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

The FDA is expediting a revolutionary clinical-stage head device to beat back Alzheimer’s disease at home

NeuroEM Therapeutics is poised to deliver a knockout blow to Alzheimer’s disease. The clinical-stage medical device company is pleased to announce FDA Breakthrough Device designation for its bioengineered head device shown to reverse Alzheimer’s memory loss in its pilot study, published last fall in the Journal of Alzheimer’s Disease.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201028005376/en/

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)

“No other drug or device has received this highest FDA designation to accelerate a treatment for Alzheimer’s disease,” said Dr. Robert Matthews, PhD, CEO of NeuroEM Therapeutics. “No other treatment has demonstrated the clinical results we have thus far, to not only slow but in fact reverse the progressive, debilitating loss of memory caused by this devastating brain disease.”

The FDA has given Breakthrough status to over 300 devices and over 100 drugs, but none to a therapeutic for Alzheimer’s disease – until now. NeuroEM’s head device (MemorEMTM) 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.

  • NeuroEM’s novel, proprietary technology, called Transcranial Electromagnetic Treatment (TEMT), achieves what other treatments for AD have not. In fact, no other therapy comes close to MemorEM’s remarkable results, made possible by its unique modes of action.

  • In just two months of daily use, the MemorEM restored on average the equivalent of 12 months of memory for 7 of 8 participants in its pilot study, none of whom experienced adverse side effects.

  • Treatment is easy, comfortable and safe. A patient wears what appears to be a simple cap that belies the complex biomedical engineering within it. The device is worn twice a day in home for an hour at a time, and its design allows the patient to move around home as usual.

NeuroEM has pioneered TEMT 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

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Rush Limbaugh says lung cancer has shown progression ‘in the wrong direction’

Conservative talk radio show host Rush Limbaugh says he’s had a setback in his fight against advanced lung cancer.

Limbaugh, 69, said recent scans show “some progression of cancer.” It’s “not dramatic, but it is the wrong direction,” he told listeners Monday, according to a transcript posted on his website.

The host said Monday that he has been diagnosed with stage 4 lung cancer.

On Feb. 3, he first disclosed that he was sick. The following day, President Donald Trump awarded Limbaugh the Presidential Medal of Freedom, the nation’s highest civilian honor, during the State of the Union address.

Limbaugh said that he had been reluctant to speak too much about his illness on-air, in part because “I’m not the only one that’s going through hardships, challenging times.”

“I want to stress here that I know countless numbers of you are experiencing the same thing. If it isn’t lung cancer, it’s some kind of cancer. If it isn’t you, it’s somebody really close to you. If it isn’t an illness, it’s something,” he said Monday.

Limbaugh said that prior to the recent scans that showed some progression, “the scans had shown that we had rendered the cancer dormant.”

“So we have to tweak the treatment plan, which we did, and the chemotherapy drugs in hopes of keeping additional progression at bay for as long as possible,” Limbaugh said. “The idea now is to keep it where it is or maybe have it reduce again. We’ve shown that that is possible.”

This story originally appeared on NBCNews.com.

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