The U.S.-based trial operating under FDA investigational device exemption (IDE) enrolled six patients in total. Synchron says it’s the first IDE awarded by the FDA to assess a permanently implanted BCI. The early feasibility study assesses safety while evaluating quantified efficacy measures of the Synchron Switch motor neuroprosthesis. It evaluates patients with severe paralysis.
(Kurt Haggstrom, Synchron’s chief commercial officer, will provide a look inside the company’s endovascular brain-computer interface at our DeviceTalks West event in Santa Clara, California, Oct. 18–19.)
Synchron says the primary goal is to assess if the device can be safely implanted into the blood vessels of the brain through neurointerventional procedures. The company also designed the study to evaluate how BCI may enable the use of thoughts to control digital devices. For patients who can no longer use their hands, this could help achieve daily tasks like texting, emailing and more.
The company spread its study across three clinical sites with support from the NIH BRAIN Initiative.
“We would like to thank everyone who partnered with us to complete this important clinical trial enrollment milestone, especially patients and caregivers as well as the physicians and research staff at our clinical sites in the United States,” said Dr. Tom Oxley, CEO & founder, Synchron. “We look forward to announcing the results from our COMMAND study and will continue to advance development of Synchron Switch towards a pivotal clinical trial in the US.”
More about Synchron
New York-based Synchron develops the catheter-delivered Stentrode BCI implant. The company says its BCI is the only one tapping into blood vessels to capture signals from the brain. Once implanted, it detects and wirelessly transmits motor intent out of the brain.
Synchron believes its endovascular delivery method could make brain-computer interface technology simpler and safer. It could also offer more accessibility than the alternative option of invasive open-brain surgery.
The company also has the backing of some big names. In December 2022, it raised an oversubscribed $75 million Series C financing round. Gates Frontier (Bill Gates’ investment fund) and Bezos Expeditions (Jeff Bezos’ investment fund) participated in the round.
Earlier this year, Synchron announced positive study data out of Australia for its BCI platform as well.
More about BCIs
The BCI space is one that, over the past few years, has heated up competition-wise. About a year ago, we compiled a list of seven BCI developers you need to know.
One of the most notable, Neuralink, is the Elon Musk-led BCI venture. The company’s N1 implant comes in at about the size of a coin. Remotely rechargeable, the implant goes along with electrode-laced threads that go further into the brain. Neuralink also has an R1 robot meant to be programmed to implant the BCI system while avoiding vasculature. After some struggles, the company finally cleared the regulatory hurdle for a first-in-human implant in May. Then, last month, Neuralink announced the raising of $280 million to support its BCI.
Blackrock Neurotech, another competitor, develops the Utah Array. They’ve implanted it in patients since 2004 through research studies, with zero FDA-reported serious adverse events. It also unveiled a next-gen BCI that comes in thinner than an eyelash almost in the form of a thin piece of lace.
Precision Neuro, co-created by a founding member of Elon Musk’s Neuralink BCI venture, has been developing its BCI since 2021. Benjamin Rapoport, a former part of the Neuralink effort, started the company with private equity investor Michael Mager. The company completed the first-in-human procedures for a pilot clinical study of its neural implant system.
