US-based neurotechnology company Paradromics has completed the first-in-human procedure using its Connexus Brain-Computer Interface (BCI).
The procedure, the first in a series of surgeries planned over the coming months, represents a significant advancement in brain therapeutics research.
It was conducted by a team led by University of Michigan neurosurgeon and biomedical engineer Matthew Willsey, alongside senior epilepsy surgeon Oren Sagher.
The Connexus BCI was implanted during an epilepsy resection surgery to explore the impact of epilepsy on brain signalling.
The device was safely implanted, recorded electrical brain signals, and was removed intact in under 20 minutes, using surgical techniques familiar to neurosurgeons worldwide.
The implantation follows nearly three years of preclinical studies with the same device.
Willsey said: “My lab is researching how we can use more advanced BCI recording platforms, like the Connexus BCI, to develop the next generation of speech and motor assistive devices.
“This work brings us one major step closer to providing treatment to patients with severe unmet medical needs.”
Paradromics’s BCI platform can record neural activity at the level of individual neurons, utilising artificial intelligence to translate brain signals into actionable outputs.
The brain implant is designed to restore communication for individuals with severe motor impairments due to conditions such as ALS, brainstem stroke, and spinal cord injury.
Paradromics will continue its clinical efforts, including a clinical trial this year to investigate the long-term use and safety of the Connexus BCI, pending regulatory approval.
The development is supported by Paradromics’ acceptance into the US Food and Drug Administration’s (FDA) Total Product Life Cycle Advisory Programme (TAP).
The programme, launched to accelerate the development and accessibility of innovative medical devices, underscores the public health importance of the Connexus BCI.
Paradromics founder and CEO Matt Angle said: “This surgery is a key inflection point for Paradromics. We are now a clinical-stage company.
“We’ve known for some time, based on our preclinical studies, that we have developed a world-class BCI platform. Now with the jump to human surgeries and recordings, we are closer to translating this neurotechnology to patients.”
