The company expects to launch a trial of its Connexus BCI system in late 2025, following the receipt of regulatory approval. Connexus has the potential to help patients communicate after losing the ability to speak and control computer devices. It translates recorded brain signals into actionable health data.
Initially, the Austin, Texas–based company’s focus centers around restoring independent communication through digital devices for individuals living with spinal cord injuries, stroke, or ALS, a motor neuron disease.
To conduct the study, Paradromics selected Dr. David Brandman as principal investigator and Dr. Daniel Rubin as investigator. Brandman serves as a neurosurgeon and assistant professor in the Department of Neurological Surgery at UC Davis Sacramento. Rubin is a critical care neurologist at Massachusetts General Hospital and an assistant professor of neurology at Harvard Medical School.
Paradromics labeled both investigators “recognized leaders in clinical BCI technology.” The company says they specialize in developing neurotechnology for people with paralysis and disorders of communication.
Paradromics expects the study to enroll people with speech impairment due to progressive neuromuscular diseases or neural injuries with severe paralysis in all four limbs at two sites in the U.S.
The study will evaluate device safety and its ability to restore communication for people living with amyotrophic lateral sclerosis or stroke. Brandman called the research “an important step” for the field of BCI technology to see how users can communicate through synthesized speech and text.
More about Paradromics and BCI
Paradromics also plans to develop future applications for mental health conditions, such as mood disorders and chronic pain. 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.
Last month, Paradromics announced that it received a strategic investment from NEOM, a region taking shape in Saudi Arabia. As part of the agreement, NEOM and Paradromics intend to establish a BCI Center of Excellence within the region. They seek to spearhead ambitious clinical research and eventually serve as the premier center for BCI-based healthcare in the MENA region and beyond.
Paradromics’ latest investment marks another sign of the ever-growing BCI space. 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.
