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▎WuXi AppTec content team editor
Rich Macary, President of Sinaptica, "This certification helps us establish the regulatory pathway for the SinaptiStim – AD System to be approved by the FDA, 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 personalized electromagnetic wave therapy
for Alzheimer's patients.
" We expect it next year Started pivotal clinical trials and continued to move forward
in the field of electromagnetic wave therapy.
”
As WuXi AppTec's CTDMO focused on cell and gene therapies, WuXi Biologics is committed to accelerating and transforming the development, testing, manufacturing and commercialization
of gene and cell therapies and other high-end therapies.
WuXi Biologics can help customers around the world bring more innovative therapies to market sooner rather than later, benefiting patients
.
If you have related business needs, please click the picture below to fill in the specific information
.
▲If you have any business needs, please long press to scan the QR code above, or
Sinaptica Therapeutics today announced that the U.
S.
FDA has granted its SinaptiStim – AD System Breakthrough Medical Device Designation (BDD) for the treatment of cognitive and functional decline
in Alzheimer's patients.
This innovative electromagnetic wave therapy, which combines neurostimulation, brain wave detection, artificial intelligence and other technologies, has the potential to revolutionize the treatment of Alzheimer's disease, allowing patients to improve
their dementia symptoms without taking medication.
Sinaptica expects to initiate pivotal clinical trials
next year.
Alzheimer's disease is a neurodegenerative disease
primarily associated with aging.
It is estimated that by the age of 80, one in three people will be diagnosed with Alzheimer's disease
.
Alzheimer's disease progresses to changes in thinking, memory and behavior, and the disease eventually progresses to dementia within a few years
.
There are many causes of Alzheimer's disease, but Alzheimer's disease is the most common
.
Alzheimer's disease is not a normal aging process, and complex changes occur in the patient's brain 20 years before symptoms begin, eventually leading to brain cell death or loss
of bonds.
There are currently about 50 million Alzheimer's patients worldwide, and as the world's population ages, it is estimated that the number of Alzheimer's patients will almost triple to 140 million by 2060
.
Genetic and environmental factors influence the development and progression
of the disease.
Synaptic plasticity, the adjustable strength of connections between nerve cells, is the basis for learning and memory, and its variation is a common brain neuropathy
in Alzheimer's patients.
Many pathological variants of Alzheimer's disease eventually lead to synaptic incapacitation and destruction
.
In addition, many patients also have brain network disorders, such as frequent variations
in the brain's default mode network (DMN) responsible for episodic memory.
In early Alzheimer's disease, synaptic incapacitation and DMN disconnection mostly evolve into local brain atrophy and accumulation of amyloid oligomers, resulting in dementia symptoms
.
Image source: 123RF
The SinaptiStim-AD system developed by Sinaptica combines neurostimulation devices, brainwave monitoring technology, and the company's proprietary artificial intelligence personalization engine to personalize the patient's brain with electromagnetic waves, a precise, non-invasive treatment that can improve synaptic plasticity and stabilize the connections between brain networks, thereby improving the symptoms
of dementia in Alzheimer's patients.
"We are excited about the FDA granting SinaptiStim – AD System breakthrough medical device designation," said Mr.
Rich Macary, President of Sinaptica, "This certification helps us establish the regulatory pathway for the SinaptiStim – AD System to be approved by the FDA, 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 personalized electromagnetic wave therapy
for Alzheimer's patients.
" We expect it next year Started pivotal clinical trials and continued to move forward
in the field of electromagnetic wave therapy.
”
As WuXi AppTec's CTDMO focused on cell and gene therapies, WuXi Biologics is committed to accelerating and transforming the development, testing, manufacturing and commercialization
of gene and cell therapies and other high-end therapies.
WuXi Biologics can help customers around the world bring more innovative therapies to market sooner rather than later, benefiting patients
.
If you have related business needs, please click the picture below to fill in the specific information
.
▲If you have any business needs, please long press to scan the QR code above, or