Paradromics Launches Patient Registry for Brain Implant Trial

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The week leading up to the Fourth of July was marked by several developments in the field of neurotechnology.

Paradromics is preparing for its first in-human trial next year by launching an official patient registry.

Since its establishment in 2015, Paradromics has been developing a brain-computer interface (BCI) known as the Connexus Direct Data Interface. This BCI translates brain signals into commands that can control external technologies.

The system developed by Paradromics will initially function as an aiding tool that converts brain signals into outputs such as text or synthesized speech. As a result, patients with severe paralysis may eventually regain their ability to communicate through this device.

For many years, BCIs have been studied in academia, and now, several companies, including Neuralink, developed their own systems. Although their designs and aspirations differ, the industry has gained momentum due to investment from prominent backers like Musk, Gates, and Bezos.

Synchron, a BCI company, has received funding from the investment firms of Gates and Bezos.

The BCI of Paradromics is intended to be directly inserted into brain tissue, necessitating major surgery for patients who wish to receive the implant. Despite the inherent risks associated with the procedure, CEO Matt Angle stated in an interview with CNBC last year that the neural signals that Paradromics can measure will enable patients to communicate at a faster and more natural rate than they would with a less invasive BCI.

Before its technology can be commercially available, the company must undergo rigorous testing with the U.S. Food and Drug Administration. The company plans to conduct its first in-human trial in 2025, and patients can express their interest in participating through Paradromics' new registry.

On Monday, Paradromics announced that it had been accepted into the FDA's Total Product Life Cycle Advisory Program, or TAP.

The FDA's TAP program is intended to streamline communication with companies that have received the agency's Breakthrough Device designation, which is given to medical devices that offer significant benefits for debilitating or life-threatening conditions. According to a statement, Paradromics has received this designation twice.

By working with thousands of organizations simultaneously, the FDA can be slow to respond or difficult to reach. However, Paradromics' access to an open line of communication through TAP will facilitate communication between the company and the agency.

"To ensure the safest timeline and deliver the best device, we value access to the TAP program," Angle stated in the release.

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Biden's debate performance shifts regulatory outlook

Medicare Advantage plan margins have been negatively impacted by new reimbursement and star bonus rules from the Centers for Medicare and Medicaid Services. However, the stocks of Medicare Advantage insurers 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.

Despite the upcoming White House election, the pressure on Pharmacy Benefit Managers (PBMs) to lower drug prices for patients is unlikely to decrease.

Rewritten sentence: Please provide any tips, suggestions, story ideas, and data to Bertha at [email protected].