Brain data transfer company Synchron has secured a $10m grant from the US government agency National Institutes of Health (NIH) to begin the clinical trial of the Stentrode brain computer interface (BCI).
With the latest grant, the company’s total funding in 2021 for the Synchron BCI programme reached $50m.
Stentrode is a minimally invasive brain implant, which will allow patients to wirelessly control digital devices through thought and enhance functional independence.
It is a motor neuroprosthesis (MNP) that will be implanted through the jugular vein using neurointerventional techniques commonly used to treat stroke.
Synchron already secured breakthrough device designation from the US Food and Drug Administration (FDA) for Stentrode device, which is small and flexible to safely pass through curving blood vessels.
Synchron CEO Dr Thomas Oxley said: “This significant investment by NIH reflects the mature stage of Synchron’s technology. We are excited to be collaborating with three world-leading U.S. institutions to deliver on the long promise of brain computer interface technology.
“We have overcome technical problems that have previously restricted clinical translation of BCI: it is wireless, mobile, fully implantable, and does not require open brain surgery or robots.”
The COMMAND US trial will be collectively conducted by the Carnegie Mellon University, University of Pittsburgh Medical Center (UPMC), Mount Sinai Health System and Synchron.
In July, the company secured approval from the FDA to begin the trial of the Stentrode, which is claimed to be the only BCI that can be implanted without open brain surgery.
Carnegie Mellon University will be responsible for the management of the grant, while UPMC and Mount Sinai Health System will enrol eligible patients and conduct the minimally-invasive neurointervention procedures and monitor the subjects’ clinical status.
The COMMAND study will assess the safety and efficacy of the Stentrode in six severely paralysed patients in the US to reclaim digital communication and functional independence.
Synchron will also continue to assess the device in the SWITCH human clinical study in Australia. The four patients were implanted with Synchron’s Stentrode to control digital devices through thought in the trial.
