Medical technology company Synchron Inc. completed an AU$110 million (US$73.9 million) series C round that will allow the company to conduct a feasibility study and pivotal trial of its implantable brain computer interface that can interpret and stimulate parts of the brain.

Stimulating the brain via implanted electrodes is used to treat both movement disorders such as Parkinson’s disease, and some psychiatric conditions such as obsessive compulsive disorder. But researchers are also working on ways to make such implanted electrodes listen instead of talk – and translate neuronal signals for people that have lost the ability speak, or the ability to move.

Stimulating the brain via implanted electrodes is used to treat both movement disorders such as Parkinson’s disease, and some psychiatric conditions such as obsessive compulsive disorder. But researchers are also working on ways to make such implanted electrodes listen instead of talk – and translate neuronal signals for people that have lost the ability speak, or the ability to move. At the Neurophysiology: Decoding and Neural Processing II session of the 2022 Annual Meeting of the Society for Neuroscience in San Diego, researchers from the Wyss Center for Bio and Neuroengineering (Switzerland) presented a device implanted in the brain that allowed restoration of movement and speech.

Synchron Inc. closed out 2021 by providing an opening for a patient with amyotrophic lateral sclerosis (ALS) to send the first thought transferred to a tweet via an implantable brain computer interface. Philip O’Keefe, who received one of the company’s Stentrode implants in April 2020, took over the Twitter account of Sychron CEO Thomas Oxley to say, “Hello, World. Short tweet. Monumental progress.”

The FDA granted Blackrock Neurotech LLC breakthrough device designation for its Moveagain brain-computer interface (BCI) system as it targets 2022 for commercialization of the neural implant. Earlier this year, the Salt Lake City-based company received $10 million from investors including, Re.Mind Capital, Sorenson Impact and Facebook investor Peter Thiel to expand its clinical program. The company said its technology could be key to providing tetraplegic patients the ability to control devices directly from the brain.

The brain-computer interface (BCI) is the subject of keen medical interest for those dealing with neurological damage, but military applications are also a point of interest among a number of national governments. With all this in mind, an agency at the Department of Commerce has posted a request for comments regarding a possible imposition of export controls on BCI devices due to national security concerns, a proposal that could complicate exports of such devices for medical use.

Using a minimally invasive brain implant, Feinstein Institutes for Medical Research scientists produced tingling sensations in the fingers of patients who lacked the sense of touch as a result of nerve damage, according to a study published in Brain Stimulation. A second study by the team, which appeared in Frontiers in Neuroscience, used stereoelectroencephalography (SEEG) electrodes to decode neural signals to improve the hand control algorithms in brain-computer interfaces.

The FDA’s device center has a mantra of sorts when it comes to the details, or lack thereof, in guidance, which is “talk to us early and often.” For device makers eyeing the brain-computer interface (BCI) device space, this mantra has been applied to the question of pivotal study enrollment numbers, suggesting that some sponsors will find their pivotal studies come with a case of sticker shock sufficient to force them to rethink their research and developmental plans.

With paralysis affecting more than 5 million Americans, devices that serve as brain-computer interfaces (BCIs) are increasingly important, even if few are commercially available. The FDA has responded to the predicament with a leapfrog guidance, a preliminary form of guidance designed to foster more interaction with industry and encourage developers to move along on development programs for devices that will aid patients in restoring lost motor and/or sensory capabilities.