Paradromics is one step closer to getting US Food and Drug Administration approval for commercial approval of its brain chip that will treat paralyzed patients and restore their ability to communicate.
It comes after his fast-growing team of nearly 50 scientists and engineers at a neurotech start-up caught the attention of federal regulators.
Paradomix, founded in 2015, is developing a brain chip that could help severely paralyzed patients regain their ability to communicate by deciphering their neural signals. Today, Thursday, the Austin, Texas-based company announced that it has received a designation for its innovative device under the FDA’s Breakthrough Device Designation program, which precedes emergency use of vaccines and drugs.
The company named its device “Connexus Direct Data Interface”.
CEO Matt Angel said the latest approval, as well as $33 million in funding, will help Paradomix bring its devices to market.
Paradomix is part of the emerging industry of brain-computer interfaces, or BCI, a system that decodes brain signals and translates them into commands for external devices. Experts believe that one day these systems will help treat diseases such as blindness and mental illness.
Perhaps the most famous name in the industry is Neuralink, thanks to the high profile of its co-founder Elon Musk, who is also the CEO of Tesla, SpaceX and Twitter.
Scientists have been studying BCI technology for decades, and several companies have developed promising systems that they hope to bring to market. But getting Food and Drug Administration (FDA) approval for a commercial medical device is no easy task—it requires companies to conduct several very rigorous rounds of testing and successfully collect safety data, according to CNBC, which was reviewed by Al Arabia.net.
As of May, no BCI companies have been able to obtain final approval from the Food and Drug Administration.
It is noteworthy that the Paradomix device works as an auxiliary means of communication, translating nerve signals into text or complex speech. An array of small electrodes is implanted directly into brain tissue, where they measure and decode brain signals, which are eventually transmitted to external devices via a transceiver located under the skin in the chest.
Angel said his company’s BCI is 10 years old and will initially be used to help patients who have lost the ability to communicate physically. The device would require invasive brain surgery, but Angel said the quality of nerve signals that can be measured will allow patients to communicate at a faster and more natural speed than non-invasive BCI devices such as those developed by competitor Synchron.
The U.S. Food and Drug Administration granted 32 such designations in fiscal year 2023, according to its website.
Engel said the appointment will help create a “fast track” between the administration and Paradomics, which could be key to getting regulatory approvals for future clinical trials faster.
The company is currently conducting animal safety trials, and data from those trials will help the FDA decide whether to approve the human study. Angel said Paradomix hopes to begin its first human clinical trial in the first half of 2024.
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