Paradromics, a company seeking to build direct data interfaces with the human brain, earned a breakthrough device designation from the Food and Drug Administration (FDA), which will grant the firm an expedited review process to incorporate the technology into medical applications.
The company is seeking to develop an implanted brain-computer interface, also called a BCI, that can function outside of a laboratory to assist patients who lose the physical ability to speak or type, such as those impacted by spinal cord injuries and strokes. The designation from the FDA occurs as Paradromics, which has received $47 million in venture funds and $18 million in federal funds to advance the technology, announces an additional $33 million funding round.
“This designation recognizes the transformative promise of our device, and we look forward to continued coordination with the FDA to accelerate its availability,” Paradromics CEO Matt Angle said in a press release. “And this investment validates our leadership position among the small group of BCI platform companies on the verge of commercialization.”
Paradromics will also seek to address motor and sensory deficits, chronic pain, and mood disorders, as well as treatment-resistant mental illnesses, which the company says represents a $240 billion market in the United States.
Other ventures have noted the various potential applications for brain implants: Neuralink, the brain-computer interface firm started by Elon Musk, also received FDA breakthrough designation for its technology three years ago. The company has repeatedly claimed that human trials would imminently start, although Neuralink has not yet received FDA authorization for the move, according to a recent investigative report from Reuters.
Neuralink posted a job advertisement last year for individuals who would “work closely with some of the most innovative doctors” on the company’s first clinical trials, as well as help to “build the team responsible for enabling Neuralink’s clinical research activities and developing the regulatory interactions that come with a fast-paced and ever-evolving environment.”
The worldwide market specific to brain implants is expected to witness a compound annual growth rate above 9% over the next five years, according to an analysis from Grand View Research. The growing population of senior citizens, who are more likely to suffer from diseases such as Parkinson’s and Alzheimer’s, is expected to serve as a key market for the technology.
Deep brain stimulators, which send electrical impulses through electrodes implanted in the brain, currently occupy the largest market share in the broader brain implant space. Increased awareness of the treatment options for neurological movement disorders is expected to accelerate growth in the segment. Vagus nerve stimulators, which send impulses to the brain through the vagus nerve, are expected to grow at the fastest annualized rate.
News of the advancements in brain-computer interface technology comes as firms rush to develop artificial intelligence solutions. Researchers at the University of Texas in Austin unveiled a system earlier this month which uses AI to transform a person’s brain activity into written words. The “semantic decoder” learns how to translate thoughts as the person listens to podcasts and the system concurrently measures brain activity, then produces text that mirrors the meaning of the individual’s thoughts. The system does not require implants but is impractical for use outside of a laboratory.
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