A neurosurgeon at University of Michigan Health has completed the world’s first implantation of the Paradromics Connexus BCI implant, a fully implantable brain-computer interface designed to restore speech in patients who have lost the ability to communicate. Matthew Willsey, professor of neurosurgery and biomedical engineering at the University of Michigan, performed the procedure alongside senior epilepsy surgeon Oren Sagher and a multidisciplinary team of clinicians and engineers.
The operation marks a milestone in the Connect-One Early Feasibility Study, which the US Food and Drug Administration approved under an Investigational Device Exemption. Paradromics became the first company to receive that approval specifically for speech restoration using a fully implantable BCI.
From electrical engineering to the operating theatre
Willsey’s path to neurosurgery began at MIT, where he completed an undergraduate degree before pursuing a master’s in electrical engineering. His thesis supervisor was Alan Oppenheim, a pioneer in digital signal processing, a discipline that extracts information from signals in ways that translate directly to decoding brain activity.
Around 2009, Willsey watched a video of a patient controlling a computer cursor using electrodes implanted in their brain. ‘That is the coolest thing I’ve ever seen in my life,’ he recalled. He shadowed a neurosurgeon in Texas shortly afterwards, and the combination sealed his decision to change course. He trained at Baylor College of Medicine, matched into a neurosurgery residency at the University of Michigan, and completed a PhD focused on BCIs before joining the faculty there.
Today he leads the University of Michigan Brain-Computer Interface Clinic in Ann Arbor, one of the first dedicated BCI clinical programmes in the country.
Inside the Paradromics Connexus BCI implant procedure
The Connexus system is designed to be entirely wireless and implanted beneath the skin, a deliberate departure from earlier research devices that required cables passing through the scalp. Willsey explained that fully implantable systems are essential for scaling the technology beyond research settings; patients, he said, do not want to be tethered to a computer.
The surgery begins with the cranial portion. The surgical team makes an incision, removes a section of bone, opens the dura, and exposes the cortex. Using pre-operative imaging and real-time navigation, the team identifies the precise cortical location before gently placing and inserting the electrode array. Once the lead is secured, the bone is replaced and a second incision is made in the chest for the transceiver. An extension lead runs under the skin from the brain component to the chest.
The procedure takes approximately four hours. Willsey described the surgical mechanics as largely familiar to trained neurosurgeons: the craniotomy and cortical access techniques are standard, which is by design. If BCI technology is to reach patients at scale, he argued, neurosurgeons need to be able to adopt the procedure without extensive retraining.
Before leaving the operating theatre, the team confirms that the electrodes are positioned correctly, bleeding has stopped, tissues are closed, and the full implanted system is communicating. Only once the patient wakes up and the post-operative examination is complete does the wider significance of the procedure fully register. ‘Wow, I can’t believe we’re at this point now where we have somebody implanted with a novel brain-computer interface,’ Willsey said.
The Connexus device has received two FDA Breakthrough Device designations: one for restoring communication in patients who have lost the ability to speak, and a second for helping patients with severe movement impairment control computers, according to Paradromics. The company has also been accepted into the FDA’s Total Product Life Cycle Advisory Programme, an accelerator reserved for Breakthrough Device-designated technologies.
According to Nature, Paradromics plans to implant the Connexus BCI into two volunteers left unable to speak owing to neurological diseases and injuries. The goal of the early feasibility study is to establish device safety and demonstrate real-time speech communication.
Willsey framed his motivation in straightforward terms: he entered medicine to bring new therapies to the patients who need them. He was aiming, he said, to make procedures like this one routine. The question now is how quickly the Connect-One data can support broader regulatory clearance, and whether the surgical simplicity Willsey described holds across more complex patient profiles.