A growing team of about 50 employees at neurotech startup Paradromics is working to develop science fiction-like brain implants. And it caught the attention of federal regulators.
Founded in 2015, Paradromics is developing a device that can help restore the ability to communicate by decoding nerve signals in severely paralyzed patients. And on Thursday, the Austin, Texas-based company said: announced that you have received breakthrough device Designated by the Food and Drug Administration for its flagship system called Connexus Direct Data Interface.
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CEO Matt Angle said the designation will help bring Paradromix’s devices to market, in addition to the $33 million funding the company announced on Thursday.
Paradromics is part of the emerging Brain Computer Interface (BCI) industry. BCI is a system that decodes brain signals and translates them into commands for external technology. Experts believe the system could one day help treat ailments such as blindness and mental illness.
Perhaps the best-known name in this space is Neuralink. This is due to the high profile of co-founder Elon, who is also his CEO of Tesla, SpaceX and Twitter, in his mask.
Scientists have been studying BCI technology for decades and have developed promising systems that several companies hope to bring to market. However, obtaining FDA approval for a marketed medical device is not an easy task. Companies have to go through several rounds of very thorough testing and data security collection in order.
As of May, no BCI companies have received final FDA approval.
Paradromics’ BCI, Connexus Direct Data Interface, is an assistive communication device that converts neural signals into text or synthesized speech. A series of tiny electrodes are implanted directly into the brain tissue where they measure and decode brain signals, which are ultimately transmitted to an external device via a transceiver under the skin on the chest.
“It’s basically taking some of the things that have been successful in clinical trials and making them better from an engineering standpoint,” Angle said in an interview with CNBC.
Paradromics scientist working
Source: Paradromics
Angle said the company’s BCI is designed to last about 10 years and will initially be used to help patients who have lost their physical ability to communicate. Although the device requires invasive brain surgery, Angle says the quality of the nerve signals it can measure makes it more patient-friendly than a minimally invasive BCI like the one being developed by Paradromics competitor Synchron. said they could communicate faster and at a more natural rate. .
So far, regulators seem to be on board with Paradromics’ approach. The FDA’s Breakthrough Device designation is given to medical devices that may provide improved treatment for debilitating or life-threatening conditions.
authorized by the agency 32 of these designations According to the company’s website, so far it’s scheduled for fiscal year 2023.
Angle said the designation will help create a “fast track” for communication between FDA and Paradromics. This is an advantage that could be key to getting regulators to approve future clinical trials more quickly.
The company is currently conducting animal safety studies, and data from those studies will help the FDA decide whether to approve human studies. Angle said Paradromics hopes to begin its first clinical trials in human patients in the first half of 2024.
The startup’s new $33 million funding round was led by Prime Movers Lab.
“It’s a beautiful story,” Prime Movers Lab founder and general partner Dakin Sloss said in an interview with CNBC. “And it’s real technology that works today. It’s not a 10-year-old pipe dream.”
Angle said it’s an exciting time in the BCI space, especially with several companies working to differentiate themselves in an industry he estimates will generate billions of dollars in value. But while it’s easy to get excited about BCI’s future capabilities, Angle believes a lot of good is already possible.
“A lot of people get excited about futuristic kind of speculative applications, but the reality of brain-computer interfaces is, in some ways, more exciting,” he said. “Without it, we can change what could be a very difficult problem in brain health.”
