Paradromics Launches Registry for Patients After Brain Implants

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This year's Fourth of July week kicked off with some neurotech announcements.

Paradromics, a startup that specializes in brain stem cell transplantation, is preparing for its first human trial next year, and the company announced Monday that it had launched its official patient registry.

Founded in 2015, Paradromics is building a brain-computer interface, or BCI, called Connexus Direct Data Interface. A BCI is a system that decodes brain signals and translates them into commands for external technologies.

The Paradromics system will initially work as a communication aid that can convert brain signals into outputs such as text or synthetic speech. This means that patients with severe paralysis could eventually use it to regain their ability to communicate.

BCIs have been studied in academia for decades, and several other companies, including Elon Musk’s Neuralink, have developed their own systems. The companies’ designs and ambitions vary, but the industry has boomed in recent years thanks to investment from high-profile backers like Musk, Microsoft co-founder Bill Gates, and Amazon founder Jeff Bezos.

Gates and Bezos' investment firms helped fund a BCI company called Synchron.

Paradromics’ BCI technology is designed to be inserted directly into brain tissue, meaning patients who want to get it implanted would have to undergo major surgery. While the procedure will always be risky, CEO Matt Angel told CNBC last year that the quality of neural signals Paradromics can measure will allow patients to communicate at a faster, more natural rate than they could with a less invasive BCI.

The company still has to go through rigorous testing with the FDA before its technology becomes commercially available. The company is targeting the first human trial in 2025, and patients can show interest in participating through the new Paradromics registry.

Paradromics also announced its acceptance into the FDA's Whole Product Life Cycle Advisory Program on Monday.

TAP is designed to help expedite communication between the FDA and companies that have already received the agency’s Breakthrough Device designation, which is given to medical devices that have the potential to provide improved treatment for debilitating or life-threatening conditions. Paradromics has received Breakthrough Device designation twice, according to a press release.

The FDA can be slow to respond or difficult to reach because it often works with thousands of organizations at once. As a result, Paradromics’ access to an open line of communication through TAP will help the company and the agency stay on the same page.

“We want to deliver the best possible device in the safest timeline, which is why we appreciate access to the TAP program,” Angel said in the statement.

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