Medical Devices for Alzheimer’s Received FDA Breakthrough Status


It is painful to forget or to be forgotten, yet Alzheimer’s disease makes things worse. Alzheimer’s disease robs you of more than just memory, but also of other cognitive skills, independence, and dignity. It is indeed frustrating for those involved, including the patients and their beloved ones. Globally, about 50 million people suffer from dementia, with Alzheimer’s disease being the most common form. Due to its complexity, Alzheimer’s disease has no known cure yet. Nevertheless, treatments and therapies are available to manage the symptoms such as maintaining mental function and so on. FDA has recently granted the breakthrough device designation to several medical devices aimed at treating Alzheimer’s disease.

MemorEMTM Head Device by NeuroEM Therapeutics

Medical devices to treat Alzheimer's disease

Easy-to-Wear Head Device from NeuroEM Therapeutics

MemorEMTM is a head-worn bioengineered device that uses an investigational technology called Transcranial Electromagnetic Treatment (TEMT). The device emits electromagnetic waves that can penetrate the entire brain and reach the neurons. Meanwhile, most drugs have difficulties to reach that far. The electromagnetic waves will then break down the amyloid plagues and neurofibrillary tangles. Both amyloid plagues and neurofibrillary tangles are aggregates of proteins — beta-amyloid and tau. They are suspected to be the culprit behind the destruction of synapses that mediate memory and cognition. Moreover, TEMT also improves mitochondrial production in neurons since mitochondria dysfunction is another potential trigger of Alzheimer’s disease.

A pilot study has showed the effectiveness of MemorEMTM in cognitive impairment reversal, leading to the receipt of FDA’s breakthrough status on 28 Oct 2020. Before this, FDA has not granted any breakthrough status to Alzheimer’s treatment (device or drug). NeuroEM Therapeutics is currently planning a 12-month pivotal clinical trial, which is about to start by mid-2021.

Vercise™ Deep Brain Stimulation (DBS) Systems by Boston Scientific

Medical devices to treat Alzheimer's

Deep brain stimulation of the fornix (DBS-f)

On 6 Jan 2021, Functional Neuromodulation has announced the receipt of FDA’s breakthrough device designation for the Vercise™ Deep Brain Stimulation (DBS) Systems. Developed and manufactured by Boston Scientific, the device delivers mild electrical pulses to targeted structures of the brain. It consists of three surgically implanted parts: stimulator, electrical leads, and extensions. Being a well-established approach to treat movement disorders, researchers are now investigating its potentials to treat Alzheimer’s disease. In fact, a Phase 3 clinical trial is ongoing now, recruiting up to 210 Alzheimer’s participants age 65 and above. The DBS will be targeting a bundle of nerve fibers called fornix, which is part of the brain’s memory circuit. It serves as a major output tract of the hippocampus, playing a key role in cognition and episodic memory recall.

An interesting fact is that the discovery of the possibility of using DBS for Alzheimer’s disease is a mere accident. It all started when a morbidly obese patient received DBS to control his appetite and reported a vivid memory unexpectedly.

GammaSense Neurostimulation Device by Cognito Therapeutics

Gamma brain waves, associated with higher-order cognitive functions, are known to decrease in the brains of Alzheimer’s patients. The medical startup, Cognito Therapeutics has developed a non-invasive neurostimulation therapy device to induce gamma brain waves using sensory stimulations. The stimulations consist of light and sound at a frequency of 40 Hz. Studies have shown the positive effects of this therapy on mice, with the reduction of amyloid plagues and tau tangles. This correlates to the activation of brain immune cells called microglia to clear these two hallmarks of Alzheimer’s disease. Besides, the results have shown the improvement of the mice memory in multiple standard tests. This includes novel object recognition, novel place recognition, and remembering escape route.

Currently, research work is ongoing to test the device for human use. According to Cognito Therapeutics, they have gathered enough early clinical data for the FDA to grant them the breakthrough status on 12 Jan 2021.

Grounds for optimism?

These breakthrough designations have come just at the right time for unmet medical need diseases like Alzheimer’s disease. It marks a significant milestone for the research and development of innovative Alzheimer’s treatments. Manufacturers will be able to go through the existing approval procedures faster and market their medical devices. Subsequently, Alzheimer’s patients can receive more timely access to these treatments. Nonetheless, there is still a long way to go before we are on the brink of a cure for Alzheimer’s. After all, the human brain is the most complex thing in the universe.


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