Brain implant company Paradromics one step closer to FDA approval

A growing team of nearly 50 employees on the neurotech startup Paradromics is working on a brain implant that feels like the work of science fiction. And it has caught the eye of federal regulators.

Paradromics, founded in 2015, is developing a tool that would help patients with severe paralysis regain their ability to speak by deciphering their neural signals. And on Thursday, the Austin, Texas-based company announced that it has received the Breakthrough Device designation from the Food and Drug Administration for its flagship system, called the Connexus Direct Data Interface. 

CEO Matt Angle said the designation, along with a $33 million funding round the corporate also announced Thursday, will help Paradromics bring its device to market.  

Paradromics is an element of the emerging brain-computer interface, or BCI, industry. A BCI is a system that deciphers brain signals and translates them into commands for external technologies. Experts consider the systems could someday help treat maladies like blindness and mental illness.   

Perhaps the best-known name within the space is Neuralink, due to the high profile of its co-founder Elon Musk, who can also be the CEO of Tesla, SpaceX and Twitter.

Scientists have been studying BCI technology for many years, and several other corporations have developed promising systems that they hope to bring to market. But receiving FDA approval for a industrial medical device isn’t any small task — it requires corporations to successfully conduct several extremely thorough rounds of testing and data safety collection.

As of May, no BCI company has managed to clinch the FDA’s final seal of approval.

Paradromics’ BCI, the Connexus Direct Data Interface, is an assistive communication device that translates neural signals into text or synthesized speech. An array of tiny electrodes is implanted directly into the brain tissue, where it measures and deciphers brain signals which are ultimately emitted to external devices through a transceiver that sits under the skin within the chest. 

“It’s essentially taking a number of the things which have been successful in previous clinical trials, after which improving on them from an engineering standpoint to make them higher,” Angle told CNBC in an interview. 

Angle said the corporate’s BCI is designed to last around 10 years and can initially be used to assist patients who’ve lost their ability to physically communicate. The device would require invasive brain surgery, but Angle said the standard of the neural signals it might probably measure will allow patients to speak at a faster and more natural rate than they might with a less invasive BCI, just like the one being developed by Paradromics competitor Synchron. 

Thus far, regulators appear to be on board with Paradromics’ approach. The FDA’s Breakthrough Device designation is granted to medical devices which have the potential to supply improved treatment for debilitating or life-threatening conditions.

The agency has granted 32 of those designations in fiscal 2023 to this point, based on its website. 

Angle said the designation will help create a “fast track” for communication between the FDA and Paradromics. It’s a bonus that might be key for getting regulators to more quickly approve future clinical trials. 

The corporate is currently conducting animal safety trials, and the information from those trials will help the FDA determine whether to approve an in-human study. Angle said Paradromics is hoping to launch its first clinical trial with human patients in the primary half of 2024. 

The startup’s recent $33 million funding round was led by Prime Movers Lab.

“It’s an exquisite story,” Prime Movers Lab founder and general partner Dakin Sloss told CNBC in an interview. “And it’s an actual technology that is working now, today. It isn’t like a pipe dream that you simply gotta wait 10 years for.”

Angle said it’s an exciting time within the BCI field, especially as multiple corporations are working to differentiate themselves in an industry that he estimates will create billions of dollars in value. But while it is simple to get excited concerning the future capabilities of BCIs, Angle believes quite a lot of good can already be done. 

“Plenty of persons are excited concerning the futuristic, type of speculative applications. But the truth of brain-computer interfaces is, in some ways, more exciting,” he said. “It might transform what would otherwise be really difficult problems in brain health.”