Paradromics just cleared a major regulatory hurdle that puts it on track to compete directly with Neuralink in the brain-computer interface race. The Austin startup announced Thursday it received FDA approval to begin human trials of its speech-restoration implant early next year, marking a pivotal moment for the emerging neural interface industry.
Paradromics just scored the regulatory win that could reshape the brain-computer interface landscape. The FDA's approval announcement on Thursday puts the Austin-based startup in direct competition with Neuralink, which has already implanted at least 12 people worldwide with its device. The race to restore speech for paralyzed patients is heating up, and Paradromics is betting on superior bandwidth to win.
The company's Connexus implant represents a fundamentally different approach than its rivals. While Neuralink uses a quarter-sized chip with robotic insertion, Paradromics deploys a dime-sized metal disk with 421 microwire electrodes that surgeons can insert using an EpiPen-like instrument. "Individual neurons are the information carriers in the brain. So the more individual neurons you can record from, the more data you have," CEO Matt Angle explained to WIRED.
The technical specs tell a compelling story. In sheep trials, Paradromics achieved a 200-bits-per-second data transfer rate according to recent scientific preprint data. That's 25 times faster than Neuralink's claimed record of eight bits per second for cursor control, though the companies are measuring different tasks. Jacob Robinson from Motif Neurotech, another BCI company, expects Paradromics to "break the bandwidth record yet again" when human trials begin.
The human trial starting early 2025 will focus on two participants who've lost the ability to speak due to severe motor impairment. Unlike mind-reading science fiction, the system decodes brain signals from the motor cortex when users attempt to move their muscles to speak. Participants will try to say words out loud, and those words will appear on screen at an expected rate of 60 words per minute - roughly half normal speaking speed but fast enough for sustained conversation.
Paradromics plans to leverage AI voice cloning technology to give patients back their original voice, assuming existing recordings exist. "They will just try to say words, and those words will appear very quickly on a screen. They'll press play, and the words will be read in their own voice," Angle told . The company already tested brief 10-minute implantation in a surgical patient earlier this year without speech restoration functionality.
