Synchron, Backed by Bezos and Gates, Advances Toward Large-Scale Clinical Trials with FDA-Ready BCI Platform

US brain-computer interface startup Synchron has recently revealed that it is preparing to recruit patients for large-scale clinical trials to secure commercial approval for its device.

On April 8 local time, according to foreign media reports, Synchron, regarded as the biggest competitor of Elon Musk’s brain-computer interface company Neuralink, launched an online registration system on that day, inviting patients interested in participating in the trial to register, with the goal of recruiting dozens of participants for this study. Thomas Oxley, CEO of Synchron, stated that approximately 120 clinical trial centers have expressed interest or intention to participate in conducting this experiment.

Oxley stated in the interview, “Part of our goal in launching this registry is to enable local physicians to begin engaging with patients who have movement disorders. There is significant interest, and we do not want to encounter major bottlenecks just before the study is set to commence.”

Public records indicate that Synchron, founded in 2012 and headquartered in New York, counts billionaires Jeff Bezos and Bill Gates among its investors. Synchron has advanced further than Neuralink in testing its brain-implant devices; both companies initially aimed to help paralyzed patients use devices that decode brain signals to perform computer input. Synchron performed its first human implant as early as 2020, received authorization from the U.S. Food and Drug Administration (FDA) for initial human trials in July 2021, and has implanted its device in six patients, with no serious adverse side effects reported among the participants.

In January this year, Musk announced that Neuralink had implanted its first product, Telepathy, into the first human patient, who is currently recovering well.

Oxley stated that Synchron will analyze the data obtained in the United States to prepare for larger-scale studies, while awaiting FDA authorization to continue the trials. Both Synchron and the FDA declined to comment on the specific date for such authorization.

Currently, Synchron and Neuralink are competing in a niche segment of the brain-computer interface (BCI) device market. These devices use electrodes that penetrate the brain or are placed on its surface to communicate directly with computers. In terms of technological approach,Synchron delivers its device into the brain via a major vein adjacent to the brain, whereas Neuralink surgically implants its device directly into the cerebral cortex.. However, no company has yet received final FDA approval to sell BCI brain implants.

Oxley also stated that the company aims to include patients paralyzed by neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS), stroke, and multiple sclerosis in its clinical trials. Mount Sinai Hospital in New York, the University at Buffalo, and the University of Pittsburgh Medical Center are collaborating with Synchron on preliminary studies, and Synchron hopes to engage these institutions in its larger-scale trials.

For stroke patients, testing implants in their brains can be particularly challenging because the individual's brain may have already suffered severe damage, resulting in insufficient neural signals that can be recorded. Oxley stated that the FDA has required Synchron to use a non-invasive test to screen stroke patients to determine whether they will respond to the implant.

Kip Ludwig, former program director for neuroengineering at the National Institutes of Health, stated: “Synchron aims to expand its market to include individuals who have suffered strokes severe enough to cause paralysis. Limiting the market solely to those with quadriplegia would render the business unsustainable due to the small market size.”

In February this year, Synchron announced its acquisition of a minority stake in Acquandas, a German supplier of medical device components. As part of the transaction, Synchron will secure exclusive rights to Acquandas’ tiered technology for medical devices. Analysts pointed out that this acquisition will strengthen Synchron’s supply chain, support the commercial development of the company’s first brain-computer interface product, and may signal that the product’s market launch is approaching.

Responsible Editor: He Junxi