Sinaptica Therapeutics announced today that it received FDA breakthrough device designation for its investigational SinaptiStim AD system.
Cambridge, Massachusetts-based Sinaptica designed its system to treat cognitive and functional decline in patients diagnosed with Alzheimer’s disease (AD).
The system creates a novel integration of neurostimulation and brain wave monitoring technologies. It combines those with a proprietary AI-derived personalization engine. Sinaptica said in a news release that SinaptiStim represents a new approach to treating patients suffering from dementia.
Under the FDA breakthrough program, Sinaptia receives priority regulatory review. The company can also maintain interactive communication with the FDA throughout the premarket review phase.
“Groundbreaking potential”
“We are excited that the FDA has recognized the groundbreaking potential of our SinaptiStim AD system with Breakthrough Device Designation,” said Rich Macary, president of Sinaptica Therapeutics. “This marks an important milestone for the company, as it helps establish our regulatory pathway for FDA clearance of our SinaptiStim AD system. We look forward to collaborating with the agency to address the significant unmet need in the treatment of Alzheimer’s disease by developing a novel, safe, effective, non-invasive, and personalized electromagnetic therapeutic for patients.
“We plan to continue working toward the initiation of our pivotal trial next year, as well as further advancing the emerging field of electromagnetic therapeutics given their unique ability to modulate key mechanisms of synaptic plasticity and network connectivity in targeted regions of the brain.”
Dr. Giacamo Koch and Emiliano Santarnecchi founded Sinaptica. Koch serves as a professor of physiology at the University of Ferrara, Italy. He also serves as director of the non-invasive brain stimulation laboratory at Santa Lucia Foundation in Rome.
Santarnecchi is an associate professor of radiology at Harvard Medical School. He also serves as director of the precision neuroscience and neuromodulation program at Massachusetts General Hospital. He directs the network control laboratory at the Boston hospital, too.