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.
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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
Oct. 26 (UPI) — To protect forests and vulnerable ecosystems, erect healthcare clinics. That’s what nonprofit organizers did in Indonesia, where deforestation rates in neighboring Gunung Palung National Park declined dramatically during the first 10 years of the clinic’s operation.
The affordable healthcare clinic was set up in 2007 by a pair of nonprofits, Alam Sehat Lestari and Health In Harmony. Prior to the arrival of the clinic, the forests of Gunung Palung were shrinking annually as a result of uncontrolled illegal logging.
To curb the losses, the clinic offered discounted services to villages that enacted community-wide logging reductions and other conservation-minded reforms.
Researchers described the clinic’s environmental and public health successes in a new paper, published Monday in the journal PNAS.
“This innovative model has clear global health implications,” study co-author Michele Barry, senior associate dean of global health at Stanford University and director of the Center for Innovation in Global Health, said in a news release. “Health and climate can and should be addressed in unison, and done in coordination with and respect for local communities.”
In addition to offering community-wide discounts pegged to reductions in logging, the clinic also provided healthcare services for barter, allowing villagers to pay with tree seedlings, handicrafts and labor.
Health data collected by the clinic revealed a significant drop in infectious and non-communicable diseases between 2007 and 2017. Satellite data showed that deforestation rates in the forests surrounding the clinic and villages receiving service declined 70 percent compared to control plots far from the clinic.
“We didn’t know what to expect when we started evaluating the program’s health and conservation impacts, but were continually amazed that the data suggested such a strong link between improvements in health care access and tropical forest conservation,” said lead study author Isabel Jones, recent recipient of a doctoral degree in biology from Stanford.
Researchers found that the biggest reductions in logging occurred surrounding the villages that used the healthcare clinic the most.
More than a third of protected forests around the globe are either owned, managed, used or occupied by indigenous groups and local communities, but conservation planning and regulatory decision rarely involves input from these communities.
The opposite was true in West Kalimantan, Indonesia, where nonprofit leaders met regularly with local villages to come up with a strategy for protecting the environment while also meeting the region’s public health needs.
Researchers suggest the clinic’s success can serve as a model for conservation and public health initiatives all over the world.
“The data support two important conclusions: human health is integral to the conservation of nature and vice versa, and we need to listen to the guidance of rainforest communities who know best how to live in balance with their forests,” said Monica Nirmala, the executive director of the clinic from 2014 to 2018 and current board member of Health In Harmony.
SAN ANTONIO — Larisa Alvarado, 36, feared she had the coronavirus when she woke up last week feeling an itch and pain in her leg that later advanced to swelling. She began running a fever and became nauseous.
A friend and poison control expert suggested her symptoms could be from a spider bite, and advised her to see a doctor. But before she went to an urgent care clinic, Alvarado first had to research the cost of a visit and of the medicine a doctor was likely to prescribe—to see if she could afford them.
That’s because she doesn’t have health insurance. Alvarado lost her job as a patient resource specialist with the American Cancer Society after the organization’s fundraising was hit due to the pandemic.
Alvarado is just one of more than 11.2 million Latinos in the United States who don’t have health insurance—in 2019, almost 17 percent of Hispanics didn’t have health coverage, the highest of any group. That was the figure from before the pandemic, which was already up from 10.22 million in 2016.
Now experts say that number is likely even higher given the pandemic’s disproportionate toll on the community.
As people lose work and health care benefits, it’s become an even tougher task to ensure residents get health coverage access, said Joe Ibarra, co-chair of EnrollSA, a coalition of organizations trying to boost insurance enrollment in the San Antonio area.
“In Texas, there is no expanded Medicaid. The rules are really harsh. Folks are losing coverage as a result of losing their jobs and they are left without good options,” Ibarra told NBC News.
Latinos gained the most under the Affordable Care Act after it was enacted in 2010, with about 4 million adults and 600,000 children obtaining health care coverage by 2016.
As more people lose health insurance, the cost and the availability of coverage are top-tier issues for Hispanics this election cycle. Latinos rank it even ahead of jobs and the economy and place more importance on it than they did about this time in 2016.
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“Latinos are going to the polls keeping health care in mind and their experience with Covid in mind and voting for change for their health and well-being,” Alberto Gonzalez, senior policy strategist at UnidosUS, a Latino civil rights organization, said.
Early in the election cycle, the GOP was pointing to record low unemployment rates Latinos were experiencing as reason to re-elect Trump, while Democrats countered that Hispanics were not economically stable if many had to work more than one job to make ends meet.
But the pandemic’s disproportionate effect on Latinos has forced a reckoning of the gaps in health care coverage, especially in states like Texas with a huge Hispanic population.
Fears of Covid-19 — without health insurance
Before Alvarado lost her job, she was already skimping on her health, forgoing therapy for carpal tunnel to save on the steep copay and deductibles. Now