Neurovascular bioelectronics medicine company Synchron Inc. has received good news in the form of a breakthrough device designation for its Stentrode. The U.S. FDA granted the designation for the fully implantable medical device that can translate brain activity or stimulate the nervous system from inside a blood vessel. As a bonus for patients, the device does not require open brain surgery.

“As this is a first-of-its-kind device, we look forward to working closely with the FDA to prioritize development of the Stentrode and ensure access for patients with paralysis, as well as lay the groundwork for future indications for brain-computer interfaces,” said Thomas Oxley, CEO of Synchron.

Of note, the Campbell, Calif.-based company’s technology relies on a brain-controlled, hands-free app platform called BrainOS to translate the brain activity into a standardized digital language, directly through thought, to control apps that restore communication and limb function. It also includes Brainport, a wireless solution implanted in the chest that provides neural data transmission.

The device has already been implanted in individuals with upper-limb paralysis and is being evaluated for its ability to enable patients with paralysis to regain functional independence by control of digital devices through thought alone. It is inserted via a catheter into the jugular vein and maneuvered into the brain. Sensors are built onto a self-expanding stent that engages into the wall of the brain and is designed to maintain blood flow. Over time, cells may grow over the sensors and incorporate them into the tissue. The sensors are placed next to the motor cortex in the brain, and the patient's motor control center can be activated by thinking.

Safety and efficacy data from an ongoing first-in-human clinical trial will aim to finalize the protocol for a pivotal study that will guide evaluation for a U.S. approval. Looking ahead, the company is eyeing research for Stentrode’s use in patients with paralysis due to spinal cord injury, ALS, stroke and muscular dystrophy.

In addition, preclinical studies have demonstrated the long-term safety as well and ability to pick up specific electrical frequencies emitted by the brain. Synchron has teamed up with the University of Melbourne to publish scientific results in Nature Biotechnology, Nature Biomedical Engineering and the Journal of Neurosurgery. Synchron was spun out of the university.

Word of the agency’s action comes roughly a month after the company said it had won almost AU$1 million (US$735,203) in funding from the Medical Research Future Fund, through MTPConnect, the Australian Government’s Biomedtech Horizons program, to advance the commercialization of Stentrode.

Neuralink, Braingate

According to Synchron, other neural interface devices, such as those being developed by Elon Musk’s Neuralink and a separate one from Braingate, require drilling into the skull and direct puncture into the brain for implantation.

Still, Musk is moving ahead. Indeed, word of Synchron’s new designation came just ahead of Musk’s demonstration of his brain-machine interface. In a July 30 tweet, Musk said he would demonstrate neurons firing in real time Aug. 28.The matrix in the matrix.”

He held a launch event for Neuralink in the summer of 2019.

Braingate reported in 2017 that a man paralyzed from the shoulders down was able to use his arm and hand to eat, drink and perform other activities. The research was published at the time in The Lancet. The group has an ongoing study to gain preliminary device safety information and demonstrate proof of principle of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts.