Paradromics has briefly implanted its device during brain surgery in a patient and plans longer-term implantation in the next study to advance speech restoration.

BCIs for speech restoration decode signals from the motor cortex during attempted speech, with users’ sentences displayed for playback and an option to generate a voice clone.

A long-term clinical trial is approved to test the BCI’s safety and functionality, with plans to implant devices in two volunteers who cannot speak due to neurological diseases.

Paradromics positions itself as a competitor to Neuralink and other players like Synchron, pursuing high-bandwidth, densely implanted BCIs with distinct approaches.

Early goals include detecting imagined hand movements to enable cursor control, with potential expansion to as many as ten volunteers and a second cortical implant to enrich signals.

The FDA granted an investigational device exemption (IDE) to launch the Connect-One early feasibility study, marking the first IDE approval for speech restoration with a fully implantable BCI.

The initial study will enroll two participants early next year to assess long-term safety and the device’s ability to enable communication, with data collection planned for about a year before expanding to more volunteers.

The trial will assess safety and the ability to restore communication, using imagined speech converted to text or real-time voice output via an electrode array in brain regions controlling lips, tongue, and larynx.

Connect-One aims to help patients with impaired speech and limited movement by translating brain signals into actionable data, with enrollment at three sites: UC Davis, Massachusetts General Hospital, and the University of Michigan.

The Austin-based company is among several startups, including Neuralink and Synchron, driving rapid advances in brain-computer interfaces, a field attracting increasing market valuation.

Two clinical sites are within four hours’ travel for participants, reflecting a multi-site, early-feasibility approach to validate safety and functionality before broader testing.

Paradromics’ leadership has publicly critiqued competitors’ devices, signaling a competitive and contentious landscape in the BCI space.

Paradromics has secured FDA approval to begin early-stage human trials of its Connexus brain-computer interface (BCI) to help severely motor-impaired individuals communicate via synthesized speech and text.

Paradromics expects users to speak at approximately 60 words per minute via the BCI, with potential voice cloning from a recording of the user’s voice when available.

The system records cortical neural activity, maps intended speech, and outputs results to a screen for approval or to generate voice from stored voice recordings.

This effort sits within a growing industry trend toward more capable BCIs, highlighting the need for careful comparative evaluation as long-term results emerge.

Connexus is a small disk-like implant hosting 421 microwire electrodes, contrasting with some rivals that use larger skull-embedded chips with thousands of electrodes.

The study targets individuals with severe loss of voluntary movement due to spinal cord injury, stroke, or ALS, to assess the device’s ability to enable communication through text or synthesized speech.

The broader brain-computer interface market is seen as expansive, with major investment interest and Morgan Stanley projecting a multi-hundred-billion-dollar potential.

Preclinical data in sheep demonstrated a data transfer rate around 200 bits per second, indicating high bandwidth, though direct comparisons to rivals are limited by differing task paradigms.

Experts emphasize the promise of fully implantable systems for clinical progress and advocate for transparency and independent academic access to devices.

The clinical study is slated to begin in the coming year, led by CEO Matt Angle, underscoring the device’s potential for high-bandwidth neural communication to restore speech and computer control.

Paradromics has previously shown that Connexus can be safely implanted, record brain signals, and be removed in under 20 minutes, with ongoing milestones toward broader clinical deployment.

The field features competition from Neuralink, Synchron, Precision Neuroscience, and Cognixion as BCIs aim to translate neural signals into commands for communication and control.

Before this IDE, Paradromics engaged with the FDA TAP program in 2024 and launched a patient registry to gauge interest from potential participants.

The FDA approval follows prior regulatory clearances and breakthrough designations as the company competes to advance its technology ahead of rivals.