A newly awarded grant from the National Institutes of Health is the cherry on top of an already groundbreaking year for Synchron, which received the go-ahead from the FDA to begin the first U.S. trial of its brain-computer interface technology last month, mere weeks after reeling in $40 million to fund the study.
The $10 million NIH grant will kickstart the trial and be split between Synchron and its three study partners. Carnegie Mellon University is managing the funds, while the University of Pittsburgh Medical Center and Mount Sinai Health System are in charge of recruiting participants, implanting Synchron’s brainwave-reading device and monitoring its effects on each patient.
The partners are aiming to enroll six severely paralyzed individuals in the trial. Each of them will be implanted with Synchron’s Stentrode device, which is inserted through the jugular vein in a minimally invasive procedure, rather than requiring open-brain surgery for placement like most other implantable brain-computer interfaces.
The device expands inside the blood vessel and uses sensors to gather neurological signals as they pass along the walls of the vein. Those signals are collected in the BrainPort receiver, a battery-less unit implanted in the chest, which then wirelessly transmits the data to the BrainOS software on a nearby smartphone, tablet or computer.
With the BrainOS platform, paralyzed patients can use their thoughts and eye movement to control a cursor, mouse buttons and keyboard. So far, those tools have been used not only to improve patients’ communication with their care teams and loved ones via email and text message, but also to perform daily tasks like online banking and shopping.
The U.S. study of Synchron’s technology will begin as the company’s Australia-based trial enters its third year. Early results of that study have demonstrated that the first two patients implanted with the Stentrode device, both of whom have been diagnosed with amyotrophic lateral sclerosis, or ALS, had achieved average mouse click accuracy of at least 92% and were able to type between 14 and 20 characters per minute without the help of predictive algorithms.
If the U.S. trial goes according to plan, Synchron is hoping to become the first implantable brain-computer interface to be FDA-approved for a commercial rollout. In an interview with Fierce Medtech earlier this year, CEO Thomas Oxley, M.D., Ph.D., said that rollout could happen as soon as sometime within the next three to five years.
That timeline will be helped along by the system's recognition by the FDA as a "breakthrough device." The agency offered up the designation last year, granting Synchron's technology an expedited pathway through the regulatory process.
The NIH grant builds on the $40 million series B funding round Synchron closed in early June. In addition to financing the U.S. clinical trial, the company said at the time, some of the series B funds were also put toward further developing the technology.
For example, Oxley told Fierce Medtech, the company is currently investigating the device’s ability to work in the other direction—that is, rather than only sending brainwaves to a computer, it might also one day be able to send computer-generated signals to the brain to treat neurological diseases like Parkinson’s, epilepsy, addiction and more.