A system which uses non-invasive neurostimulation to treat cognitive and functional decline in Alzheimer’s disease has moved another step closer to reality after the success of a Phase II clinical trial.
The SinaptiStim™ – AD System has secured Breakthrough Device Designation from the US Food and Drug Administration (FDA) – a key step on its journey towards regulatory approval.
The system, pioneered by Sinaptica Therapeutics, brings together neurostimulation and brain wave monitoring technologies with an artificial intelligence (AI) derived personalisation engine.
It represents a new approach to treating people living with dementia, and one which could transform options currently available to patients worldwide.
“We are excited that the FDA has recognised 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 personalised 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.”
The goal of the FDA’s Breakthrough Devices Program is to provide patients and healthcare 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.
Through the program, Sinaptica Therapeutics will receive priority review and interactive communication with the FDA throughout the premarket review phase, with a pivotal trial planned to start next year.
A decade of scientific and clinical evidence underpins the therapy, which the business believes has the potential to create a new, more efficient treatment paradigm for the unmet need around Alzheimer’s disease globally.
Sinaptica Therapeutics was co-founded by two leading researchers and clinicians in the fields of neurology and electrophysiology – Dr Giacomo Koch, full professor of physiology at University of Ferrara, Italy and Director, Non-invasive Brain Stimulation Laboratory, at Santa Lucia Foundation, IRCCS, Rome, Italy; and Dr Emiliano Santarnecchi, 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.
