Paradromics announced today that it successfully completed the first-in-human procedure with its Connexus brain-computer interface (BCI).
University of Michigan neurosurgeon and biomedical engineer Dr. Matthew Willsey, with senior epilepsy surgeon Dr. Oren Sagher and with a multidisciplinary team of clinicians and engineers, led the first surgical placement of the device. This milestone further advances research into the potential of intracortical BCIs in brain therapeutics, according to a news release.
Willsey and the team demonstrated the safe implantation of the Connexus system. Their procedure saw the device record electrical brain signals, followed by a fully intact removal in less than 20 minutes. The removal utilized surgical techniques familiar to neurosurgeons worldwide, Paradromics said.
Investigators implanted Connexus during an epilepsy resection surgery to better understand how epilepsy influences brain signaling. Paradromics says the procedure confirms the ability to use Connexus in humans, following nearly three years of preclinical studies.
This first-in-human procedure marks the company’s entry into the clinical stage. comes as Paradromics readies for the launch of a clinical trial set to start later this year.
“This surgery is a key inflection point for Paradromics. We are now a clinical-stage company,” said Matt Angle, CEO and founder of Paradromics. “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.” This procedure is the first of many surgeries planned over the next several months.
More about the Paradromics Connexus system and BCIs
Paradromics designed Connexus to potentially help patients communicate after losing the ability to speak and control computer devices. The Austin, Texas-based company’s technology translates recorded brain signals into actionable health data. Its initial focus centers around restoring independent communication through digital devices for individuals living with spinal cord injuries, stroke, or ALS, a motor neuron disease.
The fully implantable BCI can record from single neurons, using durable materials and packaging. Advantages could include the ability to obtain high-resolution data over long periods of time. This data can enable complex applications like decoding intended speech.
The company was accepted into the FDA Total Product Life Cycle Advisory (TAP) program in July 2024. In preparation for a clinical trial in 2025, the company also launched a patient registry so patients can submit interest. The company featured on MassDevice’s 2024 lists of BCI companies to know and neurotech companies to know.
The BCI space continues to burgeon as companies like Neuralink, Synchron and Blackrock Neurotech have long been seen as the leaders, but a number of companies aim to be the first to bring a BCI to market. Analysts said last year that they see a massive market opportunity for the technology.
