24 August 2021

While Neuralink is experimenting…

In the USA, human trials of a neurointerface implant are allowed

Sergey Syrov, XX2 century

Perhaps, in the near future, the installation of an implantable brain-computer interface in the United States will become an available option when choosing a strategy for helping paralyzed people. Synchron has announced that it has received FDA approval for testing its main product – Stentrode (Stentrode, "stent" + "electrode"). The safety and effectiveness of the device will be tested in one of the oldest American clinics – Mount Sinai in New York (Mount Sinai Hospital). Patients with severe cases of paralysis will be able to control various electronic devices, which should significantly improve their quality of life.

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The scheme of using a stentrode in the brain-computer interface (image: Dr. Thomas Oxley).

"The approval of this study was the result of long-term safety tests conducted jointly with the FDA. Together we are paving the way for the first approval of a permanently implanted neural interface for the treatment of paralysis. We are very excited to finally launch clinical trials in the USA this year," says Synchron CEO Thomas Oxley.

What makes the Stentrode neural interface project stand out among competitors? Founded by Elon Musk Neuralink continues to experiment on animals, and Synchron has already successfully tested the technology on four Australian volunteers. The fact is that installing the chip developed by Oxley's team does not require open-brain surgery. A sensor in the form of a mesh metal tube enters the brain through a vein – a two-hour operation is performed under local anesthesia. The implant is located deep in the skull and transmits the read signals via a wire to the chest, where a wireless communication module is installed. According to Oxley, the stent can be installed in almost any part of the brain and it will read exactly the signals that are needed.

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A stentrode in a blood vessel near the brain. A screenshot from the video on YouTube.

"Our first goal is a motor cortex for the treatment of paralysis, this is a great unmet need of millions of people around the world and market prospects of $ 20 billion"  Oxley says.

Six patients of the Mount Sinai Clinic in New York will be selected for experiments with Stentrode at the end of this year. Work is also continuing in Australia, where four study participants were able to communicate and use Internet services using the equipment provided by Synchron.

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