The burgeoning industry is already inundated with unrealistic expectations driven by overly-ambitious promises.
, are working to put this transformative medical technology into clinical practice, reliably and ethically.Brooklyn-based Synchron made history in 2022 when it became the first company toas part of its pioneering SWITCH study performed in partnership with Mount Sinai Hospital.
Though the Stentrode’s signal quality is not quite on par with a probe array, it doesn’t suffer the signal degradation that arrays do. Quite the opposite, in fact. “When you use penetrative electrodes and you put them in the brain,” Putrino said, “ Reaching that goal is still at least half a decade away. “Our goal over the next five years is to get market approval and then we’ll be ready to scale up that point,” Oxley said. The rate of that scaling will depend on the company’s access to cath labs. These are facilities found in both primary and secondary level hospitals so there are thousands of them around the country, Oxley said.
Still, the public interest in Synchron’s BCI work has led to such a glut of interested patients, that the team was able to perform its implantation surgery on the sixth and final patient of the study in early August — nearly 18 months ahead of schedule. The team will need to continue the study for at least another year but has already gotten permission from the NIH to extend its observation portion to the full original five years.
He also calls on the FDA to expand its evaluations of BCI companies to potentially include examining the applicant’s ongoing financial stability. “I think that this is definitely a consideration that we need to think about because we don't want to implant patients and then have them just lose this technology.”