Cognixion CEO Andreas ForslundCognixionRabbi Yitzi Hurwitz has spent a decade communicating with just his eyes. Diagnosed with Amyotrophic Lateral Sclerosis (ALS), aka Lou Gehrigs disease in 2013, the rapid loss of muscle control meant that he can only speak by tediously spelling out words with an eye chart. Its as frustrating and demoralizing as you might imagine.One of the 30,000 Americans currently living with ALS (about 5,000 new cases are diagnosed each year), Hurwitz has had few options for relief, though new ones are slowly emerging. Among them is one developed by Andreas Forslund, CEO of Cognixion. Its a brain-computer interface (BCI) that can help paralyzed patients interact with computers and communicate. And unlike similar technologies from Elon Musks Neuralink, it doesnt require the surgical implantation in the skull. The company announced today that it has launched its first clinical trial, which will study the technology with 10 ALS patients. Rabbi Hurwitz, is one, and hes already training on the device three days a week.Hurwitzs caregiver told Forbes theyre already seeing progress., It looks very promising, they said. The first time he opened up the keyboard, he actually managed to say something on his own and that was surprising. I haven't actually seen him been able to do that by himself for a while.Rabbi Hurwitz using the Axon-RCognixionCognixion has raised $25 million from venture firms like Prime Movers Lab and Amazon Alexa Fund to develop its BCI device, called Axon-R. Its a helmet that can both read brain waves using an EEG and track eye movements, letting users interact with an augmented reality display. This enables a variety of interactions, including using the device to type words that are spoken aloud via a computer speaker. The company uses generative AI models that train on the patients own speech patterns, so over time it customizes itself to them, which should make communication faster. A developer API allows others to program applications for the hardware and Forslund told Forbes that there are about a dozen teams in process right now.The clinical study will evaluate patients ability to use the Axon-R and measure their progress over time, as well as evaluate how its BCI can be optimized for patients. Its being partially funded with the support of ALS Accel, a new subsidiary of the non-profit ALS Association which supports the development of new treatments for ALS patients.InnovationRx is your weekly digest of healthcare news. To get it in your inbox every Wednesday, subscribe here.Over the next few years, brain-computer interfaces are likely to grow to a $80 billion addressable market by 2035, Morgan Stanley estimated in a report last October. The investment bank noted opportunities to treat a variety of conditions beyond ALS, including cerebral palsy, multiple sclerosis, epilepsy and more. And thats for just implanted devices.Although implanted devices do offer some advantages, Forslund sees a bigger opportunity for his companys non-invasive technology due to both the attractiveness of not needing surgery and the versatility of the platform for app developers. Cognixion aims to have over 3 million users of its technology by 2035.When the initial 10-person study concludes in the fall, Cognixion plans to run a second trial with up to 50 ALS patients. Equally good results there could make it easier for FDA, which has already granted Axon a breakthrough device designation (which accelerates the regulatory process) to clear the Axon-R for use with ALS patients. That makes him confident his company will commercialize quickly.While folks like Neuralink are struggling to get into their first patients, were going to have 10 users this summer who are all going to be hopefully having conversations when theyve been silent for a long time, he said.MORE AT FORBES