Less than four months after securing strategic investments from Saudi Arabia’s Neom, Texas-based Neurotech startup paradromics successfully ported a brain computer interface (BCI) to humans on Monday.
This procedure took place on May 14th at the University of Michigan. A patient already undergoing neurosurgery for epilepsy has become the first to receive a Connex BCI for Paradromics. The device was implanted and removed in about 20 minutes during the scheduled surgery.
Paradromics completes the first human brain implant
Paradromics says the test confirmed two important things: The technology is safe to implant in the human brain and allows you to record meaningful neural activity. For startups that have been around for nearly a decade, this represents a key step towards the next stage as a clinical stage company.
The company plans to start clinical trials later this year, with regulatory approval pending. This test evaluates the long-term safety and performance of devices used in the real world.
“Our device showed sheep that it is best for their class in terms of data and longevity. Now it also showed that it is human compatible,” Matt Angle, founder and CEO of Paradromics, told CNBC. “It’s really exciting and brings a lot of excitement for future clinical trials.”
BCIS converts brain signals into commands that allow people to interact with external devices. Paradromics targets patients with severe motor disorders, individuals who may not be able to speak. The idea is that they can ultimately communicate using computers driven by their ideas.
The Connexus system has not yet been cleared by the FDA. However, this early stage success gives the company confidence as it moves towards a wider range of testing. Paradromics will also be a more direct competition with Neuralink, the much-exaggerated BCI startup founded by Elon Musk, and other emerging players like Synchron and Precision Neuroscience.
Paradromics’ approach focuses on recording brain activity at the level of individual neurons. Angle compared it to placing the microphone inside the stadium rather than outside. It picks up not only general noise, but also fine details.
This procedure was part of a research collaboration between Paradromics and the University of Michigan. Dr. Oren Sagher oversaw the surgical part, while Dr. Matthew Willsey handled the research side, including the placement of the BCI device, CNBC reported.
“It’s absolutely thrilling,” Wilsey said, according to CNBC. “It’s motivated. It’s kind of like getting up in the morning and going to work.”
“Neurosurgeon Matthew Wilsey placed a smaller tip on the brain of a patient’s brain, a smaller penny, placed on the brain of a patient’s brain, and placed it there for 10-15 minutes. Half the diameter of a human hair pierced the brain tissue.
The agency’s ability to test unapproved medical devices comes through pathways that allow for research use, as long as it can reasonably assure patient safety. This is how Paradromics will implement the procedure without full FDA approval.
According to Pitchbook, Paradromics raised nearly $100 million in funding and announced a partnership with Saudi Arabia’s Neom in February. The investment amount has not been revealed, but it shows growing interest in BCI technology outside of Silicon Valley.
In the case of angles, this milestone was not merely technical verification, but personal.
“We’re going to do all these steps and verify the hardware. There’s a very high and reasonable certainty that things work,” he said. “But still emotionally, when it works and it happens the way you expected it, it’s still very, very pleased.”
Currently, human testing is underway, and Paradromics is stepping out of the lab and stepping into a more competitive space.
Paradromics is one of several companies in the race to bring BCIS to the market, along with celebrities like Elon Musk’s Neuralink. Earlier this month, Neuralink shared that it had implanted the technology in three human patients. Other players in the space include precision neuroscience and syncron, the latter backed by Jeff Bezos and Bill Gates, both of which carry human implants.
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