18 May 2023. A company creating brain-computer interface devices to help people with disabling communications impairments is raising $33 million in its first venture round. In addition, says Paradromics Inc. in Austin, Texas, the Food and Drug Administration designated its Connexus DDI system, the company’s lead product, as a “breakthrough device” that provides for an expedited review by the agency.
Paradromics, founded in 2015, is developing technology to enable high-volume electronic data transfers linking signals from neurons or nerve cells in the brain to computer devices for people with severe neurological disorders such as ALS and stroke or spinal cord injuries. The company says its first systems are designed as assistive devices for people with disabling conditions preventing their abilities to speak or type, thus converting brain signals into text or synthesized speech. Paradromics says its systems capture and transfer data with more brain neurons and at higher volumes than other lab-developed brain-computer interfaces.
As reported in Science & Enterprise in Oct. 2021, Paradromics is developing its Connexus Direct Data Interface or DDI system with funding in part from National Institute of Mental Health, a division of National Institutes of Health, under a three-year $3.2 million award. The company says its system uses a small low-power array of electrodes that captures data from some 1,600 neurons, implanted 1.5 millimeters into the brain’s cerebral cortex. The cerebral cortex that makes up the outer layer of the brain under the skull controls a person’s motor and sensory functions and conscious thought. The electrode array transfers the captured data to a receiving device implanted under the skin in the chest, which relays the data wirelessly in real time to external systems for processing and interpretation.
Advance the system to a clinical trial
Paradromics says beyond assisting people with communication disabilities, its technology can be adapted to help treat mental health disorders resistant to conventional drugs, addiction, and chronic pain. The company says FDA designated the Connexus DDI a breakthrough device, a program to encourage more effective medical devices addressing life-threatening or irreversible debilitating conditions. The breakthrough device designation provides companies greater access and more interaction with FDA staff during development and an expedited review.
“This designation,” says Paradromics CEO Matt Angle in a company statement released through Cision, “recognizes the transformative promise of our device, and we look forward to continued coordination with the FDA to accelerate its availability.”
Paradromics is raising $33 million in its first venture funding round, which the company plans to use for advancing Connexus DDI to a clinical trial. The financing is led by Prime Movers Lab in Jackson, Wyoming, an investor in science-based start-ups covering a wide range of technologies including a category it calls human augmentation. Joining the round are Westcott Investment Group, Dolby Family Ventures, and Green Sands Equity. According to Crunchbase, Prime Movers Lab provided some $8.9 million to Paradromics in Sept. 2022.
Dakin Sloss, founder and general partner at Prime Movers Lab notes, “I think it’s no longer a question of whether brain-computer interfaces will become the standard treatment for many neurological problems,” and adds, “We’re seeing only a couple of companies emerge as real contenders in the space, and I believe Paradromics will be the one that moves into successful human trials.”
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