• 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
    Superior Subtractive Solutions for Machining Medtech

    Assembly & Automation Experts Share Thoughts on Medtech Trends

    Power Trip: A Discussion of Custom Medical Electronics

    The MDR Transition: An Opportunity for Design Change?

    Preserve and Protect: Sustainability Initiatives for Medtech Manufacturing
    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
    Regulatory
    Financial/Business
    Top News
    Tessy Plastics Names Stafford Frearson as President

    HoneyNaps' AI Sleep Disorder Diagnosis Software Earns FDA Nod

    Biomerics Finishes Expansion of Minnesota Facility

    MPO's Most-Read Stories This Week—Sept. 23

    Beckman Coulter Helping Labs Comply With Annex 1 Regulation
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Superior Subtractive Solutions for Machining Medtech

    Assembly & Automation Experts Share Thoughts on Medtech Trends

    Power Trip: A Discussion of Custom Medical Electronics

    The MDR Transition: An Opportunity for Design Change?

    Preserve and Protect: Sustainability Initiatives for Medtech Manufacturing
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Medtech’s Most Powerful M&A Drivers

    The Link Between Medtech and Connected Medical Devices

    Is the FTC Partly Responsible for Muted M&A Activity?

    Holistic Risk Management: Navigating the Future’s Uncertainties

    Defining End of Life for Medical Devices
    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
    Medbio LLC

    Providence Enterprise USA Inc.

    Halkey-Roberts Corporation

    Johari Digital Healthcare Ltd.

    JBC Technologies
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    A One-Stop-Shop, Turnkey Solution Is Paramount for Success

    How Additive and Subtractive Manufacturing Are Revolutionizing the Medical Device Industry

    Medical Device Commercialization: It’s What, Not When, to Transfer to Manufacturing

    How In Silico Simulations Can Slash Medical Device Development Risk

    The Top 7 AI Applications Transforming Medical Device Manufacturing
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Medbio LLC

    Providence Enterprise USA Inc.

    Halkey-Roberts Corporation

    Johari Digital Healthcare Ltd.

    JBC Technologies
    • 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
    • eBook
    • Resources
    • Podcasts
    • 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.
    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
    Nissha Medical Technologies Nissha Medical Technologies
    JK Medirise-Disposable Medical Device Company JK Medirise-Disposable Medical Device Company
    DDL Inc. DDL Inc.
    sfm medical devices GmbH sfm medical devices GmbH
    Simbex Simbex
    BMP Medical - Delivering Custom Plastics Manufactured Solutions BMP Medical - Delivering Custom Plastics Manufactured Solutions
    High Tech Turning Co. Inc. High Tech Turning Co. Inc.
    Breakthrough Device Designation Granted for New Neuromodulation Platform Breakthrough Device Designation Granted for New Neuromodulation Platform
    Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles
    Accu-Tube Appoints Matthew Haddle as CEO Accu-Tube Appoints Matthew Haddle as CEO
    First CellFX Procedure Performed in Canada First CellFX Procedure Performed in Canada
    Turner Imaging Systems Announces International Expansion Turner Imaging Systems Announces International Expansion
    Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings
    MedTech Innovator Names the Finalists for the Title of MedTech Innovator 2021 MedTech Innovator Names the Finalists for the Title of MedTech Innovator 2021
    Boston Scientific Agrees to Acquire Devoro Medical Boston Scientific Agrees to Acquire Devoro Medical

    Related Buyers Guide Companies

    • Nissha Medical Technologies

      ...
      Amy Jeary, Market Development Manager 11.18.22

    • JK Medirise-Disposable Medical Device Company

      ...
      Ketan Munjani, Marketing Manager 11.17.22

    • DDL Inc.

      DDL Inc.

      DDL has been in medical device package, product and material testing industry for almost 20 years. We strive to offer the most effective business practices while employing a staff of technical experts.
      Chris Murphy, Marketing Manager 11.11.22


    • sfm medical devices GmbH

      ...
      Albert Busch, Head of Marketing 11.11.22

    • Simbex

      ...
      Greg Lange, Chief Business Development Officer 10.05.22

    Loading, Please Wait..

    Trending
    • A New Approach To Post-Market Surveillance
    • Diabetes Innovation: MIT Engineers Unveil Implantable Device With Oxygen Factory
    • FDA Clears LiveMetric's Wearable Blood Pressure Monitoring Tech
    • Cochlear Implant Study Underway At Mayo Clinic
    • MPO's Most-Read Stories This Week—Sept. 16
    Breaking News
    • Sherri Ferstler Joins Tactile Medical as Senior Sales VP
    • Tessy Plastics Names Stafford Frearson as President
    • HoneyNaps' AI Sleep Disorder Diagnosis Software Earns FDA Nod
    • Biomerics Finishes Expansion of Minnesota Facility
    • MPO's Most-Read Stories This Week—Sept. 23
    View Breaking News >
    CURRENT ISSUE

    September 2023

    • Superior Subtractive Solutions for Machining Medtech
    • Medical Device Industry Experts' Thought on Assembly & Automation
    • Power Trip: A Discussion of Custom Medical Electronics
    • The MDR Transition: An Opportunity for Design Change?
    • 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

    GOED Releases Sustainability Report for Omega-3s Industry
    ABC’s Journal HerbalGram Celebrates 40th Anniversary
    Curcumin May Be As Effective as PPI for Indigestion
    Coatings World

    Latest Breaking News From Coatings World

    Śnieżka Group Results are Above Expectations in 1H 2023
    ACS Reports Chameleon Inspired Building Coating
    Substrate Wetting Agent Available from BRB International
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    MPO's Most-Read Stories This Week—Sept. 23
    Beckman Coulter Helping Labs Comply With Annex 1 Regulation
    FDA Clears MeMed BV Direct From Whole Blood
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Eftilagimod Cleared for Clinical Trial Use in the UK
    Veranova Names William Sanders Global VP of Chemical Development Ops
    Chime, Panolos Partner to Advance Multi-specific Therapeutic Proteins
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    L’Oréal Invests in Chinese Biotech Company ‘Shinehigh Innovation’
    Investindustrial to Acquire 51% Share of Virospack
    Weekly Recap: J&J Updates Visual Identity, L’Oréal Makes Executive Changes & More
    Happi

    Latest Breaking News From Happi

    SC Johnson’s Guardian Spatial Mosquito Repellent Tool Hits Milestone in Field Testing
    Ulta Beauty’s The Joy Project Address Everyone’s Struggle with Negative Self-Talk
    Natural Products Expo East Tradeshow Closes
    Ink World

    Latest Breaking News From Ink World

    Cooper Watson Acquires Tower Products
    The Durst Group Awarded Eight 2023 PRINTING United Alliance Pinnacle Awards
    Weekly Recap: Wikoff Color, HP, INX VC Top This Week’s Stories
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    PRX Market debuts, Tower Products acquired and more
    Flexo Wash to exhibit at FTA Fall Technical Conference
    Recyclable, deinkable stand-up pouch wins Gold in Germany
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Weekly Recap: Soft N' Dry Seeks to Expand Private Label Roll Out, Albis Completes Work on Line
    Lenzing Earns EU Ecolabel at Indonesian Plant
    Albis Completes Work On Extra Wide Carding, Blending Line
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    LimaCorporate to Be Sold to Enovis
    ODT's Most-Read Stories This Week—Sept. 23
    Anika Releases RevoMotion Reverse Shoulder Arthroplasty System
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    HID to Showcase Future-Proof Solutions at GITEX 2023
    Weekly Recap: Mergers and Acquisitions, IEC’s IME Standards Top This Week’s Stories
    EU-Funded Collaboration Hub Aims to Mainstream Printed Electronics

    Copyright © 2023 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