Synchron Announces Long-Term Safety Results from Fully Implanted Endovascular Brain-Computer Interface Stentrode™ for Severe Paralysis

Synchron, a brain-computer interface (BCI) company, today announced the results from a study in which four people with ALS received an implant of Synchron’s Stentrode™ device, a small mesh-like material inserted within a patient’s blood vessel that doesn’t require invasive open-brain surgery.

The results were presented today as part of an exclusive press briefing highlighting breakthrough science at the American Academy of Neurology’s 74th Annual Meeting, held in Seattle, Washington (April 2-7) and virtually (April 24-26).

Researchers monitored participants for one year and found the device to be safe, with no serious adverse events that led to disability or death. Stentrode™ also stayed in place for all four patients and the blood vessel in which the device was implanted remained open. Receiving the Stentrode™ implant allowed participants to use a computer to communicate by text and perform daily tasks such as online shopping and banking.

“People with ALS eventually lose their ability to move their limbs, making them unable to operate devices like a phone or computer,” said study author Bruce Campbell, MD, MS, of the University of Melbourne in Australia and member of the American Academy of Neurology. “Our research is exciting because while other devices require surgery that involves opening the skull, this brain-computer interface device is much less invasive. It receives electrical signals from the brain, allowing people to control a computer by thought.”

Rather than drilling through the skull, the Stentrode™ is fed through a patient’s vein until it reaches the brain. The device, comprised of a net-like material with 16 sensors attached, expands to line the vessel wall. That device is connected to an electronic device in the chest that then relays the brain signals from the motor cortex, the part of the brain that generates signals for movement, into commands for a laptop computer.

“These results are a huge advancement for the field of BCI. We’ve shown that our endovascular BCI approach is safe, and allows patients to accomplish daily online tasks without invasive brain surgery,” said Thomas Oxley, MD, PhD, CEO & Co-Founder at Synchron. “Years of research and technological development culminated in this moment, and as we continue to develop our technology, it has the potential to change the lives of millions of patients globally who suffer from paralysis and other debilitating neurological and brain-related diseases.”

The study was supported by Synchron, in addition to the U.S. Defense Advanced Research Projects Agency, the Office of Naval Research, the National Health and Medical Research Council of Australia, the Australian Federal Government Foundation and the Motor Neurone Disease Research Institute of Australia.

Synchron is the only company to receive FDA approval to conduct clinical trials of a permanently implanted BCI. The company’s novel BCI technology leverages the blood vessels as the natural highways to the brain. Synchron is continuing this study in both the United States and Australia, and is opening the study to larger groups of patients.

About the Stentrode™

Synchron’s flagship technology, the Stentrode, is an endovascular brain implant designed to enable patients to wirelessly control digital devices through thought and improve functional independence. Synchron’s foundational technology, a motor neuroprosthesis (MNP), is implanted via the jugular vein using common neurointerventional techniques, and does not require drilling into the skull or open brain surgery. The system is designed for patients suffering from paralysis as a result of a broad range of conditions, and aims to be user friendly and dependable for patients to use autonomously.

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