After many years of being focused on everything artificial Intelligence, today’s most buzzy technology in medical research is now centered not on machines and algorithms instead, but on the distinctive non-artificial capabilities that the brain of humans.
The brain-computer interfaces — a sci-fi-themed collection of technologies that use brainwaves and control devices from the outside are at the forefront of minds for regulators and developers alike, and the FDA issuing a “leapfrog” guideline and a ground-breaking approval just in the last few weeks.
I am looking forward to being the next to receive a prestigious green light from the agency Synchron. The New York-based startup is working on implants that translate thoughts into movement on tablets and smartphones and is focused on restoring communication to those with severe paralysis.
Synchron’s Stentrode technology is set to be tested through a clinical study in the U.S., thanks to closing a series B financing round that netted 40 million dollars for the business.
If the trial is successful, it could lead to the first FDA approval. Its CEO Thomas Oxley is telling Fierce Medtech that, subject to any regulatory issues, the device will be on its market “within about three or five years.”
Oxley said that this approval could have significant implications for both technology and medicine since Synchron’s product is located in the middle of both.
“We’re creating technology that can bring electronics to the brain without the requirement for open brain procedure,” he told Fierce Medtech. “It provides a way for controlling technology directly through the brain, which was previously not possible and, therefore, an opportunity to treat patients who have paralysis, which had previously been thought to be an untreatable disease.”
Synchron’s device is already on FDA’s radar: It was awarded the status of a breakthrough device last August, which granted the company an expedited path to the review procedure.
The technology is comprised of three parts which are all centered on the Stentrode implant. It’s the only brain-computer interface implanted that doesn’t require surgery to the brain. It’s placed in the jugular vein. There, it expands to fit the blood vessel’s walls. It utilizes embedded sensors to detect brain signals.
It’s the position that makes Synchron’s platform, so innovative, Oxley said.
“The blood vessels allow you to gain access to all regions within the brain. Both superficial and deep. This is distinct from other medical technology which requires open-brain surgery which involves the removal of skulls at every brain region that you require access to,” he explained.
The signals that the Stentrode gathers go to a receiver unit implanted inside the chest. The battery-free BrainPort device sends the information via Bluetooth, and synchro’s BrainOS platform can be downloaded onto the user’s device, computer, or smartphone. The platform allows users to convert the brain signals collected into actions in apps that enable them to text messages, send emails, bank, and shop.
Synchron has begun an in-human study of the device in Australia. In the trial, four people have been fitted using the Stentrode device and have been trained to master the art of directing their minds towards controlling a computer mouse zoom or clicking on a web page. An eye motion tracker can control the cursor.
Initial results revealed that the 2 patients suffering from amyotrophic lateral degeneration could independently manage their personal computers with at least 92% precision in mouse clicks, and the average typing speed was approximately 14 to 20 words per minute.
Although its primary goal is to launch this U.S. study later this year, Synchron said it would be able to allocate some capital to develop Stentrode. Stentrode system.
Alongside controlling devices using brainwaves, this system could be utilized reversely by transmitting messages to the brain to treat neurological disorders such as epilepsy, Parkinson’s disease, depression, and others.
Although Synchron’s tech is undoubtedly innovative, however, it’s not a revolutionary one. Similar transitions from mechanical technology to electronic occurred in cardiology during the late 1990s. Oxley said in Fierce Medtech the company is giving Synchron (and the majority of the world) the roadmap for the future.
“We’ve had a long record of how it has worked with cardiology. There’s a blueprint that outlines how the field needs to develop,” he said.
The financing round was led by Khosla Ventures, whose recent investments in MedTech comprise Docbot, Bionaut Labs, and Flow Neuroscience, another neurotech developer. The acquisition is more than four times larger than Synchron’s prior round, a $10 million series A backed by the U.S. Department of Defense’s Defense Advanced Research Projects Agency.