Synchron raises $200M to run a pivotal trial of its blood-vessel BCI
The Series D funds the study Synchron needs before it can ask the FDA for full market approval of the Stentrode.
Synchron has raised a $200 million Series D led by Double Point Ventures, valuing the company at nearly $1 billion. Returning investors include ARCH Ventures, Khosla Ventures and Bezos Expeditions.
The plan: a pivotal trial
The money will fund a pivotal clinical trial, the large study the FDA requires before it will consider premarket approval (PMA). If the trial succeeds, Synchron could be the first company to file for approval of a permanently implanted BCI for communication.
Synchron’s Stentrode is delivered through the jugular vein and placed in a blood vessel next to the motor cortex, with no open brain surgery. In the US COMMAND early feasibility study, six patients were implanted with no serious device-related adverse events. Participants used the device to text, browse and control smart-home devices.
Why it matters
So far, BCI headlines have mostly come from feasibility studies. A pivotal trial is the step that turns research devices into products doctors can prescribe and insurers might pay for.
Learn more: Endovascular BCI · Clinical trial pathway · Synchron in the Directory