Sinaptica Therapeutics today announced that the FDA has awarded it a developing SinaptiStim AD System for Breakthrough Medical Device Accreditation (BDD) to treat cognitive and functional decline in Alzheimer's patients. The innovative electromagnetic wave therapy, combined with nerve stimulation, brain wave detection and artificial intelligence, has the potential to bring transformative changes to the treatment of Alzheimer's disease, allowing patients to improve their dementia symptoms without taking medicine. The Sinaptica is expected to start key clinical trials by the next year.
Alzheimer's disease is a neurodegenerative disorder mainly associated with aging. By the age of 80, a third of people would be diagnosed with Alzheimer's disease. Alzheimer's disease progression involves changes in thinking, memory, and behavior, and the disease eventually progresses into dementia (dementia) within a few years. There are many causes of dementia, but Alzheimer's disease is the most common cause. Alzheimer's disease is not a normal aging process. Complex changes occur in the brain about 20 years before the symptoms begin, eventually resulting in brain cell death or loss of association. There are currently about 50 million Alzheimer's patients worldwide, and as the world population ages, the number of AD patients is estimated to almost triple to 140 million by 2060. Genetic and environmental factors can influence the occurrence and progression of the disease.
Synaptic plasticity (synaptic plasticity), a modulation of the strength of connections between nerve cells, is fundamental to learning and memory, and its variation is also a common brain neuropathy in patients with Alzheimer's disease. Many pathological variants in Alzheimer's disease eventually lead to synaptic disability and destruction. In addition, many patients also have brain network disorders, such as the brain's default mode network (Default Mode Network, DMN), which is responsible for episodic memory, often changes. In early Alzheimer's disease, synaptic disability and DMN loss mostly evolved into local brain atrophy and the accumulation of amyloid oligomers, resulting in dementia symptoms.
The SinaptiStim AD system developed by Sinaptica combines the nerve stimulation device, brain wave monitoring technology, and the company's proprietary artificial intelligence individualized engine, can to the patient brain individualized electromagnetic wave stimulation, the precise, noninvasive treatment can improve patients with synaptic plasticity, and stabilize the connection between the brain network, so as to improve the symptoms of alzheimer's disease patients with dementia.
"We are excited about the FDA granting SinaptiStim AD systems breakthrough medical device recognition," said Mr.Rich Macary, President of Sinaptica. " This certification helps us establish a regulatory path for SinaptiStim AD systems to obtain FDA licenses, which is an important milestone for the company. We look forward to working with the FDA to develop an innovative, safe, effective, non-invasive, and individualized electromagnetic wave therapy for people with Alzheimer's disease. We expect to begin key clinical trials next year and continue to move on in electromagnetic wave therapy.”
