First-Ever Treatment Shown to Reverse Alzheimer’s Earns NeuroEM Therapeutics FDA Breakthrough Device Status

Posted 10/28/20

PHOENIX--(BUSINESS WIRE)--Oct 28, 2020--

The clinical-stage medical device company is pleased to announce in its pilot study, published last fall in the

This press release features multimedia. …

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First-Ever Treatment Shown to Reverse Alzheimer’s Earns NeuroEM Therapeutics FDA Breakthrough Device Status

Posted

PHOENIX--(BUSINESS WIRE)--Oct 28, 2020--

The clinical-stage medical device company is pleased to announce in its pilot study, published last fall in the

This press release features multimedia. View the full release here:

Woman pictured wearing NeuroEM Therapeutics’ bioengineered MemorEM™ cap and arm control box. This revolutionary head device has earned FDA Breakthrough Device designation, having demonstrated in a pilot study that it can reverse Alzheimer's disease. This woman’s participation in the study resulted in her regaining the equivalent of 12 months of memory. (Photo: Business Wire)

said Dr. Robert Matthews, PhD, CEO of NeuroEM Therapeutics. thus far, to not only slow but in fact reverse the progressive, debilitating loss of memory caused by this devastating brain disease.”

NeuroEM’s head device (MemorEM TM ) is the first-ever Alzheimer’s treatment (device or drug) to receive FDA Breakthrough status. The FDA program is designed to expedite the development and review process of new technology for patients with life-threatening or irreversibly debilitating conditions, such as Alzheimer’s Disease.

to successfully penetrate the skull to reach vital nerve cells in the brain called neurons. NeuroEM’s revolutionary TEMT technology works by breaking up small aggregates (oligomers) of two toxic proteins, called β-amyloid and tau, that are made inside the brain’s neurons during the Alzheimer’s disease process. These two toxic oligomers appear to be the root cause of Alzheimer’s disease by wreaking havoc on vital functions within neurons - especially in brain areas involved in memory. The electromagnetic waves emanating from multiple emitters within NeuroEM’s MemorEM head device easily penetrate the human brain and gently disassociate the toxic oligomers inside neurons resulting in a reversal of Alzheimer’s memory impairment in key tasks used to evaluate cognitive performance.

Despite over 20 years of searching for an Alzheimer’s therapeutic, there still is no drug or device other than MemorEM that has demonstrated the ability to stop or reverse Alzheimer’s memory decline. The researchers at NeuroEM Therapeutics believe that the MemorEM device’s ability to treat Alzheimer’s disease processes going on inside the brain’s neurons will at last effectively treat this dread disease. While drugs have great difficulty getting into the brain and then into neurons, the MemorEM device’s electromagnetic wave therapy has shown the ability to do so.

The company is planning a 12-month Pivotal clinical trial beginning in mid-2021. This trial will test the effectiveness of various TEMT treatments compared to a control group. If successful, this trial could result in FDA approval of the MemorEM device to treat the cognitive dysfunction of Alzheimer’s Disease within the next several years.

“While initial efforts focus on developing an effective treatment for the increasing scourge of Alzheimer’s disease, NeuroEM’s continuing mission will use our disruptive biomedical engineering to treat other neurodegenerative disorders, such as traumatic brain injury and Parkinson’s disease,” Dr. Matthews said, adding, “The FDA Breakthrough Device designation allows us to move faster and help those who are struggling with these brain disorders and the loved ones who care for them.”

To learn more about NeuroEM Therapeutics’ , see the full and behind the technology, visit .

Alzheimer’s disease (AD) is a progressive, lethal brain disease that destroys neurons, which are specialized cells that control memory, thinking and behavior. Over time, patients become unable to function in the world and even in their own home as severe stages of decline result in significant confusion, the ability to communicate, respond to their environment, control their bladder and bowels, feed themselves or even swallow. Ultimately, they become bed-ridden and require 24-hour care.

The annual cost of dementia worldwide is currently over $1 trillion and is projected to top $2.5 trillion by 2030.

NeuroEM Therapeutics, headquartered in Phoenix, AZ, is a clinical-stage medical device company focused on the development of to treat neurodegenerative disorders such as NeuroEM’s head device (MemorEM™) is the

The company has obtained , a prominent charitable foundation and angel investors. NeuroEM is currently preparing to launch its upcoming clinical trials. For information about upcoming clinical trials, sign up

This communication contains certain forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements, which may include but are not limited to statements concerning the projections, financial condition, results of operations and businesses of NeuroEM Therapeutics, are based on management's current expectations and estimates and involve risks and uncertainties that could cause actual results or outcomes to differ materially from those contemplated by the forward-looking statements.

View source version on businesswire.com:

CONTACT: Media Contact

Bill Gordon, COO

NeuroEM Therapeutics, Inc.

(602) 857-8234

bill.gordon@neuroem.com

KEYWORD: UNITED STATES NORTH AMERICA ARIZONA

INDUSTRY KEYWORD: BIOTECHNOLOGY FDA HEALTH PHARMACEUTICAL CLINICAL TRIALS

SOURCE: NeuroEM Therapeutics, Inc.

Copyright Business Wire 2020.

PUB: 10/28/2020 08:04 AM/DISC: 10/28/2020 08:04 AM

http://www.businesswire.com/news/home/20201028005376/en

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