The company said its study aims to bring patients, carers and clinicians together to learn about BCI design and its benefits for people with limited mobility.
Synchron designed its BCI technology to decipher the neural code of the brain, finding ways to restore motor intent to control digital devices. Read more about BCIs and companies in the space that you should know here.
“We are thrilled to launch our community-centered BCI registry,” said Tom Oxley, CEO and founder, Synchron. “There is a grass roots movement happening with BCI. We are creating an avenue for potential users and their physicians to engage and stay connected while we prepare for the next stage of clinical trials.”
According to Reuters, Synchron wants to launch the registry ahead of a study “required to seek commercial approval.” The report says the company already received interest from about 120 clinical trial centers to participate. The company plans to analyze data from the registry to prepare for the larger study that aids in the FDA approval process. Reuters said Synchron and the FDA had no additional information on potential timing for that authorization.
More about Synchron and its BCI
New York-based Synchron developed its BCI system for delivery through an endovascular approach. The company says its BCI is the only one tapping into blood vessels to capture signals from the brain.
The implant goes on the surface of the motor cortex of the brain via the jugular vein. Once implanted, it detects and wirelessly transmits motor intent out of the brain.
Synchron company manufactures its Stentrode implant with a thin-film process. It prints layers of nitinol and layers of insulation contacts that serve as electrodes, according to Synchron’s Chief Technology Officer Riki Banerjee. The company in February announced an acquisition of an equity stake in thin-film component maker Acquandas to aid in this process.
The system could allow paralyzed patients to compose text messages and operate smart devices. Its implantable brain electrode stent, called Stentrode, helps perform these tasks by picking up brain signals. Synchron believes its endovascular delivery method could make brain-computer interface technology simpler and safer. It could also offer more accessibility than the alternative option of invasive open-brain surgery.
The company also has the backing of some big names, raising an oversubscribed $75 million Series C financing round in 2022. Gates Frontier (Bill Gates’ investment fund) and Bezos Expeditions (Jeff Bezos’ investment fund) participated in the round.
Synchron completed enrollment for its COMMAND clinical trial in September 2023. It also won the first FDA investigational device exemption for assessment of a permanently implanted BCI. The company hopes to beat Neuralink to FDA approval and commercialization. Neuralink is in the midst of its own in-human trial, recently live-streaming the first recipient of its implant using his mind to play online chess.
