS) devices. The FDA first approved
Medtronic’s implant, to treat Parkinson’s disease, in 1997.
Since then, more than 175,000 patients have been implanted with
the device. The device reduces Parkinson’s tremors and lessens
other motor-control symptoms such as stiffness and slowness.

NEUROPACE
NeuroPace  NPCE.O , founded in 1997, didn’t secure FDA approval
for its brain implant to treat epilepsy until 2013. The device
is used by adult patients who have tried at least two
medications but still suffer from frequent and disabling
seizures, according to the company. The device lessens the
frequency of such episodes.

BLACKROCK NEUROTECH
Blackrock Neurotech, established in 2008, has tested its brain
implant in humans for almost two decades. It says the device has
been shown to enable people with paralysis to control digital
devices, prosthetics, and their own limbs. The company had hoped
to secure approval to commercialize the implant from the FDA by
last year but is still working on it, according to the company.

PRECISION NEUROSCIENCE
Precision Neuroscience, founded in 2021, includes as its
co-founder former Neuralink founding member Benjamin Rapoport.
The company bills its brain implant as “minimally invasive.” The
implant, shaped like a piece of tape, is designed to conform to
the surface of the brain. Unlike some other implants, its wires
and electrodes do not need to pierce brain tissue, the company
says. Like Neuralink, the company has not yet secured approval
for clinical trials.

 (Reporting by Marisa Taylor; additional reporting by Rachael
Levy)
 ((marisa.taylor@thomsonreuters.com))