INVEST Precision Medicine winner spotlight: Nia Therapeutics

Memory is the stored collection of knowledge and experiences in life. However, age and injury can make it difficult to recall memories. The startup Nia Therapeutics wants to solve this problem with a medical device that stimulates the brain.

Memories that form in the head create signals that can be read. With a good memory state, the signals appear in a certain way, said Nia founder and CEO Dan Rizzuto. Nia’s technology reads these brain signals. When the signals move in the direction of poor memory, the device delivers targeted electrical stimulation to bring the brain back into good memory.

“It’s like an orchestra, all sorts of instruments play together,” Rizzuto said of the brain signals. “It is out of tune in a bad memory condition. The conductor doesn’t do his job. With brain stimulation in the right place at the right time, we can tune the orchestra. We can bring the vibrations back into the beautiful sound. “

Based in Radnor, Pennsylvania, Nia was one of 10 startups featured during the recent MedCity News Precision Medicine Conference. The company was chosen as the winner in the life sciences track.

“We made the decision after much deliberation,” said Yizhen Dong, partner at Global Founders Capital and one of the jurors. “It is mainly based on the company generating initial evidence of clinical efficacy, which somewhat diminishes the product and the great market opportunity it is seeking.”

Nia technology originated in research at the University of Pennsylvania. The device consists of four electrical leads that are surgically implanted in the brain. The external component is an earpiece that is worn while the patient is awake. The Defense Advanced Research Projects Agency gave Penn $ 24 million in grants, part of which was used to build a prototype. Nia’s intelligent neurostimulation system does not require any input from the patient. It constantly decides when to stimulate the brain and where in the brain the signal is sent.

The hardware is connected to Nias software in the cloud, where algorithms analyze each patient’s memory signatures, Rizzuto said. The artificial intelligence-based analysis leads to a personalized therapy that determines the location and time of a patient’s brain stimulation. The first indication that Nia is targeting is memory loss from traumatic brain injury.

Deep brain stimulation has been used to treat the tremors in Parkinson’s disease for more than 20 years. Since then, it has found additional uses for treating essential tremor and epilepsy. However, the early applications of deep brain stimulation did not perform brain sensing to assess brain activity, Rizzuto said.

Deep brain stimulation technology was advanced in 2013 with FDA approval of Neuropace’s RNA system, an implantable electrical stimulation device used to treat epilepsy. The medical device from the Mountain View, Calif. Based company continuously monitors the brain and learns the activity that is normal for the patient. Based on an AI-controlled analysis, the device provides the patient with the appropriate stimulation to prevent seizures. Nia’s device follows the path that Neuropace has pioneered, Rizzuto said.

“It’s the same approach to delivering stimulation, just taking it into new areas,” he said.

Nia’s medical device will go through the FDA’s pre-market approval pathway, which requires two clinical studies, one to demonstrate feasibility and a second to demonstrate safety and efficacy. The company has already met with the FDA to review portions of the clinical and technical plans.

Nia has not done any animal testing, nor is it planned. It’s not possible to test the device on animals because they lack verbal memory, Rizzuto said. Memory is tested by assessing a patient’s ability to remember lists of words. Rizzuto said the medical literature supports the use of list learning as an indicator of memory in daily life.

Rizzuto said Nia is about 18 months away from starting her first clinical trial, which is estimated to cost $ 13-15 million. The company needs to raise money to do this research. To date, Nia has raised approximately $ 4.4 million in funding and $ 1.2 million in Department of Defense contracts.

Rizzuto said he is currently raising an additional $ 4 million that will move the company to its next testing milestone over the next year. The military is interested in the research, and the U.S. Army has placed a $ 1 million contract with Nia that the startup will use to complete engineering work on the medical device.

“Veterans have a heavy burden of traumatic brain injury,” said Rizzuto. “The most common symptom of a brain injury is memory loss and there are currently no effective treatments that have been approved by the FDA.”

Image: Wigglestick, Getty Images

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