Brain implant Paradromics launches patient registry

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Good morning! 

This Fourth of July week kicked off with some announcements in the neurotech field. 

The brain implant startup Paradromics is taking steps to prepare for its first in-human trial next year, and the company announced on Monday that it has launched its official patient registry. 

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

Paradromics’ system will initially serve as an assistive communication device that can turn brain signals into outputs like text or synthesized speech. This means 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 been developing their own systems. The companies’ designs and ambitions all vary, but the industry has heated up in recent years thanks to investment from prominent backers like Musk, Microsoft co-founder Bill Gates and Amazon founder Jeff Bezos.

Gates and Bezos’ investment firms have contributed financing to a BCI company called Synchron. 

Paradromics’ BCI is designed to be inserted directly into the brain tissue, which means patients who want the implant will have to undergo major surgery. While the procedure will always come with risks, CEO Matt Angle told CNBC last year that the quality of the neural signals Paradromics can measure will allow patients to communicate at a faster and more natural rate than they could with a less invasive BCI. 

The company still has to undergo rigorous testing with the U.S. Food and Drug Administration before its technology will be commercially available. It aims to carry out its first in-human trial in 2025, and patients can demonstrate interest in participating through Paradromics’ new registry.

Paradromics also announced that it had been accepted to the FDA’s Total Product Life Cycle Advisory Program, or TAP, 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 granted to medical devices that have the potential to provide improved treatment for debilitating or life-threatening conditions. Paradromics has earned the Breakthrough Device designation twice, according to a release.

The FDA can be slow to respond or difficult to reach since it is often working with thousands of organizations at a time. 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 on the safest possible timeline, and so we appreciate access to the TAP program,” Angle said in the release. 

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Medicare Advantage insurers’ stocks rallied the morning after the first presidential debate, as investors speculated about a Trump win in November leading to a more favorable regulatory outlook for companies. New reimbursement and star bonus rules from the Centers for Medicare and Medicaid Services have weighed on Medicare Advantage plan margins.

But CVS Health, Cigna and UnitedHealth Group have also seen pressure on their pharmacy benefits units from a number of bipartisan bills introduced in both houses of Congress and growing public scrutiny over their role in setting the drug prices patients pay. Regardless of who wins the White House, the pressure on PBMs isn’t likely to go away.

Feel free to send any tips, suggestions, story ideas and data to Bertha at [email protected].