Paradromics Submits IPO Prospectus Following FDA Approval for First Long-Term Brain-Computer Interface Clinical Trial

[News Report] U.S. brain-computer interface company Paradromics recently announced that its brain-computer interface (BCI) has received approval from the U.S. Food and Drug Administration (FDA) to conduct its first long-term clinical trial.

According to Nature, early next year, Paradromics, one of the biggest competitors to Neuralink, the brain-computer interface company owned by American entrepreneur Elon Musk, will implant BCIs in two volunteers who have lost their ability to speak due to neurological disorders or accidental injuries. The trial has two major objectives: first, to ensure the safety of the device, and second, to restore patients' real-time verbal communication capabilities.

Paradromics’ BCI features an effective area approximately 7.5 millimeters in diameter, with built-in slender and rigid platinum-iridium alloy electrodes. When these electrodes penetrate the surface of the cerebral cortex, they can record the activity of individual neurons at a depth of about 1.5 millimeters. The electrodes are connected via wires to a power source and wireless transceiver implanted in the patient’s chest.

Matt Angle, CEO of Paradromics, stated that this is the first BCI clinical trial aimed at synthetic speech generation. “It can be said that the most significant improvement BCIs can currently offer to patients’ quality of life is the restoration of their ability to communicate through speech.”

The trial will also explore whether neural activity during volunteers’ imagined hand movements can be precisely detected, thereby enabling them to control a computer cursor via thought. Based on preliminary results, the trial may be expanded to include 10 volunteers, who will receive two cortical implants to enhance signal richness and cover broader brain regions.

“I am very curious about this; it is an exciting step,” said Mariska Vansteensel of the University Medical Center Utrecht in the Netherlands.

In addition to Paradromics, the U.S. company Synchron is also making rapid progress in the field of brain-computer interfaces (BCIs). Its device, the Stentrode, is based on an endovascular stent equipped with 12 to 16 electrodes, enabling the recording of neuronal population activity from within blood vessels. In contrast, Neuralink prioritizes the acquisition of high-bandwidth data by recording output signals from a large number of individual neurons. Its BCI comprises 64 flexible polymer threads, each featuring 16 recording sites.

Each company is committed to making the implantation process minimally invasive and the devices replaceable. Angle stated that in this trial, Paradromics “will simultaneously focus on safety, durability, and data transmission rates.” “The extra-cortical information transmission rate achieved by the device is approximately 20 times that of other devices, and we believe the device’s lifespan should exceed 10 years.”

As long-term clinical trials progress, clinicians and neuroscientists will closely monitor and compare the efficacy of various devices. Vansteensel stated that he hopes companies will maintain full transparency and make their devices available to the academic community to facilitate independent research. (Wang Fang)