ClearPoint Neuro Congratulates Blackrock Neurotech on Receiving Breakthrough Device Designation from the FDA for the MoveAgain Brain-Computer Interface System

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Nov. 16, 2021

ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global therapy-enabling platform company providing navigation and delivery to the brain, today congratulates partner Blackrock Neurotech for receiving Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its groundbreaking MoveAgain Brain Computer Interface (BCI) system.

There are an estimated 5.35 million1 people in the United States who suffer from paralysis due to central nervous system disorders, autoimmune diseases, and spinal cord injuries. Blackrock’s MoveAgain BCI system is comprised of an array which, when implanted in the brain, has demonstrated in scientific studies that it can read, analyze, and translate neuronal activity into commands that are relayed to output devices, such as a wheelchair. With the decoding of these signals, Blackrock aims to improve the mobility, independence, and quality of life for patients with paralysis.

Under the terms of a recently announced joint agreement, ClearPoint is leveraging its 20+ year expertise innovating novel neuro-navigation platforms and software, with the aim of developing a new surgical solution to allow neurosurgeons to efficiently implant Blackrock’s BCIs in a hospital setting.

“We are proud to be partnered with the leader in brain-computer interface technology,” stated Joe Burnett, President and CEO of ClearPoint Neuro. “Every step towards commercialization, including this important designation from the FDA, as well as the great strides our innovation team is making towards development of a new surgical solution, will bring this novel BCI system closer to patients suffering from the most debilitating neurological disorders.”

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