Sinaptica Therapeutics Announces FDA Breakthrough Device Designation for its Novel Noninvasive Neurostimulation Treatment for Alzheimer’s Disease
SinaptiStim™ – AD System provides personalized and precision-delivered electromagnetic therapeutic approach to treating cognitive and functional decline in Alzheimer’s disease patients
Breakthrough designation is based on positive outcomes from a Phase II clinical trial in mild-to- moderate Alzheimer’s disease patients to be published in a peer-reviewed journal imminently
CAMBRIDGE, Mass., October 19, 2022 – Sinaptica Therapeutics, Inc., a clinical-stage company leading the development of a new class of personalized electromagnetic therapeutics to treat neurodegenerative diseases, today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the company’s investigational SinaptiStim™ – AD System for the treatment of cognitive and functional decline in patients diagnosed with Alzheimer’s disease (AD). The system, a novel integration of neurostimulation and brain wave monitoring technologies in combination with a proprietary artificial intelligence (AI)-derived personalization engine, represents a new approach to treating patients suffering from dementia.
The goal of the FDA’s Breakthrough Devices Program is to provide patients and health care providers with timely access to new technologies by expediting the development, assessment, and review of medical devices that provide more effective treatment of life-threatening or irreversibly debilitating diseases or conditions than existing approved or cleared therapies. Under the program, Sinaptica will receive priority review and interactive communication with the FDA throughout the premarket review phase.
“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, noninvasive, 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.”
Sinaptica Therapeutics was co-founded by two leading researchers and clinicians in the fields of neurology and electrophysiology: Giacomo Koch, MD, PhD, Full Professor of Physiology at University of Ferrara, Italy and Director, Non-invasive Brain Stimulation Laboratory, at Santa Lucia Foundation, IRCCS, Rome, Italy; and Emiliano Santarnecchi, PhD, Associate Professor of Radiology at Harvard Medical School, as well as Director, Precision Neuroscience & Neuromodulation Program and Director, Network Control Laboratory, at Massachusetts General Hospital in Boston, MA, USA.
About Sinaptica Therapeutics
Sinaptica Therapeutics is a clinical-stage electromagnetic therapeutics company pioneering a personalized noninvasive brain stimulation approach with the potential to revolutionize the treatment of Alzheimer’s disease (AD). The company’s investigational SinaptiStim™ – AD System is a medical device that designs and precision-delivers a personalized electromagnetic therapeutic for each patient. This approach has been evaluated in a first-of-its-kind, randomized, sham-controlled clinical trial. The SinaptiStim™ – AD System integrates electromagnetic stimulation of the brain with powerful proprietary artificial intelligence-derived protocols, brain modeling, and network targeting to create a personalized and precision-delivered therapeutic approach. A decade of scientific and clinical evidence underpins the therapy, which has the potential to create a new, more efficient treatment paradigm for the staggering unmet need and burden of AD, as well as other neurodegenerative disorders. The company has received Breakthrough Device Designation from the U.S. Food and Drug Administration for the SinaptiStim™ – AD System.
The SinaptiStim™ – AD System is for investigational use only. It has not been approved by the U.S. Food and Drug Administration and is not available for commercial sale.