• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Seeking a Revolution in Clinical Care Through AI

    Diversifying Supply Chains: New Opportunities Post Pandemic and After Brexit

    Addition by Subtraction: The Latest of Machining for Medtech

    Innovation Incubators: An R&D Roundtable

    Virtual Allies: Electronics Manufacturing Services Providers Offer Real Solutions
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Top News
    Terumo to Purchase Predictive Analytics Firm Health Outcomes Sciences

    Abiomed Leader Michael Minogue Named AdvaMed Board Chairman

    TransEnterix Changes Name to Asensus Surgical

    Previon, Spectrum Solutions Partner to Deliver At-Home COVID-19 Test

    NTT Research, Japanese Entity to Collaborate on Cardiovascular Disease Interventions
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Seeking a Revolution in Clinical Care Through AI

    Diversifying Supply Chains: New Opportunities Post Pandemic and After Brexit

    Addition by Subtraction: The Latest of Machining for Medtech

    Innovation Incubators: An R&D Roundtable

    Virtual Allies: Electronics Manufacturing Services Providers Offer Real Solutions
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Rethink Your Medtech ASC Strategy, Part 1

    Pandemic-Level Playing Field: How COVID-19 Made Space for Progress

    Tips for Reigniting Your MDR/IVDR Preparation

    Three Major Innovation Opportunities for Biomedical Textiles

    Use Vertical Integration to Increase Productivity, Drive Innovation
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    PTI Engineered Plastics Inc.

    Forefront Medical Technology

    FUTEK Advanced Sensor Technology Inc.

    maxon

    Creganna Medical, part of TE Connectivity
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Taking the First Step with Metal Components

    4 Trends Driving Medical Manufacturing in 2021

    Pioneering AI Solutions to Reinforce Healthcare Services

    The 8 Major Types of PPE Supply Chain Fraud

    Evolving Trends in the Medical and Orthopedic Devices Industry
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Forefront Medical Technology

    Concise Engineering

    Spectrum Plastics Group

    Creganna Medical, part of TE Connectivity

    Medicoil
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • Podcasts
    • Resources
    • eBook
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Breaking News

    First-Ever Treatment Shown to Reverse Alzheimer’s Earns Breakthrough Status

    Revolutionary clinical-stage head device to beat back Alzheimer’s disease at home.

    First-Ever Treatment Shown to Reverse Alzheimer’s Earns Breakthrough Status
    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 courtesy of Business Wire.
    Related CONTENT
    • Millstone Medical Outsourcing Reaches 600-Employee Milestone
    • FDA Approves Daytime Treatment for Sleep Apnea and Snoring
    • Apple iPhone 12 Magnet Can Deactivate Implantable Cardiac Devices
    • Masimo Releases softFlow High-Flow Nasal Cannula Therapy in U.S.
    • SteriPack Acquires HS Design
    Business Wire10.28.20
    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.
     
    “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 (MemorEM) 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 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.”
    Related Searches
    • Neurological
    Related Knowledge Center
    • Neurological
    Suggested For You
    Millstone Medical Outsourcing Reaches 600-Employee Milestone Millstone Medical Outsourcing Reaches 600-Employee Milestone
    FDA Approves Daytime Treatment for Sleep Apnea and Snoring FDA Approves Daytime Treatment for Sleep Apnea and Snoring
    Apple iPhone 12 Magnet Can Deactivate Implantable Cardiac Devices Apple iPhone 12 Magnet Can Deactivate Implantable Cardiac Devices
    Masimo Releases softFlow High-Flow Nasal Cannula Therapy in U.S. Masimo Releases softFlow High-Flow Nasal Cannula Therapy in U.S.
    SteriPack Acquires HS Design SteriPack Acquires HS Design
    Rice University Researchers Receive Funding to Develop Covid-19 Sensor System Rice University Researchers Receive Funding to Develop Covid-19 Sensor System
    BD Collaborates with Scanwell Health BD Collaborates with Scanwell Health
    Investment Advisor Joins Ra Medical Investment Advisor Joins Ra Medical's Board
    Navient Receives Chinese Regulatory Clearance for ENT Applications Navient Receives Chinese Regulatory Clearance for ENT Applications
    Global Medical Device Venture Financing Deals Total $3.84 Billion in Q4 2020 Global Medical Device Venture Financing Deals Total $3.84 Billion in Q4 2020
    Trademark Plastics Inc. Partners with MedAccred Trademark Plastics Inc. Partners with MedAccred
    South Korean HIV Testing to Reach Peak Market Value This Year South Korean HIV Testing to Reach Peak Market Value This Year
    FDA Clears B-Secur FDA Clears B-Secur's HeartKey EKG/ECG Technology
    Medtronic Receives FDA Approval for Expanded MRI Labeling Medtronic Receives FDA Approval for Expanded MRI Labeling
    Study Validates Vocalis Health’s COVID-19 Screening Tool Study Validates Vocalis Health’s COVID-19 Screening Tool

    Related Breaking News

    • Neurological
      Medtronic Receives FDA Approval for Expanded MRI Labeling

      Medtronic Receives FDA Approval for Expanded MRI Labeling

      Updated MRI Guidelines allow for a wider range of MRI scan parameters and shorter wait time between MRI scans.
      Charles Sternberg, Assistant Editor 02.18.21

    • Neurological
      FDA OKs electroCore

      FDA OKs electroCore's gammaCore nVNS for Adolescent Migraine

      It’s now cleared for most forms of primary headache.
      Sam Brusco, Associate Editor 02.16.21

    • Neurological
      FDA Approves Axonics

      FDA Approves Axonics' 3rd-Gen Implantable Neurostimulator

      Upgrades its embedded software and the patient remote control’s functionality.
      Sam Brusco, Associate Editor 02.16.21


    • Cardiovascular | Neurological
      Cerus Endovascular

      Cerus Endovascular's Contour Neurovascular System Gains Breakthrough Status

      Indicated for the treatment of intracranial aneurysms.
      Sam Brusco, Associate Editor 02.12.21

    • Neurological
      Nēsos Earbud Receives Validation for Treatment of Rheumatoid Arthritis

      Nēsos Earbud Receives Validation for Treatment of Rheumatoid Arthritis

      New study shows promising efficacy and safety profile for novel ‘e-mmunotherapy’ approach to disease treatment.
      Charles Sternberg, Assistant Editor 02.02.21

    • Neurological
      Boston Scientific

      Boston Scientific's Vercise Genus DBS Earns FDA Approval

      Fourth-generation DBS portfolio features full-body MR conditional devices.
      Sam Brusco, Associate Editor 01.22.21


    • Neurological
      Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation

      Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation

      Next-generation digital therapeutic is designed for the treatment of Alzheimer’s disease.
      Business Wire 01.14.21

    • Neurological
      Medtronic Begins Adaptive Deep Brain Stimulation Trial for Parkinson

      Medtronic Begins Adaptive Deep Brain Stimulation Trial for Parkinson's

      First-of-its-kind study tests automated therapy that responds to brain signals in Parkinson's patients.
      PR Newswire 01.14.21

    • Neurological | Surgical
      FDA OKs ClearMind Biomedical

      FDA OKs ClearMind Biomedical's Axonpen Neuroendoscope

      Requires only a narrow channel of 6.5mm through the skull for insertion into the brain.
      PR Newswire 01.12.21


    • Diagnostics | Neurological
      FDA OKs Abbott

      FDA OKs Abbott's First-of-Its-Kind Rapid, Handheld TBI Test

      Produces a result within 15 minutes after a plasma sample is inserted.
      Abbott Laboratories 01.11.21

    • Neurological
      BioSerenity Achieves FDA Clearance for Wearable Device System

      BioSerenity Achieves FDA Clearance for Wearable Device System

      Neuronaute EEG System and IceCap bring comprehensive remote electroencephalography monitoring services to people living with neurological disorders.
      PRNewswire 01.07.21

    • Cardiovascular | Neurological | Surgical
      FDA OKs Rapid Medical

      FDA OKs Rapid Medical's Steerable Neurovascular Guidewire

      Provides efficient access in difficult neuro and peripheral vascular procedures.
      Business Wire 01.04.21


    • Neurological

      'Smart Wrap' Implant May Help Improve Bladder Control

      Delivers light to the bladder for optogenetic neuromodulation of underactive bladders.
      Penn State 11.12.20

    • Neurological | Patient Monitoring
      FDA OKs Nightware

      FDA OKs Nightware's Device to Reduce Nightmare-Based Sleep Disturbance

      Device provides gentle vibration through touch based on analysis of heart rate and motion during sleep.
      U.S. Food and Drug Administration 11.09.20

    • Neurological
      Salvia BioElectronics

      Salvia BioElectronics' Neurostim System for Chronic Migraine Earns Breakthrough Status

      Bioelectronics solution addresses drug-refractory chronic migraine.
      PR Newswire 11.03.20


    Trending
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • FDA Approves Daytime Treatment For Sleep Apnea And Snoring
    • Hardy Diagnostics Releases Rapid Test For COVID-19
    • Understanding Food-Grade Vs. Biocompatibility For Medical Device Materials
    Breaking News
    • Terumo to Purchase Predictive Analytics Firm Health Outcomes Sciences
    • Abiomed Leader Michael Minogue Named AdvaMed Board Chairman
    • TransEnterix Changes Name to Asensus Surgical
    • Previon, Spectrum Solutions Partner to Deliver At-Home COVID-19 Test
    • NTT Research, Japanese Entity to Collaborate on Cardiovascular Disease Interventions
    View Breaking News >
    CURRENT ISSUE

    January/February 2021

    • Seeking a Revolution in Clinical Care Through AI
    • Diversifying Supply Chains: New Opportunities Post Pandemic and After Brexit
    • Addition by Subtraction: The Latest of Machining for Medtech
    • Innovation Incubators: An R&D Roundtable
    • Virtual Allies: Electronics Manufacturing Services Providers Offer Real Solutions
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Clinical Trial Finds Metabolic Benefits for Polyphenols Formula
    JRF Technology Debuts Elderberry Oral Film Strip
    Danone Adds to Plant-Based Portfolio with Acquisition of Follow Your Heart Brand
    Coatings World

    Latest Breaking News From Coatings World

    Hempel Launches Sustainability Framework: Futureproof
    ChemQuest Hires Rich Gibson
    New Increase in Kynar Fluoropolymer Capacities at Arkema's Chinese Site
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Terumo to Purchase Predictive Analytics Firm Health Outcomes Sciences
    Abiomed Leader Michael Minogue Named AdvaMed Board Chairman
    TransEnterix Changes Name to Asensus Surgical
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Altasciences Contributes to Vibegron Approval
    Cyprium, Sentynl Therapeutics Ink Asset Purchase Agreement
    Pfizer Selects Seven Bridges to Support RNA Sequencing Data
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Madison Reed Raises $52 Million in Financing Round
    The Estée Lauder Companies Closes Becca Cosmetics
    Afro Sheen Launches New Brand Initiatives
    Happi

    Latest Breaking News From Happi

    PBA Opposes House Bill 2325 in West Virginia
    J.R. Watkins Tackles Pain with New Lines
    RB Launches Vanish Miracle
    Ink World

    Latest Breaking News From Ink World

    Etiflex Enters New Markets with Nilpeter FA-22 Installation
    Hydrocarbon Solvents Market to Surpass $8.1 Billion by 2030
    Lowe-Martin Adds 2 KODAK NEXFINITY Digital Presses
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Eaglewood Technologies debuts new anilox cleaning system
    INX International and VerifyMe sign supply agreement
    Soma partners with DTM Flexo Services
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    H&V Announces Price Increase
    Fiber Bond VE3 Technology Inactivates SARS-CoV-2 in HVAC Filtration Systems
    Citizens Provides $325 Million Senior Credit Facility to Nice-Pak
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    NuVasive Nabs Simplify Medical for $150M
    SeaSpine Begins Limited Launch of WaveForm TA (TLIF Articulating) 3D-Printed Interbody
    Nexus Spine Implants for Use in Spinal Surgeries Become Available
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Comercial Kywi Improves Customer Service, Front-Store Operations with Zebra Mobile Solution
    Global Printed Circuit Board Market Projected to Reach $69.32 Billion by 2027
    RFID Locks Market to Reach $9.93 Billion by 2027: Allied Market Research

    Copyright © 2021 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login