Under the direction of Co-Founders Dan Rizzuto, President & Chief Technical Officer, and Mike Kahana, Chief Executive Officer, Nia Therapeutics is developing cutting-edge neurostimulation technology to restore memory function. The company’s innovation targets memory loss resulting from TBI, neurodegenerative diseases, and other conditions, aiming to improve patients’ quality of life and redefine the treatment landscape.
Rizzuto shared, “Nia Therapeutics is building a flywheel of therapy innovation. Our brain-computer interface (BCI) platform will generate massive brain data sets that increase the pace of therapy innovation at Nia Therapeutics and for our partners. Brain data are key for developing the next generation of neuroscience therapies—and Nia Therapeutics is at the very forefront of this.”
Nia Therapeutics was born out of groundbreaking research funded by the DoD through the DARPA Restoring Active Memory (RAM) project. In 2013, DARPA launched a program to address memory loss in veterans suffering from TBIs sustained during service. Mike Kahana, a renowned memory researcher, led one of two teams awarded $25 million to conduct pioneering research.
“I realized that I needed someone extraordinary to help pull off the most ambitious brain recording and stimulation study ever attempted,” Kahana recalled. He turned to his former PhD student, Dan Rizzuto, who had become a prominent figure in neurotechnology.
“From 2014 to 2018, we collected very large datasets of human brain activity during memory tasks while also applying targeted brain stimulation,” Rizzuto explained. “This research demonstrated that we could reliably improve human memory performance using personalized, closed-loop brain stimulation.”
Inspired by their groundbreaking findings, Rizzuto and Kahana founded Nia Therapeutics in 2018 to translate their research into a commercial therapy. “We realized that the only way to turn this into something that would help people would be commercializing the technology and spinning out a company,” Kahana said.
Memory loss is one of the most significant unmet needs in healthcare today, affecting millions worldwide. In the U.S. alone, 2.3 million people live with memory impairment from TBI, 6.3 million have Alzheimer’s disease, and over 9 million suffer from mild cognitive impairment.
Despite these staggering numbers, the current standard of care offers little relief. “There are no good treatments for these patients today, and this is the great unmet need we're targeting,” Rizzuto said. “For TBI, there are no FDA-approved therapies. Patients are left with cognitive rehabilitation strategies, which teach coping mechanisms like note-taking but don’t improve memory.”
For Alzheimer’s, the options are similarly limited. “Existing drugs delay further decline temporarily, but they don’t restore memory function,” Rizzuto added.
Kahana emphasized the profound societal impact of memory loss: “This isn’t just about an aging relative forgetting things. Memory loss at any age can devastate lives, preventing people from completing their education, holding a job, or maintaining relationships. It’s a burden we must address.”
Nia Therapeutics’ technology is a personalized, closed-loop neurostimulation platform designed to improve memory by optimizing brain function. At its core is a groundbreaking discovery from their DARPA-funded research: memory lapses can be predicted and mitigated by stimulating specific brain regions at precise moments.
“Our system records high-resolution brain activity from multiple memory centers and uses AI models to predict when memory is underperforming,” Kahana explained. “It then delivers targeted stimulation to shift the brain into its optimal state for memory performance.”
The system includes an implantable neurostimulator, a wearable earpiece, and cloud-based software. Rizzuto described the setup: “The implant records brain activity and applies stimulation, while the earpiece powers the device and connects it to the cloud for personalized therapy adjustments. It’s a novel form factor that builds on decades of success in deep brain stimulation (DBS) for conditions like Parkinson’s disease.”
The technology represents a shift from traditional treatments. “Unlike drugs targeting specific biological pathways, our therapy works at a network level, improving the brain’s overall memory function regardless of the underlying cause,” Kahana said.
Nia Therapeutics has made significant strides toward bringing its memory restoration technology to patients. The company’s journey began with breakthrough research under the DARPA-funded RAM project, where they demonstrated for the first time that memory could be improved using closed-loop brain stimulation. “We're in the process of publishing a manuscript based on some very compelling preclinical data we collected in a large animal model. The data shows the ability of our device platform to sense brain activity and stimulate the brain to affect the underlying neural signals,” Rizzuto shared.
On the regulatory front, Nia has engaged with the FDA to establish a clear pathway for its Class III medical device, targeting PMA. The company has finalized the design of its device and is currently conducting preclinical testing to meet FDA requirements. These efforts are bolstered by a robust funding base, with over $15 million raised in Seed funding and an additional $1 million in non-dilutive grants from the DoD. Looking ahead, the company plans to initiate human clinical trials in 2026.
First approved in July 1997, DBS has grown into a $1.1 billion global market. According to LSI’s Market Analysis and Projections (MAP), from 2023 to 2028, the global DBS market will increase at a modest 2.9%. While primarily focused on managing movement disorders, such as Parkinson’s disease and epilepsy, the opportunity to utilize the technology in a broader range of clinical indications continues to expand as our understanding of the brain increases.
Taking a look at procedure volumes, according to LSI’s Global Surgical Procedure Volumes database, we project that each year, approximately 6,000 DBS implant procedures are performed in the U.S. With a focus on high-growth markets, companies developing DBS technologies should consider early assessments of entry into China and Germany, which are projected to see the highest growth in DBS procedure volumes. We estimate that DBS procedures in China and Germany will increase at a CAGR of 8.4% and 5.9%, respectively, from 2023 to 2028. During that same period, the U.S. is projected to see slower growth in procedures, growing at a CAGR of 3.7%.
The focus on movement-related neurological conditions has historically been one of many limiters of market growth. Broadening the use of these technologies to other neurological conditions would increase procedure growth. Indication expansion would also reinvigorate the U.S. market as new patients become eligible to undergo this procedure.
Rizzuto and Kahana have been selected to present at LSI USA ‘25 next March 17-21 in front of hundreds of global medical technology companies. Join us in welcoming Rizzuto and Kahana to the event in Dana Point, CA, where they will share the latest updates on Nia Therapeutics’ technology and development.
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