Unlocking the natural highways of the brain: Synchron

The Silicon Review

Synchron is a clinical-stage endovascular brain-computer interface (BCI) company. Since 2012, the company has been developing a BCI platform that avoids the need for open brain surgery by using a minimally-invasive procedure. The Synchron Switch™ BCI received FDA Breakthrough Device Designation in 2020, and is currently in human clinical trials in the US and Australia. Synchron has been published in multiple peer-reviewed journals including JAMA Neurology, Nature Biotechnology, Nature Biomedical Engineering, and JNIS. Synchron is based in Brooklyn, New York with R&D facilities in Melbourne, Australia.

Synchron’s flagship technology, the Stentrode, is an endovascular brain implant designed to enable patients to wirelessly control digital devices through thought to improve functional independence. Synchron’s foundational technology, a motor neuroprosthesis, or motor BCI, is implanted via the jugular vein using neurointerventional techniques commonly used to treat stroke, and does not require 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.

The Endovascular Solution

Synchron’s team has collectively spent decades studying these pathways and the application of its technology with an endovascular surgical procedure. Synchron has solved how to deliver electronics into the wall of the blood vessel, giving it access to an unprecedented amount of data from untouched areas of the brain. Applications of Neuro EP will fundamentally change how we study, diagnose, and treat the brain. Neurointerventional Electrophysiology (Neuro EP) is a new field of medical science that combines and elevates three existing areas of research: neuroprosthetics, neuromodulation, and neurodiagnostics.

Synchron’s Neuro EP platform is built on the stentrode™, an endovascular electrode array. It is designed to record or stimulate the brain or nerves from within the blood vessels. The device is designed to become incorporated into the wall of the blood vessel like a tattoo. Similar to a stent, it is designed not to cause long term inflammation or trauma to the brain. The stentrode™ is the key to our platform.

First human BCI implant

Synchron, an endovascular brain-computer interface (BCI) company, announced the first human BCI implant in the United States. This procedure represents a significant technological milestone for scalable BCI devices and is the first to occur in the U.S. using an endovascular BCI approach, which does not require invasive open-brain surgery. The procedure was performed at Mount Sinai West in New York, led by clinical investigator Shahram Majidi, MD, assistant professor of neurosurgery, neurology and radiology at the Icahn School of Medicine at Mount Sinai. The procedure was performed in the angiography suite with a minimally invasive, endovascular approach. Mount Sinai’s Department of Rehabilitation and Human Performance helped coordinate the procedure. The procedure marks the first U.S. patient implant in Synchron’s COMMAND trial, which is being conducted under the first investigational device exemption (IDE) awarded by the FDA to a company assessing a permanently implanted BCI. The U.S.-based trial is being conducted with support from the NIH Neural Interfaces Program.

The COMMAND study will assess the safety and efficacy of the company’s motor BCI technology platform, including the Stentrode™, in patients with severe paralysis with the goal of enabling the patient to control digital devices hands-free. Study outcomes include the use of brain data to control digital devices and achieve improvements in functional independence. “This is an incredibly exciting milestone for the field, because of its implications and huge potential,” said Shahram Majidi, MD, the neurointerventional surgeon who performed the procedure, and assistant professor of neurosurgery, neurology and radiology at the Icahn School of Medicine at Mount Sinai. “The implantation procedure went extremely well, and the patient was able to go home 48 hours after the surgery."

“We are beyond excited to get to work with our patient, guiding them through the training process as they learn to use this device to live more independently and, most importantly, communicate with their family and friends,” said David Putrino, PhD, PT, Director of Rehabilitation Innovation for the Mount Sinai Health System and a Principal Investigator of the COMMAND study.

The Stentrode is implanted within the motor cortex of the brain via the jugular vein in a minimally-invasive endovascular procedure. Once implanted, it detects and wirelessly transmits motor intent using a proprietary digital language to allow severely paralyzed patients to control personal devices with hands-free point-and-click. The trial will assess the impact of everyday tasks such as texting, emailing, online shopping and accessing telehealth services, and the ability to live independently. The FDA granted Breakthrough Device designation to Synchron in August 2020. Synchron will continue to advance enrollment in its COMMAND trial as the industry-first FDA-approved clinical trial for a permanently implanted BCI in the U.S. Recently reported long-term safety results have demonstrated this technology to be safe in four patients out to 12 months in Synchron’s SWITCH trial in Australia, as reported at the 2022 American Academy of Neurology Conference.

Tom Oxley, CEO