In a significant development within the brain-computer interface (BCI) industry, Synchron Inc. is advancing towards a pivotal clinical trial for its innovative brain implant technology, potentially rivaling Elon Musk‘s Neuralink.
What Happened: On Monday, Synchron’s CEO Thomas Oxley mentioned that the company is gearing up to recruit patients for a pivotal clinical trial. This is a step towards commercial approval for its brain implant technology, challenging Musk’s Neuralink, Reuters reported.
The trial will seek to enroll dozens of participants, with about 120 clinical trial centers expressing interest in conducting the study. Oxley emphasized the importance of preventing bottlenecks by starting patient and physician dialogues early.
Synchron, based in New York, has already conducted preliminary tests authorized by the U.S. in July 2021, implanting devices in six patients without serious adverse effects. These tests follow successful initial trials in Australia.
The company is now analyzing U.S. data to prepare for the upcoming trial while awaiting a green light from the U.S. Food and Drug Administration. The trial will include patients with ALS, stroke, and multiple sclerosis.
Notable medical centers such as Mount Sinai in New York, the University at Buffalo Neurosurgery, and the University of Pittsburgh Medical Center are involved in the preliminary study and are expected to participate in the larger trial.
Synchron’s device, which has attracted investment from billionaires like Jeff Bezos and Bill Gates, is inserted into the brain via a vein, differing from Neuralink’s approach of surgical implantation into the brain cortex.
While Neuralink has not provided updates on its clinical trials, Synchron continues to advance in the brain-computer interface market, which has yet to see a company gain final FDA approval for a BCI brain implant.
Why It Matters: The race to develop a successful BCI has been a focal point for tech billionaires, with Musk’s Neuralink and Synchron, backed by Bezos and Gates, leading the charge. The human brain’s complexity and the potential to assist those with neurological conditions make this technology highly significant.
However, the path to FDA approval is fraught with challenges. Neuralink has faced scrutiny over its animal testing and regulatory compliance, as highlighted by U.S. Representative Earl Blumenauer’s concerns about the FDA's oversight of the company.
Moreover, the first human patient of Neuralink, Noland Arbaugh, was assured of the safety of the implant despite previous animal subjects dying, raising ethical and safety questions.
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